北海康成发布2026年中期业绩，收入增长但仍亏损并保留持续经营重大不确定性

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no responsibility for the contents of this announcement, make no representation as to its accuracy or
completeness and expressly disclaim any liability whatsoever for any loss howsoever arising from or in
reliance upon the whole or any part of the contents of this announcement.

CANbridge Pharmaceuticals Inc.
北海康成製藥有限公司
(Incorporated in the Cayman Islands with limited liability)
(Stock Code: 1228)

INTERIM RESULTS ANNOUNCEMENT
FOR THE SIX MONTHS ENDED JUNE 30, 2026
The board (the “Board”) of directors (the “Director(s)”) of CANbridge Pharmaceuticals Inc. (the
“Company”) is pleased to announce the unaudited condensed consolidated results of the Company and
its subsidiaries (the “Group”, “CANbridge”, “we”, “our” or “us”) for the six months ended June 30,
2026 (the “Reporting Period”), together with comparative figures for the six months ended June 30,
2025 as follows.
Certain amounts and percentage figures included in this announcement have been subject to rounding
adjustments, or have been rounded to one or two decimal places. Any discrepancies in any table, chart
or elsewhere between totals and sums of amounts listed therein are due to rounding.
BUSINESS HIGHLIGHTS
The Company has made significant progress in its drug pipeline and business operations as of the
announcement date, including the following key milestones and achievements:
Strategic Investment by WuXi Biologics On 15 February 2026, the Company entered into the
Subscription Agreement with WuXi Biologics HealthCare Venture, an indirectly wholly-owned
investment entity of WuXi Biologics, pursuant to which 84,033,613 new shares were allotted at a
subscription price of HK$2.38 per share, raising gross proceeds of approximately HK$200.0 million.
Sixty per cent of the proceeds will be utilised for settlement of the Group’s trade payables, 28%
for research and development expenses of the existing pipeline, and 12% for working capital and
registration maintenance of commercialised products. Upon completion of the transaction, the WuXi
Biologics affiliate held a 16.27% equity interest in the Company and became the second substantial
shareholder of the Company.

1

Hunterase® (idursulfase beta, formerly known as CAN101), an enzyme replacement therapy (ERT)
for the treatment of Mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. MPS II is
number 73 in the “First National List of Rare Diseases” in China published in May 2018.
•

In May 2021, CANbridge commercially launched Hunterase ® in China for the non-reimbursed
market. Patient identification has accelerated since launch; 921 patients had been identified
cumulatively as of June 30, 2026. We have rolled-out commercial insurance programmes
(Huiminbao) across 142 cities, covering a population of 626 million in China.

•

In August 2026, Hunterase ® obtained marketing approval from the Taiwan Food and Drug
Administration (“TFDA”). With this approval, Hunterase ® has obtained marketing approval in
Chinese Mainland, Hong Kong and Taiwan.

Livmarli® (maralixibat oral solution, formerly known as CAN108), an oral, minimally absorbed,
reversible inhibitor of the ileal bile acid transporter (IBAT) that is under development to treat rare
cholestatic liver diseases including Alagille syndrome (ALGS) and progressive familial intrahepatic
cholestasis (PFIC). ALGS is number 5 in the “Second National List of Rare Diseases” in China
published in September 2023.
•

In January 2024, CANbridge commercially launched Livmarli® in China for the non-reimbursed
market. Patient identification has accelerated since launch; 920 ALGS patients had been identified
cumulatively as of June 30, 2026. We have rolled-out commercial insurance programmes
(Huiminbao) across 64 cities, covering a population of 299 million in China.

•

On August 14, 2026, Livmarli ® obtained reimbursement approval from the National Health
Insurance Administration (“NHIA”) of Taiwan, with the reimbursement coverage effective
September 1, 2026.

Gaurunning ® (velaglucerase-beta for injection, formerly known as CAN103), an ERT for the
treatment of Gaucher Disease. Gaucher Disease is number 31 in the “First National List of Rare
Diseases” in China published in May 2018.
•

Since launch, patient identification has accelerated; 42 Gaucher disease patients had been identified
as of June 30, 2026. We have rolled out commercial insurance programmes (Huiminbao) across 40
cities, covering a population of 175 million in China.

•

In July 2026, the Company fully initiated registration procedures and commercial readiness work
for Gaurunning® covering key North African markets. Launch preparations for Gaurunning® in the
region have commenced. Expansion into North Africa constitutes the first important milestone for
Gaurunning® in building its global Gaucher disease footprint.

2

•

In addition, the Company is actively advancing the registration procedures for Gaurunning® in Hong
Kong.

•

In August 2026, an NMPA approved registration trial is ongoing, aiming to expand Gaurunning®’s
label to children aged 2 to 12 years.

CAN204 Gene Therapy, a CANbridge-developed area of excellence, is a therapeutic modality that uses
adeno-associated virus (AAV) as a gene delivery vehicle. It holds the potential to serve as a one-time,
durable treatment for a broad range of genetic diseases. Duchenne Muscular Dystrophy (DMD), the most
common form of progressive muscular dystrophy, is Entry No. 98 in China’s “First National List of Rare
Diseases”, which was published in May 2018.
CANbridge and Scriptr have published a paper in the journal Science , reporting the discovery of the
StitchR™ technology and its application for the treatment of muscular dystrophies. To date, we have
successfully completed in-vivo proof-of-concept studies in mice and generated key preclinical data for
DMD. We are advancing the screening and evaluation of multiple AAV capsids for robust delivery
of StitchR™ to the muscle and heart and optimising the therapeutic payload, while making orderly
preparations for subsequent non-human-primate studies.
New Global Pipeline CAN301 (Next-Generation BBB-Penetrant ERT Candidate for Gaucher
Disease), we have initiated the in-house research and development of CAN301, a next-generation
therapeutic pipeline asset for Gaucher disease. CAN301 is a glucocerebrosidase (GCase) enzyme
replacement therapy (ERT) paired with central nervous system (CNS) targeting. CAN301 is
CANbridge’s first program leveraging its development of a technology platform for CNS macromolecule
delivery and therefore aims to specifically address the unmet clinical need of CNS manifestations
associated with Type 3 Gaucher disease, thereby serving as an upgraded successor to our marketed
product, Gaurunning® (formerly CAN103).

Organizational Updates:
With effect from March 30, 2026, Mr. Wai Chiu Wong (“Mr. Wong”), resigned as joint company
secretary of the Company and ceased to act as one of the authorised representatives of the Company
(the “Authorised Representative”) under Rule 3.05 of the Rules Governing the Listing of Securities
(the “Listing Rules”) on The Stock Exchange of Hong Kong Limited (the “Stock Exchange”) and the
authorised representative for accepting service of process or notices on behalf of the Company in Hong
Kong under Part 16 of the Companies Ordinance (Chapter 622 of the Laws of Hong Kong) (the “Process
Agent”). Ms. Qian Ma (“Ms. Ma”) remains in office and will continue to serve as a company secretary
of the Company.
With effect from March 30, 2026, (i) Ms. Ma has been appointed as one of the Authorised
Representatives; and (ii) Ms. Lin Sio Ngo has been appointed as the Process Agent.

3

With effect from August 5, 2026, Dr. Richard James Gregory (“Dr. Gregory”) resigned as an
independent non-executive director of the Company, the Chairman of the Remuneration Committee of
the Company (the “Remuneration Committee”) and a member of the Audit Committee of the Company
(the “Audit Committee”) due to change in his personal arrangements.
With effect from August 5, 2026, Dr. Richard Arthur Moscicki (“Dr. Moscicki”) was appointed as
an independent non-executive director, Chairman of the Remuneration Committee and a member
of the Audit Committee. Having accumulated over 50 years of comprehensive experience across
clinical practice, biotechnology, pharmaceutical regulation and academia, Dr. Moscicki possesses
senior management experience at the U.S. Food and Drug Administration (“FDA”) and multinational
biopharmaceutical companies. His profound cross-disciplinary expertise will further optimise the
professional governance structure of the Board.
FINANCIAL HIGHLIGHTS
•

Our revenue increased by approximately RMB5.7 million or 25.6%, from RMB22.2 million for the
six months ended June 30, 2025 to RMB27.9 million for the six months ended June 30, 2026, which
was mainly attributable to the increase of sales from Hunterase and Livmarli.

•

Our other income and gains decreased by approximately RMB92.8 million or 89.1%, from
RMB104.1 million for the six months ended June 30, 2025 to RMB11.3 million for the six
months ended June 30, 2026, primarily due to a gain of RMB101.0 million arising from the US
lease termination in the six months ended June 30, 2025. The gain arose as the tenant, a whollyowned subsidiary of the Company, and the US lease property’s landlord entered into a termination
agreement to early terminate the lease related to the US leased property on February 24, 2025
with effect from February 28, 2025. Since the right-of-use assets related to the US lease property
had been fully written off as of December 31, 2024, the lease liabilities and other payables of
approximately RMB97.7 million and RMB3.3 million, respectively, were derecognised and credited
to profit or loss during the six months ended June 30, 2025.

•

Our research and development expenses decreased by approximately RMB5.5 million or 30.5%,
from RMB18.0 million for the six months ended June 30, 2025 to RMB12.5 million for the six
months ended June 30, 2026, which was mainly attributable to lower operational costs resulting
from the completion of previous clinical trials, as well as the fact that new R&D projects had just
been initiated in the second quarter of 2026.

4

•

Our administrative expenses increased by approximately RMB6.7 million or 40.3%, from RMB16.6
million for the six months ended June 30, 2025 to RMB23.3 million for the six months ended
June 30, 2026. Such increase was primarily due to higher share-based payment expenses arising
from newly granted equity incentives, together with increased professional service fees related to
financing activities.

•

Our selling and distribution expenses increased by approximately RMB8.2 million or 36.3%, from
RMB22.7 million for the six months ended June 30, 2025 to RMB30.9 million for the six months
ended June 30, 2026, mainly due to investment in the launch of commercialization of new product
(i.e. Gaurunning®) and one-time costs arising from the switch from a self-operated sales model to a
CSO model.

•

Loss for the Reporting Period turning from a profit of RMB59.2 million for the six months ended
June 30, 2025 to a loss of RMB37.1 million for the six months ended June 30, 2026 which was
primarily due to the decrease of other income and gains.

•

The adjusted loss for the period decreased by approximately RMB9.1 million, from RMB37.4
million for the six months ended June 30, 2025, to RMB28.2 million for the six months ended June
30, 2026. The adjusted loss for the period was arrived at by adjusting the IFRS profit/(loss) for the
Reporting Period of RMB37.1 million (for the six months ended June 30, 2025: profit of RMB59.2
million) through excluding the effect of share-based payment expenses, gain/(loss) on lease
termination, and written-off of right-of-use assets. Please refer to the section headed “Non-IFRS
Measures” of this announcement for details.

