撥康視雲製藥公布2026年中期業績：無商業收入、虧損擴大但核心管線時間表基本延續

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reliance upon the whole or any part of the contents of this announcement.

CLOUDBREAK PHARMA INC.
撥康視雲製藥有限公司*
(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 2592)

ANNOUNCEMENT OF INTERIM RESULTS
FOR THE SIX MONTHS ENDED 30 JUNE 2026
INTERIM RESULTS
The board (the “Board”) of directors (the “Directors”) of Cloudbreak Pharma Inc. (the “Company”;
together with its subsidiaries, the “Group”) hereby announces the unaudited consolidated interim
results of the Group for the six months ended 30 June 2026 (the “Reporting Period”), which have
been prepared in accordance with International Accounting Standards (“IAS”) 34 “Interim Financial
Reporting” issued by the International Accounting Standards Board (the “IASB”) and the applicable
disclosure requirements of the Listing Rules, together with the unaudited comparative figures for the six
months ended 30 June 2025 (the “Previous Period”), as follows:

1

CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 30 JUNE 2026

Notes

For the six months ended 30 June
2026
2025
US$’000
US$’000
(Unaudited)
(Unaudited)
–
44
(737)
(15,797)
(31,846)

–
28
(594)
(9,365)
(23,732)

(48,336)

(33,663)

Finance income
Finance costs

414
(25)

506
(11)

Finance income, net

389

495

5

–

38,421

6

(47,947)
–

5,253
(67)

(47,947)

5,186

870

748

Items that will not be reclassified subsequently to
profit or loss:
Change in fair value of convertible redeemable
preferred shares due to own credit risk

–

42

Other comprehensive income for the period

870

790

(47,077)

5,976

Revenue
Other income
Other gains or losses, net
General and administrative expenses
Research and development expenses
Operating loss

5

Change in fair value of financial liabilities at fair
value through profit or loss
(Loss)/profit before income tax
Income tax expenses
(Loss)/profit for the period
Other comprehensive income
Items that may be reclassified subsequently to
profit or loss:
Currency translation difference

Total comprehensive (loss)/income for the period

2

CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE INCOME
FOR THE SIX MONTHS ENDED 30 JUNE 2026

Notes

(Loss)/earnings per share attributable to
Shareholders (expressed in US$ per share)
– Basic
– Diluted

7
7

3

For the six months ended 30 June
2026
2025
US$’000
US$’000
(Unaudited)
(Unaudited)

(0.06)
(0.06)

0.01
(0.04)

CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION
AT 30 JUNE 2026

Assets
Non-current assets
Property, plant and equipment
Right-of-use assets
Deposits

Current assets
Prepayments, deposits and other receivables
Inventories
Financial assets at fair value through profit or loss
Current income tax receivables
Pledged bank deposits
Cash and cash equivalents

Total assets
Equity
Share capital
Other reserves
Accumulated losses
Total equity
Liabilities
Non-current liability
Lease liabilities

4

30 June
2026
US$’000
(Unaudited)

31 December
2025
US$’000
(Audited)

233
2,032
89

322
1,902
44

2,354

2,268

2,600
143
12,081
62
4,153
32,745

5,432
110
18,201
447
–
40,150

51,784

64,340

54,138

66,608

88
492,452
(450,527)

84
472,316
(411,912)

42,013

60,488

53

98

CONDENSED CONSOLIDATED INTERIM STATEMENT OF FINANCIAL POSITION
AT 30 JUNE 2026
30 June
2026
US$’000
(Unaudited)

31 December
2025
US$’000
(Audited)

5,665
6,001
374
32

5,317
444
220
41

12,072

6,022

Total liabilities

12,125

6,120

Total equity and liabilities

54,138

66,608

Net current assets

39,712

58,318

Note

Current liabilities
Trade and other payables
Bank borrowings
Lease liabilities
Current income tax liabilities

9

5

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
FOR THE SIX MONTHS ENDED 30 JUNE 2026
1.

GENERAL INFORMATION
The Company was incorporated in the Cayman Islands on 20 November 2020 as an exempted company with limited
liability and its shares are listed on the Main Board of the Stock Exchange with effect from 3 July 2025. The address of
the Company’s registered office is 4th Floor, Harbour Place, 103 South Church Street, P.O. Box 10240, Grand Cayman
KY1-1002, Cayman Islands and the Company’s principal place of business in Hong Kong is Suite 23A11, 23Ath Floor,
Tower 2, the Gateway, Harbour City, Kowloon, Hong Kong.
The Company is an investment holding company and its subsidiaries are principally engaged in the research and
development of therapeutic biologics.
The condensed consolidated interim financial information is presented in US$, which is also the functional currency of
the Company.
The condensed consolidated interim financial information was authorised for issue by the Board of Directors on 31
August 2026.

2.

BASIS OF PREPARATION
The condensed consolidated interim financial information of the Group for the Reporting Period has been prepared in
accordance with IAS 34 “Interim Financial Reporting” issued by the IASB and the applicable disclosure requirements of
the Listing Rules.
The condensed consolidated interim financial information has been prepared under the historical cost basis except for
certain financial instruments which are measured at fair values at the end of each reporting period.
Other than change in accounting policies resulting from application of amendments to IFRS Accounting Standards
disclosed in Note 3, the accounting policies and methods of computation used in the condensed consolidated interim
financial statements for the Reporting Period are the same as those presented in the Group’s annual consolidated
financial statements for the year ended 31 December 2025.
The condensed consolidated interim financial information contains condensed consolidated interim financial statements
and selected explanatory notes. The notes include explanations of events and transactions that are significant to an
understanding of the changes in consolidated interim financial position and consolidated interim financial performance
of the Group since the consolidated financial statements of the Group for the year ended 31 December 2025. These
condensed consolidated interim financial information and explanatory notes thereon do not include all of the information
required for the preparation of full set of consolidated financial statements in accordance with IFRS Accounting
Standards issued by the IASB and should be read in conjunction with the consolidated financial statements of the Group
for the year ended 31 December 2025.
The preparation of an interim financial report in conformity with IAS 34 requires management to make judgements,
estimates and assumptions that affect the application of policies and reported amounts of assets and liabilities, income
and expenses on a year to date basis. Actual results may differ from these estimates.
The financial information relating to the financial year ended 31 December 2025 that is included in the interim financial
report as comparative information does not constitute the Company’s statutory annual consolidated financial statements
for that financial year but is derived from the annual report for the year ended 31 December 2025.

6

3.

APPLICATION OF AMENDMENTS TO IFRS ACCOUNTING STANDARDS
In the Reporting Period, the Group has applied, for the first time, the following amendments to IFRS Accounting
Standards which are effective for the Group’s financial year beginning 1 January 2026:
Amendments to IFRS 9 and IFRS 7
Amendments to IFRS 9 and IFRS 7
Amendments to IFRS Accounting Standards

Amendments to the Classification and Measurement of Financial
Instruments
Contracts Referencing Nature-dependent Electricity
Annual Improvements to IFRS Accounting Standards – Volume 11

The application of the amendments to IFRS Accounting Standards in the Reporting Period has had no material impact
on the Group’s consolidated financial position and financial performance for the current and prior periods and/or on the
disclosures set out in the condensed consolidated interim financial information.
4.

SEGMENT INFORMATION
The Executive Directors are identified as the chief operating decision makers (“CODM”) of the Group who review
the Group’s internal reporting in order to assess performance and allocate resources. The CODM identifies operating
segments based on the internal organisation structure, management requirements and internal reporting system, and
discloses segment information of reportable segments which is determined on the basis of operating segments.
The Group is principally engaged in the research and development of therapeutic biologics. The CODM assesses the
performance of the business based on a measure of operating results and considers the business in a single operating
segment. Information reported to the CODM for the purposes of resources allocation and performance assessment
focuses on the operation results of the Group as a whole as the Group’s resources are integrated. Accordingly, the
Group has identified one operating segment and no further analysis of this single segment is presented for both periods.
The Group’s non-current assets by geographical location, which is determined by the location in which the asset is
located, is as follows:

PRC
Hong Kong
United States

7

30 June
2026
US$’000
(Unaudited)

31 December
2025
US$’000
(Audited)

1,941
125
288

2,058
163
47

2,354

2,268

5.

OPERATING LOSS
Operating loss is stated after charging/(crediting) the following:
For the six months ended 30 June
2026
2025
US$’000
US$’000
(Unaudited)
(Unaudited)
Clinical research expenses
Employee benefit expenses (including directors’ remunerations)
Auditors’ remuneration for audit services
Auditor of the Company
– current period
Other auditors
– current period
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Expenses relating to short-term leases
Gain on fair value change of financial liabilities at fair value through
profit or loss (“FVTPL”) (Note)
Legal and professional fees
Listing expenses

10,841
31,750

9,210
18,900

153

–

3
122
171
114

4
164
187
55

–
3,202
–

(38,421)
819
2,833

Note:
During the Previous Period, the Group recognised a gain on fair value change of CRPS of US$38,421,000 and credited
to profit or loss. All CRPS have been automatically converted into Shares upon the Listing on 3 July 2025.
6.

INCOME TAX EXPENSES
For the six months ended 30 June
2026
2025
US$’000
US$’000
(Unaudited)
(Unaudited)
–

Current income tax expenses

67

The Group’s principal applicable taxes and tax rates are as follows:
Cayman Islands
Under the current laws of the Cayman Islands, the Company and its subsidiary incorporated in the Cayman Islands
are not subject to tax on income or capital gains. In addition, no Cayman Islands withholding tax is imposed upon the
payment of dividends by the Company to its Shareholders.
British Virgin Islands (“BVI”)
Subsidiary of the Company incorporated in the BVI is exempted from income tax on its foreign-derived income in the
BVI. There are no withholding taxes in the BVI.

8

Hong Kong
Hong Kong profits tax rate was 16.5% for the Reporting Period and the Previous Period respectively. No Hong Kong
profits tax was provided for as there was no estimated assessable profit that was subject to Hong Kong profits tax during
the Reporting Period and the Previous Period respectively.
The United States
Cloudbreak USA and ADS USA were established in California and Delaware, the United States, respectively.
Cloudbreak USA is subject to both federal income tax and California income tax, whereas ADS USA is subject to
federal income tax and Delaware income tax. Federal income tax rate, California income tax rate and Delaware income
tax rate were 21%, 8.84% and 8.7% respectively for the Reporting Period and the Previous Period respectively.
PRC
Provision for PRC corporate income tax is calculated at the statutory rate of 25% on the assessable income of
the Group’s subsidiaries incorporated and operated in the PRC for the Reporting Period and the Previous Period
respectively.
Income tax for other foreign countries
Taxes on profits in other foreign countries, including Germany, Sweden and Australia, have been calculated at the
rates of tax prevailing in the jurisdictions in which the Group operates, based on existing legislation, interpretations
and practices in respect thereof. No income tax for other foreign countries was provided for as there was no estimated
assessable profit that was subject to the income tax for other foreign countries during the Reporting Period and the
Previous Period respectively.
7.

(LOSS)/EARNINGS PER SHARE
(Loss)/earnings per share attributable to Shareholders
The calculation of basic and diluted (loss)/earnings per share is based on:

(a)

Basic (loss)/earnings per share
For the six months ended 30 June
2026
2025
(Unaudited)
(Unaudited)
(Loss)/profit attributable to the Shareholders (US$’000)
Weighted average number of Shares outstanding
Basic (loss)/earnings per share (expressed in US$ per share)

9

(47,947)
851,758,902

5,186
475,386,302

(0.06)

0.01

(b) Diluted loss per share
The calculation of the diluted loss per share is based on the (loss)/profit attributable to Shareholders, adjusted
to reflect the impact from any dilutive potential shares that would have been outstanding, as appropriate. The
weighted average number of Shares used in calculating diluted loss per share is the weighted average number
of Shares, as used in the basic (loss)/earnings per share calculation, and the weighted average number of Shares
assumed to have been issued at no consideration on the deemed exercise or conversion of all dilutive potential
shares into shares.
For the six months ended 30 June
2026
2025
(Unaudited)
(Unaudited)
(Loss)/profit attributable to Shareholders (US$’000)
Fair value changes on CRPS (US$’000)

(47,947)
–

5,186
(38,421)

Net loss attributable to the Shareholders (US$’000)

(47,947)

(33,235)

Weighted average number of Shares outstanding
Adjustment for CRPS

851,758,902
–

475,386,302
300,699,572

Weighted average number of Shares in issue during the period
used in the diluted loss per share

851,758,902

776,085,874

(0.06)

(0.04)

Diluted loss per share (expressed in US$ per share)
(i)

As the Group incurred losses for the Reporting Period, the potential shares were not included in the
calculation of diluted loss per share as their inclusion would be anti-dilutive. Accordingly, diluted loss per
share for the Reporting Period was the same as basic loss per share.

(ii) For the Reporting Period, the Group had one (Previous Period: two) category of potential shares, namely
share awards and share options (Previous Period: (i) CRPS and (ii) share awards and share options) with
vesting schedules granted to the eligible participants. Share awards and share options were anti-dilutive.
8.

DIVIDEND
No dividend was paid or proposed during the Reporting Period (Previous Period: nil).

9.

TRADE AND OTHER PAYABLES

Trade payables
Accrued legal and professional expenses (Note)
Accrued staff cost
Other accruals and payables

10

30 June
2026
US$’000
(Unaudited)

31 December
2025
US$’000
(Audited)

2,477
2,227
632
329

836
2,805
810
866

5,665

5,317

An ageing analysis of the Group’s trade payables as at the end of the Reporting Period and the year ended 31 December
2025, based on invoice date, is as follows:

Within 30 days
31-60 days
61 days to 1 year
Over 1 year

30 June
2026
US$’000
(Unaudited)

31 December
2025
US$’000
(Audited)

1,982
51
–
444

390
–
446
–

2,477

836

The average credit period is 30 days (31 December 2025: 30 days).

Note:
The accrued legal and professional expenses of the Group as at 31 December 2025 included a provision of US$170,000
representing the difference between the settlement sum of approximately US$2.22 million paid by the Company to
Cedar Wealth Management SPC (“Cedar Wealth”) and the alleged outstanding fees and disbursements in the amount
of US$2.05 million claimed by Cedar Wealth in the arbitration proceedings commenced by Cedar Wealth against
the Company and Cloudbreak Guangzhou on 11 August 2025. The said arbitration proceedings and the related asset
preservation order were discontinued with effect from 23 January 2026 and 22 January 2026, respectively, and the
provision was fully settled upon the payment of the settlement sum to Cedar Wealth during the Reporting Period. For
further details of the proceedings and settlement of the same, please refer to the announcements of the Company dated 7
January 2026, 15 January 2026, 29 January 2026 and 30 January 2026, respectively.
10. CONTINGENT LIABILITIES
As at the end of the Reporting Period, the Group did not have any material contingent liabilities.
11. EVENTS AFTER THE REPORTING PERIOD
There has been no significant event occurred after the Reporting Period which requires additional disclosures or
adjustments to the condensed consolidated interim financial information.

11

MANAGEMENT DISCUSSION AND ANALYSIS
I.

BUSINESS REVIEW
1.

Overview
We are a clinical-stage ophthalmology biotechnology company dedicated to developing
innovative treatments for ophthalmic diseases through our proprietary drug discovery and
development capabilities, with operations primarily based in the United States and the PRC.
Our key technologies include MKIs, non-aqueous topical drug delivery, and antibody drug
synergism. These technologies have enabled the development of a pipeline currently consisting
of ten drug candidates targeted for the treatment of major anterior and posterior ophthalmic
diseases, including six clinical stage and four pre-clinical stage candidates, all developed
proprietarily in-house.
MKIs are small molecules targeted to address abnormal angiogenesis/vascularity and fibrosis
that are areas of intervention for many ocular surface diseases. Our lead MKI product, CBT001, is being developed for the treatment of pterygium. Following closely behind is our other
late-stage development product, CBT-004, indicated for the treatment of pinguecula.
Our non-aqueous topical drug delivery system, SFA+, offers several significant advantages over
standard topical solutions and suspensions. These include the ability to self-preserve, reducing
ocular surface exposure to toxic chemicals while maintaining good shelf life and stability,
as well as increased comfort. The platform opens opportunities for drugs that are difficult to
formulate in aqueous systems.
Three of our pipeline products have reached a relatively more advanced clinical development
stage with plans and roadmap for commercialisation upon obtaining the requisite regulatory
approvals, namely: (i) CBT-001, one of our Core Products which is indicated for treating
pterygium; (ii) CBT-009, our other Core Product which utilises our SFA+ technology for
treating juvenile myopia; and (iii) CBT-004, which is indicated for treating pinguecula. CBT199, which is indicated for the treatment of presbyopia, has also entered clinical stage with
the successful IND application made to the FDA. Similarly, the IND application for CBT358, a combination of SFA+ and a TRPM8 agonist drug candidate for the treatment of dry
eye disease, was submitted by the Group on 21 May 2026 and has passed the 30-day clinical
safety hold comment period of the FDA. While we intend to continue to develop CBT-006, our
other clinical stage drug candidate indicated for the treatment of MGD, in the longer term, the
development of CBT-006 is currently on a temporary pause to allow us to focus our resources
on projects of higher priority. Our remaining four drug candidates, CBT-007, CBT-145, CBT011 and CBT-277, are in earlier pre-clinical development stage.

12

2.

Pipeline

2.1. Core Products
CBT-001
Our Core Product CBT-001 is a potential first-in-class drug therapy using a MKI targeting
VEGFRs, PDGFRs and FGFRs, indicated for the prevention of pterygium progression,
reduction of conjunctival hyperaemia and related symptoms associated with pterygium.
Pterygium is a disease where the tissues on the surface of the eye abnormally grow over
the cornea or front of the eye. Hundreds of millions of people globally are impacted,
especially those who are exposed to chronic ultraviolet light from working outside or
spending time at the beach. In many cases, this progressive fibrovascular growth may cause
persistent redness, irritation, foreign body sensation, and can lead to astigmatism and vision
impairment. Depending on the location of the lesion, it may also make wearing contact
lenses uncomfortable or impossible.
Patients and eye care professionals alike express strong dissatisfaction with current nonsurgical treatment options, which are severely limited and often only offer temporary
symptomatic relief. These include artificial tears and off-label short-term use of
corticosteroids to manage symptom flare ups. Surgical excision is an option in more serious
cases which carries significant risks including high recurrence rates (3-38%), painful
recovery, and complications occurring in up to 80% of patients. Because of this, there is a
strong need for pharmacological treatment that addresses both fibrovascular growth of the
lesion as well as related symptoms.
CBT-001, also known as nintedanib free base, is formulated as a topical ocular eye drop
emulsion and is currently being studied in a Phase 3 MRCT. This represents a breakthrough
in addressing an unmet medical need, given that, according to the F&S Report and to our
knowledge, there is currently no approved drug therapy for the treatment of pterygium
globally, with surgical excision being the only existing treatment option. CBT-001 has
been developed under Section 505(b)(2) of the FDCA, a regulatory pathway commonly
adopted by ophthalmic biotechnology companies (the “505(b)(2) pathway”), which allows
us to leverage validated safety and efficacy data from previously approved drugs, thereby
accelerating our development timeline and reducing costs.
We have commenced our first of two Phase 3 MRCTs in the United States in June 2022
and in the PRC in September 2023. We have also initiated additional clinical trials in New
Zealand, Australia and India as part of our global Phase 3 MRCT program to assess the
efficacy of CBT-001 in May 2024, May 2024 and July 2024, respectively. In May 2025,
we completed patient recruitment across all five jurisdictions, enrolling 660 patients in
total. We expect to complete the Phase 3 MRCT in the third quarter of 2027 and obtain the
initial efficacy and safety data later in the year.

13

As disclosed in the announcement of the Company dated 4 June 2026, the final patient
has completed the 12-month visit, at which the primary efficacy endpoints for CBT-001,
namely pterygium lesion reduction and bothersome ocular symptoms score, are assessed
in the Phase 3 MRCT. The Company considers the completion of the final 12-month
endpoint visit to be a significant milestone in the development of CBT-001 and positions
the Company to deliver top-line 12-month efficacy data in the third quarter of 2026. Such
top-line data, if positive, could support multiple simultaneous commercial filings and could
change the current “surgery only” treatment paradigm, if approved.
Following the analysis of the safety and efficacy results from the first Phase 3 MRCT,
we plan to discuss with the NMPA and FDA on the clinical and regulatory pathway
accordingly as early as fourth quarter of 2026.
We have established key commercialisation partnerships to maximise CBT-001’s global
reach. On 13 April 2020, we entered into an exclusive commercialisation licensing
arrangement with Grand Pharma (the “Grand Pharma Licensing Agreement”) for Greater
China. On 6 August 2024, we also entered into a license agreement with Santen (the
“Santen License Agreement”) for Japan, Korea, Vietnam, Thailand, Malaysia, Singapore,
the Philippines and Indonesia, granting to Santen exclusive rights to, amongst other things,
develop, manufacture, and commercialise pharmaceutical products containing nintedanib
for topical therapeutic treatment of pterygium.
In the United States and other regions, we are exploring both self-commercialisation
and out-licensing options and are in active discussions with potential partners with the
aim of maximising the value of the relevant products and technologies while laying the
groundwork for the rest of our pipeline.

CBT-009
CBT-009 is a novel ophthalmic formulation of atropine indicated for the treatment of
juvenile myopia in children and adolescents aged 5 to 19 years. CBT-009 is designed with
our SFA+ non-aqueous formulation to improve stability, safety, and patient tolerability
compared to existing aqueous-based formulations.
Juvenile myopia affects hundreds of millions of children worldwide and represents a
critical unmet medical need in ophthalmology. Unlike refractive myopia caused by ciliary
muscle fatigue, progressive myopia is characterised by rapid increase of axial length
and progressive elongation of the eyeball during the critical stage of visual development
in children and adolescents. This progressive worsening of nearsightedness can lead to
high myopia and significantly increase the lifetime risk of serious ocular complications
including retinal detachment, retinal degeneration, glaucoma, and cataracts.

14

Current treatment options are limited, with children relying on increasingly strong
spectacle glasses that some children do not want to wear, specialised contact lenses that are
difficult for younger children to wear, or, in some cases, off-label use of compounded lowdose atropine eye drops. However, existing aqueous atropine formulations suffer from poor
stability (due to rapid decomposition in water-based solutions), require refrigeration and
often come in multidose bottles with preservatives that can cause ocular surface stress as
well. In the United States, multiple companies have attempted clinical programs for lowdose atropine in pediatric myopia without success. One of those companies has requested
and was granted an FDA clinical advisory panel to review its study results. Should that
panel recommend approval of their product, there would be a clearer pathway for approval
of these products in the United States. As of today, the FDA requirements are more
stringent than those for Europe or Japan.
We commenced pre-clinical studies for CBT-009 in the PRC in 2021 and in the United
States in 2022. The Phase 1 and Phase 2 clinical trials for CBT-009 were combined into
a single trial, and we have completed combined Phase 1 and 2 clinical trials for CBT-009
in Australia in January 2023, demonstrating favourable safety and efficacy profiles. We
have completed data analysis and a clinical study report on the Phase 1 and 2 clinical trial
results of CBT-009. In September 2023, the FDA granted to us approval to proceed with
Phase 3 clinical trial under the 505(b)(2) pathway in the United States utilising the Phase 1
and 2 clinical results in Australia. In September 2024, after the completion of a six-month
ocular toxicity study, we further received an approval letter from the FDA stating that it
had no objection to us proceeding with Phase 3 clinical trial for CBT-009.
We have also completed the toxicity study on juvenile animals in the PRC in November
2025 and submitted an IND application to the NMPA in December 2025. As disclosed in
the announcement of the Company dated 19 March 2026, following the submission of the
IND application, the CDE approved a comparable drug for marketing in the PRC. After
subsequent communications with the CDE, the Company believes it might be difficult to
include the PRC in MRCT due to the different regulatory requirements across regions.
To avoid subsequent research and development risks and better concentrate the Group’s
resources, the Company has decided to voluntarily withdraw its IND application for the
possible Phase 3 trial in the PRC.
The Company is committed to continue developing its SFA+ platform and will reassess
the clinical development strategy for CBT-009 in accordance with the latest regulatory
requirements and market conditions. As disclosed in the announcement of the Company
dated 22 May 2026, an investigator initiated trial to evaluate the safety and efficacy of
CBT-009 eye drop on other indications is planned to start in the fourth quarter of 2026.
Upon completion of relevant supplementary studies or adjustments to the clinical trial
protocol, the Company will, depending on the circumstances, either hold pre-submission
consultation meetings with the CDE or resubmit a clinical studies application.

15

2.2. Other Clinical-Stage Drug Candidates
CBT-004
CBT-004 is a potential first-in-class ophthalmic drug using MKI targeting VEGFRs and
PDGFRs, indicated for the treatment of pinguecula.
Pinguecula is a round, yellowish, elevated tissue that develops on the surface of the
eye. The condition is very common among people with increased UV light exposure and
increasing age. Pinguecula is more common than pterygium, likely impacting over a billion
people worldwide. When the tissue becomes vascularised or inflamed, it can produce a
number of symptoms including ocular redness, discomfort and pain, foreign body sensation,
tearing and itching. Depending on the location of the pinguecula, it may also make wearing
contact lenses uncomfortable or impossible.
To our knowledge, there are currently no approved pharmacological treatments for
pinguecula. To treat some symptoms, such as dry eye and foreign body sensation,
lubricating eye drops may be used. For pinguecula that are large or inflamed, non-steroidal
anti-inflammatory drugs or corticosteroids are used although the latter is limited in its
duration due to complications like glaucoma and cataract formation. With few existing
reliable options for symptom relief, there is a strong need for pharmacological treatment
specifically designed to address this condition.
CBT-004 is expected to have advantages over the currently used off-label options which
are only capable of temporary reduction of certain symptoms. To our knowledge, as at
30 June 2026, CBT-004 was the only clinical-stage drug therapy indicated for pinguecula
globally.
CBT-004 was developed under the 505(b)(2) pathway in the United States. We applied
for the IND approval for CBT-004 under the 505(b)(2) pathway in the United States in
December 2020, and obtained the IND approval from the FDA in February 2021. Since
then, our R&D team has been optimising the formulation and conducting clinical trials for
the product.
We commenced a Phase 2 clinical trial of CBT-004 in December 2023 and completed the
trial in May 2025. CBT-004 was able to meet the primary efficacy endpoint and several
secondary endpoints as part of the pre-set specifications. We completed the clinical
trial report in July 2025 and an end-of-phase 2 (“EOP2”) meeting with the FDA was
successfully held on 10 December 2025.
At the EOP2 meeting, the FDA provided feedback on questions regarding drug stability and
specification studies, non-clinical studies to support the proposed New Drug Application to
be made with the FDA, as well as the design and endpoints of the Phase 3 clinical studies
for CBT-004. Amongst other things, the FDA and our Group have reached agreement on
the statistical and clinical significance of hyperemia reduction as a primary endpoint and of
symptom relief as a potential co-primary endpoint for the approval of CBT-004.
16

We view the success of the EOP2 meeting as a major step forward in the clinical
development of CBT-004, in particular its advancement to Phase 3 clinical studies.
If successful, CBT-004 would be the only topical therapy to have demonstrated both
significant reduction in hyperemia and symptomatic relief, paving the way for the New
Drug Application and commercialisation of CBT-004 upon its approval.

CBT-199
CBT-199 is a novel, once-daily preservative-free topical ophthalmic emulsion containing
a parasympathomimetic miotic agent formulated in the Group’s proprietary non-aqueous
platform for the treatment of presbyopia. CBT-199 works by inducing pupil constriction
to create a pinhole effect that increases depth of focus, thereby temporarily improving
near vision. The water-free formulation significantly improves drug stability by preventing
decomposition of the active ingredient over time, eliminates the need for refrigeration
(stable at room temperature), and provides a comfortable, soothing dosing experience
in a consumer-friendly self-preserved multi-dose bottle with long shelf-life. CBT-199
demonstrates superior pharmacologic selectivity, being more selective for the iris sphincter
muscle versus the ciliary muscle compared to pilocarpine, potentially reducing common
adverse effects such as headaches associated with ciliary muscle spasm. Additionally, the
proprietary formulation enables predominant trans-corneal drug delivery with minimal
systemic exposure, further enhancing the safety profile. CBT-199 represents a potential
best-in-class approach to pharmacological presbyopia treatment, offering once-daily
convenience with an improved tolerability profile compared to existing therapies.
Presbyopia affects approximately 2 billion people globally and represents a major unmet
medical need in ophthalmology. This age-related progressive loss of the ability to focus
on near objects impacts nearly all adults over age 45. The condition causes significant
difficulty with reading, smartphone use, and other near-vision tasks that substantially
impact quality of life and productivity.
Current non-drug treatment options include reading glasses, bifocals, contact lenses,
or refractive surgery. Many patients find optical correction inconvenient, cosmetically
undesirable, signaling of their age, or limiting to their lifestyle, while surgical options carry
risks of poor outcomes, irreversibility, late complications, and prolonged postoperative
recovery. The presbyopia drug market is projected to exceed US$3 billion globally by 2038
(Delveinsight, 2025), reflecting enormous unmet demand for effective topical therapeutic
options that can restore functional vision without the limitations of current alternatives.
As disclosed in the announcement of the Company dated 30 April 2026, the review period
of the IND application to the FDA in respect of CBT-199 has concluded, upon which the
FDA concluded that the Group may proceed with clinical investigation for CBT-199. This
represents a critical milestone in the clinical development of CBT-199 and ADS USA has
become officially authorised to initiate its Phase 2 clinical trials.

17

CBT-358
CBT-358 is a combination SFA+ and TRPM8 agonist drug candidate under development
for the treatment of dry eye disease (“DED”), which represents a multi-billion dollar
global market. DED, scientifically known as keratoconjunctivitis sicca, is a complex,
multifactorial breakdown of the ocular surface’s “life support system”. At its core, DED
is an imbalance in the tear film, the sophisticated fluid layer that keeps vision crisp and
corneas comfortable. DED is commonly caused by decreased tear production, excessive
evaporation of tears, or both of these processes, leading to damage and inflammation of
the surface of the eye. Common symptoms of dry eye patients include a gritty or burning
sensation in the eyes, blurry vision and sometimes paradoxical tearing. DED is one of the
most frequent reasons for patient visits to eye care professionals.
The proposed investigational product of CBT-358 is formulated in a novel non-aqueous
ophthalmic solution designed for the treatment of aqueous deficiencies. Unlike traditional
passive lubricants, this formulation leverages the physiological “cooling” reflex to stimulate
endogenous tear production. This activation mimics the effect of cold temperature,
triggering a reflex arc that increases basal lacrimation and blink frequency, thereby
restoring the ocular surface moisture naturally. Therefore, CBT-358 is expected to address
aqueous deficiency of DED. At the same time, the novel non-aqueous formulation, which
utilises SFA+ technology, has yielded unexpected findings that suggest CBT-358 may also
minimise evaporation of tears, as indicated by the in vitro assay and in vivo animal model
results. Consequently, CBT-358 could potentially address both aqueous deficiencies and
evaporative dry eye, the root causes of the majority of DEDs. As a result of this promising
breakthrough during the Reporting Period, we have expedited the development timeline of
CBT-358 and successfully completed IND-enabling studies much sooner than anticipated.
As disclosed in the announcement of the Company dated 17 July 2026, the FDA has
completed its safety review of the IND application in respect of CBT-358 and has raised no
objection to the proposed clinical investigation proceeding.

CBT-006
Our clinical-stage drug candidate CBT-006 is a potential first-in-class drug candidate
indicated for the treatment of MGD-associated DED. The product is designed to dissolve
cholesterol and other lipids deposited at the orifice of meibomian glands and thus improve
meibum quality and the health of meibomian gland.
CBT-006 was developed under the 505(b)(2) pathway in the United States. We applied for
the IND approval for CBT-006 under the 505(b)(2) pathway in the United States in October
2020, and the FDA issued an approval letter in November 2020 stating that it had no
objection to us proceeding with Phase 2 clinical trial in the United States. We commenced
Phase 2 clinical trial for CBT-006 in September 2021 and completed the same in May
2022.

18

We have temporarily paused the advancement of CBT-006 into Phase 3 in order to focus
our resources on more immediate opportunities including, without limitation, CBT-001
and CBT-004. However, we intend to continue the clinical development of CBT-006 at an
appropriate time having regard to the Group’s resources and business strategies.

2.3. Pre-Clinical Stage Drug Candidates
CBT-277 is a combination drug eye drop intended to treat both evaporative and aqueous
deficiency DED. Similar in profile to CBT-358, CBT-277 may serve as a back-up to the
more advanced candidate. We have completed all necessary pre-clinical studies and may
move into discussions for clinical trials in the USA as needed.
CBT-007 is a multi-kinase inhibitor being developed as an adjunct therapy to improve
outcomes of glaucoma filtration surgery. The current standard of care uses antimetabolite
drugs that can impact healing and ocular health. CBT-007 targets pathways that can prevent
post-surgical scarring and fibrosis, thereby minimising or eliminating the need for these
older, cytotoxic drugs. CBT-007 is currently in the formulation phase and we will perform
pharmacokinetics and toxicology studies once ready for testing.
CBT-011 is an antibody-drug conjugate being developed as a treatment for DME, a serious
complication of diabetes that causes retinal blood vessels to leak fluid into the central
retina, leading to permanent reduction in central vision. While intravitreally delivered
antiangiogenic agents are the mainstay of treatment for DME, up to 50% of cases become
refractive to therapy. By leveraging our proprietary technology platform, CBT-011 delivers
the dual potency of two antiangiogenic agents in a single injection, which is expected
to effectively treat DME while also overcoming the potential for developing treatmentrefractory disease. The DME market is valued at over US$4 billion globally according
to Delveinsight. We are currently investigating options for CBT-011 in animal models to
validate the concept before moving into human safety trials.
CBT-145 is a back-up for our CBT-199 project for the treatment of presbyopia. It is a new
chemical entity that is designed to shrink the size of the pupil by acting on muscarinic
receptors to increase the depth of field of focusing to improve near vision, while retaining
distance vision. Effectively, CBT-145 and CBT-199 eliminate the need for glasses for those
that rely on them to achieve sharp close-up vision. As we have obtained FDA approval to
proceed with Phase 2 clinical trials for CBT-199 upon completion of the safety review,
CBT-145 has been deprioritised in the meantime unless and until the need to reactivate its
development arises.

19

2.4. Summary of Pipeline Development
The following chart summarises and illustrates the development status of each of our drug
candidates as at 30 June 2026:
Drug Candidate

Indication

Commercial
Availability

Patent Status

CBT-001

Pterygium (hyperemia,
symptoms, size)

Global (Ex. the
PRC and Japan)

Granted US, European Union
(“EU”), the PRC, Japan (“JPN”),
Australia (“AUS”), Brazil, Canada
(“CDN”), South Korea
(“S. Korea”), Mexico, HK, Taiwan
& India. Pending AUS, EU, JPN, S.
Korea, HK, US, Mexico & Brazil.

CBT-004

Pinguecula
(hyperemia, symptoms)

Global

Granted US. AUS, S. Korea, CDN,
JPN, Mexico. Pending Rest of
World (“ROW”)

CBT-007

Glaucoma

Global

Granted US, JPN, AUS and India.
Pending ROW

CBT-009 (muscarinic
receptor agonist)

Pediatric Progressive
Myopia

Global

Granted US, Japan and EU.
Pending ROW

CBT-199
(Parasympathomimetic miotic
agent)

Presbyopia

Global

Pending

Phase 1 in US not needed
under 505(b)(2) pathway

CBT-358 (TRPM8
agonist)

Aqueous-deficient
PLUS evaporative dry
eye

Global

Pending

Phase 1 in US not needed
under 505(b)(2) pathway

CBT-145

Presbyopia (back-up to
CBT-199)

Global

Granted US. Pending ROW.

Pending CBT-199 results

CBT-277

Evaporative and
aqueous deficiency
dry eye disease

Global

Pending

Completed all necessary
pre-clinical studies

ADS (antibody – drug
synergism)

CBT-011 (antibody
drug synergism)

DME / age-related
macular degeneration

Global

Pending

Evaluating formulation
partners

Cholesterol dissolving
agent

CBT-006

MGD associated dry
eye disease

Global

Granted US, Japan. Pending
ROW

Phase 2b study paused due to
priority change

Technology

MKI (PDGFRs,
VEGFRs, FGFRs,
and/or TGF-β)

SFA+ Delivery

Pre-clinical

Phase 1

Phase 2

Phase 3

Clinical Trial
Authority

Regulatory Pathway

Status

FDA
NMPA

FDA 505(b)(2) NMPA
chemical drug application

Results of first MRCT
expected Q3 2026

FDA
NMPA

FDA 505(b)(2) NMPA
chemical drug application

Agreement reached with
FDA for Phase 3 design

Phase 1 in US not needed under 505(b)(2) pathway

Phase 1 in US not needed under 505(b)(2) pathway

Deprioritised pending proof
of concept evaluation

Phase 1 in US not needed under 505(b)(2) pathway

FDA

FDA 505(b)(2)

IND submitted to and
accepted by US FDA
for Phase 3 clinical trail

FDA
NMPA

FDA 505(b)(2) NMPA
chemical drug application

IND submitted to US FDA
for Phase 2 trial

Toxicity evaluation of
potential clinical
formulations in progress

Note: As disclosed in the announcement of the Company dated 17 July 2026, the FDA has completed its
safety review of the IND application and has raised no objection to the proposed clinical investigation
proceeding of CBT-358. As such, at the date of this announcement, the information of CBT-358 in the
above chart had been revised as follows:–

Technology

Drug Candidate

Indication

Commercial
Availability

Patent Status

SFA+ Delivery

CBT-358 (TRPM8
agonist)

Aqueous-deficient
PLUS evaporative dry
eye

Global

Pending

Pre-clinical

Phase 1

Phase 1 in US not needed
under 505(b)(2) pathway

Phase 2

Phase 3

Clinical Trial
Authority

Regulatory Pathway

Status

FDA

FDA 505(b)(2)

Agreement reached with
FDA for Phase 3 design

Warning: There is no assurance that any of our Core Products or any other drug
candidates will ultimately be successfully developed and marketed by the Group.
Shareholders and potential investors should exercise caution when dealing in the
Shares.

20

3.

Manufacturing Facilities
We have developed our own pilot production facility in Suzhou, the PRC, with a gross floor
area of 1,226.43 sq.m., designed to comply with good manufacturing practice standards in
the United States, the PRC, and the European Union, which will support our global clinical
trials. We were assigned the land use right of a parcel of land in Suzhou, the PRC, with a site
area of 33,332.9 sq.m. in May 2023. We are currently in the course of discussions with the
relevant governmental authorities in relation to the land use right. For details, please refer to
the paragraphs of the Prospectus headed “Business – Manufacturing – Our Production Facility
in Suzhou” and “Business – Land and Properties” and the paragraph of our annual report for
the year ended 31 December 2025 headed “Management Discussion and Analysis – I. Business
Review – 3. Manufacturing facilities”.

4.