5

INTERIM CONDENSED CONSOLIDATED STATEMENT OF PROFIT OR LOSS AND OTHER
COMPREHENSIVE INCOME
For the six months ended June 30, 2026

Notes
Revenue
Cost of sales

Six months ended June 30,
2026
2025
(Unaudited)
(Unaudited)
RMB’000
RMB’000
27,940
(9,283)

22,248
(6,828)

18,657
11,343
(30,909)
(23,325)
(12,504)
(249)
(107)

15,420
104,145
(22,674)
(16,627)
(17,990)
(1,769)
(1,267)

(37,094)
–

59,238
–

(37,094)

59,238

Exchange differences on translation of foreign operations, net
Other comprehensive income that will not be reclassified to
profit or loss in subsequent periods:

1,412

1,783

Exchange differences on translation of the Company

(3,536)

641

Other comprehensive (expenses)/income for the period,
net of tax

(2,124)

2,424

Total comprehensive (expenses)/income for the period
attributable to owners of the Company

(39,218)

61,662

(0.07)

0.14

4

Gross profit
Other income and gains, net
Selling and distribution expenses
Administrative expenses
Research and development expenses
Finance costs
Other expenses

5

(Loss)/profit before tax
Taxation

6
7

(Loss)/profit for the period
Other comprehensive (expense)/income
Other comprehensive (expenses)/income that may be
reclassified to profit or loss in subsequent periods

(Loss)/earnings per share attributable to owners of
the Company
– Basic and diluted (RMB per share)
6

9

INTERIM CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION
For the six months ended June 30, 2026
June 30,
2026
(Unaudited)
RMB’000

December 31,
2025
(Audited)
RMB’000

ASSETS
Non-current assets
Property, plant and equipment
Right-of-use assets
Intangible assets

179
475
48,107

136
375
54,712

Total non-current assets

48,761

55,223

Current assets
Inventories
Trade receivables
Prepayments, other receivables and other assets
Cash and bank balances

23,174
10,853
21,493
88,098

20,569
15,119
7,855
66,625

143,618

110,168

237,862
76,576
2,895
19,000
662

368,834
75,842
2,727
7,025
913

Total current liabilities

336,995

455,341

Net current liabilities

(193,377)

(345,173)

Total assets less current liabilities

(144,616)

(289,950)

Notes

10

Total current assets
LIABILITIES
Current liabilities
Trade payables
Other payables and accruals
Contract liabilities
Interest-bearing bank and other borrowings
Lease liabilities

11

7

June 30,
2026
(Unaudited)
RMB’000

December 31,
2025
(Audited)
RMB’000

Non-current liabilities
Contract liabilities
Interest-bearing bank and other borrowings
Lease liabilities

42,170
9,000
144

43,661
8,000
144

Total non-current liabilities

51,314

51,805

(195,930)

(341,755)

40
(195,970)

34
(341,789)

(195,930)

(341,755)

Note

Net liabilities
EQUITY
Share capital
Reserves

12

Total deficit

8

NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For the six months ended June 30, 2026
1.

GENERAL INFORMATION
The Company was incorporated as an exempted company with limited liability in the Cayman Islands on January
30, 2018. The addresses of the registered office and principal place of business of the Company are disclosed in the
“Corporate Information Section” to the interim report.
The Company is an investment holding company. The Group was principally engaged in the research and development
and commercialization of medical products.
The shares of the Company have been listed on the Main Board of the Stock Exchange of Hong Kong Limited (the
“Stock Exchange”) effective from December 2021.
The financial statements are presented in Renminbi (“RMB”), which is the currency of the primary economic
environment in which the major entities of the Group operate. The functional currency of the Company is US dollar
(“USD”).

2.

BASIS OF PRESENTATION OF CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Statement of compliance
The condensed consolidated interim financial information for the six months ended June 30, 2026 has been prepared
in accordance with International Accounting Standard (“IAS”) 34 “Interim Financial Reporting”. The condensed
consolidated interim financial information should be read in conjunction with the annual financial statements for
the year ended December 31, 2025, which have been prepared in accordance with International Financial Reporting
Standards (“IFRS”).
Going concern assessment
The condensed consolidated financial statements have been prepared on the assumption that the Group will continue as
a going concern, which assumes that the Group will be able to meet its obligations and continue its operations for the
next twelve months after June 30, 2026, notwithstanding that the Group incurred a net loss of RMB37,094,000 during
the six months ended June 30, 2026 and as at June 30, 2026, the Group had net current liabilities and net liabilities
of approximately RMB193,377,000 and RMB195,930,000 respectively. These conditions indicate that a material
uncertainty exists that may cast significant doubt on the Group’s ability to continue as a going concern.
In view of these circumstances, the Directors of the Company have given careful consideration to the future liquidity
and performance of the Group and its available sources of financing in assessing whether the Group will have sufficient
financial resources to continue as a going concern. Certain measures have been and will continue to be taken to mitigate
the liquidity pressure and to improve the Group’s financial position which include, but not limited to, the following:
1.

the Group continues to monitor expenditure and take action to tighten cost controls over various operating
expenses;

9

2.

the Group has been and will continue to actively negotiate with banks for renewal and extension of existing bank
borrowings that will become due during the next twelve months after June 30, 2026. Discussions regarding the
renewal and extension of existing bank borrowings as well as new bank borrowings are ongoing but no binding
agreements have been entered into;

3.

the Group will also continue to actively negotiate with the suppliers and the related parties to extend the repayment
dates of the overdue payables based on amicable relationships with the suppliers and related parties;

4.

the Group has been and will continue to actively negotiate with certain third parties to license out its pipeline assets
to streamline its operations further and improve liquidity position. As at the date of this announcement, discussions
are on-going but no binding agreements have been entered into;

5.

the Group will further improve the profitability with three commercialised products, namely Hunterase®, Livmarli®
and Gaurunning® to generate cash inflow for the Group; and

6.

the Company has been actively exploring opportunities to obtain further financing when necessary including but
not limited to equity financing and new share placing to potential investor to improve the liquidity of the Group.

Assuming that the above-mentioned plans and measures will succeed and having reviewed the Group’s cash flow
projections prepared by management, which cover a period of twelve months from June 30, 2026, the Board are of the
opinion that, the Group will have sufficient working capital to finance its operations and to meet its financial obligations
as and when they fall due within twelve months from June 30, 2026. Accordingly, the Directors are satisfied that it is
appropriate to prepare the condensed consolidated financial statements on a going concern basis.
Notwithstanding the above, significant uncertainties exist as to whether the Group is able to achieve its plans and
measures as described above and continue to operate as a going concern. Whether the Group will be able to continue as
a going concern would depend upon the following:
1.

the successful and timely implementation of the plans to control costs and reduce expenditures;

2.

the successful obtaining of continuous support from the banks for provision of new bank loans and renewal and
extension of existing bank borrowings;

3.

the successful negotiation with the suppliers and the related parties to extend the repayment dates of overdue
payables;

4.

the successful signing of binding agreement with third parties to license out certain of its products or pipelines;

5.

the successful increase of profitability of commercialised products; and

6.

the successful obtaining of financing or capital investments in the Group.

Should the Group be unable to achieve the above-mentioned plans and measures and operate as a going concern,
adjustments would have to be made to write down the carrying values of the Group’s assets to their recoverable
amounts, to provide for any further liabilities which might arise, and to reclassify non-current assets and non-current
liabilities as current assets and current liabilities, respectively. The effects of these adjustments have not been reflected
in these consolidated financial statements.

10

3.

APPLICATION OF NEW AND AMENDMENTS TO IFRSS
The accounting policies adopted in the preparation of the condensed consolidated interim financial statements are
consistent with those applied in the preparation of the Group’s annual consolidated financial statements for the year
ended December 31, 2025, except for the adoption of the following new and amendments to IFRS Accounting Standards
for the first time for the current period’s financial information.
New and amendments to IFRS Accounting Standards that are mandatorily effective for the current period
In the reporting period, the Group has applied the following new and amendments to IFRS Accounting Standards issued
by the IASB for the first time, which are mandatorily effective for the annual period beginning on or after January 1,
2026 for the preparation of the Group’s condensed consolidated interim financial statements:
Amendments to IFRS 9 and IFRS 7
Amendments to IFRS Accounting Standards

Contracts Referencing Nature dependent Electricity
Annual Improvements to IFRS Accounting Standards – Volume 11

The application of the amendments to IFRS Accounting Standards in the current year has had no material impact on the
Group’s financial positions and performance for the current and prior period and/or on the disclosures set out in these
condensed consolidated interim financial statements.
4.

OPERATING SEGMENT INFORMATION AND REVENUE
For management purpose, the Group has only one reportable operating segment, which is the development, production,
marketing and sale of medical products.
Geographical information

Revenue from external customers
For the six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)
Chinese Mainland
Other regions

27,940
–

22,248
–

Total revenue

27,940

22,248

The revenue information above is based on the locations of the customers.

11

Non-current assets
For the six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)
Chinese Mainland
Other countries/regions

724
48,037

773
61,250

Total non-current assets

48,761

62,023

The non-current asset information above is based on the locations of the assets.
Information about major customers
Revenue from customers which contributed over 10% of the Group’s revenue for the six months ended June 30, 2026
and 2025 is as following:
For the six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)
18,174
–
7,977

Customer A
Customer B
Customer C

16,131
6,073
–

Disaggregated revenue information
For the six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)
Type of goods
Sales of medical products
Strategic cooperation income

Timing of revenue recognition
A point in time
Over-time

12

26,617
1,323

22,248
–

27,940

22,248

26,617
1,323

22,248
–

27,940

22,248

5.

OTHER INCOME AND GAIN, NET
For the six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)

6.

Other incomes
Bank interest income
Government grants
Others

376
–
–

4
250
116

Total other incomes

376

370

Other gain/(loss), net
(Loss)/gain on lease termination, net
Foreign exchange difference, net
Gain/(loss) on disposal of property, plant and equipment

(4)
10,971
–

101,037
1,802
936

Total other gains

10,967

103,775

Total other income and gain

11,343

104,145

(LOSS)/PROFIT BEFORE TAX
(Loss)/profit before tax has been arrived at after charging/(crediting):
For the six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)
Employee benefit expenses (including directors’ and chief executive’s remuneration):
Wages, salaries, bonus and welfare
Pension scheme contributions
Staff welfare expenses
Share-based payment expenses

Cost of inventories sold
Research and development costs (excluded related employee benefit
expenses, depreciation and amortization)
Depreciation of property, plant and equipment
Depreciation of right-of-use assets
Amortization of intangible assets
Short-term lease payment
Written-off of the right-of-use assets
Written-off of the property, plant and equipment
Impairment of inventories
Donation

13

12,283
1,529
592
8,883

20,600
2,410
915
3,746

23,287

27,671

9,283

6,828

7,106
27
321
5,032
–
–
–
–
107

9,347
184
903
5,326
37
703
501
61
–

7.

TAXATION
The Group is subject to income tax on an entity basis on profits arising in or derived from the jurisdictions in which
members of the Group are domiciled and operated.
No provision of profit tax has been made in the condensed consolidated financial statements as no assessable profit was
derived from the jurisdictions in which member of the Group and dominated and operated for both periods.
Cayman Islands
Under the current laws of the Cayman Islands, the Company is not subject to tax on income or capital gains. In addition,
upon payments of dividends by the Company to its shareholders, no Cayman Islands withholding tax is imposed.
Hong Kong
Hong Kong profits tax has been provided at the rate of 16.5% (2025: 16.5%) on the estimated assessable profits arising
in Hong Kong during the period, except for one subsidiary of the Group which is a qualifying entity under the twotiered profits tax rates regime. The first HK$2,000,000 of assessable profits of this subsidiary are taxed at 8.25% and
the remaining assessable profits are taxed at 16.5%.
Taiwan
The subsidiary incorporated in Taiwan is subject to income tax at a rate of 20% (2025: 20%) on the estimated assessable
profits arising in Taiwan during the period.
Chinese Mainland
Pursuant to the Corporate Income Tax Law of the PRC and the respective regulations (the “CIT Law”), the subsidiaries
which operate in Chinese Mainland are subject to CIT at a rate of 25% (2025: 25%) on the taxable income.
United States of America
The subsidiary incorporated in Delaware, the United States was subject to statutory United States federal corporate
income tax at a rate of 21% (2025: 21%) during the period.