Commercialisation

CBT-001
Subject to regulatory approval, we expect to launch CBT-001 in the United States market
within approximately four years (namely, by 2030). In the meantime, we will evaluate our
commercialisation options while maximising the value of our proprietary technologies and
assets as part of our portfolio. Given the large number of patients affected by pterygium and
conjunctival hyperaemia and limited market competition, we anticipate significant market
opportunities with sizeable revenue potential for CBT-001 upon its commercialisation.
We have conducted extensive research into the market opportunities, both in terms of number
of available patients as well as potential managed care or insurance coverage for the drug as
well as the willingness of doctors to prescribe CBT-001. Our research to date shows that the
pterygium opportunity in the United States is large, on an order of magnitude similar to the
glaucoma market, but without any direct competition both now and in the foreseeable future.
We have also seen very high interest in prescribing from eye doctors, as well as a willingness
of managed care to provide insurance coverage at an attractive price.
To bring CBT-001 to the market, we are evaluating whether this would be best achieved by
the Group on its own, or in partnership with a larger, ophthalmic-focused company. We are in
active discussions with potential business partners and will evaluate each opportunity based on
the value provided.
During this process, we are establishing relationships with KOLs and professional organisations
who will be important in the future to help communicate the value of CBT-001 and the
benefits it may bring to patients suffering with pterygium. We have also initiated social media
campaigns to raise awareness of the disease with both medical practitioners and patients.

21

For Greater China, we have entered into the Grand Pharma Licensing Agreement with Grand
Pharma in April 2020, granting to Grand Pharma an exclusive, sublicensable, royalty-bearing
licence to manufacture and commercialise CBT-001 in all human use of CBT-001. Additionally,
for Asia Pacific, we entered into an exclusive licensing agreement with Santen in August 2024
covering Japan, Korea, Vietnam, Thailand, Malaysia, Singapore, the Philippines and Indonesia
for the development, manufacturing and commercialisation of nintedanib-based products,
including CBT-001.
We also intend to seek to establish similar licensing arrangements with business partners in
Europe and other regions later in 2026, once the results from our first of two Phase 3 studies
are available.

CBT-009
We also plan to partner for the commercialisation of CBT-009 in parts of Asia, Europe and
Japan once its Phase 3 clinical trial commences. We will focus on supporting the efforts of
those business partners as they build awareness of the benefits of our SFA+ formulation through
KOL education and conference presentations.
5.

Collaboration and Licensing Arrangements
As at 30 June 2026, we have entered into the following licensing agreements to promote the
development and commercialisation of our products, in particular our most advanced Core
Product, CBT-001:

Grand Pharma Licensing Agreement
On 13 April 2020, we entered into the Grand Pharma Licensing Agreement with Grand Pharma,
pursuant to which we granted to Grand Pharma an exclusive, sublicensable, royalty-bearing
licence to manufacture and commercialise CBT-001 in all human use of CBT-001 (including
the prevention of pterygium progression and reduction of conjunctival hyperaemia) in Greater
China. However, we retain the right of applying for the New Drug Application and expect to be
the market authorisation holder of CBT-001.
Notwithstanding the Grand Pharma Licensing Agreement, we have effective control over CBT001 in all material aspects, in that either within or outside Greater China: (i) we are responsible
for all development activities for CBT-001, including conducting pre-clinical studies, and
engaging and supervising CROs and CDMOs to assist us with the clinical trials for CBT001; and (ii) we prepare, submit and maintain regulatory filings, conduct communication with
regulatory authorities and obtain regulatory approvals for CBT-001 in our names (such as the
approvals we obtained from the FDA and the NMPA for us to proceed with Phase 3 MRCT in
the United States and the PRC respectively).

22

Santen License Agreement
We also entered into the Santen License Agreement with Santen on 6 August 2024, pursuant
to which we granted to Santen an exclusive, fee-based, milestone and royalty-bearing license
to: (a) develop, manufacture, and commercialise any pharmaceutical product that contains
Nintedanib as a sole or one of the active pharmaceutical ingredients (including without
limitation CBT-001) (the “Product”) and/or nintedanib in the topical therapeutic treatment
of sign and/or symptom of ophthalmic disease related to pterygium, pinguecula and any other
indication(s) to be mutually agreed by Santen and us in writing (the “Field”) in Japan, Korea,
Vietnam, Thailand, Malaysia, Singapore, the Philippines and Indonesia (collectively, the
“Territory”); and (b) develop and manufacture nintedanib outside the Territory but solely for
the commercialisation of the Product in the Field in the Territory.
The licence granted under item (a) above is exclusive in the Territory, even with respect to us,
save and except that we reserve the non-exclusive right, subject to Santen’s consent, to conduct
or have conducted any development and/or manufacturing activities in the Territory solely
for commercialisation of the Product outside the Territory. The license granted under item (b)
above is non-exclusive.
At Santen’s request, we may discuss in good faith with Santen on entering into a commercial
supply arrangement, under which we may supply CBT-001 to Santen for Santen’s
commercialisation efforts in the Field in the Territory. The details of such potential commercial
supply arrangement would be set forth in a separate agreement.
6.

Intellectual Property
As a clinical-stage ophthalmology biotechnology company, we attach great importance in
maintaining and protecting our intellectual property rights.
As at 30 June 2026, we had: (a) 82 granted patents, including 23 in the United States, 3 in the
PRC and 56 in other jurisdictions; and (b) 186 pending patent applications, including 20 in the
United States, 15 in the PRC and 151 in other jurisdictions.
As at 30 June 2026, we had 58 granted patents and 59 pending patent applications worldwide
for our Core Product CBT-001, as well as 5 granted patents and 33 pending patent applications
worldwide for our Core Product CBT-009.

23

7.

Human Resources
As at 30 June 2026, we had 61 full-time employees, including 32, 11, 17 and 1 employees
located in the PRC, the United States, Hong Kong and Sweden, respectively.
Number of
employees

Function

8.

Management
R&D
Manufacturing
Quality control and quality assurance
Administrative

6
17
5
10
23

Total:

61

Research and Development
We believe that R&D is essential to the success of our ophthalmic drug candidates throughout
various development stages, and we have established an innovative pipeline of drug candidates
that cover major anterior and posterior ophthalmic diseases. All of the drug candidates in our
pipeline are proprietarily developed, and we believe they have the potential to become first-inclass or best-in-class therapies to address unmet medical needs in the global ophthalmic drug
market.

R&D Capabilities and Infrastructure
We have built strong R&D capabilities to capture the potential in the global ophthalmic
pharmaceutical market. Our R&D operations are supported by three strategically located R&D
centers in the United States and the PRC, enabling us to conduct clinical trials in multiple
jurisdictions and maximise the commercial potential of our products across global markets.
As at 30 June 2026, our R&D team comprised 21 experienced professionals, including 4
members from senior management and 17 from our dedicated R&D department. Six team
members hold master’s degrees or higher, including four with doctoral degrees. Our team
is led by seasoned professionals with decades of pharmaceutical R&D and entrepreneurship
experience from global ophthalmology companies and renowned research institutions.

24

Proprietary Technology Platforms
Our R&D strategy is anchored by two proprietary technology platforms designed specifically
for ophthalmic drug development, namely, MKI and ADS platforms, designed for developing
drug candidates targeting anterior and posterior ophthalmic diseases, respectively. Each of MKI
platform and ADS platform targets the development of small molecule drugs and conjugates
between an antibody and a small molecule drug, respectively. The combination of our two
technology platforms offers comprehensive solutions to cover a wide range of ophthalmic
diseases.
9.

Prospects
As a clinical-stage ophthalmology biotechnology company, we are committed to developing
and commercialising innovative treatments for a range of eye diseases. Looking forward, our
primary focus is to advance our drug pipeline, enhance our proprietary technology platforms,
and prepare for the potential commercial launch of our Core Products.
We plan to implement the following strategies to achieve our long-term vision:
•

Accelerate clinical development of our pipeline of drug candidates in global markets;

•

Continue to enhance our R&D capabilities to develop technology platform and modalities
that support our pipeline expansion;

•

Pursue diversified and tailored commercialisation strategies for our drug candidates; and

•

Scale up our organisation to build an international platform.

As a clinical-stage ophthalmology biotechnology company pending commercialisation of its
products, we have incurred significant net losses in the past years and expect to continue to
incur net losses in the foreseeable future, and there is no assurance that we will achieve or
maintain profitability. As disclosed in various voluntary announcements of the Company since
the Listing Date and this announcement, there is significant progress in certain pipelines which
included without limitation CBT-001, CBT-004 and CBT-358. When the Group advances to the
Phase 3 clinical development of CBT-004, the clinical testing expenses would grow sharply.
Drug development involves a long and expensive process and the Group may need to adjust the
clinical testing work orders in order to obtain regulatory approval and commercialise these drug
candidates. It is also expected that the expenses incurred for our clinical research expenses may
further increase so as to enhance our technology platform. Such increase in R&D expenses may
bring negative impact to the financial position of the Group.
Since the Listing, the Group has also deployed more resources in handling the compliance
matters and audit. It is estimated that the compliance cost will continue to increase in the future
so that the Group can meet the relevant legal and regulatory requirements.
25

Notwithstanding this, the Group will use its best endeavours to achieve the above long-term
vision and utilise its resources appropriately to support the Group’s development.
Going forward, the Group will continue to execute its global growth strategy through strategic
collaborations with international and domestic biopharmaceutical companies and academic
institutions, spanning R&D activities and commercialisation arrangements. In parallel, the
Group will actively explore appropriate commercialisation strategies to accelerate market
entry, optimise capital efficiency and maximise asset value. Together, it is expected that
these initiatives will strengthen the Group’s position as a leading ophthalmic pharmaceutical
enterprise globally, enhance its revenue potential and expand long-term commercial
opportunities across the Group’s product pipeline.
10. Legal and Arbitration Proceedings
On 11 August 2025, Cedar Wealth commenced arbitration proceedings (the “Arbitration
Proceedings”) at the Shanwei Arbitration Commission* (汕尾仲裁委員會) against the
Company and Cloudbreak Guangzhou, claiming for certain alleged outstanding service fees
and disbursements amounting to approximately US$2.05 million, plus interest and costs. In
connection with the Arbitration Proceedings, on 24 December 2025, upon the application
of Cedar Wealth by way of legal proceedings (the “Legal Proceedings”; together with the
Arbitration Proceedings, the “Proceedings”), an order was granted by the People’s Court of
Huangpu District, Guangzhou* (廣州市黃埔區人民法院) for the judicial preservation of a bank
account of Cloudbreak Guangzhou and the cash balances therein (the “Asset Preservation
Order”).
On 15 January 2026, a settlement agreement was entered into between, among others, Cedar
Wealth, the Company and Cloudbreak Guangzhou, pursuant to which the Company paid to
Cedar Wealth a settlement sum of approximately US$2.22 million in full and final settlement
of the Proceedings. The Asset Preservation Order and the Arbitration Proceedings were
discontinued with effect from 22 January 2026 and 23 January 2026, respectively.
For further details, please refer to the announcements of the Company dated 7 January 2026, 15
January 2026, 29 January 2026 and 30 January 2026, respectively.
Save as disclosed above, as at 30 June 2026 and the date of this announcement, neither the
Company nor any of its subsidiaries was involved in any material litigation, arbitration or claim
and, to the best of the knowledge of the Company and the Directors, no material litigation,
arbitration or claim was pending or threatened by or against the Group.

26

II. FINANCIAL REVIEW
Revenue
The Group is a clinical-stage ophthalmology biotechnology company. The Group currently has
no drugs approved for commercial sale and has not generated any revenue from drug sales for the
Reporting Period (Previous Period: nil).
Other Income
Other income mainly represents government grants obtained from local authorities in Suzhou, the
PRC, in relation to the Group’s R&D activities. The Group did not obtain large government grants
during the Reporting Period and Previous Period in Suzhou, the PRC. As such, the amount of
grants obtained by the Group during the Reporting Period remained stable and comparable to those
obtained in the Previous Period.
Other Gains or Losses, net
Other gains primarily consisted of gain on the redemption of financial assets at FVTPL while other
losses primarily consisted of change in fair value on financial assets at FVTPL and net foreign
exchange losses during the Reporting Period. The Group recorded exchange losses during the
Reporting Period as the Group exchanged its deposits in the PRC from USD into RMB for daily
operational use. As such, a net loss in foreign exchange resulted.
General and Administrative Expenses
The general and administrative expenses during the Reporting Period primarily consisted of (i)
employee benefit expenses, consisting of staff costs including salaries, bonuses, pensions, benefits,
and share-based compensation for our management and administrative personnel, (ii) legal and
professional fees paid to counsels and other professional agencies, (iii) auditors’ remuneration,
(iv) depreciation of property, plant and equipment and right-of-use assets, (v) expenses relating
to short-term leases, and (vi) other expenses. The amount of general and administrative expenses
during the Reporting Period increased as compared to the Previous Period as the Group incurred
more legal and professional fees after the Listing. In addition, salaries of administrative staff and
share-based payment expenses increased during the Reporting Period compared with the Previous
Period, as the Group continued to incur costs associated with the additional employees recruited
since February 2025. Furthermore, share awards were granted to administrative staff in May 2025
and June 2025, the expenses of which are recognised by amortisation over the vesting periods from
the respective grant dates such that the Reporting Period covered the share-based payments to these
administrative staff for the entirety of the six-month period as compared to partial coverage during
the Previous Period since the respective grant dates. Accordingly, overall expenses increased during
the Reporting Period.

27

R&D Expenses
R&D expenses during the Reporting Period primarily consisted of (i) clinical research expenses,
which primarily consisted of service fees paid to CROs and CDMOs for the clinical trials, expenses
for raw materials and consumables used in clinical trials, and other miscellaneous expenses such as
IP registration fees and maintenance and, (ii) employee benefit expenses, consisting of staff costs
including salaries, pensions, and share-based compensation for the R&D personnel. The amount
of R&D expenses during the Reporting Period increased as compared to the Previous Period as
the Company granted RSUs to a consultant during the Reporting Period. In addition, the Company
granted share awards to R&D staff in May 2025 and June 2025 and the associated expenses are
recognised by amortisation over the vesting periods from the respective grant dates such that the
Reporting Period covered the share-based payments to these R&D staff for the entirety of the sixmonth period as compared to partial coverage during the Previous Period since the respective grant
dates.
The following table sets forth a breakdown of the clinical research expenses by Core Products and
other drug candidates, and their respective percentage of the total clinical research expenses, for the
periods indicated:
For the six months ended 30 June
2026
2025
US$’000
%
US$’000

%

Core Products
– CBT-001
– CBT-009
Other drug candidates

8,950
71
1,820

82.5
0.7
16.8

8,200
223
787

89.0
2.4
8.6

Total

10,841

100.0

9,210

100.0

The clinical research expenses for CBT-001 increased slightly as there was cost incurred for the
preparation and set up for the second Phase 3 clinical trial which included the pre-study preparation
such as investigational products, equipment, study documents. In addition, RSUs were granted to
a consultant on 22 October 2025 and part of the performance conditions was related to CBT-001.
Such share-based payment expenses were included in CBT-001 clinical research expenses.
The clinical research expenses for CBT-009 in the Reporting Period further decreased when
compared to that of the Previous Period, given that, as disclosed in the announcement of the
Company dated 22 May 2026, the Group has decided to voluntarily withdraw its IND application
for CBT-009 as the Group believes that it might be difficult to include the PRC in MRCT due to the
different regulatory requirements across regions. In view of the foregoing, the Group is reassessing
the clinical development strategy and will not deploy substantial resources in clinical research at
this stage. As such, the clinical research expenses relating to CBT-009 decreased.

28

As to other drug candidates, the clinical research expenses mainly related to CBT-004. The Phase
2 clinical trial of CBT-004 was completed in early 2025 and the Group started the toxicity study in
the PRC during the Reporting Period. In addition, RSUs were granted to a consultant on 22 October
2025 and part of the performance conditions was related to CBT-004, which also formed part of the
clinical research expenses for CBT-004.
Finance Income
The finance income during the Reporting Period and Previous Period consisted of interest income
from time deposits. The finance income for the Reporting Period decreased as a result of the
decreased amount of deposits with banks as the Group has been utilising the funds in the deposits
accounts for R&D activities and daily operations.
Finance Cost
The finance cost during the Reporting Period consisted primarily of interest expense on bank
borrowings and lease liabilities of the leased properties, including laboratories and offices. The
amount increased as the Group had bank borrowings drawn down during the Reporting Period
(Previous Period: nil).
Liquidity and Capital Resources
During the Reporting Period, the Group primarily financed its operations through cash inflows from
bank borrowings. As at 30 June 2026, the Group had cash and cash equivalents of approximately
US$32.7 million, compared to approximately US$40.2 million as at 31 December 2025. The Group
monitors and maintains a level of cash and cash equivalents which the Group considers adequate to
finance its business operations.
As at 30 June 2026, the Group had unutilised banking facilities of approximately US$66.4 million,
and none of which were restricted. The Group does not anticipate any changes to the availability of
bank financing or net proceeds of the Global Offering for its operations in the future.
Borrowings and Gearing Ratio
As at 30 June 2026, the Group had aggregated interest-bearing bank borrowings of approximately
US$6.0 million (31 December 2025: US$0.4 million).
The gearing ratio is calculated by using current and non-current liabilities, divided by total assets
and multiplied by 100%. As at 30 June 2026, the Group’s gearing ratio was 22.4%, as compared
with 9.2% as at 31 December 2025. The increase was primarily due to the drawdown of bank
borrowings.

29

Lease Liabilities
The Group recognised right-of-use assets and the corresponding lease liabilities in respect of all
leases, except for short-term leases and leases of low-value assets. The lease liabilities increased
from US$0.3 million as at 31 December 2025 to US$0.4 million as at 30 June 2026, primarily due
to the renewal of lease terms.
Capital Commitments
As at 30 June 2026 and 31 December 2025, the Group had no capital commitments.
Contingent Liabilities
As at 30 June 2026, the Group did not have any material contingent liabilities, guarantees or any
litigations or claims of material importance pending or threatened against any member of the Group
that are likely to have a material and adverse effect on the business, financial condition or results of
operations of the Group.
Capital Expenditures
During the Reporting Period, the capital expenditures of the Group primarily consisted of purchases
of property, plant and equipment and intangible assets. The capital expenditures were approximately
US$26,000 and US$120,000 for the Reporting Period and the Previous Period, respectively.
Significant Investments
The Group did not make any significant investments during the Reporting Period. In addition, there
are no plans of the Group for significant investments or additions of material capital assets as at the
date of this announcement except for those disclosed in the Prospectus and the annual report of the
Company for the year ended 31 December 2025.
Material Acquisitions and Disposals
The Group did not have any material acquisitions or disposals of subsidiaries, associates or joint
ventures during the Reporting Period.
Funding and Treasury Policies
The Group adopts a prudent approach in its funding and treasury policies, aiming to maintain
an optimal financial position, stable finance costs and minimal financial risks. Cash and cash
equivalents of the Group are primarily placed at financial institutions with low credit risk. The
Group regularly reviews its funding requirements to maintain adequate financial resources in order
to support its business operations, research and development activities and any future investments
and expansion plans. Cash is invested solely in relatively liquid and low-risk instruments.

30

Foreign Exchange Risk and Hedging
The Group’s financial statements are expressed in USD, but the Company has subsidiaries operating
in other countries or regions where transactions are made in other currencies. This exposes the
Group to foreign currency risk which may affect the financial condition and results of operation of
the Group. The Group currently does not hold any financial instruments for hedging purposes. The
Group manages currency risks by closely monitoring the movement of the foreign currency rates
and will consider hedging significant foreign currency exposure should the need arise.
Pledge of Assets
As at 30 June 2026, the Group pledged its right-of-use assets of approximately US$1.6 million and
bank deposits of approximately US$4.2 million to secure the banking facilities granted to the Group.
Future Plans for Material Investments and Capital Assets
Save as disclosed in this announcement, as at 30 June 2026, the Group did not have any plans for
material investments or additions of material capital assets.
Employees and Remuneration
As at 30 June 2026, the Group had 61 employees (30 June 2025: 60 employees). The total
remuneration cost incurred by the Group for the Reporting Period was US$31.8 million, as
compared to US$18.9 million for the Previous Period.
The Group is committed to establishing competitive and fair remuneration which promotes
the success of the Group. To effectively motivate employees, the Group continually refines its
remuneration and incentive policies through market research. The Group conducts performance
evaluations for its employees on an annual basis to provide feedback on their performance and
consider any appropriate adjustments to their remuneration. Compensation for staff typically
consists of a base salary and discretionary performance-based bonuses.
The Company has also adopted the Equity Incentive Arrangements to provide incentives for its
employees.
INTERIM DIVIDEND
The Board did not recommend the payment of an interim dividend for the Reporting Period (Previous
Period: nil).