8.

DIVIDENDS
The directors of the Company do not recommend the payment of an interim dividend for the six months ended June 30,
2026 (2025: Nil).

9.

(LOSS)/EARNINGS PER SHARE ATTRIBUTABLE TO THE OWNERS OF THE COMPANY
The calculation of the basic (loss)/earnings per share amounts is based on the (loss)/profit for the six months period
attributable to the owners of the Company and the weighted average number of ordinary shares 564,114,932 (2025:
424,838,320) in issue during the period.
No adjustment has been made to the basic loss per share amounts presented for the six months ended June 30, 2026
as the impact of the share options and share awards outstanding had an anti-dilutive effect on the basic loss per share
amounts presented.
The computation of diluted (loss)/earnings per share does not assume the exercise of the Company’s share options
because the exercise price of those options was higher than the average market price for the six months ended June 30,
2025.

14

The calculations of basic and diluted (loss)/earnings per share are based on:
Six months ended June 30,
2026
2025
RMB’000
RMB’000
(Unaudited)
(Unaudited)
(Loss)/earnings for the purpose of basic and diluted (loss)/earnings per share

(37,094)

59,238

Six months ended June 30,
2026
2025
(Unaudited)
(Unaudited)
Number of shares
Weighted average number of ordinary shares in issue

564,114,932

424,838,320

June 30,
2026
RMB’000
(Unaudited)

December 31,
2025
RMB’000
(Audited)

Trade receivables
Impairment

10,853
–

15,119
–

Net carrying amount

10,853

15,119

10. TRADE RECEIVABLES

The credit period is generally 30 to 90 days.
The ageing analysis of trade receivables, based on invoice dates, as at June 30, 2026 and December 31, 2025 are as
follows:

Within 3 months

June 30,
2026
RMB’000
(Unaudited)

December 31,
2025
RMB’000
(Audited)

10,853

15,119

11. TRADE PAYABLES
An ageing analysis of the trade payables as at the end of the reporting period, based on the invoice date, is as follows:

Within 6 months
Over 6 months

15

June 30,
2026
RMB’000
(Unaudited)

December 31,
2025
RMB’000
(Audited)

8,120
229,742

90,318
278,516

237,862

368,834

The trade payables are non-interest-bearing and are normally settled in less than six months or based on the specific
agreement with certain suppliers.
12. SHARE CAPITAL
June 30,
2026
‘000
(Unaudited)

December 31,
2025
‘000
(Audited)

June 30,
2026
RMB’000
(Unaudited)

December 31,
2025
RMB’000
(Audited)

5,000,000

5,000,000

350

350

June 30,
2026

December 31,
2025

(Unaudited)

(Audited)

June 30,
2026
RMB’000
(Unaudited)

December 31,
2025
RMB’000
(Audited)

Issued and fully paid
At beginning of the period/year
Share options exercised (note a)
Issue of shares (note b)
Issue of shares (note c)

511,120,234
289,500
2,000,000
84,033,613

424,838,320
1,314,250
–
84,967,664

34
–*
–*
6

28
–*
–*
6

At the end of period/year

597,443,347

511,120,234

40

34

Authorised:
Ordinary shares of US$0.00001 each

*

Less than RMB1,000

(a)

During the period ended June 30, 2026, the subscription rights attaching to 289,500 share options were exercised
at the subscription price, resulting in the issue of 2,289,500 shares with a par value of US$0.00001 each for a total
cash consideration of RMB344,000. An amount of RMB984,000 was transferred from the share-based payment
reserve to share premium upon the exercise of the share options.

(b)

The Company has adopted a post-IPO share award scheme (the “Scheme”) on November 18, 2021. For the
purposes of the awards of restricted share units (“Awards”) under the Scheme, the Company has established a trust
for which Computershare Hong Kong Trustees Limited acts as the trustee. To satisfy the grant and/or settlement of
the Awards, the Company allotted 2,000,000 shares of the Company to the trustee during the period ended June 30,
2026.

(c)

On March 10, 2026, the Company have allotted and issued a total of 84,033,613 shares to the subscriber
at the subscription price of HK$2.38 per subscription share. The subscription generated gross proceeds of
HKD200,000,000 (approximately to RMB177,571,000). The net proceeds receivable by the Company under the
subscription was approximately HK$199,000,000 (approximately to RMB176,683,000) after deducting the relevant
expenses incurred in relation to the subscription.

16

MANAGEMENT DISCUSSION AND ANALYSIS
OVERVIEW
CANbridge was founded in 2012 and listed on the Main Board of HKEX in 2021. The Company is a
global biopharmaceutical company, with a foundation in China, committed to the research, development
and commercialization of transformative therapies to treat rare diseases. As of June 30, 2026, the
Company has a comprehensive pipeline of 8 drug assets targeting prevalent rare diseases that have
high unmet needs and significant market potential. The robust pipeline includes 3 marketed products
(Hunterase®, Livmarli®, Gaurunning®) and 1 drug candidate at the late clinical stage, covering biologics,
small molecules and gene therapies. In the rare disease area, the Company currently has seven biologic
and small molecule product candidates. These include MPS II (Hunter syndrome) and other lysosomal
storage disorders (LSDs), complement-mediated disorders, hemophilia A, metabolic disorders and rare
cholestatic liver diseases including Alagille syndrome (ALGS) and Progressive Familial Intrahepatic
Cholestasis (PFIC). Furthermore, the Company is actively investing in the R&D of next-generation
gene therapy technologies to develop innovative, potentially curative therapies for rare genetic diseases
with limited treatment options. These efforts are intended to support the Company’s transition to a
pipeline-portfolio strategy focused on First-in-Class and Best-in-Class assets, as well as to capture
value-creating partnering opportunities for long-term value growth.
The Company is led by a professional management team with in-depth expertise in the rare-disease
sector. Core members possess end-to-end experience spanning R&D through commercialization,
and most have senior working backgrounds at multinational pharmaceutical enterprises. They have
systematic insights and hands-on practical experience across the full industrial chain of rare-disease
medicines, from target discovery to post-launch commercialization. Dr. Qun Xue, Founder of the
Company, is a pioneer in China’s rare-disease industry. He has long been deeply engaged in China’s
rare-disease space and has played an instrumental role in drug R&D, ecosystem building and policy
advocacy. The Company is one of the founding members of the China Rare Disease League (CHARD,
中國罕見病聯盟). Dr. Qun Xue serves as Vice-Chairman of CHARD. He also holds concurrent positions
as Vice-Chairman of the Drug Research Professional Committee of the China Pharmaceutical Innovation
and Research Development Association (PhIRDA, 中國藥促會), Member of the Rare-Disease Drugs
Special Committee of the Chinese Pharmaceutical Association (中國藥學會), and Vice-Chairman of
the Shanghai Rare Disease Prevention and Treatment Foundation (上海市罕見病防治基金會), devoting
efforts to advancing and enhancing the development of the rare-disease industry.
The Company has built full-value-chain capabilities covering pre-clinical research, clinical development,
manufacturing and commercialization, and has established deep ecological collaboration with leading
CXO industry players including WuXi AppTec (藥明康德), WuXi Biologics (藥明生物), Baheal
Medical (百洋醫藥) and Tigermed (泰格醫藥). Building on this foundation, the Company actively
promotes in-depth integration of “industry-academia-research-medicine”. It has jointly established an
innovative translation base for rare-disease genetic defects with Peking Union Medical College Hospital
(北京協和醫院), and continues to build an integrated rare-disease industrial ecosystem.

17

18

Note:

Rare
Disease

Gaucher
Disease

NDA

In Global
for Global

In China
for Global

In China
for China

/ Privus

ignificant
market
potential. Partner
Marketed
Dev Strategy

Global

Global

Global

Global

Greater China

Greater China

Commercial
Rights

The company’s early-stage pipeline includes CAN104 (Fabry disease) and CAN105 (Hemophilia A). Future development will be evaluated based on strategic priorities.

Gene
Therapy

ERT BBB GBA

CAN 301

Small
Molecule

AAV

CAN 204
Gene Therapy

Biologic

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Anti-C5 mAb

DMA

Gaucher Disease (type 1&3 without targeting central nervous system)

Progressive Familial Intrahepatic Cholestasis (PFIC)

Alagille Syndrome (ALGS)

ERT GBA

IBAT Inhibitor

LIVMARLI®
(maralixibat oral
solution)

Hunter Syndrome (Mucopolysaccharidosis Type II)

Gaurunning®
(velaglucerase-beta
for injection)
CAN 106
Omoprubart

ERT IDS

Hunterase®
(Idursulfase beta)

diseases
andMechanism
oncology indications,
withIND-enabling
proven mechanisms
and
s
Ph 2/3
Ph 1
Candidate
Discovery

CANbridge holds global rights to 4 out of 6 assets spanning biologics, small molecules and gene-therapy platforms. These assets target
some of the most prevalent rare-disease indications, featuring proven mechanisms of action and significant market potential.

Our Comprehensive and Diversified Pipeline

PIPELINE

BUSINESS REVIEW
The Company has made significant progress with respect to its drug pipeline and business operations,
including the following milestones and achievements.
HUNTERASE® (idursulfase beta injection, formerly CAN101)
Hunterase® It is in-licensed from our Korean partner GC Biopharma (formerly GC Pharma, previously
Green Cross Corporation). Under the collaboration agreement with GC Biopharma, CANbridge holds the
exclusive development and commercialization rights for Hunterase® in Greater China. The product has
obtained marketing approvals in more than 10 countries globally, supported by solid real-world clinical
experience and proven international market validation.
Mucopolysaccharidoses (MPS) represent a group of rare multisystemic disorders caused by deficiencies
of lysosomal enzymes responsible for breaking down glycosaminoglycans (GAGs, also called
mucopolysaccharides). MPS II is an X-linked recessive disorder arising from deficiency of iduronate-2sulfatase (IDS), which leads to accumulation of GAGs within lysosomes. The condition predominantly
affects males, with female cases extremely rare. The incidence rate among Asian populations is
approximately 0.84 per 100,000 live births. The median age of initial symptom onset is generally
before the age of five. Clinical manifestations include severe airway obstruction, skeletal deformities
and cardiomyopathy; most patients experience progressive neurological decline and poor quality of
life. Without treatment, the disease advances rapidly, with a median age at death of approximately 13.4
years. MPS was included in China’s “First National List of Rare Diseases in 2018”. Clinical guidelines
and consensus statements worldwide recommend ERT as the standard-of-care for MPS II. Hunterase®
provides exogenous IDS for lysosomal uptake by cells to metabolise accumulated GAGs. As the only
ERT approved for MPS II in China, Hunterase ® addresses clear unmet clinical needs and occupies a
unique market position.
•

In September 2020, CANbridge obtained marketing approval from the National Medical Products
Administration (“NMPA”) for Hunterase®, as the first and only ERT therapy for MPS II in China.

•

In May 2021, CANbridge commercially launched Hunterase ® in China for the non-reimbursed
market. Patient identification has accelerated since launch; 921 patients had been identified
cumulatively as of June 30, 2026. We have rolled-out commercial insurance programmes
(Huiminbao) across 142 cities, covering a population of 626 million in China.

•

In August 2026, Hunterase ® obtained marketing approval from the Taiwan Food and Drug
Administration (“TFDA”). With this approval, Hunterase ® has obtained marketing approval in
Chinese Mainland, Hong Kong and Taiwan.

LIVMARLI® (maralixibat oral solution, formerly known as CAN108)
Livmarli ® is a minimally-absorbed ileal bile acid transporter (IBAT) inhibitor that blocks the
enterohepatic circulation of bile acids, reduces hepatic and serum bile acid levels, mitigates resultant
liver injury and relieves cholestatic pruritus (extreme itching). Livmarli® is in-licensed from our U.S.
partner Mirum Pharmaceuticals, Inc. (“Mirum”). Under the agreement with Mirum, CANbridge holds
the exclusive rights for the development, commercialization and, under certain conditions, manufacturing
of Livmarli® in Greater China.
19

Livmarli® is indicated for rare genetic cholestatic liver diseases including Alagille syndrome (ALGS)
and Progressive Familial Intrahepatic Cholestasis (PFIC). ALGS is an autosomal-dominant multisystem
disorder characterized by intrahepatic bile duct paucity, which may result in cholestasis, severe pruritus
and progressive liver injury. Its incidence ranges from 1 in 30,000 to 1 in 50,000 live births, and it was
included in China’s “Second National List of Rare Diseases” in 2023. PFIC is a group of rare genetic
liver diseases caused by defects in hepatocellular transport proteins leading to intrahepatic cholestasis.
Symptoms including severe pruritus, jaundice and liver failure manifest from infancy; 70-80% of
patients will ultimately require liver transplantation, with an incidence ranging from 1 in 50,000 to 1 in
100,000 live births.
Livmarli ® has been granted Breakthrough Therapy Designation by the U.S. Food and Drug
Administration (“FDA”) for ALGS and PFIC Type II, as well as Orphan Drug Designation for ALGS
and PFIC. In Europe, the European Medicines Agency (“EMA”) has granted Orphan Medicinal Product
Designation for ALGS and PFIC. In Taiwan, Livmarli® has obtained Orphan Drug Designation from the
Taiwan Food and Drug Administration (“TFDA”), enjoying ten-year market exclusivity.
•

As of December 31, 2024, Livmarli® gained marketing approvals for ALGS in mainland China,
Hong Kong and Taiwan, and marketing approval for PFIC in Taiwan. These broad approvals make
Livmarli® the first and only approved product for the treatment of cholestatic pruritus in patients
with ALGS across these regions.

•

In May 2024, the approved patient population for Livmarli® in mainland China was expanded from
patients aged one year and older to patients aged three months and above.

•

In December 2024, Livmarli® obtained marketing approval in Taiwan for the treatment of cholestatic
pruritus in PFIC patients aged three months and older.

•

In December 2024, the approved patient population for Livmarli® in Taiwan was expanded from
patients aged one year and older to ALGS patients aged two months and above.

•

In January 2024, CANbridge commercially launched Livmarli® in China for the non-reimbursed
market. Patient identification has accelerated since launch; 920 ALGS patients had been identified
cumulatively as of June 30, 2026. We have rolled-out commercial insurance programmes
(Huiminbao) across 64 cities, covering a population of 299 million in China.

•

On August 14, 2026, Livmarli ® obtained reimbursement approval from the National Health
Insurance Administration (“NHIA”) of Taiwan, with the reimbursement coverage effective
September 1, 2026. As the first approved therapy for ALGS and PFIC in Taiwan, Livmarli® gaining
NHIA reimbursement approval for both indications marks a significant milestone for patients living
with ALGS and PFIC. This development will immediately and substantially alleviate the financial
burden on patient families in Taiwan.

20

GAURUNNING® (velaglucerase-beta for injection, formerly known as CAN103)
Gaurunning® (velaglucerase-beta for injection) obtained marketing approval from NMPA in May 2025.
It is the first domestically independently-developed long-term ERT for adolescents aged 12 and above
and adults with Type I and Type III Gaucher disease.
Gaucher disease is caused by a deficiency of glucocerebrosidase (acid β-glucosidase), an enzyme that
breaks down glucocerebroside (glucosylceramide), a membrane-bound cellular glycosphingolipid within
lysosomes. Glucocerebroside accumulates predominantly in monocyte-macrophage cells in certain
organs, forming characteristic Gaucher cells and resulting in splenomegaly, hepatomegaly, anemia,
thrombocytopenia, bone pain and fractures. Early-onset neurological manifestations may occur in severe
forms of Gaucher disease (perinatal-lethal, Type II and Type III). Gaucher disease was included in the
China’s “First National List of Rare Diseases” in 2018.
Administered via intravenous infusion, Gaurunning® specifically replenishes the glucocerebrosidase
deficient within the lysosomes of Gaucher disease patients. The Company holds global proprietary rights
for the development and commercialization of the product. As an innovative biologic drug, Gaurunning®
can fully replace comparable imported products. Its expected materially lower treatment cost is poised
to substantially reduce patients’ long-term financial burden and fundamentally improve the accessibility
and sustainability of therapy for Gaucher disease patients worldwide.
•

In March 2025, CANbridge (Shanghai) Life Sciences Ltd., a wholly-owned subsidiary of
the Company and the marketing authorization holder for Gaurunning ® , successfully passed
the registration verification and pre-marketing GMP compliance inspection for the divided
manufacturing pilot product. Gaurunning® represents the first innovative biologic product in China
to pass the divided manufacturing inspection for biological products.

•

In May 2025, Gaurunning®, an innovative biologic drug for the treatment of Type I and Type III
Gaucher disease, obtained marketing approval in China.

•

In December 2025, Gaurunning ® was included in China’s first commercial health insurance
innovative drug list.

•

Since launch, patient identification has accelerated; 42 Gaucher disease patients had been identified
as of June 30, 2026. We have rolled out commercial insurance programmes (Huiminbao) across 40
cities, covering a population of 175 million in China.

•

In July 2026, the Company fully initiated registration procedures and commercial readiness work
for Gaurunning® covering key North African markets. Launch preparations for Gaurunning® in
the region have commenced. Expansion into North Africa constitutes the first important milestone
for Gaurunning® in building its global Gaucher disease footprint. Gaucher disease in North Africa
presents a substantial and growing market with significant unmet clinical needs.

21

•

In addition, the Company is actively advancing the registration procedures for Gaurunning® in Hong
Kong.

•

In August 2026, an NMPA-approved registration trial is ongoing, aiming to expand Gaurunning®’s
label to children aged 2 to 12 years.

CAN106 (OMOPRUBART)
CAN106 is a novel, long-acting, monoclonal antibody directed against C5 complement that is being
developed for the treatment of complement-mediated diseases, including paroxysmal nocturnal
hemoglobinuria (PNH), myasthenia gravis (MG), as well as other approved and emerging potential
complement-related indications. Based on clinical data, CAN106 has demonstrated a favorable PK/
PD profile, safety and tolerability, indicating that CAN106 has the potential to effectively inhibit C5 in
patients with PNH with a convenient four-week dosing frequency.
•

CANbridge obtained global rights to develop, manufacture and commercialize CAN106 in PNH,
as well as for other complement-mediated diseases that involve activation of the C5 protein, from
WuXi Biologics Ireland Limited and Privus Biologics, LLC in 2019 and 2020, respectively.

•

CAN106 has received Orphan Drug Designation from the FDA for the treatment of MG, an
autoimmune neuromuscular disease that causes muscle weakness. CAN106 is eligible to receive
the benefits provided under the Orphan Drug Act, including 50% tax credit for qualifying clinical
trials, waivers for regulatory submission fees, eligibility to receive federal research grants, and upon
marketing authorization for MG, 7 years of market exclusivity.

•

In June 2023, CANbridge announced positive preliminary results from the ongoing Phase 1b study
of CAN106 being conducted in China for PNH. The trial is being conducted under the direction of
principal investigator, Dr. Bing Han, MD, PhD, Chief Physician and Professor in the Department
of Hematology at Peking Union Medical College Hospital in Beijing, China. CAN106 showed
doseproportional exposure and rapid, dose-dependent reductions in free C5 levels within 24 hours,
with all subjects in Cohort 3 maintaining values below 0.5 ug/mL, a threshold for complete C5
inhibition. CAN106 was safe and well-tolerated at all doses, and all drug-related adverse events
were mild or moderate and transient, and none led to discontinuation from the study. There were no
drug-related serious adverse events, and no cases of anaphylaxis or meningococcal infection.

•

Complement-mediated diseases amenable to treatment with an anti-C5 antibody remain an area of
broad interest, demonstrating potential for CAN106 in multiple indications beyond PNH.

•

We view CAN106 as a strong candidate in addressing multiple complement mediated diseases.
CANbridge is exploring opportunities, either independently or through partnerships, with the aim
to advance CAN106 to a late-stage clinical development track with substantial potential financial
values.

22

CAN204 GENE THERAPY
Gene Therapy, a CANbridge-developed area of excellence, is a therapeutic modality that includes adenoassociated virus (AAV) as a gene delivery vehicle due to its potential to be a safe and durable one-time
treatment for many genetic diseases. Duchenne Muscular Dystrophy (DMD), the most common form
of progressive muscular dystrophy, is Entry No.98 in China’s “First National List of Rare Diseases”
published in 2018. It is an X-linked inherited neuromuscular rare disease that predominantly affects
boys. Patients typically succumb to disease in their twenties due to cardiac and respiratory muscle
weakness. There are approximately 50,000 DMD patients in China, and substantial unmet clinical need
exists globally.
The Group’s next-generation dual-AAV vector DMD gene therapy (CAN204) is built upon the StitchR™
RNA assembly dual-vector technology platform licensed from Scriptr Global. It enables high-fidelity,
efficient delivery of larger gene payloads via two independent AAVs. For CAN204, the encoded midiDystrophin protein for DMD is more than twice the length of the micro-Dystrophins used in firstgeneration gene therapies. The protein design of CAN204 is directly informed from human genetics,
allowing the production of a truncated dystrophin longer than those described in patients with mild
forms of Becker muscular dystrophy, reducing technical-failure-related risks from a biological design
standpoint. This therapy has the potential to become a transformative treatment for DMD.
•

In November 2024, CANbridge and Scriptr announced publication in the journal Science reporting
the discovery of the StitchR™ RNA assembly technology and its application for the treatment of
muscular dystrophies.

•

As of December 31, 2025, we have successfully completed in vivo proof-of-concept studies in mice
and obtained key preclinical data for DMD.

•

In H1 2026, we continue to advance the screening and evaluation of multiple AAV capsids for robust
delivery of StitchR™ to the muscle and heart and optimise the therapeutic payload. Preparations for
subsequent non-human-primate studies are ongoing. We are steadily accumulating preclinical data
to progress the development of our DMD gene therapy, with a view to ultimately generating clinical
proof-of-concept data in humans.