31

USE OF PROCEEDS FROM GLOBAL OFFERING
With the Shares listed on the Stock Exchange on 3 July 2025, the net proceeds from the Global Offering
(after deduction of professional fees, underwriting commissions and other related costs and expenses
incurred in connection with the Global Offering) were approximately HK$524.6 million (the “Net
Proceeds”).
Such Net Proceeds have been used according to the allocation set out in the Prospectus and the annual
report of the Company for the year ended 31 December 2025 published on 31 March 2026, and the
subsequent change in use of the Net Proceeds as set out in the Company’s announcement dated 22 May
2026 (the “Change in Use of Proceeds Announcement”).
As disclosed in the Change in Use of Proceeds Announcement, in view that the Group had decided to
voluntarily withdraw its IND application for the possible Phase 3 trial of CBT-009 in the PRC to avoid
research and development risks and better concentrate the Group’s resources, approximately HK$103.6
million originally allocated to CBT-009 will not be required in the near future. The remaining proceeds
originally allocated for CBT-009 will be retained to fund an investigator initiated trial to evaluate
the safety and efficacy of CBT-009 eye drop on other indications, which is planned to start in the
fourth quarter of 2026. Meanwhile, there are more urgent funding needs for the ongoing clinical R&D
activities, including costs and expenses for R&D staff and activities, as well as registration filings and
post-approval studies for CBT-001, CBT-004, CBT-358, and CBT-277. Administrative expenses and
other general costs are expected to increase correspondingly.
Taking into account the above, the Board resolved to re-allocate approximately HK$103.6 million
originally designated for CBT-009 as follows:
•

HK$31.8 million was re-allocated for the continuing clinical R&D activities including costs and
expenses of R&D staff and R&D activities as well as registration filings and post-approval studies
of CBT-001 and CBT-004;

•

HK$42.9 million was re-allocated for the continuing clinical R&D activities including costs and
expenses of R&D staff and R&D activities as well as registration filings and post-approval studies
of CBT-358 and CBT-277; and

•

HK$28.9 million was re-allocated for the working capital and other general corporate purposes of
the Group.

The revised use of proceeds also integrates the Net Proceeds allocated to (i) CBT-001 and CBT-004 and
(ii) CBT-009, CBT-358 and CBT-277, which use the same proprietary technology platform, respectively.
This enables the Company to use the unutilised Net Proceeds more efficiently, as products using the
same proprietary technology platform can share R&D achievements and inputs, leading to mutually
beneficial synergies.

32

To the extent that the Net Proceeds are not immediately required for the above purposes or if the
Company is unable to put into effect any part of our development plan as intended, it will only hold
such funds in short-term interest-bearing accounts at licensed commercial banks and/or other authorised
financial institutions (as defined under the SFO or applicable laws and regulations in other jurisdictions).
The following table sets out the allocation of the Net Proceeds and expected utilisation timeframe as at
30 June 2026:

Amount of Net
Proceeds as
disclosed in
the Prospectus
Use of Proceeds

(HK$ million)

Utilised
amount from
1 January 2026 Reallocation as
Unutilised to the date of stated in the
amount
the Change
Change
as at
in Use of
in Use of
31 December
Proceeds
Proceeds
2025 Announcement Announcement
(HK$ million) (HK$ million) (HK$ million)

Amount
utilised from
reallocation as
stated in the
Amount of the Change in Use
Unutilised
unutilised Net
of Proceeds
amount
Proceeds after Announcement
as at
reallocation to 30 June 2026 30 June 2026
(HK$ million) (HK$ million) (HK$ million)

Expected
timeframe for
the unutilised
Net Proceeds

To fund the continuing clinical R&D
activities, including costs and expenses
of R&D staff and R&D activities, as well
as registration filings and post-approval
studies of CBT-001 and CBT-004

327.4
(solely for
CBT-001)

230.3
(solely for
CBT-001)

(36.9)
(solely for
CBT-001)

31.8

225.2

(16.9)

208.3 By the end of 2027

To fund the continuing clinical R&D
activities, including costs and expenses
of R&D staff and R&D activities, as well
as registration filings and post-approval
studies of CBT-009, CBT-358 and CBT277

144.8
(solely for
CBT-009)

118.4
(solely for
CBT-009)

(0.1)
(solely for
CBT-009)

(60.7)

57.6

(3.8)

53.8 By the end of 2027

To fund the manufacturing facilities and
commercialisation activities

28.8

0.9

–

–

0.9

–

0.9 By the end of 2031

Working capital and other general corporate
purposes

23.6

1.3

(1.3)

28.9

28.9

(12.8)

16.1 By the end of 2026

524.6

350.9

(38.3)

–

312.6

(33.5)

279.1

Note: Any discrepancies in any table between totals and sums of amounts listed therein are due to rounding.

During the Reporting Period, the Company and ARC Group International Limited (“ARC”), an
independent third party, entered into a subscription agreement dated 18 June 2026 pursuant to which
the Company shall have the right to issue and ARC shall subscribe up to US$15.0 million of the
Company’s shares. No shares of the Company have been issued, and no proceeds have been generated
under the subscription agreement up to the date of this announcement. For details, please refer to the
announcement of the Company dated 18 June 2026.

33

CHANGES IN DIRECTORS’ INFORMATION PURSUANT TO RULES 13.51(2) AND 13.51B(1)
OF THE LISTING RULES
There was no change in the composition of the Board and the Chief Executive Officer or any the
information of Directors and Chief Executive Officer during the Reporting Period and up to the date of
this announcement which is required to be disclosed pursuant to Rules 13.51(2) and 13.51B(1) of the
Listing Rules.
PURCHASE, SALE OR REDEMPTION OF THE COMPANY’S LISTED SECURITIES
Neither the Company nor any of its subsidiaries purchased, redeemed or sold any of the Company’s
listed securities during the Reporting Period.
CORPORATE GOVERNANCE PRACTICES
The Company is committed to maintaining high standards of corporate governance to safeguard the
interests of the Shareholders and to enhance corporate value and accountability. Since the Listing Date,
the Company has adopted the CG Code as its own code of corporate governance and complied with all
applicable code provisions as set out in the CG Code except the following:
Pursuant to code provision C.2.1 of the CG Code, listed issuers are expected to comply with, but may
choose to deviate from, the requirement that the responsibilities between the chairman and the chief
executive should be segregated and should not be performed by the same individual. The Company does
not have a separate Chairman and Chief Executive Officer and Dr. Ni currently performs both roles. The
Board believes that, given his experience, personal profile, his extensive understanding of the business
and his roles in the Company, Dr. Ni is the Director best suited to identify strategic opportunities
and focus for the Board. The Board also believes that vesting the roles of both Chairman and Chief
Executive Officer in the same person has the following benefits: (i) ensuring consistent leadership
within the Group, (ii) enabling more effective and efficient overall strategic planning and execution of
the Board’s initiatives, and (iii) facilitating the flow of information between management and the Board.
The Board considers that the balance of power and authority for the current arrangement is not impaired
and this structure will enable the Company to make and implement decisions promptly and effectively.
The Board will continue to review and consider separating the roles of Chairman and the Chief
Executive Officer when appropriate, taking into account the circumstances of the Group as a whole.
Save as disclosed above, as at the date of this announcement and to the best of the knowledge,
information and belief of the Directors, having made all reasonable enquiries, the Directors are not
aware of any other deviation from the code provisions in the CG Code during the Reporting Period and
up to the date of this announcement.

34

MODEL CODE FOR SECURITIES TRANSACTIONS BY DIRECTORS
Since the Listing Date, the Company has adopted the Model Code as its own code for securities
transactions which applies to all Directors and senior management.
Upon specific enquiry, each Director confirmed that he or she has strictly complied with the
required standards set out in the Model Code during the Reporting Period and up to the date of this
announcement.
AUDIT COMMITTEE
The Company has established an audit committee (the “Audit Committee”) with written terms
of reference in accordance with the Listing Rules. As at the date of this announcement, the Audit
Committee comprises four Directors, namely, Mr. Ma Yiu Ho Peter, Ms. Nie Sijiang, Dr. Li Jun Zhi and
Mr. Lee Alex Jao Jang. Mr. Ma Yiu Ho Peter, who possesses appropriate accounting or related financial
management expertise in compliance with the requirements under Rules 3.10(2) and 3.21 of the Listing
Rules, is the current chairperson of the Audit Committee. The primary duties of the Audit Committee are
to review and oversee the financial reporting procedures, risk management and internal control system
of the Group, review the Group’s financial information, provide advice and comments to the Board, and
perform other duties and responsibilities as may be assigned by the Board.
The unaudited condensed consolidated interim financial information of the Group for the Reporting
Period contained in this announcement has not been reviewed or audited by the independent auditors
of the Company, but has been reviewed by the Audit Committee, which concluded that such financial
information and this announcement had been prepared in accordance with applicable accounting
standards and relevant requirements and that adequate disclosures had been made as required under
the Listing Rules and applicable laws. The Audit Committee has also discussed matters concerning the
accounting policies and practices adopted by the Company for the Reporting Period.
PUBLICATION OF INTERIM RESULTS ANNOUNCEMENT AND INTERIM REPORT
This announcement is published on the respective websites of the Stock Exchange (www.hkexnews.
hk) and the Company (https://cloudbreakpharma.com/). The interim report for the Reporting Period
containing all the information required by the Listing Rules will be despatched to the Shareholders and
published on the respective websites of the Stock Exchange and the Company in due course.
APPRECIATION
The Board would like to extend its sincere gratitude to the Shareholders, management team, employees
and business partners of the Group for their support and contribution to the Group.

35

GLOSSARY
“2023 Equity Incentive
Scheme”

the equity incentive scheme approved and adopted by the Shareholders on
14 March 2025, as amended from time to time, a summary of its principal
terms is set out in “Statutory and General Information – D. Equity
Incentive Arrangements – 3. 2023 Equity Incentive Scheme” in Appendix
IV to the Prospectus

“active pharmaceutical
ingredient” or “API”

active pharmaceutical ingredient, the substance in a pharmaceutical drug
that is biologically active

“ADS” or “ADS platform” antibody-drug synergism or antibody-drug synergism platform developed
by the Company, an innovative technology developed by the Group
to either improve the efficacy or extend the duration of drug effect
for intravitreally administered drugs by involving conjugating an
antibody drug with a small molecule drug, using a linker designed to be
enzymatically hydrolysed in the vitreous humour in a controlled manner
“ADS USA”

ADS Therapeutics LLC, a limited liability company initially formed in
Nevada, the United States on 16 January 2017 and later converted into a
limited liability company in Delaware, the United States on 16 November
2020, and a wholly owned subsidiary of our Company

“best-in-class”

the drug with the best clinical advantage within a drug class

“CDE”

Center for Drug Evaluation of the National Medical Products
Administration

“CDMO”

contract development and manufacturing organisation, a company that
provides comprehensive drug development and manufacturing services for
other companies on a contract basis

“CG Code”

Appendix C1 of the Listing Rules

“Chairman”

the chairman of the Board

“Chief Executive Officer”

the chief executive officer of the Company

“Cloudbreak Guangzhou”

Cloudbreak Bio-Pharmaceutical Science and Technology (Guangzhou)
Co., Ltd.* (撥康視雲生物醫藥科技（廣州）有限公司) (formerly known
as Boyun Bio-Pharmaceutical Science and Technology (Guangzhou) Co.,
Ltd.* (撥雲生物醫藥科技（廣州）有限公司)), a company established in the
PRC on 30 September 2018, and an indirect wholly owned subsidiary of
our Company

36

“Cloudbreak USA”

Cloudbreak Therapeutics LLC, a company incorporated in California, the
United States on 14 September 2015, and a wholly owned subsidiary of
the Company

“Core Product”

has the meaning ascribed to it in Chapter 18A of the Listing Rules; for the
purposes of this announcement, the Core Products refer to CBT-001 and
CBT-009

“CRO”

contract research organisation, a company that provides a range of
professional research services on a contract basis

“CRPS”

convertible redeemable preferred shares of the Company

“Dr. Ni”

Dr. Ni Jinsong, the Chairman, Executive Director, Chief Executive Officer
and a co-founder of the Group

“DME”

diabetic macular edema, a complication of diabetes wherein the patient
loses the central vision to a certain degree due to accumulation of excess
fluid in the extracellular space within retina’s macular

“dry eye”

a condition associated with inadequate tear production and marked by
redness, itching and burning of the eye

“Equity Incentive
Arrangements”

the Series B Equity Incentive Arrangement, the Series C Equity Incentive
Arrangement, the 2023 Equity Incentive Scheme and the Post-IPO Equity
Incentive Scheme

“Executive Director”

an executive director of the Company

“F&S Report”

an independent market research report commissioned by us and prepared
by Frost & Sullivan for the purpose of Prospectus

“FDA”

the United States Food and Drug Administration

“FDCA”

the Federal Food, Drug, and Cosmetic Act

“FGFRs”

fibroblast growth factor receptors, membrane-spanning proteins that are a
subgroup of the family of tyrosine kinase receptor

“first-in-class”

a drug that uses a new and unique mechanism of action for treating a
medical condition

“glaucoma”

a group of eye diseases that are usually characterised by progressive
structural and functional changes of the optic nerve, leading to a typical
appearance of the optic disc and visual field damage if untreated
37

“Global Offering”

the Hong Kong Public Offering and the International Offering

“Grand Pharma”

Grand Pharmaceutical Group Limited （遠大醫藥集團有限公司）, a
company incorporated in Bermuda with limited liability and the shares of
which are listed on the Main Board of the Stock Exchange (stock code:
512)

“Greater China”

the PRC, Hong Kong, the Macau Special Administrative Region of the
PRC and Taiwan

“Group” or “our Group”

the Company and all of its subsidiaries or, where the context so requires,
in respect of the period before our Company became the holding company
of its present subsidiaries, the businesses operated by such subsidiaries or
their predecessors (as the case may be)

“HK$” or “HKD”

Hong Kong dollars, the lawful currency of Hong Kong

“Hong Kong” or “HK”

The Hong Kong Special Administrative Region of the People’s Republic
of China

“Hong Kong Public
Offering”

the offer for subscription of 12,115,500 Shares (as adjusted on
reallocation) at the offer price of HK$10.10 per Share to the public in
Hong Kong

“IFRS”

IFRS Accounting Standards, which include standards, amendments and
interpretations promulgated by the International Accounting Standards
Board and the International Accounting Standards and Interpretation
issued by the International Accounting Standards Committee

“IND”

investigational new drug, the application for which is the first step in the
drug review process by regulatory authorities to decide whether to permit
clinical trials (also known as “clinical trial application” or “CTA” in the
PRC)

“Independent
Non-executive Director”

an independent non-executive director of the Company

38

“International Offering”

the offer of 48,466,500 Shares (as adjusted on reallocation) at the offer
price of HK$10.10 per Share outside the United States in offshore
transactions in accordance with Regulation S under the United States
Securities Act of 1933 (as amended from time to time) or any other
available exemption from registration under the United States Securities
Act of 1933 (as amended from time to time)

“IP”

intellectual property

“juvenile myopia”

myopia in children and adolescents aged 5 to 19 years old

“KOLs”

key opinion leaders, individuals or organisations who have expert product
knowledge and influence in a particular field, and who are trusted
by relevant interest groups and have significant effects on consumer
behaviour

“Listing”

the listing of the Shares on the Main Board of the Stock Exchange, which
took place on the Listing Date

“Listing Date”

3 July 2025

“Listing Rules”

the Rules Governing the Listing of Securities on The Stock Exchange of
Hong Kong Limited, as amended or supplemented from time to time

“Macau”

The Macau Special Administrative Region of the People’s Republic of
China

“MGD”

meibomian gland dysfunction, a chronic diffuse abnormality of the
meibomian glands, characterised by terminal duct obstruction along with
qualitative or quantitative changes in the glandular secretion

“MKI”

multi-kinase inhibitor

“MKI platform”

multi-kinase inhibitor platform, a technology platform that uses selective
MKIs that target VEGFRs, and to a lesser extent, PDGFRs and FGFRs, for
treating ocular indications involving abnormal angiogenesis or vascularity,
current indications of interest of which include pterygium, pinguecula,
and glaucoma filtration surgery

“Model Code”

the Model Code for Securities Transactions by Directors of Listed Issuers
as set out in Appendix C3 to the Listing Rules

“MRCT”

multi-regional clinical trial, a clinical trial that is conducted in different
regions under a common trial design for simultaneous global new drug
development
39

“New Drug Application”

new drug application, an application through which the drug sponsor
formally proposes that the relevant regulatory authority approve a new
drug for sales and marketing

“NMPA”

the National Medical Products Administration（國家藥品監督管理局）and
its predecessor, the China Food and Drug Administration

“Non-executive Director”

a non-executive director of the Company

“off-label use”

medication which is being used in a manner not specified in the approved
packaging label

“ophthalmology”

a branch of medical science dealing with the structure, functions and
diseases of the eye

“PDGFRs”

platelet-derived growth factor receptors, cell surface tyrosine kinase
receptors for members of the platelet-derived growth factor family

“Phase 1 clinical trial” or
“Phase 1”

a study in which a drug is introduced into healthy human subjects or
patients with the target disease or condition and tested for safety, dosage
tolerance, absorption, metabolism, distribution, excretion, and if possible,
to gain an early indication of its effectiveness

“Phase 2 clinical trial” or
“Phase 2”

a study in which a drug is administered to a limited patient population to
identify possible adverse effects and safety risks, to preliminarily evaluate
the efficacy of the drug for specific targeted diseases, and to determine
dosage tolerance and optimal dosage

“Phase 3 clinical trial” or
“Phase 3”

a study in which a drug is administered to an expanded patient population
at geographically dispersed clinical trial sites to generate statistically
sufficient data to evaluate the efficacy and safety of the drug for
regulatory approval and to provide adequate information for the labelling
of the product

“pinguecula”

a round, yellowish, elevated tissue that develops on the conjunctiva
adjacent to the cornea

“Post-IPO Equity
Incentive Scheme”

the equity incentive scheme adopted by the Company on 14 March
2025, the principal terms of which are set out in “Statutory and General
Information – D. Equity Incentive Arrangements – 4. Post- IPO Equity
Incentive Scheme” in Appendix IV to the Prospectus

40

“PRC”

the People’s Republic of China, excluding, for the purposes of this
announcement and for geographical reference only and except where the
context requires otherwise, Hong Kong, Macau and Taiwan

“Preferred Shares”

preferred shares in the share capital of the Company, with par value
US$0.0001 per share, comprising Series A Preferred Shares, Series B
Preferred Shares, and Series C Preferred Shares

“presbyopia”

an eye condition where the patient has difficulty seeing near items clearly
due to declines in refractive abilities of the lens

“Previous Period”

the six months ended 30 June 2025

“Prospectus”

the prospectus of the Company dated 24 June 2025 issued in connection
with the Listing and the Hong Kong Public Offering as part of the Global
Offering

“R&D”

research and development

“Renminbi” or “RMB”

the lawful currency of the PRC

“Reporting Period”

the six months ended 30 June 2026

“retina”

a thin layer of tissue that lines the back of the eye on the inside

“RSU(s)”

restricted share unit(s)

“Santen”

Santen Pharmaceutical Co., Ltd., a company incorporated in Japan with
limited liability and the shares of which are listed on Prime Market of the
Tokyo Stock Exchange (stock code: 4536)

“Series B Equity Incentive the equity incentive arrangement approved by Cloudbreak Cayman on
Arrangement”
27 August 2020, and which was subsequently approved by our Company
on 24 November 2021, a summary of its principal terms is set out in
“Statutory and General Information – D. Equity Incentive Arrangements
– 1. Series B Equity Incentive Arrangement” in Appendix IV to the
Prospectus
“Series C Equity Incentive the equity incentive arrangement approved by our Company on 24
Arrangement”
November 2021, a summary of its principal terms is set out in “Statutory
and General Information – D. Equity Incentive Arrangements – 2. Series
C Equity Incentive Arrangement” in Appendix IV to the Prospectus

41

“SFA+”

semifluorinated alkanes in combination with additional proprietary
moieties

“SFC”

the Securities and Futures Commission of Hong Kong

“SFO”

the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong
Kong), as amended, supplemented or otherwise modified from time to
time

“Shareholder”

a holder of Share(s)

“Shares”

ordinary shares with par value of US$0.0001 per share in the share capital
of the Company

“standard of care”

a treatment that is accepted and widely used by medical experts as a
proper and standard treatment for a certain disease

“Stock Exchange”

The Stock Exchange of Hong Kong Limited

“Taiwan”

Taiwan Province of the People’s Republic of China

“TRPM8”

transient receptor potential melastatin 8

“US$”, “USD” or
“U.S. Dollars”

U.S. dollars, the lawful currency of the United States

“USA” or “U.S.” or
“United States”

the United States of America, its territories, its possessions and all areas
subject to its jurisdiction

“VEGF”

vascular endothelial growth factor, a signal protein produced by cells that
stimulates the formation of blood vessels

“VEGFRs”

vascular endothelial growth factor receptors, tyrosine kinase receptors
responsible for binding with VEGF to initiate signal cascades that
stimulate angiogenesis among other effects

“%”

per cent

42

In this announcement: (a) unless otherwise defined herein, capitalised terms shall have the same
meanings as those ascribed to them in the Prospectus; and (b) unless the context otherwise requires,
the terms “associate”, “subsidiary” and “substantial shareholder” shall have the meanings given to such
terms in the Listing Rules.
By order of the Board
Cloudbreak Pharma Inc.
Dr. NI, Jinsong
Chairman, Executive Director and Chief Executive Officer
Hong Kong, 31 August 2026

As at the date of this announcement, the Board comprises: (i) Dr. Ni Jinsong, Mr. Dinh Son Van
and Dr. Yang Rong as Executive Directors; (ii) Dr. Li Jun Zhi, Mr. Cao Xu and Mr. Xia Zhidong as
Non- executive Directors; and (iii) Ms. Nie Sijiang, Mr. Ma Yiu Ho Peter and Mr. Lee Alex Jao Jang as
Independent Non-executive Directors.
* For identification purpose only

43

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完
整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因倚賴該等內
容而引致之任何損失承擔任何責任。

CLOUDBREAK PHARMA INC.
撥康視雲製藥有限公司*
（於開曼群島註冊成立的有限公司）

（股份代號：2592）

截至2026年6月30日止六個月中期業績公告
中期業績
撥康視雲製藥有限公司（「本公司」，連同其附屬公司「本集團」）董事（「董事」）會（「董事會」）謹此宣佈，
本集團截至2026年6月30日止六個月（「報告期間」）未經審核綜合中期業績，乃根據國際會計準則理事
會（「國際會計準則理事會」）頒佈的國際會計準則（「國際會計準則」）第34號「中期財務報告」及上市規則
適用披露規定編製，連同截至2025年6月30日止六個月（「過往期間」）的未經審核比較數字載列如下：

1

簡明綜合中期全面收益表
截至2026年6月30日止六個月

附註

收益
其他收入
其他收益或虧損淨額
一般及行政開支
研發開支

截至6月30日止六個月
2026年
2025年
千美元
千美元
（未經審核）
（未經審核）
–
44
(737)
(15,797)
(31,846)

–
28
(594)
(9,365)
(23,732)

(48,336)

(33,663)

財務收入
財務成本

414
(25)

506
(11)

財務收入淨額

389

495

5

–

38,421

6

(47,947)
–

5,253
(67)

(47,947)

5,186

870

748

–

42

870

790

(47,077)

5,976

經營虧損

5

按公平值計入損益的金融負債公平值變動
除所得稅前（虧損）╱溢利
所得稅開支
期內（虧損）╱溢利
其他全面收益
隨後可能重新分類至損益的項目：
貨幣匯兌差額

隨後將不會重新分類至損益的項目：
可換股可贖回優先股由於本身信貸風險的
公平值變動
期內其他全面收益
期內全面（虧損）╱收益總額
2

簡明綜合中期全面收益表
截至2026年6月30日止六個月

附註

股東應佔每股（虧損）╱盈利（以每股美元列示）
－基本
－攤薄

7
7

3

截至6月30日止六個月
2026年
2025年
千美元
千美元
（未經審核）
（未經審核）

(0.06)
(0.06)

0.01
(0.04)

簡明綜合中期財務狀況表
於2026年6月30日
2026年
6月30日
千美元
（未經審核）

2025年
12月31日
千美元
（經審核）

233
2,032
89

322
1,902
44

2,354

2,268

2,600
143
12,081
62
4,153
32,745

5,432
110
18,201
447
–
40,150

51,784

64,340

資產總額

54,138

66,608

權益
股本
其他儲備
累計虧損

88
492,452
(450,527)

84
472,316
(411,912)

權益總額

42,013

60,488

53

98

資產
非流動資產
物業、廠房及設備
使用權資產
按金

流動資產
預付款項、按金及其他應收款項
存貨
按公平值計入損益的金融資產
即期所得稅應收款項
已質押銀行存款
現金及現金等價物

負債
非流動負債
租賃負債
4

簡明綜合中期財務狀況表
於2026年6月30日
2026年
6月30日
千美元
（未經審核）

2025年
12月31日
千美元
（經審核）

5,665
6,001
374
32

5,317
444
220
41

12,072

6,022

負債總額

12,125

6,120

權益及負債總額

54,138

66,608

流動資產淨額

39,712

58,318

附註

流動負債
貿易及其他應付款項
銀行借款
租賃負債
即期所得稅負債

9

5

簡明綜合中期財務資料附註
截至2026年6月30日止六個月
1.

一般資料
本公司於2020年11月20日於開曼群島註冊成立為獲豁免有限公司且其股份於聯交所主板上市，自2025年7月3日起生
效。本公司的註冊辦事處地址為4th Floor, Harbour Place, 103 South Church Street, P.O. Box 10240, Grand Cayman
KY1-1002, Cayman Islands，及本公司於香港的主要營業地點為香港九龍海港城港威大廈2座23A樓23A11室。
本公司為一間投資控股公司，及其附屬公司主要從事治療性生物製劑研發。
簡明綜合中期財務資料乃以美元呈列，而美元亦為本公司的功能貨幣。
簡明綜合中期財務資料已於2026年8月31日經董事會授權發布。

2.

編製基準
本集團報告期間的簡明綜合中期財務資料乃根據國際會計準則理事會頒佈的國際會計準則第34號「中期財務報告」及
上市規則的適用披露規定編製。
除於各個報告期末按公平值計算的若干金融工具外，簡明綜合中期財務資料乃根據歷史成本基準編製。
除附註3所披露因應用國際財務報告準則會計準則修訂本而導致之會計政策變動外，報告期間之簡明綜合中期財務
報表所採用之會計政策及計算方法，與本集團截至2025年12月31日止年度之年度綜合財務報表所呈列者相同。
簡明綜合中期財務資料包括簡明綜合中期財務報表及部分說明附註。該等附註包括就理解本集團自截至2025年12月
31日止年度之綜合財務報表以來之綜合中期財務狀況及綜合中期財務表現變動而言屬重大的事件及交易之解釋。該
等簡明綜合中期財務資料及說明附註並不包括就根據由國際會計準則理事會頒佈的國際財務報告準則會計準則編製
的整份綜合財務報表所規定的全部資料，並應與本集團截至2025年12月31日止年度之綜合財務報表一併閱讀。
根據國際會計準則第34號編製的中期財務報告要求管理層作出判斷、估計及假設，該等判斷、估計及假設均會影響
會計政策的採用及呈報按年度累計的資產及負債、收入及開支。實際業績可能會跟該等估計有差別。
於本中期財務報告顯示有關截至2025年12月31日止財政年度之財務資料（作為比較資料）乃節錄自截至2025年12月31
日止年度的年報，並不構成本公司有關財政年度之法定年度綜合財務報表。

6

3.

應用國際財務報告準則會計準則修訂本
於報告期間，本集團首次應用以下國際財務報告準則會計準則的修訂本，該等修訂本自本集團2026年1月1日開始的
財政年度起生效：
國際財務報告準則第9號及國際財務報告準則第7號修訂本

金融工具分類及計量修訂本

國際財務報告準則第9號及國際財務報告準則第7號修訂本

涉及依賴自然能源生產電力的合約

國際財務報告準則會計準則修訂本

國際財務報告會計準則之年度改進－第11冊

於報告期間應用的國際財務報告準則會計準則的修訂本對本集團本期間及過往期間的綜合財務狀況及財務表現及╱
或簡明綜合中期財務資料所載披露並無重大影響。
4.

分部資料
執行董事被認定為本集團主要營運決策者（「主要營運決策者」），審閱本集團內部報告，以評估表現及分配資源。主
要營運決策者根據內部組織結構、管理需要及內部報告制度確定經營分部，並披露按經營分部基準釐定的可報告分
部的分部資料。
本集團主要從事治療性生物製劑的研發。主要營運決策者根據經營業績的衡量標準評估業務的表現，並視業務為單
一經營分部。由於本集團的資源為已整合，故就資源分配及表現評估向主要營運決策者報告的資料集中於本集團的
整體經營業績。因此，本集團已識別一個經營分部，且於兩個期間並無就該單一分部作出進一步分析。
本集團的非流動資產按地區（按資產所在地點釐定）劃分如下：

中國
香港
美國

7

2026年
6月30日
千美元
（未經審核）

2025年
12月31日
千美元
（經審核）

1,941
125
288

2,058
163
47

2,354

2,268

5.

經營虧損
經營虧損已扣除╱（計入）以下各項：
截至6月30日止六個月

臨床研究開支
僱員福利開支（包括董事薪酬）
核數師審計服務酬金
本公司核數師
－本期間
其他核數師
－本期間
物業、廠房及設備折舊
使用權資產折舊
與短期租賃有關的開支
按公平值計入損益（「按公平值計入損益」）的金融負債公平值收益
（附註）
法律及專業費用
上市開支

2026年
千美元
（未經審核）

2025年
千美元
（未經審核）

10,841
31,750

9,210
18,900

153

–

3
122
171
114
–
3,202
–

4
164
187
55
(38,421)
819
2,833

附註：
於過往期間，本集團已將可換股可贖回優先股公平值變動所產生的收益38,421,000美元計入損益。所有可換股可贖
回優先股已於2025年7月3日上市時自動轉換為股份。
6.

所得稅開支
截至6月30日止六個月

即期所得稅開支

2026年
千美元
（未經審核）

2025年
千美元
（未經審核）

–

67

本集團主要適用稅項及稅率如下：
開曼群島
根據開曼群島現行法律，本公司及其於開曼群島註冊成立的附屬公司毋須繳納所得稅或資本收益稅。此外，於本公
司向其股東支付股息時，毋須繳納開曼群島預扣稅。
英屬處女群島（「英屬處女群島」）
本公司於英屬處女群島註冊成立的附屬公司獲豁免就其外國所得收入繳納英屬處女群島所得稅。英屬處女群島並無
預扣稅。

8

香港
於報告期間及過往期間，香港利得稅稅率均為16.5%。由於報告期間及過往期間並無估計應課稅溢利須繳納香港利
得稅，故並無就香港利得稅計提撥備。
美國
Cloudbreak USA及ADS USA分別於美國加州及特拉華州成立。Cloudbreak USA需繳納聯邦所得稅及加州所得稅，
而ADS USA則需繳納聯邦所得稅及特拉華州所得稅。於報告期間及過往期間，聯邦所得稅稅率、加州所得稅稅率及
特拉華州所得稅稅率分別為21%、8.84%及8.7%。
中國
於報告期間及過往期間，中國企業所得稅撥備乃就本集團於中國註冊成立及營運的附屬公司的應課稅收入均按法定
稅率25%計算。
其他外國所得稅
其他外國（包括德國、瑞典及澳洲）的利得稅根據其有關現行法例、詮釋及慣例，按本集團營運所在司法權區的現行
稅率計算。由於報告期間及過往期間並無須繳納其他外國所得稅的估計應課稅溢利，故並無就其他外國所得稅計提
撥備。
7.

每股（虧損）╱盈利
股東應佔每股（虧損）╱盈利
每股基本及攤薄（虧損）╱盈利的計算基準如下：

(a)

每股基本（虧損）╱盈利
截至6月30日止六個月

股東應佔（虧損）╱溢利
（千美元）
發行在外的股份加權平均數
每股基本（虧損）╱盈利（以每股美元列示）

9

2026年
（未經審核）

2025年
（未經審核）

(47,947)
851,758,902

5,186
475,386,302

(0.06)

0.01

(b) 每股攤薄虧損
每股攤薄虧損乃根據股東應佔（虧損）╱溢利計算，並作出調整以反映發行在外的任何潛在攤薄股份的影響（倘
適用）。用於計算每股攤薄虧損的股份加權平均數為用於計算每股基本（虧損）╱盈利時使用的股份加權平均
數，以及假設所有潛在攤薄股份被視作行使或轉換為股份而無償發行股份的加權平均數。
截至6月30日止六個月
2026年
（未經審核）

2025年
（未經審核）

股東應佔（虧損）╱溢利
（千美元）
可換股可贖回優先股的公平值變動
（千美元）

(47,947)
–

5,186
(38,421)

股東應佔虧損淨額
（千美元）

(47,947)

(33,235)

發行在外的股份加權平均數
調整可換股可贖回優先股

851,758,902
–

475,386,302
300,699,572

用於計算每股攤薄虧損的期內已發行股份加權平均數

851,758,902

776,085,874

(0.06)

(0.04)

每股攤薄虧損（以每股美元列示）
(i)

由於本集團於報告期間產生虧損，因此，將潛在股份納入每股攤薄虧損的計算中將產生反攤薄效應，故並
未計入該等潛在股份。因此，報告期間每股攤薄虧損與每股基本虧損相同。

(ii) 於報告期間，本集團擁有一類（過往期間：兩類）潛在股份，即授予合資格參與者的股份獎勵及附帶歸屬
時間表的購股權（過往期間：(i)可換股可贖回優先股及(ii)股份獎勵及購股權）。股份獎勵及購股權為反攤
薄。
8.

股息
於報告期間並無派發或建議派發股息（過往期間：無）。

9.

貿易及其他應付款項

貿易應付款項
應計法律及專業開支
（附註）
應計員工成本
其他應計費用及應付款項

10

2026年
6月30日
千美元
（未經審核）

2025年
12月31日
千美元
（經審核）

2,477
2,227
632
329

836
2,805
810
866

5,665

5,317

於報告期末及2025年12月31日止年度，本集團貿易應付款項按發票日期的賬齡分析如下：

30天內
31至60天
61天至1年
超過1年

2026年
6月30日
千美元
（未經審核）

2025年
12月31日
千美元
（經審核）

1,982
51
–
444

390
–
446
–

2,477

836

平均信貸期為30天（2025年12月31日：30天）。

附註：
本集團於 2025 年 12 月 31 日的應計法律及專業開支中，包含一筆 170,000 美元的撥備，該金額為本公司支付予 Cedar
Wealth Management SPC（
「Cedar Wealth」
）的和解款項約2.22百萬美元與Cedar Wealth於2025年8月11日針對本公司及撥康
視雲廣州提起的仲裁程序中所聲稱尚欠費用及其他支出2.05百萬美元之間的差額。上述仲裁程序及相關的資產保全令已
分別自2026年1月23日及2026年1月22日起終止，且該撥備已於報告期間內向Cedar Wealth支付和解款項後全數結清。有
關該等程序及和解的進一步詳情，請參閱本公司分別於2026年1月7日、2026年1月15日、2026年1月29日及2026年1月30
日發布的公告。
10. 或然負債
於報告期末，本集團並無任何重大或然負債。
11. 報告期後事項
截至本公告日期為止，並無發生任何需對簡明綜合中期財務資料作出額外披露或調整的重大事件。

11

管理層討論及分析
I.

業務回顧
1.

概覽
我們是一間臨床階段眼科生物科技公司，致力於透過我們專有的藥物研發及開發能力開發眼
科疾病的創新療法，主要於美國及中國經營業務。我們的關鍵技術包括多激酶抑制劑、非水
性局部給藥及抗體藥物協同作用。該等技術可支撐當前的研發管線，包括十款候選藥物，針
對治療眼睛前部及後部主要疾病，包括六款處於臨床階段及四款處於臨床前階段的候選藥
物，均為我們內部自主開發。
多激酶抑制劑是一種針對治療許多眼表疾病呈現的異常血管生成╱血管化以及纖維化現象的
靶向小分子藥物。我們的主要多激酶抑制劑產品CBT-001正被開發用於治療翼狀胬肉。緊隨
其後的是我們的另一款處於後期開發階段的產品CBT-004，用於治療瞼裂斑。
我們的非水性局部給藥系統SFA+相較於標準的局部溶液及混懸液具有多項顯著優勢。這些
優勢包括能夠自我保存，在維持良好保質期和穩定性的同時減少眼表接觸有毒化學物質，並
提升用藥舒適度。該平台為難以在水性體系中製劑的藥物提供了應用機會。
三個管線產品進入相對較後期臨床開發階段，並已制定計劃及路線圖，在獲得所需的監管
批准後進行商業化，即：（i）我們的核心產品之一CBT-001（用於治療翼狀胬肉）；(ii)另一款
核心產品CBT-009（採用SFA+技術以治療青少年近視）；及（iii）CBT-004（用於治療瞼裂斑）。
CBT-199用於治療老花眼，亦已進入臨床階段，並已成功向美國藥管局申請新藥臨床試驗申
請。同樣地，本集團於2026年5月21日針對CBT-358（一款用於治療乾眼症的SFA+及TRPM8
激動劑候選藥物組合）提交了新藥臨床試驗申請，並已通過美國藥管局為期30天的臨床安全
性暫停審查意見徵詢期。我們雖計劃繼續推進CBT-006（另一款處於臨床階段、用於治療瞼
板腺功能異常的候選藥物），但為了長遠的發展計劃，CBT-006的研發工作目前暫時停止。
這是為了讓我們能夠將更多資源集中投入到更優先的項目上。餘下四款候選藥物CBT-007、
CBT-145、CBT-011及CBT-277，目前正處於較早期的臨床前開發階段。

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2.