New Global Pipeline CAN301: Next-Generation BBB-Penetrant ERT Candidate for Gaucher Disease
We have initiated the in-house research and development of CAN301, a next-generation therapeutic
pipeline asset for Gaucher disease. CAN301 is a glucocerebrosidase (GCase) enzyme replacement
therapy (ERT) paired with central nervous system (CNS) targeting. CAN301 is CANbridge’s first
program leveraging its development of a technology platform for CNS macromolecule delivery and
therefore aims to specifically address the unmet clinical need of CNS manifestations associated with
Type 3 Gaucher disease, thereby serving as an upgraded successor to our marketed product, Gaurunning ®
(formerly CAN103). We are steadily advancing a suite of preclinical R&D activities for CAN301,
including platform establishment, novel molecular screening and in vivo proof-of-concept (POC) studies,
alongside parallel work on intellectual property protection and expansion of our CNS delivery platform
into additional disease indications.
23

As the second-generation CNS-targeted therapy following Gaurunning®, CAN301 forms a synergistic
and complementary product portfolio with our first-generation marketed asset. It addresses the treatment
gap for CNS pathology, expands the overall target patient population, and further strengthens the
Group’s market reach in Gaucher disease and related disorders.
Strategic Investment by WuXi Biologics
On February 15, 2026, the Company entered into the Subscription Agreement with WuXi Biologics
HealthCare Venture, an indirectly wholly-owned investment entity of WuXi Biologics, pursuant to
which 84,033,613 new shares were allotted at a subscription price of HK$2.38 per share, raising gross
proceeds of approximately HK$200.0 million. 60% of the proceeds will be utilised for settlement of the
Group’s trade payables, 28% for research and development expenses of the existing pipeline, and 12%
for working capital and registration maintenance of commercialised products. Upon completion of the
transaction, the WuXi Biologics affiliate held a 16.27% equity interest in the Company and became the
second substantial shareholder of the Company.
As a world-leading integrated biologic CRDMO service provider, WuXi Biologics has established longterm in-depth business collaboration with the Group. This equity cooperation delivers deep synergy
between industrial capital and business partnership, and continuously consolidates the Group’s leading
position in the rare disease biologic sector in China.
Market Opportunities in the Rare-Disease Industry
The global orphan-drug space features unique industrial attributes and long-term growth potential. The
vast majority of rare diseases stem from genetic mutations with relatively well-understood pathogenic
mechanisms, which materially boost the R&D success rate of candidate therapies. Commercial activities
in this sector are highly targeted: academic promotion only needs to focus on a small pool of specialist
physicians and designated hospitals, delivering outstanding operational efficiency. Many jurisdictions
worldwide have put in place supportive regulatory incentives. Represented by the U.S. Orphan Drug Act
and expedited review pathways, such policies lower barriers for R&D and commercialization through
market exclusivity and accelerated approval timelines. According to an IMARC Group report, the global
orphan-drug market is projected to grow from USD214.8 billion in 2023 to USD541.3 billion in 20321,
demonstrating solid growth certainty. Compared with developed markets, developing countries exhibit
low penetration rates for rare-disease drugs given their immature screening and diagnosis systems,
leaving substantial room for future improvement.

1

https://www.imarcgroup.com/orphan-drugs-market

24

China’s rare-disease industry is expected to continue benefiting from multi-dimensional national
regulatory and supportive reimbursement policies, with the overall operating environment for the sector
continuously improving. On the regulatory front, authorities have streamlined R&D and marketing
application procedures for rare-disease drugs and opened dedicated approval pathways. Enterprises are
permitted to directly leverage global multi-center clinical trial data to support domestic registration
applications. Coupled with incentive mechanisms such as priority review and conditional approval,
these measures have substantially shortened the time-to-market for innovative rare-disease therapies. In
terms of disease-category governance, China issued its First National List of Rare Diseases covering 121
conditions in 2018, followed by the second list adding 86 conditions in 2023. Taken together, the two
editions cover 207 rare diseases in total, establishing a clear standardized framework for rare-disease
screening, diagnosis, clinical R&D and market commercialization.
Major upgrades have also taken place in the reimbursement security system. In January 2025, the
National Healthcare Security Administration (NHSA) unveiled the 2025 National Reimbursement Drug
List adjustment framework, introducing for the first time the Class C commercial health insurance
innovative drug list. Serving as an important complement to the basic medical insurance Class A
and Class B lists, the Class C list specifically includes high-innovation frontier products such as
rare-disease specialty drugs and gene therapies with prominent clinical value yet high price points.
Supplementary payment channels are built via commercial health insurance, supported by supportive
policies including exemption from self-payment ratio assessment and exclusion from certain centralized
procurement monitoring scope, broadening reimbursement pathways for innovative rare-disease
drugs. From the perspective of R&D incentives, the revised Regulations for the Implementation of the
Drug Administration Law , which formally took effect in May 2026, established China’s first market
exclusivity protection regime for rare-disease drugs. Qualified new rare-disease therapeutics with
commitments to stable supply may enjoy up to seven years of market exclusivity, during which no
identical products will be granted marketing approval. This mechanism effectively safeguards returns on
corporate R&D investment and fully stimulates industrial incentives to develop rare-disease treatments.
According to Frost & Sullivan data, approximately 80% of rare diseases are genetic disorders 2. Gene
therapies, which hold curative potential by targeting the root causes of illnesses, represent a highly
promising innovative therapeutic direction for the industry. Driven by iterative advances in viral
vector and gene-editing technologies, multiple gene therapy products have achieved commercialization
globally. Our forward-looking development of cutting-edge pipelines such as the DMD dual-vector gene
therapy is precisely anchored in the pathogenic mechanisms of rare diseases, aiming to address unmet
medical needs with root-cause-oriented therapeutic solutions.

2

https://www.frostchina.com/content/news/detail/68afe91c2cd88e5f3d93f806

25

OUTLOOK
Going forward, the Company will fully capitalise on the substantial market opportunities and
continuously-improving policy environment in the rare-disease space, and further deepen its dual-driven
strategy of R&D and commercialization:
1)

Commercial sales: Leveraging Baheal Zhihe, our exclusive CSO, the Company will continue to
drive sales expansion and improve patient-medicine accessibility for its three marketed products,
Hunterase®, Livmarli® and Gaurunning®, in domestic markets, and pursue the overseas-market layout
and commercial expansion of its in-house developed product Gaurunning® in an orderly manner.
With Livmarli ® included under Taiwan’s national-health-insurance reimbursement coverage, the
Taiwan market is expected to deliver material revenue growth and provide solid support to the
Company’s overall business performance.

2)

R&D: The Company will continue to advance global business-development (BD) collaborations to
fully unlock the commercial potential of its in-house pipeline. Meanwhile, it will keep expanding
its technology-platform matrix, drive iterative upgrades to existing products, and proactively lay out
first-in-class cutting-edge technologies and innovative drug candidates.

Backed by the Company’s first-mover advantages in the rare-disease sector, deep-collaboration benefits
from leading CXO partners across the full industrial chain, and sustained favourable industrial-policy
support at the national level, CANbridge will accelerate the re-evaluation of corporate value and deliver
long-term, stable and sustainable investment returns to its shareholders.

26

Manufacturing
In March 2025, we announced that Gaurunning®, for which CANbridge (Shanghai) Life Sciences Ltd.,
the Company’s wholly-owned subsidiary, acts as the marketing authorization holder, successfully
passed the pre-approval inspection and premarketing GMP compliance inspection for the pilot biological
product of divided manufacturing. Gaurunning® was the first innovative biological product in China to
pass the inspection of divided manufacturing of biological products. We have secured manufacturing
capacity for selected in-licensed programs, including from third party collaboration partners such as
WuXi Biologics, GC Biopharma and Mirum. We aim to balance cost efficiency and quality control of
our drug products and/or candidates. In an effort to advance our gene therapy pipelines, we are exploring
manufacturing strategy for gene therapy that can help us to achieve high quality and capital efficiency
and anticipate using CDMO to enable the further development of our gene therapy products.
Commercialization
In August 2025, Beijing Baheal Zhihe Medical Achievement Transformation Service Co., Ltd. (“Baheal
Zhihe”), a subsidiary of Baheal Medical, became the Company’s exclusive contract sales organisation
(CSO) to promote our three core commercial products, Hunterase®, Livmarli ® and Gaurunning ®, in
mainland China, Hong Kong and Macau. Pursuant to the agreement, upon request by Baheal Zhihe, its
affiliate shall be appointed as the exclusive distributor in mainland China. As at the end of 2025, the
Company successfully completed the transfer of promotion and distribution arrangements to Baheal,
ensuring continuity and efficiency of operational processes.
During the first half of 2026, Baheal Zhihe officially commenced commercial-operation activities for
the three products. Teams from both parties worked closely together to advance national-level and local
market-access initiatives for all three products, while generating joint efforts across multiple dimensions
including marketing, channel management and patient-service programmes. The collaboration
accelerates early-patient identification and treatment conversion, striving to translate increased disease
awareness rates into tangible improvements in patient-medication accessibility. As at 30 June 2026,
the shareholding percentage of Baheal Medical related parties in the Company increased to 17.07%,
reflecting the strategic shareholder’s recognition of the Company’s long-term value.
Beyond the mainland-China market, the Company’s commercial team is actively advancing commerciallayout initiatives for Taiwan, Hong Kong and overseas markets, and positive progress has been achieved
across various initiatives. Please refer to the respective product-line descriptions above for further
details.

27

KEY EVENTS AFTER THE REPORTING PERIOD
Save as disclosed in this announcement, the Company has no key events after the Reporting Period that
need to be brought to the attention of the shareholders of the Company (the “Shareholders”).
FINANCIAL REVIEW
Overview
The following discussion is based on, and should be read in conjunction with, the financial information
and notes included elsewhere in this announcement.
Revenue
Our revenue increased by RMB5.7 million from RMB22.2 million for the six months ended June 30,
2025 to RMB27.9 million for the six months ended June 30, 2026, which was mainly attributable to the
increase of sales from Hunterase and Livmarli.
Cost of Sales
Our cost of sales increased by RMB2.5 million from RMB6.8 million for the six months ended June 30,
2025 to RMB9.3 million for the six months ended June 30, 2026, which was primarily attributable to the
increase in costs incurred as a result of the increased sales of commercialized products.
Gross Profit and Gross Profit Margin
Our gross profit increased by RMB3.2 million from RMB15.4 million for the six months ended June 30,
2025 to RMB18.7 million for the six months ended June 30, 2026. Our gross profit margin for the six
months ended June 30, 2026 was 66.8% (for the six months ended June 30, 2025: 69.3%).
Other Income and Gains
Our other income and gains decreased by RMB92.8 million from RMB104.1 million for the six months
ended June 30, 2025 to RMB11.3 million for the six months ended June 30, 2026, primarily due to a
gain of RMB101.0 million arising from the US lease termination in the six months ended June 30, 2025.
The gain arose as the tenant, a wholly-owned subsidiary of the Company, and the US lease property’s
landlord entered into a termination agreement to early terminate the lease related to the US leased
property on February 24, 2025 with effect from February 28, 2025. Since the right-of-use assets related
to the US lease property had been fully written off as of December 31, 2024, the lease liabilities and
other payables of approximately RMB97.7 million and RMB3.3 million, respectively, were derecognised
and credited to profit or loss during the six months ended June 30, 2025.