管線

2.1. 核心產品
CBT-001
我們的核心產品CBT-001是一種潛在的同類首創藥物，採用多激酶抑制劑，以血管內皮
生長因子受體、血小板衍生生長因子受體及成纖維細胞生長因子受體為靶點，適用於預
防翼狀胬肉發展、減少結膜充血及與翼狀胬肉相關的症狀。
翼狀胬肉是一種眼表組織異常增生，覆蓋角膜或眼球前部的疾病。全球數億人受其影
響，尤其是長期暴露於紫外線環境中的人群，如戶外工作者或海灘活動者。在許多情況
下，這種漸進性纖維血管增生常引發持續紅腫、刺激感、異物感，並可能導致散光及視
力受損。根據病變位置，亦可能造成佩戴隱形眼鏡時的不適甚至無法佩戴。
患者及眼部護理專業人員均對目前非手術治療方案表示強烈不滿，這些方案不僅選擇極
為有限，而且往往僅能提供暫時性症狀緩解。現有方案包括人工淚液及標示外短期使用
皮質類固醇以控制症狀發作。在病情較為嚴重的情況下，手術切除是一種選項，但這種
手術存在諸多風險，包括復發率高(3%- 38%)、痛苦的康復過程及高達80%的患者會出
現併發症。有鑒於此，迫切需要一種能夠同時針對病變的纖維血管增生及相關症狀進行
治療的藥物療法。
CBT-001又稱尼達尼布游離鹼，是一種局部眼用滴眼液乳液，目前正進行第3期多地區
臨床試驗研究。鑒於根據弗若斯特沙利文報告且據我們所知，目前全球並無獲批用來治
療翼狀胬肉的藥物，手術切除為現有唯一的治療方案，這代表在解決未滿足的醫療需求
方面取得突破。CBT-001乃根據聯邦食品、藥品和化妝品法案第505(b)(2)條（為眼科生物
科技公司普遍採用的監管途徑（「505(b)(2)途徑」）
）開發，讓我們可利用先前獲批藥物的
經驗證之安全性及療效數據，從而加快開發時間線及降低成本。
我們已分別於2022年6月在美國及於2023年9月在中國開展兩項第3期多地區臨床試驗的
首項臨床試驗。我們亦已分別於2024年5月、2024年5月及2024年7月在紐西蘭、澳洲及
印度開展更多臨床試驗，作為全球第3期多地區臨床試驗計劃的一部分，以評估CBT001的療效。於2025年5月，我們於全部五個司法權區完成患者招募，合共招募660名患
者。我們預期於2027年第三季完成第3期多地區臨床試驗，並於同年晚些時候獲得初步
的療效及安全性數據。

13

誠如本公司於2026年6月4日發布之公告所披露，最後一名受試者已完成12個月的隨訪，
在此階段，針對CBT-001的主要療效終點，即翼狀胬肉病變縮小程度及眼部不適症狀評
分，將於第3期多地區臨床試驗中進行評估。本公司認為，最後一次12個月終點隨訪的
完成是CBT-001研發過程中的重要里程碑，並使本公司得以在2026年第三季公布12個月
療效的初步數據。若該初步數據結果為正面，不僅可支持多項商業申請同時提交，且一
旦獲批，更可能改變當前「僅限手術」的治療模式。
在分析首次第三期多地區臨床試驗的安全性及療效結果後，我們計劃最早於2026年第四
季，據此與國家藥監局及美國藥管局商討臨床及監管路徑。
我們已建立重要的商業化合作夥伴關係，以盡量擴大CBT-001的全球覆蓋範圍。於2020
年4月13日，我們與遠大醫藥訂立一項針對大中華區的獨家商業化許可安排（「遠大醫藥
許可協議」）。於2024年8月6日，我們亦與參天訂立一項針對日本、韓國、越南、泰國、
馬來西亞、新加坡、菲律賓及印尼的許可協議（「參天許可協議」），向參天授予獨家權
利，以（其中包括）開發、生產及商業化含有尼達尼布的醫藥產品，用於局部治療翼狀胬
肉。
在美國及其他地區，我們正同時探索自主商業化及對外授權兩種選擇，並與潛在合作夥
伴展開積極討論，旨在最大化相關產品及技術的價值，同時為我們後續的研發管線奠定
基礎。

CBT-009
CBT-009是一種新型阿托品眼用製劑，用於治療5至19歲兒童及青少年的青少年近視。
CBT-009採用SFA+非水性製劑設計而成，與現有水性製劑相比，可改善穩定性、安全
性及患者耐受性。
青少年近視影響全球數億兒童，是眼科領域關鍵且未滿足的醫療需求。與睫狀肌疲勞引
發的屈光性近視不同，進行性近視的特徵在於兒童及青少年視覺發育關鍵期，眼軸長度
快速增長及眼球持續拉長。這種持續加深的近視可能導致高度近視，並顯著增加終生罹
患嚴重眼部併發症的風險，包括視網膜脫離、視網膜退化、青光眼及白內障。

14

當前治療手段有限，需依賴部分兒童抗拒佩戴的度數不斷加深的眼鏡、幼童難以適應的
特殊隱形眼鏡，或在某些情況下使用低劑量阿托品眼藥水的標示外用藥。然而現有水性
阿托品製劑存在穩定性差（在水溶液中快速分解）、需冷藏保存等問題，且常採用含防腐
劑的多劑量瓶裝形式，可能引發眼表壓力。在美國，多家公司曾嘗試針對兒童近視進行
低劑量阿托品的臨床試驗，但均未成功。其中一家公司已向美國藥管局臨床諮詢小組提
出申請，並獲准由該小組審查其研究結果。若該小組建議批准其產品，將為此類產品在
美國的核准開闢更明確的途徑。截至目前，美國藥管局的審核要求比歐洲或日本更為嚴
格。
我們於2021年在中國以及於2022年在美國開始進行CBT-009的臨床前研究。CBT-009的
第1期及第2期臨床試驗已合併為單一試驗，而我們已於2023年1月在澳洲完成CBT-009
的第1期及第2期合併臨床試驗，顯示出良好的安全性及療效。我們已完成對CBT-009的
第1期及第2期臨床試驗結果的數據分析及臨床研究報告。於2023年9月，美國藥管局批
准我們利用在澳洲第1期及第2期臨床試驗結果根據505(b)(2)途徑在美國進行第3期臨床
試驗。於2024年9月，於完成為期六個月的眼部毒性研究後，我們另外收到美國藥管局
的批准函，表示不反對我們進行CBT-009的第3期臨床試驗。
我們亦已於2025年11月在中國完成對幼年動物進行毒性研究，並於2025年12月向國家
藥監局提交新藥臨床試驗申請。誠如本公司於2026年3月19日發布的公告所披露，在提
交新藥臨床試驗申請後，藥審中心批准了一款可比藥品在中國上市。經後續與藥審中心
溝通後，本公司相信由於各區域監管要求不同，將中國納入多地區臨床試驗可能存在困
難。為避免後續研發風險，及更好地分配本集團的資源，本公司已決定主動就可能於中
國進行的第3期試驗撤回其新藥臨床試驗申請。
本公司致力於繼續開發其SFA+平台，並將根據最新的法規要求和市場環境，重新評估
CBT-009的臨床開發策略。如本公司於2026年5月22日發布的公告所披露，一項旨在評
估CBT-009眼藥水在其他適應症下安全性和有效性的研究者發起試驗，預計將於2026年
第四季啟動。待完成相關補充研究或調整臨床試驗方案後，本公司將根據情况再次與藥
審中心進行臨床試驗申請前諮詢會議或重新提交臨床試驗申請。

15

2.2. 其他臨床階段候選藥物
CBT-004
CBT-004是一種潛在的同類首創眼科藥物，採用多激酶抑制劑，靶向血管內皮生長因子
受體及血小板衍生生長因子受體，適用於治療瞼裂斑。
瞼裂斑是一種生長於眼表的圓形、淡黃色的隆起組織。該病症在長期接觸紫外線及年齡
增長的人群中極為常見。瞼裂斑的發病率高於翼狀胬肉，可能影響全球超過十億人。當
組織發生血管化或炎症時，可引發多種症狀，包括眼部發紅、不適及疼痛、異物感、流
淚及痕癢。根據瞼裂斑的位置，其亦可能導致佩戴隱形眼鏡時的不適甚至無法佩戴。
據我們所知，目前尚無獲批的瞼裂斑藥物治療。為治療乾眼症及異物感等症狀，可使用
潤滑眼藥水緩解。對於大型或炎症性瞼裂斑，可使用非類固醇消炎藥或皮質類固醇治
療，但後者因可能引發青光眼及白內障等併發症而需限制長期使用。鑒於現有緩解症狀
的可靠方案有限，極需針對該病症專門設計的藥物治療。
CBT-004與當前使用僅能暫時緩解某些瞼裂斑症狀的非適應症治療方案相比，預計會較
有優勢。據我們所知，截至2026年6月30日，CBT-004是全球唯一適用於治療瞼裂斑的
臨床階段藥物。
CBT-004在美國透過505(b)(2)途徑開發。我們於2020年12月在美國透過505(b)(2)途徑
就CBT-004申請新藥臨床試驗批准，並於2021年2月取得美國藥管局的新藥臨床試驗批
准。此後，我們的研發團隊一直在優化配方並開展臨床試驗。
我們於2023年12月開始CBT-004的第2期臨床試驗，並於2025年5月完成。CBT-004能夠
達到主要療效終點及若干次要終點，作為預設規格的一部分。我們於2025年7月完成臨
床試驗報告，並於2025年12月10日與美國藥管局成功舉行第2期臨床試驗後（「第2期臨床
試驗後」）會議。
於第2期臨床試驗後會議上，美國藥管局就下列事項提供意見回饋：藥物穩定性及規格
研究、支持向美國藥管局提交擬議新藥申請所需的非臨床研究，以及CBT-004第3期臨
床研究的設計及終點。其中，美國藥管局與本集團就以下事項達成共識：將充血症狀減
輕作為CBT-004獲批的主要終點，其統計學及臨床意義，並將症狀緩解作為潛在的共同
主要終點。

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我們認為第2期臨床試驗後會議的成功標誌著CBT-004臨床開發取得重大進展，特別是
其邁向第3期臨床研究的步伐。倘成功，CBT-004將成為唯一同時顯著減輕充血症狀並
緩解病症的局部療法，為新藥申請及CBT-004獲批後的商業化鋪平道路。

CBT-199
CBT-199是一種新型、每日一次且無防腐劑的局部眼用乳液，含副交感神經性縮瞳劑，
採用本集團專有的非水溶性平台製劑，用於治療老花眼。CBT-199透過誘導瞳孔收縮形
成針孔效應，增加焦距深度從而暫時改善近距離視力。此無水配方透過防止活性成分隨
時間分解，以顯著提升藥物穩定性，無需冷藏（在室溫下穩定），並採用對消費者友善的
自保存多劑量瓶裝設計，具備長效保質期，提供舒適、舒緩的用藥體驗。CBT-199展現
出卓越的藥理選擇性，相較於毛果芸香鹼，對虹膜括約肌的選擇性較對睫狀肌更強，可
能減少常見的不良反應，例如與睫狀肌痙攣相關的頭痛。此外，專有製劑可實現經角膜
給藥為主的藥物輸送，同時將全身暴露量降至最低，進一步提升安全性。CBT-199代表
潛在同類最佳的藥理學老花眼治療方案，相較於現有療法，其每日僅需用藥一次，且耐
受性亦有所改善。
老花眼影響全球約20億人口，是眼科領域中未滿足的主要醫療需求。這種隨年齡增長而
逐漸喪失聚焦近物的能力，幾乎影響所有45歲以上的成年人。該症狀會導致閱讀、使用
智能手機及其他近距離視物出現顯著困難，大幅影響生活品質及生產力。
目前非藥物治療方案包括閱讀眼鏡、雙焦點眼鏡、隱形眼鏡或屈光手術。許多患者認為
光學矯正不便、外觀不佳、暴露年齡，或限制生活方式，而手術方案則存在效果不佳、
不可逆轉、晚期併發症及術後恢復期漫長的風險。老花眼藥物市場預計將於2038年超過
30億美元的全球規模（Delveinsight, 2025年），這反映出市場對有效局部治療方案存在龐
大的未滿足需求，此類方案應能恢復功能性視力，且不受現行替代療法的限制。
誠如本公司於2026年4月30日發布之公告所披露，針對CBT-199向美國藥管局提交的新
藥臨床試驗申請審查期已結束，據此，美國藥管局認定本集團可就CBT-199進行臨床試
驗。這標誌著CBT-199臨床開發的關鍵里程碑，ADS USA已正式獲准啟動其第2期臨床
試驗。

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CBT-358
CBT-358是SFA+及TRPM8激動劑的組合候選藥物，用於治療乾眼症（「乾眼症」），該病
症在全球市場規模達數十億美元。乾眼症，學名為乾性角結膜炎，是眼表「生命維持系
統」因多種因素而導致的複雜失調。從根本上說，乾眼症是淚膜失衡所致，而淚膜這層
精密的液體層，正是維持視力清晰與角膜舒適的關鍵。乾眼症通常由淚液分泌減少、淚
液過度蒸發，或兩者兼而有之所引起，進而導致眼表受損及發炎。乾眼症患者的常見症
狀包括眼睛有異物感或灼熱感、視力模糊，有時還會出現悖論性流淚。乾眼症是患者就
診眼科專業人員的最常見原因之一。
擬議的試驗產品CBT-358採用新型非水性眼用溶液配方，專為治療淚液不足而設計。有
別於傳統的被動式潤滑劑，此配方利用生理性的「降溫」反射來刺激內源性淚液分泌。此
激活機制模擬低溫的影響，觸發反射弧以增加基礎淚液分泌量及眨眼頻率，從而自然恢
復眼表濕潤度。因此，預期CBT-358能改善乾眼症中的淚液缺乏問題。與此同時，此創
新非水性配方採用了SFA+技術，並產生了出乎意料的發現：根據體外實驗及體內動物
模型結果顯示，CBT-358亦可能減緩淚液蒸發。因此，CBT-358有望同時解決淚液分泌
不足與蒸發性乾眼症這兩大問題，而這兩者正是多數乾眼症的根本成因。鑑於報告期間
取得這項極具前景的突破，我們已加速CBT-358的開發進度，並比預期更早成功完成支
持新藥臨床試驗申請的研究。誠如本公司於2026年7月17日之公告所披露，美國藥管局
已完成針對CBT-358之新藥臨床試驗申請的安全性審查，並對擬議之臨床研究程序未提
出異議。

CBT-006
臨床階段候選藥物CBT-006是一款潛在的同類首創候選藥物，適用於治療瞼板腺功能異
常所引發的乾眼症。該產品旨在溶解沉積在瞼板腺孔口的膽固醇和其他脂質，從而改善
瞼脂質量和瞼板腺的健康。
CBT-006乃透過美國505(b)(2)途徑開發。我們於2020年10月在美國透過505(b)(2)途徑就
CBT-006申請新藥臨床試驗批准，而美國藥管局已於2020年11月發出批准函，表示不反
對我們在美國進行第2期臨床試驗。我們於2021年9月啟動CBT-006的第2期臨床試驗，
並於2022年5月完成該試驗。

18

我們已暫停將CBT-006推進至第3期臨床試驗，以便將資源集中於更迫切的發展項目，
包括但不限於CBT-001及CBT-004。然而，我們將根據本集團的資源及業務策略，適時
繼續推動CBT-006的臨床發展。

2.3. 臨床前階段候選藥物
CBT-277是一種複方眼藥水，旨在同時治療蒸發性及缺水型乾眼症。其特性與CBT-358
相似，CBT-277可作為該更先進候選藥物的備用方案。我們已完成所有必要的臨床前研
究，並可能視需要展開關於在美國進行臨床試驗的討論。
CBT-007是一種多激酶抑制劑，目前正作為輔助療法進行開發，旨在改善青光眼濾過手
術的治療成效。現行護理標準雖採用抗代謝藥物，但此類藥物可能影響傷口癒合及眼部
健康。CBT-007針對能預防術後瘢痕形成與纖維化的路徑，從而減少或消除對這些較舊
式、具細胞毒性的藥物的需求。CBT-007目前處於製劑開發階段，待準備就緒後將進行
藥代動力學及毒理學研究。
CBT-011是一種抗體藥物偶聯物，正在開發用於治療糖尿病黃斑水腫。糖尿病黃斑水腫
是糖尿病的一種嚴重併發症，會導致視網膜血管滲漏液體至中央視網膜，進而造成中央
視力永久性下降。玻璃體內注射的抗血管生成藥物雖是治療糖尿病黃斑水腫的主要手
段，但多達50%的病例會對治療產生抗藥性。透過運用我們的專有技術平台，CBT-011
能在單次注射中發揮兩種抗血管生成藥物的雙重功效，預期不僅能有效治療糖尿病黃斑
水腫，更能克服疾病發展為治療抗藥性的潛在風險。根據Delveinsight的數據，全球糖
尿病黃斑水腫市場規模超過40億美元。我們目前正在動物模型中探索CBT-011的應用方
案，以驗證其概念，隨後將進入人體安全性試驗階段。
CBT-145是我們用於治療老花眼的CBT-199項目的備用方案。這是一種新化學實體，旨
在透過作用於膽鹼能受體來縮小瞳孔，從而增加焦點景深以改善近視力，同時保留遠視
力。實際上，CBT-145與CBT-199能讓那些依賴眼鏡才能獲得清晰近距離視力的人擺脫
對眼鏡的依賴。鑑於我們已於安全性審查完成後獲得美國藥管局批准，可就 CBT-199
進行第2期臨床試驗，因此 CBT-145 暫時被降為次要優先級，直至有需要重新啟動其開
發為止。

19

2.4. 管線發展概要
下圖概述及闡述於2026年6月30日各候選藥物的開發狀況：
技術

多激酶抑制劑
（血小
板衍生生長因子
受體、血管內皮生長
因子受體、成纖維細
胞生長因子受體、
及╱或乙型轉化生長
因子）

臨床前

第1期

第2期

第3期

候選藥物

適應症

商業可用性

專利狀態

臨床試驗部門

監管途徑

狀態

CBT-001

療翼狀胬肉（充血、
症狀、大小）

全球（不包括中國
及日本）

美國、歐盟
（
「歐盟」
）
、中國、
日本
（
「日本」
）
、澳大利亞
（
「澳
大利亞 」
）
、巴西、加拿大
（
「加
拿大」
）
、韓國
（
「韓國」
）
、墨西
哥、香港、台灣及印度已獲批。
澳大利亞、歐盟、日本、韓國、
香港、美國、墨西哥及巴西
待批

美國藥管局
國家藥監局

美國藥管局 505(b)(2)
國家藥監局化學藥物
申請

首次多地區臨床試驗
結果預計於 2026年
第三季度公佈

CBT-004

翼狀胬肉（充血，
症狀）

全球

美國、澳大利亞、韓國、加拿大、
日本、墨西哥已獲批。
其他地區（
「其他地區」
）待批

美國藥管局
國家藥監局

美國藥管局 505(b)(2)
國家藥監局化學藥物
申請

就第 3 期試驗設計與美國
藥管局達成協議

CBT-007

青光眼

CBT-009
（毒蕈鹼受體拮抗劑）

兒童進行性近視

全球

美國、日本及歐盟已獲批。
其他地區待批

CBT-199
（副交感神經性縮
瞳劑）

老花眼

全球

待批

根據 505(b)(2) 途徑在美國無須
進行第 1 期

CBT-358
（瞬態
受體電位蛋白 8）
激動劑

缺水乏型 PLUS蒸發性
乾眼症

全球

待批

根據 505(b)(2) 途徑在美國無須
進行第 1 期

CBT-145

老花眼
（CBT-199的備份）

全球

美國已獲批。其他地區待批

CBT-199 結果待定

CBT-277

蒸發性及房水
缺乏性乾眼症

全球

待批

已完成所有必要的臨床前
研究

（抗體藥物協同作用） 糖尿病性黃斑水腫╱
老年黃斑病變

全球

待批

評估配方合作夥伴

瞼板腺功能異常相關
的乾眼症

全球

美國、日本已獲批。
其他地區待批

因優先順序變更，
第 2b 期研究暫停

根據 505(b)(2) 途徑在美國無須進行第 1 期

根據 505(b)(2) 途徑在美國無須進行第 1 期

美國、日本、
澳大利亞及印度已獲批。
其他地區待批

全球

待優先順序調整的概念
驗證評估

根據 505(b)(2) 途徑在美國無須進行第 1 期

美國藥管局

美國藥管局 505(b)(2)

新藥臨床試驗申請已提交
及已被美國藥管局接納
進行III期臨床試驗

美國藥管局
國家藥監局

美國藥管局 505(b)(2)
國家藥監局化學藥物
申請

新藥臨床試驗申請已提交至
美國藥管局進行 II 期
臨床試驗

SFA+ 給藥

ADS
（抗體藥物協同
作用）

膽固醇溶解劑

CBT-006

潛在臨床製劑的毒性
評估正在進行中

附註： 誠如本公司於2026年7月17日發布之公告所披露，美國藥管局已完成對該新藥臨床試驗申請的安全
性審查，並未對CBT-358擬進行之臨床試驗提出異議。因此，截至本公告日期，上表中有關CBT358之資訊已修訂如下：－

技術

候選藥物

適應症

商業可用性

專利狀態

SFA+ 給藥

CBT-358
（瞬態
受體電位蛋白 8）
激動劑

缺水乏型 PLUS 蒸發性
乾眼症

全球

待批

臨床前

第1期

根據 505(b)(2) 途徑在美國無須
進行第 1 期

第2期

第3期

臨床試驗部門

監管途徑

狀態

美國藥管局

美國藥管局 505(b)(2)

就第 3 期試驗設計與
美國藥管局達成協議

警告：本集團無法保證任何核心產品或任何其他候選藥物最終將可成功開發及上市。股
東及潛在投資者於買賣股份時須審慎行事。

20

3.