28

Selling and Distribution Expenses
Our selling and distribution expenses increased by RMB8.2 million from RMB22.7 million for the six
months ended June 30, 2025 to RMB30.9 million for the six months ended June 30, 2026, mainly due
to investment in the launch of commercialization of new product (i.e. Gaurunning®) and one-time costs
arising from the switch from a self-operated sales model to a CSO model.
Administrative Expenses
Our administrative expenses increased by RMB6.7 million from RMB16.6 million for the six months
ended June 30, 2025 to RMB23.3 million for the six months ended June 30, 2026, primarily due to
higher share-based payment expenses arising from newly granted equity incentives, together with
increased professional service fees related to financing activities.
Research and Development Expenses
Our research and development expenses decreased by RMB5.5 million from RMB18.0 million for the
six months ended June 30, 2025 to RMB12.5 million for the six months ended June 30, 2026, which was
mainly due to lower operational costs resulting from the completion of previous clinical trials, as well as
the fact that new R&D projects had just been initiated in the second quarter of 2026.
Six months ended June 30,
2026
2025
RMB’000
RMB’000

Research and development expenses
Staff costs
Testing and clinical trial expenses
License fees
Depreciation and amortization
Other expenses

5,392
4,162
–
6
2,944

8,629
6,818
–
14
2,529

Total

12,504

17,990

Other expenses
Our other expenses decreased by RMB1.2 million from RMB1.3 million for the six months ended June
30, 2025 to RMB0.1 million for the six months ended June 30, 2026, which was primarily due to the
absence of provision for impairment of right-of-use assets and the property, plant and equipment.

29

Finance Costs
Our finance costs decreased by RMB1.6 million from RMB1.8 million for the six months ended June 30,
2025 to RMB0.2 million for the six months ended June 30, 2026, primarily due to the decrease of bank
loan interest expenses and interest on lease liabilities.
Non-IFRS Measures
In addition to the Group’s consolidated financial statements, which are presented in accordance with
IFRSs, the Company also uses adjusted loss for the period as an additional financial measure, which
is not required by, or presented in accordance with IFRSs. We present this financial measure because
it is used by our management to evaluate our financial performance by eliminating the impacts of
items that we do not consider indicative of our performance results. The Company believes that these
adjusted measures provide additional information to investors and others, helping them to understand
and evaluate our consolidated results of operations in the same manner as our management, and thus,
facilitate comparisons of operating performance from period to period and company to company to the
extent applicable.
We define adjusted profit/loss for the period as profit/(loss) for the period excluding the effect of sharebased payment expenses, written-off of right-of-use assets and gain/(loss) on lease termination. The term
adjusted profit/loss for the period is not defined under the IFRSs. The use of this non-IFRS measure has
limitations as an analytical tool, and you should not consider it in isolation from, or as substitute for
analysis of, the Group’s results of operations or financial condition as reported under IFRSs.
The table below sets forth a reconciliation of the adjusted profit/loss for the period during the periods
indicated:
Six months ended June 30,
2026
2025
RMB’000
RMB’000
(Loss)/profit for the period
Add:
Share-based payment expenses(1)
Written-off of right-of-use assets(2)
Less:
(Loss)/gain on lease termination(3)

(37,094)

59,238

8,883
–

3,746
703

(4)

101,037

Adjusted loss for the period

(28,207)

(37,350)

30

Notes:
(1)

This represents the compensation for employee services, settled by issuing shares, share options, linked to share price.
Such expenses are accounted for under IFRS 2 and are recognized in the profit and loss statement over the vesting
period, based on the fair value at grant date. This item is adjusted as it is non-cash, and is not expected to result in the
Group’s future cash inflow or outflow.

(2)

This represents the lease properties terminated early or are no longer expected to provide future economic benefits to
the Group. This item is adjusted as it is non-cash, and is not expected to result in the Group’s future cash inflow or
outflow.

(3)

This represents the recognition of a financial gain/(loss) that occurs when a lease ended early and the difference between
the carrying amounts of the right-of-use asset and the lease liability. The item is adjusted as it is non-cash, and is not
expected to result in the Group’s future cash inflow or outflow.

Capital Management
The primary objectives of the Group’s capital management are to safeguard the Group’s ability to
continue as a going concern and to maintain healthy capital ratios in order to support its business and
maximize Shareholders’ value.
The Group manages its capital structure and makes adjustments to it in light of changes in economic
conditions and the risk characteristics of the underlying assets. To maintain or adjust the capital
structure, the Group may adjust the dividend payment to shareholders, return capital to shareholders or
issue new shares. There is no material seasonality of borrowing requirements for the Group.
Liquidity and Financial Resources
Our cash and bank balances as of June 30, 2026 were RMB88.1 million, of which RMB29.8 million,
RMB41.0 million, RMB16.3 and RMB1.0 million, were denominated in RMB, USD, HKD and TWD,
respectively. As compared to RMB66.6 million as of December 31, 2025, the increase of cash and bank
balances was primarily attributable to financing from subscription and bank loans. Our primary uses of
cash are to fund research and development efforts, milestone payments and working capital and for other
general corporate purposes.
Funding and Treasury Policy
The Group adopts a prudent funding and treasury policy, aiming to maintain an optimal financial
position and minimal financial risks. The Group regularly reviews its funding requirements to maintain
adequate financial resources in order to support its business operations as well as its research and
development, business operation and expansion plans. For the six months ended June 30, 2026, we
funded our operations primarily through revenue generated from sales of commercialized products, share
subscription and debt financing.
We closely monitor the uses of cash and cash equivalents to ensure that our financial resources have
been used in the most cost-effective and efficient way. We also consider and will endeavor to seek
various funding sources depending on the Group’s funding needs.
31

Bank Loans and Other Borrowings
Our bank loans and other borrowings as of June 30, 2026 were RMB28.0 million (December 31, 2025:
RMB15.0 million). All of our bank loans and other borrowings as of June 30, 2026 were denominated in
RMB and carried fixed nominal interest rates ranging from 2.65% to 3.45% per annum.
Current Ratio
Current ratio (calculated by current assets divided by current liabilities) of the Group as of June 30,
2026 was 42.9% (December 31, 2025: 24.2%). The increase in current ratio was primarily due to the
increase in cash and bank balances, and the decrease in trade payables as of June 30, 2026.
Gearing Ratio
The gearing ratio (calculated by total interest-bearing borrowings divided by total assets) of the Group as
of June 30, 2026 was 14.5% (December 31, 2025: 9.1%).
Foreign Currency Risk
We have transactional currency exposures. Certain of our cash and bank balances, trade receivables and
other receivables and trade and other payables are denominated in non-functional currencies and exposed
to foreign currency risk.
We currently do not have a foreign currency hedging policy. However, the management monitors foreign
exchange exposure and will consider hedging significant foreign currency exposure should the need
arise.
Contingent Liabilities
As of June 30, 2026, we did not have any material contingent liabilities.
Capital Expenditure and Commitments
The Group’s capital expenditures during the six months ended June 30, 2026 were primarily related to
the purchase of property, plant and equipment. During the six months ended June 30, 2026, the Group
incurred RMB84,000 in relation to capital expenditures.
Charges on Group Assets
As of June 30, 2026, the Group did not have any charges over its assets.
Significant Investment Held
As of June 30, 2026, the Group did not have any significant investments.

32

Material Acquisition and Disposal of Subsidiaries, Associates and Joint Ventures
The Group did not have any material acquisitions and disposals of subsidiaries, associates and joint
ventures during the Reporting Period. Save as otherwise disclosed in the Prospectus, the Group does
not have any specific future plans on material investments or capital assets as of the date of this
announcement.
Share Schemes

Pre-IPO Equity Incentive Plan
The Company adopted the 2019 equity incentive plan (the “Pre-IPO Equity Incentive Plan”) on July
25, 2019 and amended it on June 11, 2021.
The maximum number of the ordinary shares in the share capital of the Company (the “Shares”) that
may be subject to the awards granted and sold under the Pre-IPO Equity Incentive Plan is 54,549,230
Shares and share options (including those have subsequently lapse or been fully exercised) to subscribe
for 55,708,000 Shares thereof had been granted. No share options were granted under the Pre-IPO
Equity Incentive Plan after the Company’s listing.
During the Reporting Period, nil options were exercised, and 886,000 options lapsed. As of June 30,
2026, the Company had 20,767,760 options outstanding.

Post-IPO RSU Scheme
The Company has conditionally adopted the post-IPO RSU scheme by Shareholders’ resolution dated
November 18, 2021 and amended on June 27, 2024 (the “Post-IPO RSU Scheme”).
On June 27, 2024, the scheme limit for the Post-IPO RSU Scheme was refreshed. Accordingly, the
maximum number of Shares which may be allotted and issued in respect of all awards that may be
granted under the Post-IPO RSU Scheme, when aggregated with the maximum number of Shares in
respect of which options or awards may be granted under any other share scheme over Shares, shall
not exceed 10 per cent of the issued capital of the same class of the Company (excluding any treasury
shares) as of June 27, 2024 (or of the date on which the refreshing of the 10 per cent limit is approved
by the shareholders of the Company). All outstanding RSUs granted prior to June 27, 2024, and awards
lapsed in accordance with the terms of the Post-IPO RSU Scheme, shall not be counted for the purpose
of calculating the scheme limit.

33

During the Reporting Period, the Company granted 6,372,575 RSUs to 28 grantees on January 12, 2026
and 6,372,574 RSUs to Dr. Xue on April 10, 2026 respectively under the Post-IPO RSU Scheme. The
grant of RSUs to Dr. Xue was approved by the independent Shareholders’ at the annual general meeting
held on June 23, 2026. Accordingly, the maximum number of RSUs available for grant under the PostIPO RSU Scheme (i.e. maximum number of Shares which may be allotted and issued), taking into
account the number of Shares in respect of which options or awards already granted under any other
share scheme over Shares, was 30,432,790, representing approximately 5.09% of the total number of
Shares in issue (excluding treasury shares) as at June 30, 2026.
During the Reporting Period, 748,107 RSUs lapsed. As of June 30, 2026, the Company had 16,578,792
RSUs outstanding.
Post-IPO Share Option Scheme
The Company has conditionally adopted the post-IPO share option scheme by the Shareholders’
resolution dated November 18, 2021 and amended on June 27, 2024 (the “Post-IPO Share Option
Scheme”).
On June 27, 2024, the scheme limit for the Post-IPO Share Option Scheme was refreshed. Accordingly,
the maximum number of Shares which may be allotted and issued in respect of all options that may
be granted under the Post-IPO Share Option Scheme, when aggregated with the maximum number of
Shares in respect of which options or awards may be granted under any other share scheme over Shares,
shall not exceed 10 per cent of the issued capital of the same class of the Company (excluding any
treasury shares) as of June 27, 2024 (or of the date on which the refreshing of the 10 per cent limit is
approved by the shareholders of the Company). All outstanding options granted prior to June 27, 2024,
and options lapsed in accordance with the terms of the Post-IPO Share Option Scheme, shall not be
counted for the purpose of calculating the scheme limit.
During the Reporting Period, the Company granted 6,372,575 share options at an exercise price of
HK$2.32 per Share to 30 grantees on January 12, 2026 and 6,372,574 share options at an exercise price
of HK$2.724 per Share to Dr. Xue on April 10, 2026 respectively under the Post-IPO Share Option
Scheme. The grant of Options to Dr. Xue was approved by the independent Shareholders’ at the annual
general meeting held on June 23, 2026. Accordingly, the maximum number of options available for
grant under the Post-IPO Share Option Scheme (i.e. maximum number of Shares which may be allotted
and issued), taking into account the number of Shares in respect of which options or awards already
granted under any other share scheme over Shares, was 30,346,915, representing approximately 5.08%
of the total number of Shares in issue (excluding treasury shares) as at June 30, 2026.
During the Reporting Period, 289,500 share options were exercised, and 863,232 share options lapsed.
As of June 30, 2026, the Company had 20,341,917 share options outstanding.