生產設施
我們已在中國蘇州市建立自身的試生產設施，總建築面積為1,226.43平方米，其設計符合美
國、中國及歐洲聯盟的良好生產規範標準，將支持我們的全球臨床試驗。我們於2023年5月
獲得位於中國蘇州一幅地盤面積為33,332.9平方米土地的土地使用權。我們目前正就土地使
用權的事宜與相關政府機關進行磋商。有關詳情，請參閱招股章程「業務－製造－蘇州生產
設施」及「業務－土地及物業」各段，以及本公司截至2025年12月31日止年度年報「管理層討論
與分析－I.業務回顧－3.生產設施」一段。

4.

商業化

CBT-001
待監管機構批准後，我們預計將在約四年內（即2030年前）於美國市場推出CBT-001。同時，
我們將評估商業化方案，同時最大限度地發揮我們專有技術及資產，作為我們投資組合的一
部分。鑑於翼狀胬肉及結膜充血患者數目眾多，且市場競爭有限，我們預期CBT-001上市後
將有巨大市場機會及可觀收益。
我們已針對市場機遇開展深入調查，涵蓋潛在患者人數、藥物納入醫療管理或保險覆蓋的可
能性，以及醫生開具CBT-001處方的意願。現有研究表明，美國可能罹患翼狀胬肉的病者人
數龐大，其規模與青光眼市場相當，但當前及可預見的未來在治療方面均無直接競爭。我們
亦觀察到眼科醫生對開具該藥物的極大興趣，以及醫療管理機構以合理價格提供保險覆蓋的
意願。
為了將CBT-001推向市場，我們正評估由本集團獨自完成，或與大型專注於眼科的公司合
作，以達到最佳成效。我們目前正與潛在商業合作夥伴積極討論，並將根據所提供的價值評
估每個機會。
在此過程中，我們正在與關鍵意見領袖及專業組織建立關係，這些關係將在未來幫助傳遞
CBT-001的價值及其可能為翼狀胬肉患者帶來的益處發揮重要作用。我們亦開展了社交媒體
活動，以提高處方醫生及患者對這種疾病的認識。

21

就大中華區而言，我們已於2020年4月與遠大醫藥訂立遠大醫藥許可協議，向遠大醫藥授出
生產和商業化CBT-001的獨家、可轉授權、含專利權費的許可，該許可適用於CBT-001的所
有人類用途。此外，就亞太地區而言，我們於2024年8月與參天訂立一項獨家許可協議，涵
蓋日本、韓國、越南、泰國、馬來西亞、新加坡、菲律賓及印尼，以開發、生產及商業化含
有尼達尼布的產品，包括CBT-001。
我們亦計劃於我們的兩項第3期研究中的第一項結果可用後，於2026年晚些時候與歐洲及其
他地區的商業合作夥伴訂立類似授權安排。

CBT-009
我們亦計劃於第3期CBT-009臨床試驗開始後，在亞洲、歐洲及日本的部分地區進行商業化
合作。我們將專注於支持商業合作夥伴通過關鍵意見領袖教育及會議演講等方式，提升市場
對我們SFA+配方益處的認知。
5.

合作及許可安排
於2026年6月30日，我們已訂立以下許可協議以促進產品的開發及商業化，尤其是我們最成
熟的核心產品CBT-001：

遠大醫藥許可協議
於2020年4月13日，我們與遠大醫藥訂立遠大醫藥許可協議，據此，我們向遠大醫藥授出
在大中華區生產及商業化CBT-001的獨家、可轉授權、含專利權費的許可，該許可適用於
CBT-001的所有人類用途（包括預防翼狀胬肉惡化和減少結膜充血）。然而，我們保留申請新
藥申請的權利及預期將成為CBT-001的市場授權持有人。
儘管訂立遠大醫藥許可協議，惟我們於所有重大方面對CBT-001擁有實際控制權，不論在大
中華區境內或境外，(i)我們負責CBT-001的所有開發活動，包括進行臨床前研究，及委聘及
監督合約研究機構及合約開發和製造機構，以協助我們進行CBT-001的臨床試驗；及(ii)我
們籌備、提交及存置監管備案，與監管部門溝通及以我們的名義取得CBT-001的監管批准
（如我們就分別於美國及中國進行第3期多地區臨床試驗取得美國藥管局及國家藥監局的批
准）。

22

參天許可協議
我們亦於2024年8月6日與參天訂立參天許可協議，據此，我們向參天授予一項獨家、收費、
里程碑式及含專利權費的許可，以：(a)開發、生產及商業化任何含有尼達尼布作為單一或
其中一種活性藥物成分（包括但不限於CBT-001）
（「該產品」）及╱或尼達尼布用於局部治療與
翼狀胬肉、瞼裂斑及由參天與我們在日本、韓國、越南、泰國、馬來西亞、新加坡、菲律賓
及印尼（統稱「該區域」）以書面形式共同協定的任何其他適應症（「該領域」）相關的眼科疾病的
體徵及╱或症狀的任何藥物產品；及(b)於該區域外開發及生產尼達尼布，但僅用於在該區
域內將該產品在該領域商業化。
上文第(a)項下授出的許可在該區域具有排他性，即使對我們而言也是如此，惟我們保留在
該區域進行或已進行任何開發及╱或生產活動的非排他性權利，僅用於在該區域外將該產品
商業化，且須經參天同意。上文第(b)項下授出的許可並無排他性。
應參天的要求，我們可能與參天就訂立商業供應安排進行真誠的討論，據此，我們可能向參
天供應CBT-001，供參天在該區域內該領域進行商業化工作。該潛在商業供應安排的詳情將
載於另行一份協議中。
6.

知識產權
作為一間臨床階段的眼科生物科技公司，我們非常重視維護及保護知識產權。
於2026年6月30日，我們有(a) 82項獲授專利，其中23項在美國，3項在中國及56項在其他司
法權區；及(b) 186份待授專利申請，其中20份在美國，15份在中國及151份在其他司法權
區。
於2026年6月30日，我們的核心產品CBT-001於全球有58項獲授專利及59份待授專利申請，
以及核心產品CBT-009於全球有5項獲授專利及33份待授專利申請。

23

7.

人力資源
於2026年6月30日，我們共有61名全職僱員，其中32名位於中國，11名位於美國，17名位於
香港及1名位於瑞典。
職能

8.

僱員人數

管理
研發
製造
質量控制及質量保證
行政

6
17
5
10
23

總計：

61

研究及開發
我們相信，研發對於眼科候選藥物在不同開發階段取得成功至關重要，而我們已建立涵蓋眼
睛前部及後部主要疾病的創新候選藥物管線。在該管線中的所有候選藥物均為自主研發，我
們相信該等藥物有潛力成為同類首創或同類最佳療法，以解決全球眼科藥物市場尚未滿足的
醫療需求。

研發能力及基礎設施
我們已建立強大的研發能力，以把握全球眼科醫藥市場的潛力。我們的研發業務由位於美國
及中國的三個戰略性研發中心提供支持，使我們能夠在多個司法權區開展臨床試驗，並最大
限度地發揮產品在全球市場的商業潛力。
於2026年6月30日，我們的研發團隊由21名經驗豐富的專業人士組成，其中包括4名來自高級
管理層的成員及17名來自專責研發部門的成員。團隊成員中有6名擁有碩士或以上學位，當
中4名擁有博士學位。我們的團隊由來自全球眼科公司及知名研究機構且經驗豐富的專業人
士領導，彼等擁有數十年藥物研發及創業經驗。

24

專有技術平台
我們的研發策略以兩個專為眼科藥物開發而設的專有技術平台為基礎，即MKI平台及ADS平
台，分別用於開發治療眼睛前部及後部疾病的候選藥物。MKI平台及ADS平台各自分別以開
發小分子藥物以及抗體與小分子藥物的偶聯物為目標。該兩個技術平台的結合提供了涵蓋多
種眼科疾病的全面解決方案。
9.

前景
作為一家臨床階段的眼科生物技術公司，我們致力於開發及商業化一系列眼部疾病的創新療
法。展望未來，我們的主要重點是推進我們的藥物管線，增強我們的專有技術平台，並為我
們核心產品的潛在商業發布做好準備。
我們計劃實施以下策略以達致我們的長期願景：
•

加速候選藥物管線在全球市場的臨床開發；

•

繼續加強研發能力，開發技術平台及模式，支持我們的管線擴展；

•

為候選藥物量身定制多元化的商業化戰略；及

•

擴大組織規模，打造國際平台。

作為一間臨床階段、產品尚待商業化的眼科生物科技公司，本集團於過去數年已錄得重大淨
虧損，並預期在可預見的未來將繼續錄得淨虧損，且無法保證我們將實現或維持盈利。誠如
本公司自上市日期以來發布的各項自願公告及本公告所披露，若干在研管線（包括但不限於
CBT-001、CBT-004及CBT-358）已取得重大進展。當本集團推進至CBT-004的第三期臨床開
發階段時，臨床試驗費用將急劇上升。
藥物開發涉及漫長且昂貴的過程，本集團可能需要調整臨床試驗工作計劃，以取得監管批准
並將該等候選藥物推向市場。此外，為強化本集團的技術平台，預期臨床研究費用亦可能進
一步增加。此類研發費用的增加可能對本集團的財務狀況造成負面影響。
自上市以來，本集團亦投入更多資源處理合規事宜及審核工作。預計未來合規成本將持續增
加，以確保本集團能符合相關法律及監管要求。

25

儘管如此，本集團將竭盡所能實現上述長期願景，並妥善運用資源以支持本集團的發展。
展望未來，本集團將透過與國際及本地生物製藥公司及學術機構建立戰略合作，涵蓋研發活
動及商業化安排，持續執行其全球增長戰略。與此同時，本集團將積極探索合適的商業化策
略，以加速進入市場、優化資本效率並最大化資產價值。預期上述各項舉措將共同鞏固本集
團作為全球領先眼科製藥企業的地位，提升其營收潛力，並擴大本集團整個產品管線的長期
商業機會。
10. 法律及仲裁程序
於2025年8月11日，Cedar Wealth向汕尾仲裁委員會針對本公司及撥康視雲廣州提起仲裁程
序（「仲裁程序」），聲稱有若干未付服務費及其他支出，總額約為2.05百萬美元，另加利息及
訴訟費用。就該仲裁程序而言，於2025年12月24日，根據Cedar Wealth透過法律程序提出申
請（「法律程序」，連同仲裁程序稱為「該等程序」），廣州市黃埔區人民法院作出裁定，對撥康
視雲廣州的銀行賬戶及其中的現金結餘實施司法保全（「資產保全令」）。
於2026年1月15日，Cedar Wealth、本公司及撥康視雲廣州等各方簽訂和解協議，據此，本
公司向Cedar Wealth支付總額約2.22百萬美元的和解款項，作為該等程序之完全及最終解
決。該資產保全令及仲裁程序已分別自2026年1月22日及2026年1月23日起終止。
有關進一步詳情，請參閱本公司分別於2026年1月7日、2026年1月15日、2026年1月29日及
2026年1月30日刊發的公告。
除上文所披露者外，截至2026年6月30日及本公告日期，本公司及其任何附屬公司均未涉及
任何重大訴訟、仲裁或申索，且據本公司及董事所知，本集團亦未面臨或可能面臨任何重大
訴訟、仲裁或索賠。

26

II. 財務回顧
收益
本集團是一間臨床階段眼科生物科技公司。本集團目前並無獲批作商業銷售的藥品，於報告期
間亦無從藥品銷售中產生任何收益（過往期間：無）。
其他收入
其他收入主要指本集團研發活動所獲得中國蘇州地方政府的政府補助。本集團於報告期間及過
往期間並無於中國蘇州獲得大額政府補助。因此，於報告期間，本集團獲得的補助金額維持穩
定，與過往期間相比基本持平。
其他收益或虧損淨額
其他收益主要包括按公平值計入損益的金融資產贖回收益，而其他虧損主要包括按公平值計入
損益的金融資產公平值變動及外匯虧損淨額。於報告期間，由於本集團將其於中國之美元存款
兌換為人民幣以應付日常營運需要，因此產生外匯虧損淨額。
一般及行政開支
於報告期間，一般及行政開支主要包括(i)僱員福利開支，包括由薪金、花紅、退休金及福利與
管理層及行政人員以股份為基礎的薪酬組成的員工成本)；(ii)支付予顧問及其他專業機構的法
律及專業費用；(iii)核數師酬金；(iv)物業、廠房及設備以及使用權資產的折舊；(v)短期租賃相
關開支；及(vi)其他開支。於報告期間的一般及行政開支較過往期間增加乃由於本集團於上市後
產生較多法律及專業服務費用。此外，由於本集團自2025年2月起增聘僱員，相關員工成本持續
產生，因此行政人員薪金及以股份為基礎的付款開支於報告期間較過往期間有所增加。同時，
於2025年5月及2025年6月授予行政人員的股份獎勵，相關費用自各授出日期起於歸屬期間內攤
銷；因此，相較於過往期間僅涵蓋自各授出日期起的部分期間，報告期間涵蓋了完整六個月期
間向該等行政人員支付的全部以股份為基礎的付款。因此，整體開支於報告期間有所增加。

27

研發開支
於報告期間，研發開支主要包括：(i)臨床研究開支（主要包括就臨床試驗向合約研究機構及合約
開發和製造機構支付的服務費）、臨床試驗所用原材料及消耗品開支，以及其他雜項開支（如知
識產權註冊費及維護費）；及(ii)僱員福利開支，包括由薪金、退休金及研發人員以股份為基礎的
薪酬組成的員工成本。於報告期間的研發開支較過往期間增加乃由於本公司於報告期間向一名
顧問授出受限制股份單位。此外，本公司分別於2025年5月及2025年6月向研發人員授予股份獎
勵，相關費用自各授出日期起於歸屬期間內攤銷；因此，相較於過往期間僅涵蓋自各授出日期
起的部分期間，報告期間涵蓋了完整六個月期間該等研發人員的相關以股份為基礎的付款。
下表載列於所示期間按核心產品及其他候選藥物及其各自佔臨床研究開支總額百分比劃分的臨
床研究開支明細：

截至6月30日止六個月
2026年
千美元
核心產品
– CBT-001
– CBT-009
其他候選藥物
總計

%

2025年
千美元

%

8,950
71
1,820

82.5
0.7
16.8

8,200
223
787

89.0
2.4
8.6

10,841

100.0

9,210

100.0

CBT-001的臨床研究費用略有增加，原因是進行第二次第3期臨床試驗的準備及籌備工作產生了相
關成本，其中包括試驗用產品、設備及研究文件等試驗前準備工作。此外，本集團於2025年10月
22日向一名顧問授予受限制股份單位，其中部分績效條件與CBT-001相關。該項以股份為基礎的
付款支出已計入CBT-001的臨床研究費用中。
與過往期間相比，CBT-009的臨床研究開支於報告期間進一步減少，原因是誠如本公司於2026
年5月22日的公告所披露，本集團已決定自願撤回CBT-009的新藥臨床試驗申請，因為本集團認
為，鑑於各地區的監管要求不同，可能難以將中國納入多地區臨床試驗。鑒於上述情況，本集
團正重新評估臨床發展策略，並決定現階段不會在臨床研究方面投入大量資源。因此，CBT-009
相關臨床研究開支有所減少。

28

至於其他候選藥物，臨床研究開支主要與CBT-004有關。CBT-004的第2期臨床試驗已於2025年
初完成，而本集團於報告期間在中國展開了毒性研究。此外，本集團於2025年10月22日向一名
顧問授予受限制股份單位，其中部分績效條件與 CBT-004 相關，該部分亦構成CBT-004的臨床
研究開支的一部分。
財務收入
於報告期間及過往期間，財務收入包括定期存款利息收入。於報告期間的財務收入減少乃由於
本集團已動用存款賬戶中的資金用於研發活動及日常營運，導致銀行存款金額減少。
財務成本
於報告期間，財務成本主要包括銀行借款利息開支及租賃物業（包括實驗室及辦公室）的租賃負債
利息開支。由於本集團於報告期間提取了銀行借款（過往期間：無），故該金額有所增加。
流動資金及資本資源
於報告期間，本集團以銀行借款產生的現金流入撥付營運所需。截至2026年6月30日，本集團的
現金及現金等價物為約32.7百萬美元，而截至2025年12月31日則為約40.2百萬美元。本集團會監
控及維持足以支持其業務營運的現金及現金等價物水平。
截至2026年6月30日，本集團的未動用銀行融資為約66.4百萬美元，且均無限制。本集團預計未
來可用於撥付營運所需的銀行融資及全球發售所得款項淨額不會有任何變動。
借款及資產負債比率
截至2026年6月30日，本集團的計息銀行借款合計為約6.0百萬美元（2025年12月31日： 0.4百萬
美元）。
資產負債比率按流動負債和非流動負債的總和，除以資產總額再乘以100%計算。截至2026年6月
30日，本集團的資產負債比率為22.4%，而截至2025年12月31日則為9.2%。該增幅主要由於提取
銀行借款。

29

租賃負債
本集團就所有租賃確認使用權資產及相關租賃負債，惟短期租賃及低價值資產租賃除外。租賃
負債由2025年12月31日的0.3百萬美元增加至2026年6月30日的0.4百萬美元，主要由於租期續
約。
資本承擔
截至2026年6月30日及2025年12月31日，本集團並無任何資本承擔。
或然負債
截至2026年6月30日，本集團並無任何重大或然負債、擔保，亦無任何針對本集團任何成員公司
且可能對本集團業務、財務狀況或經營業績造成重大不利影響之待決或潛在訴訟或申索。
資本開支
於報告期間，本集團資本開支主要包括購買物業、廠房及設備以及無形資產。於報告期間及過
往期間的資本開支分別約為26,000美元及120,000美元。
重大投資
本集團於報告期間並無作出任何重大投資 。此外，截至本公告日期，除招股章程及截至2025年
12月31日止年度之本公司年報所披露者外，本集團並無計劃重大投資或添置重大資本資產。
重大收購及出售
於報告期間，本集團並無任何重大收購或出售附屬公司、聯營公司或合營企業。
融資及庫務政策
本集團在融資及庫務政策方面採取審慎的方針，旨在維持最佳財務狀況、穩定融資成本及將財
務風險降至最低。本集團的現金及現金等價物主要存放於信貸風險較低的金融機構。本集團定
期檢討其資金需求，以維持充足的財務資源，用以支持其業務營運、研發活動，以及任何未來
的投資與擴張計劃。現金僅投資於相對流動性高且風險較低的工具。

30

外匯風險及對沖
本集團的財務報表以美元列示，惟本公司於其他國家或地區營運的附屬公司以其他貨幣進行交
易。這使本集團面臨外幣風險，可能影響本集團的財務狀況及經營業績。本集團目前並無持有
任何金融工具作對沖用途。本集團透過密切監察外幣匯率變動管理貨幣風險，並在有需要時考
慮對沖重大外幣風險。
資產抵押
截至2026年6月30日，本集團已將其約1.6百萬美元的使用權資產及約4.2百萬美元的銀行存款作
為質押，以擔保授予本集團的銀行信貸額度。
重大投資及資本資產的未來計劃
除本公告披露者外，截至2026年6月30日，本集團並無任何重大投資或添置重大資本資產計劃。
僱員及薪酬
截至2026年6月30日，本集團共有61名僱員（2025年6月30日：60名僱員）。本集團於報告期間產
生的薪酬成本總額為31.8百萬美元，而過往期間則為18.9百萬美元。
本集團致力制定具有競爭力且公平的薪酬，從而促進本集團取得成功。為有效激勵僱員，本集
團透過市場調查持續完善其薪酬及獎勵政策。本集團每年對僱員進行表現評估，就其表現給予
反饋及考慮對彼等的薪酬作出任何適當調整。員工薪酬一般包括基本薪金及按表現釐定的酌情
花紅。
本公司亦採納股權激勵安排，為其僱員提供激勵。

中期股息
董事會不建議派付本報告期間的中期股息（過往期間：無）。

31

全球發售所得款項用途
隨著股份於2025年7月3日在聯交所上市，全球發售所得款項淨額（經扣除專業費用、包銷佣金及全球
發售產生的其他相關成本及開支後）約為524.6百萬港元（「所得款項淨額」）。
該等所得款項淨額已根據招股章程及於2026年3月31日刊發的截至2025年12月31日止年度的年報所載
的分配方案予以運用，以及本公司於2026年5月22日發布之公告（「所得款項用途變更公告」）所載之後
續所得款項淨額用途變更。
誠如所得款項用途變更公告所披露，鑒於本集團已決定自願撤回就CBT-009於中國可能進行的第3
期臨床試驗所提交的新藥臨床試驗申請，以避免研發風險並更有效地集中本集團的資源，原分配予
CBT-009的約103.6百萬港元，在近期將無需動用。原分配予CBT-009的餘下資金將保留，用以資助
一項由研究人員發起的臨床試驗，以評估CBT-009眼藥水在其他適應症上的安全性及療效，該試驗
計劃於2026年第四季展開。與此同時，正在進行的臨床研發活動有更迫切的資金需求，包括研發人
員及研發活動的成本及開支，以及CBT-001、CBT-004、CBT-358和CBT-277的註冊備案及獲批後研
究。行政開支及其他一般成本預計將相應增加。
鑒於上述情況，董事會決議將原指定用於CBT-009的約103.6百萬港元重新分配如下：
•

將31.8百萬港元重新分配用於CBT-001及CBT-004的持續臨床研發活動，包括研發人員及研發活
動的成本及開支，以及註冊備案及獲批後研究；

•

將42.9百萬港元重新分配用於CBT-358及CBT-277的持續臨床研發活動，包括研發人員及研發活
動的成本及開支，以及註冊備案及獲批後研究；及

•

將28.9百萬港元重新分配用於本集團營運資金及其他一般企業用途。

經修訂的所得款項用途亦整合了分別分配予(i) CBT-001及CBT-004，以及(ii) CBT-009、CBT-358及
CBT-277的所得款項淨額，上述項目均採用相同的專有技術平台。此舉使本公司能更有效率地運用
未動用所得款項淨額，因為採用相同專有技術平台的產品可共享研發成果及投入資源，從而產生互
利共贏的協同效應。

32

倘若上述用途暫時無需動用所得款項淨額，或本公司無法如期落實其發展計劃的任何部分，則本公
司僅會將該等資金存放於持牌商業銀行及╱或其他獲授權金融機構（定義見證券及期貨條例或其他司
法管轄區的適用法律及法規）的短期計息賬戶內。
下表載列截至2026年6月30日所得款項淨額分配及預期動用時間表：

所得款項用途

自2026年1月1日
自所得款項
至所得款項
用途變更公告
招股章程所披
截至
用途變更 所得款項用途 於重新分配後 所述重新分配至
露的所得款項 2025年12月31日
公告日期的 變更公告所述的 尚未動用的所 2026年6月30日
淨額 尚未動用的金額
已動用金額
重新分配
得款項淨額 的已動用金額
（百萬港元） （百萬港元） （百萬港元） （百萬港元） （百萬港元） （百萬港元）

截至2026年
6月30日尚未
動用的金額
（百萬港元）

尚未動用所得
款項淨額預期
時間表

撥付CBT-001及CBT-004的持續臨床研發活
動（包括研發人員及研發活動的成本及開
支），以及註冊備案及獲批後研究所需資
金

327.4
（僅適用於
CBT-001）

230.3
（僅適用於
CBT-001）

(36.9)
（僅適用於
CBT-001）

31.8

225.2

(16.9)

208.3

2027年年底之前

撥付CBT-009、CBT-358及CBT-277的持續
臨床研發活動（包括研發人員及研發活動
的成本及開支），以及註冊備案及獲批後
研究所需資金

144.8
（僅適用於
CBT-009）

118.4
（僅適用於
CBT-009）

(0.1)
（僅適用於
CBT-009）

(60.7)

57.6

(3.8)

53.8

2027年年底之前

撥付生產設施及商業化活動所需資金

28.8

0.9

–

–

0.9

–

0.9

2031年年底之前

營運資金及其他一般企業用途

23.6

1.3

(1.3)

28.9

28.9

(12.8)

16.1

2026年年底之前

524.6

350.9

(38.3)

–

312.6

(33.5)

279.1

附註： 任何表格所示總額與所列數值總和之間的差異均由約整引致。

於報告期間，本公司與獨立第三方ARC Group International Limited（「ARC」）訂立日期為2026年6月
18日之認購協議，據此，本公司有權發行，而ARC則有權認購總額不超過15.0百萬美元之本公司股
份。截至本公告日期，根據認購協議，本公司尚未發行任何股份，亦未因此產生任何所得款項。詳
情請參閱本公司於2026年6月18日發布的公告。

33

上市規則第13.51(2)及13.51B(1)條項下的董事資料變動
於報告期間內及截至本公告日期，概無有關董事會成員及首席執行官的變動或有關董事及首席執行
官資料的變動須根據上市規則第13.51(2)及13.51B(1)條予以披露。

購買、出售或贖回本公司上市證券
於報告期間內，本公司或其任何附屬公司均無購買、贖回或出售任何本公司上市證券。

企業管治常規
本公司致力維持高水平的企業管治，以保障股東權益，提升企業價值並加強問責。自上市日期以
來，本公司已採納企業管治守則作為其本身的企業管治守則，並已遵守企業管治守則所載所有適用
守則條文，惟以下除外：
根據企業管治守則守則條文第C.2.1條，上市發行人應遵守但可選擇偏離有關主席與主要行政人員職
責應有區分且不應由同一人兼任的規定。本公司並無區分主席與首席執行官，目前由Ni博士兼任兩
職。董事會認為，鑒於Ni博士的經驗、個人履歷、其對業務的廣泛了解及其於本公司擔任的職位，
Ni博士是物色策略機會及作為董事會核心的最佳人選。董事會亦認為，由同一人兼任主席與首席執
行官有以下益處：(i)確保本集團內部統一領導；(ii)使董事會各項措施的整體策略規劃及執行更有效
及更具效率；及(iii)促進管理層與董事會之間的信息交流。董事會認為，現行安排不會損害權力及職
權的平衡，該架構將使本公司更為迅速且有效地作出決策並予以執行。董事會將持續進行檢討，並
會在顧及本集團整體情況後考慮適時將主席與首席執行官的角色區分。
除上文所披露者外，截至本公告日期以及據董事經作出一切合理查詢後所知、所悉及所信，董事並
不知悉於報告期間內及截至本公告日期任何偏離企業管治守則守則條文的情況。

34

董事進行證券交易的標準守則
自上市日期起，本公司亦採納標準守則作為其本身的證券交易守則，適用於全體董事及高級管理人
員。
經具體查詢後，各董事確認，於報告期間內及截至本公告日期，彼等已嚴格遵守標準守則所載的規
定標準。

審核委員會
本公司已成立審核委員會（「審核委員會」），且根據上市規則訂有書面職權範圍。截至本公告日期，
審核委員會由四名董事組成，即馬遙豪先生、聶四江女士、Li Jun Zhi博士及李朝昌先生。馬遙豪先
生當前擔任審核委員會主席，彼具備適當的會計或相關財務管理專業知識，符合上市規則第3.10(2)
條及第3.21條的規定。審核委員會的主要職責為審閱及監察本集團的財務報告程序、風險管理及內部
控制系統、審閱本集團的財務資料、向董事會提供意見及建議，以及履行董事會可能指派的其他職
責及責任。
本公告所載本集團於報告期間的未經審核簡明綜合中期財務資料尚未由本公司獨立核數師審閱或審
核，但已由審核委員會審閱，並認為有關財務資料及本公告乃根據適用會計準則及相關規定編製，
且已根據上市規則及適用法律規定作出充分披露。審核委員會亦已討論有關本公司於報告期間所採
納會計政策及慣例的事宜。

刊發中期業績公告及中期報告
本公告刊登於聯交所網站(www.hkexnews.hk)及本公司網站(https://cloudbreakpharma.com/)。本報
告期間的中期報告載有上市規則規定的所有資料，將適時寄發予股東並將刊載於聯交所及本公司網
站。

致謝
董事會謹此向股東、管理團隊、僱員及本集團業務夥伴對本集團的支持及貢獻致以誠摯謝意。

35

詞彙
「2023年股權激勵計劃」

股東於2025年3月14日批准及採納的股權激勵計劃（經不時修訂），其主要
條款概要載於招股章程附錄四「法定及一般資料－ D.股權激勵安排-3.2023
年股權激勵計劃」

「活性藥物成分」

活性藥物成分，藥品所含具有生物活性的物質

「ADS」或「ADS平台」

本公司開發的抗體藥物協同作用或抗體藥物協同作用平台，為本集團開發
的一項創新技術，通過將抗體藥物與小分子藥物綴合，採用一種專為在玻
璃體中以受控方式酶促水解而設計的聯接頭，以提高玻璃體內施用藥物的
有效性或延長藥效持續時間

「ADS USA」

ADS Therapeutics LLC，一間最初於2017年1月16日在美國內華達州組建
的有限公司，隨後於2020年11月16日轉換為在美國特拉華州的有限公司，
為本公司全資附屬公司

「同類最佳」

一類藥物中具有最佳臨床優勢的藥物

「藥審中心」

國家藥品監督管理局藥品審評中心

「合約開發和製造機構」

合約開發和製造機構，以合約方式為其他公司提供全面藥物開發及製造服
務的公司

「企業管治守則」

上市規則附錄C1

「主席」

董事會主席

「首席執行官」

本公司首席執行官

「撥康視雲廣州」

撥康視雲生物醫藥科技（廣州）有限公司（前稱撥雲生物醫藥科技（廣州）有限
公司），一間於2018年9月30日在中國成立的公司，並為本公司間接全資附
屬公司

36

「Cloudbreak USA」

Cloudbreak Therapeutics LLC，一間於2015年9月14日在美國加州註冊成立
的公司，並為本公司全資附屬公司

「核心產品」

具有上市規則第18A章賦予的涵義；就本公告而言，核心產品指CBT-001
及CBT-009

「合約研究機構」

合約研究機構，以合約形式提供一系列專業研究服務的公司

「可換股可贖回優先股」

本公司可換股可贖回優先股

「Ni博士」

Ni Jinsong博士，主席、執行董事、首席執行官兼本集團聯合創始人

「糖尿病黃斑水腫」

糖尿病黃斑水腫，糖尿病的一種併發症，由於視網膜上的黃斑細胞外空間
積聚過多液體，患者在一定程度上喪失中心視力

「乾眼」

一種與淚液分泌量不足有關的狀況，特徵為眼睛發紅、瘙癢及灼熱

「股權激勵安排」

系列B股權激勵安排、系列C股權激勵安排、2023年股權激勵計劃及首次
公開發售後股權激勵計劃

「執行董事」

本公司執行董事

「弗若斯特沙利文報告」

由我們委託弗若斯特沙利文並由其就招股章程編製的獨立市場研究報告

「美國藥管局」

美國食品及藥物管理局

「聯邦食品、
藥品和化妝品法案」

聯邦食品、藥品和化妝品法案

「成纖維細胞生長
因子受體」

成纖維細胞生長因子受體，酪氨酸激酶受體家族的一個子組的跨膜蛋白質

「同類首創」

使用全新獨特的作用機理治療疾病的藥物

「青光眼」

一組眼科疾病，通常以視神經結構和功能逐漸改變為特徵，如不治療，會
導致典型的視盤外觀和視野損害

37

「全球發售」

香港公開發售及國際發售

「遠大醫藥」

遠大醫藥集團有限公司，一家在百慕達註冊的有限公司，其股份在聯交所
主板上市（股份代號：512）

「大中華區」

中國、香港、中國澳門特別行政區及台灣

「本集團」

本公司及其所有附屬公司，或（按文義所指）就本公司成為其現時附屬公司
的控股公司前之期間，由該等附屬公司或其前身公司（視乎情況而定）經營
的業務

「港元」

港元，香港的法定貨幣

「香港」

中華人民共和國香港特別行政區

「香港公開發售」

向香港公眾人士發售12,115,500股股份（經重新分配後調整）的認購要約，
發售價為每股10.10港元

「國際財務報告準則」

國際財務報告準則的會計準則，包括國際會計準則理事會頒佈的準則、修
訂及詮釋以及國際會計準則委員會頒佈的國際會計準則及詮釋

「新藥臨床試驗」

新藥臨床試驗，其申請是監管機構決定是否允許進行臨床試驗的藥物審批
過程的第一步（在中國亦被稱為「臨床試驗申請」）

「獨立非執行董事」

本公司的獨立非執行董事

38

「國際發售」

根據《1933年美國證券法》）
（經不時修訂）項下S規例或根據《1933年美國證
券法》）
（經不時修訂）項下任何其他可豁免登記規定，在美國境外以離岸交
易方式發售48,466,500股股份（經重新分配調整），發售價為每股10.10港元

「知識產權」

知識產權

「青少年近視」

5至19歲兒童及青少年近視

「關鍵意見領袖」

關鍵意見領袖，在特定領域擁有專業的產品知識和影響力，受到相關利益
群體信任，對消費者行為有重大影響的個人或組織

「上市」

股份於上市日期在聯交所主板上市

「上市日期」

2025年7月3日

「上市規則」

香港聯合交易所有限公司證券上市規則，經不時修訂或補充

「澳門」

中華人民共和國澳門特別行政區

「瞼板腺功能異常」

瞼板腺功能異常，瞼板腺的慢性瀰漫性異常，其特徵是終末管線阻塞以及
腺體分泌物的質或量的變化

「多激酶抑制劑」

多激酶抑制劑

「MKI平台」

多激酶抑制劑平台，採用選擇性多激酶抑制劑靶向血管內皮生長因子受體
（其次靶向血小板衍生生長因子受體及成纖維細胞生長因子受體）的技術平
台，治療涉及異常血管生成或血管分佈的眼部適應症，目前涉及的適應症
包括翼狀胬肉、瞼裂斑及青光眼濾過手術

「標準守則」

上市規則附錄C3載列之上市發行人董事進行證券交易的標準守則

「多地區臨床試驗」

多地區臨床試驗，按相同試驗設計在不同地區就全球同步開發新藥進行的
臨床試驗

39

「新藥申請」

新藥申請，新藥研發主辦人通過該申請正式建議相關監管機構批准新藥銷
售及上市

「國家藥監局」

國家藥品監督管理局及其前身國家食品藥品監督管理總局

「非執行董事」

本公司非執行董事

「標示外用藥」

以經批准包裝標籤中未指定的方式使用藥品

「眼科」

研究眼部結構、功能和疾病的醫學分支

「血小板衍生生長
因子受體」

血小板衍生生長因子受體，血小板衍生生長因子家族成員的細胞表面酪氨
酸激酶受體

「第1期臨床試驗」或
「第1期」

對健康人類受試者或出現目標疾病或狀況的患者給藥的研究，測試安全
性、劑量耐受性、吸收、代謝、分佈、排泄，並在可能情況下提早了解其
藥效

「第2期臨床試驗」或
「第2期」

對有限數量的患者群體給藥的研究，以確定潛在的不良反應及安全風險，
初步評估該藥物對特定目標疾病的有效性，並確定劑量耐受性及最佳劑量

「第3期臨床試驗」或
「第3期」

對地域分散的臨床試驗點的經擴大患者群體給藥的研究，以統計學方式產
生充足數據，以評估藥品的有效性及安全性以供監管審批，並為產品標籤
提供充分信息

「瞼裂斑」

一團淡黃色的隆起組織，生長在角膜附近的結膜上

「首次公開發售後股權
激勵計劃」

本公司於2025年3月14日採納的股權激勵計劃，其主要條款載於招股章程
附錄四「法定及一般資料－D.股權激勵安排－4.首次公開發售後股權激勵計
劃」

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「中國」

中華人民共和國，除文義另有所指外，就本公告及僅就地域參考而言，不
包括香港、澳門及台灣

「優先股」

本公司股本中每股面值0.0001美元的優先股，包括系列A優先股、系列B優
先股及系列C優先股

「老花眼」

一種眼部疾病，由於晶狀體屈光能力下降，患者難以看清近處物體

「過往期間」

截至2025年6月30日止六個月

「招股章程」

本公司為上市及香港公開發售（作為全球發售的一部分）而刊發的日期為
2025年6月24日的招股章程

「研發」

研究及開發

「人民幣」

中國法定貨幣

「報告期間」

截至2026年6月30日止六個月

「視網膜」

覆蓋眼球內側後部的薄層組織

「受限制股份單位」

受限制股份單位

「參天」

參天製藥株式會社，一間於日本註冊成立的有限公司，其股份於東京證券
交易所主要市場上市（股份代號：4536）

「系列B股權激勵安排」

Cloudbreak Cayman於2020年8月27日批准及隨後由本公司於2021年11月24
日批准的股權激勵安排，其主要條款概要載於招股章程附錄四所載「法定
及一般資料－D.股權激勵安排－1.系列B股權激勵安排」

「系列C股權激勵安排」

由本公司於2021年11月24日批准的股權激勵安排，其主要條款概要載於
招股章程附錄四「法定及一般資料－D.股權激勵安排－2.系列C股權激勵安
排」

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「SFA+」

半氟化烷烴與額外專有部分相結合

「證監會」

香港證券及期貨事務監察委員會

「證券及期貨條例」

香港法例第571章證券及期貨條例（經不時修訂、補充或以其他方式修改）

「股東」

股份持有人

「股份」

本公司股本中每股面值0.0001美元的普通股

「護理標準」

被醫學專家接受或廣泛用作某種疾病的適當及標準治療的一種治療

「聯交所」

香港聯合交易所有限公司

「台灣」

中華人民共和國台灣省

「TRPM8」

瞬態受體電位蛋白8

「美元」

美元，美國法定貨幣

「美國」

美利堅合眾國、其領土、屬地及受其司法管轄權管轄的所有地區

「血管內皮生長因子」

血管內皮生長因子，細胞產生的可促進血管形成的一種信號蛋白質

「血管內皮生長
因子受體」

血管內皮生長因子受體，酪氨酸激酶受體，負責與血管內皮生長因子結
合，啟動信號級聯，刺激血管生成等效應

「%」

百分比

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在本中公告中：(a)除非文義另有界定，詞彙應與招股章程中賦予其相同的涵義；及(b)除非文義另有
界定，「聯繫人」、「附屬公司」及「主要股東」應具有上市規則賦予該等詞彙的涵義。
承董事會命
撥康視雲製藥有限公司*
主席、執行董事兼首席執行官
NI Jinsong博士
香港，2026年8月31日

於本公告日期，董事會包括：(i)執行董事Ni Jinsong博士、Dinh Son Van先生及Yang Rong博士；
(ii)非執行董事Li Jun Zhi博士、曹旭先生及夏志東先生；及(iii)獨立非執行董事聶四江女士、馬遙豪先生
及李朝昌先生。
* 僅供識別

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