34

CORPORATE GOVERNANCE AND OTHER INFORMATION
Compliance with the Corporate Governance Code (“CG Code”)
The Company is committed to maintaining high standard of corporate governance to safeguard the
interests of the Shareholders, enhance corporate value, formulate its business strategies and policies, and
enhance its transparency and accountability. The Company has complied and adopted the principles and
the code provisions of the CG Code as set out in Appendix C1 to the Listing Rules as its own code of
corporate governance.
The Board is of the view that the Company has complied with the principles and all applicable code
provisions of the CG Code during the Reporting Period, save for the deviation from C.2.1 of the CG
Code as disclosed below.
We have not separated the roles of the Chairman of the Board and the Chief Executive Officer. Dr.
Xue has served as chairman of the board and general manager of CANbridge Life Sciences Ltd. since
June 2012 and as Chairman of the Board, Director and Chief Executive Officer since the inception of
our Company in January 2018. Dr. Xue is the founder of the Group and has extensive experience in the
business operations and management of our Group. Our Board believes that, in view of his experience,
personal profile and his roles in our Company, Dr. Xue is the Director best suited to identify strategic
opportunities and focus of the Board due to his extensive understanding of our business as our Chief
Executive Officer. Our Board also believes that the combined role of Chairman of the Board and Chief
Executive Officer can promote the effective execution of strategic initiatives and facilitate the flow
of information between management and the Board. Our Directors consider that the balance of power
and authority will not be impaired due to this arrangement. In addition, all major decisions are made in
consultation with members of the Board, including the relevant Board committees, and four independent
non-executive Directors.
The Board will review the corporate governance structure and practices from time to time and shall
make necessary arrangements when the Board considers appropriate.
Compliance with Model Code
The Company has adopted a code of conduct regarding Directors’ securities transactions on terms
no less exacting than the required standard set out in the Model Code for Securities Transactions by
Directors of Listed Issuers set out in Appendix C3 to the Listing Rules (the “Model Code”). Specific
enquiries have been made to all the Directors and they have confirmed that they have complied with the
Model Code during the Reporting Period.

35

Purchase, Sale or Redemption of the Company’s Listed Securities
Neither the Company nor any of its subsidiaries has purchased, sold or redeemed any of the Company’s
listed securities during the Reporting Period (including sale of treasury shares (as defined under the
Listing Rules)). As at June 30, 2026, the Company did not hold any treasury shares.
Employee and Remuneration Policy
As of June 30, 2026, the Group had 39 employees (December 31, 2025: 41 employees) and 15 external
consultants. The Group’s employees’ remuneration consists of salaries, bonuses, share-based incentive
plans, an employees’ provident fund, and social security contributions and other welfare payments. In
accordance with applicable laws in China and other relevant jurisdictions, we have made contributions
to social security insurance funds (including pension plans, unemployment insurance, work-related
injury insurance, medical insurance and maternity insurance) and housing funds for the employees of the
Group.
We conduct new staff training regularly to guide new employees and help them adapt to the new
working environment. In addition, we provide on-line and in-person formal and comprehensive
company-level and department-level training to our employees periodically in addition to on-the-job
training. We also encourage our employees to attend external seminars and workshops to enrich their
technical knowledge and develop competencies and skills.
During the Reporting Period, the total staff costs (including Director’s emoluments) were approximately
RMB23.3 million (for the six months ended June 30, 2025: RMB27.7 million).
INTERIM DIVIDEND
The Board has resolved not to declare the payment of an interim dividend for the six months ended June
30, 2026 (six months ended June 30, 2025: nil).
AUDIT COMMITTEE AND REVIEW OF INTERIM RESULTS
The audit committee of the Board (the “Audit Committee”) has three members comprising Mr. Peng
Kuan Chan (chairperson), Mr. James Arthur Geraghty and Dr. Richard Arthur Moscicki, with its terms
of reference in compliance with the Listing Rules.
The Audit Committee has considered and reviewed the unaudited interim results and the interim report
of the Group for the six months ended June 30, 2026 and the accounting principles and practices adopted
by the Group, and has discussed with management and external auditor on issues in relation to, among
others, financial reporting. The Audit Committee is of the opinion that the unaudited interim results
of the Group for the six months ended June 30, 2026 are in compliance with the relevant accounting
standards, laws and regulations.

36

Further, the Group’s unaudited interim condensed consolidated financial information for the six
months ended June 30, 2026 has been reviewed by HLB Hodgson Impey Cheng Limited (“HLB”), the
Company’s auditor, in accordance with Hong Kong Standard on Review Engagements 2410, “Review of
Interim Financial Information Performed by the Independent Auditor of the Entity” (“HKSRE 2410”)
issued by the Hong Kong Institute of Certified Public Accountants.
EXTRACT OF INDEPENDENT REVIEW REPORT ON THE INTERIM FINANCIAL
INFORMATION
The following is an extract of the HLB’s Review Report.
CONCLUSION
Based on our review, nothing has come to our attention that causes us to believe that the condensed
consolidated financial statements are not prepared, in all material respects, in accordance with IAS 34.
MATERIAL UNCERTAINTY RELATED TO GOING CONCERN
We draw attention to Note 2 to the condensed consolidated financial statements, which indicates that
the Group incurred a net loss of RMB37,094,000 during the six months ended June 30, 2026 and as
at June 30, 2026, the Group had net current liabilities and net liabilities of RMB193,377,000 and
RMB195,930,000 respectively. These conditions, along with other matters as set forth in Note 2 to the
condensed consolidated financial statements, indicate the existence of a material uncertainty which
may cast significant doubt on the Group’s ability to continue as a going concern. Our conclusion is not
modified in respect of this matter.
The above Note 2 to the condensed consolidated financial statements is disclosed as Note 2 to this
announcement.
PUBLICATION OF INTERIM RESULTS AND INTERIM REPORT
This results announcement is published on the Company’s website (www.canbridgepharma.com) and the
website of the Stock Exchange (www.hkexnews.hk).

37

The 2026 interim report of the Company containing all relevant information required under the Listing
Rules will be published on the aforementioned websites in September 2026.
By order of the Board
CANbridge Pharmaceuticals Inc.
北海康成製藥有限公司
Dr. James Qun Xue
Chairman
Hong Kong, August 28, 2026

As of the date of this announcement, the Board comprises Dr. James Qun Xue as executive Director;
Ms. Wei Zhao and Mr. Tingwei Wang as non-executive Directors; and Dr. Richard Arthur Moscicki,
Mr. James Arthur Geraghty, Mr. Peng Kuan Chan and Dr. Lan Hu as independent non-executive Directors.

38

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的內容概不負責，對其準確性或完
整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚賴該等內
容而引致的任何損失承擔任何責任。

CANbridge Pharmaceuticals Inc.
北海康成製藥有限公司
（於開曼群島註冊成立的有限公司）
（股份代號：1228）

截至2026年6月30日止六個月
中期業績公告
北海康成製藥有限公司（「本公司」）董事（「董事」）會（「董事會」）欣然公佈本公司及其附屬公司（「本集
團」
、
「北海康成」或「我們」）截至2026年6月30日止六個月（「報告期間」）的未經審核簡明綜合業績，連
同截至2025年6月30日止六個月的比較數字如下。
本公告所載若干金額及百分比數字已經約整，或約整至小數點後一位或兩位數。任何表格、圖表或
其他地方所列總數與金額總和之間的任何差異乃因約整所致。

業務摘要
截至公告日期，本公司在藥物產品線及業務運營方面取得重大進展，包括以下里程碑及成就：
藥明生物戰略入股 2026年2月15日，公司與WuXi Biologics HealthCare Venture訂立股份認購協定
（藥明生物間接全資附屬投資實體），配發84,033,613股新股，認購價格為每股2.38港元，募集資金總
額約2.0億港元。所募集的資金當中，60%用於清償集團貿易應付款，28%用於現有產品管線的研發
開支，12%用於營運資金及已商業化產品的註冊維護。交易完成後藥明生物關聯方持股16.27%，躍
升為公司第二大股東。
海芮思 ®（艾度硫酸酯酶β，前稱為CAN101），一款用於治療黏多糖貯積症II型（MPS II，亦稱為亨特
綜合症）的酶替代療法。MPS II於2018年5月公佈的中國「第一批罕見病目錄」中為第73號。
•

我們於2021年5月在中國商業化推出海芮思 ®，並進入非醫保市場。自推出以來，患者識別速度
加快，截至2026年6月30日，我們已累計識別921名患者，已在142個城市實施商業保險計劃（惠
民保），覆蓋中國6.26億人口。

•

2026年8月，海芮思 ®已獲得台灣衛生福利部食品藥物管理署(TFDA)頒發的藥品上市許可證。至
此，海芮思在中國內地、香港及台灣均已獲批上市。

1

邁芮倍 ®（氯馬昔巴特口服液，前稱為CAN108），一款用於治療罕見膽汁淤積性肝病，包括阿拉傑里
綜合症(ALGS)及進行性家族性肝內膽汁淤積症(PFIC)的口服液藥物，是一種幾乎不被吸收的迴腸膽
汁酸轉運蛋白(IBAT)抑制劑。ALGS於2023年9月公佈的中國「第二批罕見病目錄」中為第5號。
•

我們於2024年1月在中國商業化推出邁芮倍 ®，並進入非醫保市場。自推出以來，患者識別速度
加快，截至2026年6月30日，我們已累計識別920名ALGS患者，已在64個城市實施商業保險計劃
（惠民保），覆蓋中國2.99億人口。

•

2026年8月14日，邁芮倍已獲台灣健保署核准納入健保支付，相關健保支付將於2026年9月1日正
式生效。

戈芮寧 ®（注射用維拉苷酶β，前稱為CAN103），一款用於治療戈謝病的酶替代療法。戈謝病於2018
年5月公佈的中國「第一批罕見病目錄」中為第31號。
•

截至2026年6月30日，我們已識別42名戈謝病患者，已在40個城市實施商業保險計劃（惠民保），
覆蓋中國1.75億人口。

•

2026年7月，我們已全面啟動戈芮寧 ® 在北非重點市場的註冊申報流程及商業化籌備工作，上
市各項準備工作也在全面推進中。出海北非市場是戈芮甯佈局全球戈謝病市場的首個重要里程
碑。

•

此外，本公司亦正積極推進戈芮寧®於香港地區的註冊申報工作。

•

2026年8月，本公司目前正開展一項獲NMPA批准的注冊臨床試驗，將戈芮寧®的適用人群擴展至
2歲及12歲以下兒童。

CAN204基因治療 腺相關病毒(AAV)作為基因轉染工具的治療方法，具有成為多種遺傳疾病一次性
持久療法的潛力，是北海康成開發的重點領域。杜興氏肌肉萎縮症（DMD，進行性肌肉萎縮症的最常
見形式）於2018年5月公佈的中國「國家第一批罕見病目錄」中為第98號。
北海康成與Scriptr已於《科學》期刊上發表論文，報告StitchR ™技術之發現及其於治療肌肉萎縮症之
應用。截至目前，我們已順利完成小鼠體內概念驗證研究，並取得DMD臨床前關鍵數據。2026年上
半年，我們持續推進多種AAV病毒衣殼的篩選與評估，以優化StitchR ™對肌肉及心臟組織的遞送效
率，並同步完成治療載荷的改進與非人靈長類動物實驗的前期籌備。

2

全球新管線CAN301（新一代可穿透血腦屏障戈謝病酶替代療法候選藥物） 我們已啟動新一代戈謝病
療法管線CAN301的自主研發。CAN301是一款具備中樞神經系統靶向能力的葡糖腦苷脂酶(GCase)酶
替代療法，是本公司首個依託中樞神經系統大分子遞送技術平台的研發項目，旨在針對性解決III型
戈謝病中樞神經系統相關表現的未滿足臨床需求，作為本公司已上市產品戈芮寧 ®（前稱CAN103）的
迭代升級候選藥物。

組織更新：
自2026年3月30日起，黃偉超先生（「黃先生」）辭任本公司聯席公司秘書，並不再擔任香港聯合交易所
有限公司（「聯交所」）證券上市規則（「上市規則」）第3.05條項下之本公司授權代表（「授權代表」）之一及
根據香港法例第622章公司條例第16部代表本公司於香港接收法律程序文件或通知之授權代表（「法律
程序文件代理人」）。馬倩女士（「馬女士」）將留任並繼續擔任本公司之公司秘書。
自2026年3月30日起，(i)馬女士已獲委任為授權代表之一；及(ii)練少娥女士已獲委任為法律程序文
件代理人。
自2026年8月5日起，Richard James Gregory博士（「Gregory博士」）因個人安排變動，已辭任本公司獨
立非執行董事、本公司薪酬委員會（「薪酬委員會」）主席及本公司審核委員會（「審核委員會」）成員。
自2026年8月5日起，Richard Arthur Moscicki博士（「Moscicki博士」）獲委任為獨立非執行董事、薪酬
委員會主席及審核委員會成員。Moscicki博士在臨床實踐、生物科技、藥品監管及學術領域累積逾
50年豐富經驗，曾於美國食品和藥物監督管理局（「美國食藥監局」）及跨國生物製藥公司擔任高級管
理職位，其深厚之跨學科專業知識將進一步優化董事會之專業管治架構。

3

財務摘要
•

我們的收益由截至2025年6月30日止六個月的人民幣22.2百萬元增加約人民幣5.7百萬元或25.6%
至截至2026年6月30日止六個月人民幣27.9百萬元，主要由於Hunterase與邁芮倍的銷售增長。

•

其他收入及收益由截至2025年6月30日止六個月的人民幣104.1百萬元減少約人民幣92.8百萬元或
89.1%至截至2026年6月30日止六個月的人民幣11.3百萬元，主要由於截至2025年6月30日止六個
月美國租賃終止產生的收益人民幣101.0百萬元。由於承租人（本公司的全資附屬公司）與美國租
賃物業的業主於2025年2月24日訂立終止協議，以提前終止與美國租賃物業有關的租約，自2025
年2月28日起生效，因此產生收益。由於截至2024年12月31日與美國租賃物業相關的使用權資
產已悉數撇銷，截至2025年6月30日止六個月，分別終止確認租賃負債及其他應付款項約人民幣
97.7百萬元及人民幣3.3百萬元，且計入損益。

•

我們的研發開支由截至2025年6月30日止六個月的人民幣18.0百萬元減少約人民幣5.5百萬元或
30.5%至截至2026年6月30日止六個月人民幣12.5百萬元，主要由於先前臨床試驗完成令營運成
本下降，以及新研發項目於2026年第二季度剛啟動。

•

我們的行政開支由截至2025年6月30日止六個月的人民幣16.6百萬元增加約人民幣6.7百萬元或
40.3%至截至2026年6月30日止六個月人民幣23.3百萬元。該增加主要歸因於新授出股權激勵導
致股份為基礎的付款開支增加以及與融資活動相關的專業服務費用上升。

•

我們的銷售及分銷開支由截至2025年6月30日止六個月的人民幣22.7百萬元增加約人民幣8.2百萬
元或36.3%至截至2026年6月30日止六個月人民幣30.9百萬元。該減少主要由於投資於新產品（即
戈芮寧®）的商業化推出以及由自營銷售模式轉為專業合同銷售模式所產生的一次性成本。

•

報告期間內虧損由截至2025年6月30日止六個月的溢利人民幣59.2百萬元轉為截至2026年6月30
日止六個月的虧損人民幣37.1百萬元，主要歸因於其他收入及收益減少。

•

期內經調整虧損由截至2025年6月30日止六個月的人民幣37.4百萬元減少約人民幣9.1百萬元至截
至2026年6月30日止六個月人民幣28.2百萬元。期內經調整虧損乃通過調整報告期間內國際財務
報告準則溢利╱（虧損）人民幣37.1百萬元（截至2025年6月30日止六個月：溢利人民幣59.2百萬元）
得出，不包括股份為基礎的付款開支、租賃終止的收益╱（虧損）及撇銷使用權資產的影響。詳情
請參閱本公告「非國際財務報告準則計量」一節。

4

中期簡明綜合損益及其他全面收益表
截至2026年6月30日止六個月

附註
收益
銷售成本

截至6月30日止六個月
2026年
2025年
（未經審核） （未經審核）
人民幣千元
人民幣千元
27,940
(9,283)

22,248
(6,828)

18,657

15,420

5

11,343
(30,909)
(23,325)
(12,504)
(249)
(107)

104,145
(22,674)
(16,627)
(17,990)
(1,769)
(1,267)

6
7

(37,094)
–

59,238
–

(37,094)

59,238

換算海外業務的匯兌差額淨額
後續期間將不會重新分類至損益的其他全面收益：

1,412

1,783

換算本公司的匯兌差額

(3,536)

641

期內其他全面（開支）╱收益（扣除稅項）

(2,124)

2,424

本公司擁有人應佔期內全面（開支）╱收益總額

(39,218)

61,662

(0.07)

0.14

4

毛利
其他收入及收益淨額
銷售及分銷開支
行政開支
研發開支
融資成本
其他開支
除稅前（虧損）╱溢利
稅項
期內（虧損）╱溢利
其他全面（開支）╱收益
後續期間可能會重新分類至損益的其他全面（開支）╱收益

本公司擁有人應佔每股（虧損）╱盈利
－基本及攤薄（每股人民幣元）

9

5

中期簡明綜合財務狀況表
截至2026年6月30日止六個月
2026年
6月30日
（未經審核）
人民幣千元

2025年
12月31日
（經審核）
人民幣千元

資產
非流動資產
物業、廠房及設備
使用權資產
無形資產

179
475
48,107

136
375
54,712

非流動資產總值

48,761

55,223

流動資產
存貨
貿易應收款項
預付款項、其他應收款項及其他資產
現金及銀行結餘

23,174
10,853
21,493
88,098

20,569
15,119
7,855
66,625

143,618

110,168

237,862
76,576
2,895
19,000
662

368,834
75,842
2,727
7,025
913

流動負債總額

336,995

455,341

流動負債淨額

(193,377)

(345,173)

總資產減流動負債

(144,616)

(289,950)

附註

10

流動資產總值
負債
流動負債
貿易應付款項
其他應付款項及應計費用
合約負債
計息銀行及其他借款
租賃負債

11

6

2026年
6月30日
（未經審核）
人民幣千元

2025年
12月31日
（經審核）
人民幣千元

非流動負債
合約負債
計息銀行及其他借款
租賃負債

42,170
9,000
144

43,661
8,000
144

非流動負債總額

51,314

51,805

(195,930)

(341,755)

儲備

40
(195,970)

34
(341,789)

虧絀總額

(195,930)

(341,755)

附註

負債淨額
權益
股本

12

7

中期簡明綜合財務報表附註
截至2026年6月30日止六個月
1.

一般資料
於2018年1月30日，本公司於開曼群島註冊成立為獲豁免有限公司。本公司的註冊辦事處地址及主要營業地點披露
於中報「公司資料」一節。
本公司為投資控股公司。本集團主要從事醫藥產品的研發及商業化。
本公司股份已於香港聯合交易所有限公司（「聯交所」）主板上市，自2021年12月起生效。
財務報表乃以人民幣（「人民幣」）呈列，是由於本集團主要實體經營所處首要經濟環境的貨幣為人民幣。本公司的功
能貨幣為美元（「美元」）。

2.

簡明綜合財務報表呈列基準
合規聲明
截至2026年6月30日止六個月的簡明綜合中期財務資料乃根據國際會計準則（「國際會計準則」）第34號「中期財務報
告」編製。簡明綜合中期財務資料應與已根據國際財務報告準則（「國際財務報告準則」）編製的截至2025年12月31日
止年度的年度財務報表一併閱讀。
持續經營評估
儘管本集團於截至2026年6月30日止六個月產生虧損淨額人民幣37,094,000元，且於2026年6月30日，本集團流動負
債淨額及負債淨額分別約為人民幣193,377,000元及人民幣195,930,000元，簡明綜合財務報表乃假設本集團將持續經
營而編製，即假設本集團將能夠履行其責任及於2026年6月30日後未來十二個月繼續其營運。該等情況顯示存在重
大不明朗因素，可能對本集團持續經營的能力構成重大疑問。
鑑於該等情況，本公司董事已審慎考慮本集團的未來流動資金和表現以及其可用的融資來源，以評估本集團是否將
有足夠財務資源進行持續經營。本集團已經並將繼續採取若干措施以減輕流動資金壓力，並改善其財務狀況，包括
但不限於以下措施：
1.

本集團將持續監控支出情況，並採取措施加強各項營運開支的成本控制；

8

2.

本集團已經及將繼續積極與銀行磋商重續及延長於2026年6月30日後未來十二個月內到期的現有銀行借款。有
關重續及延長現有銀行借款及新銀行借款的討論正在進行中但並無訂立具約束力的協議；

3.

基於與供應商及關聯方的友善關係，本集團將繼續積極與供應商及關聯方協商延長到期應付款的還款日期；

4.

本集團已經及將繼續積極與若干第三方磋商其產品線資產對外授權事宜，以進一步精簡其業務及改善流動資金
狀況。於本公告日期，討論正在進行中但並無訂立具約束力的協議；

5.

本集團將憑藉其三個商業化產品（即海芮思®、邁芮倍®及戈芮寧®）進一步改善其盈利能力；及

6.

本公司將於需要時積極物色取得進一步融資（包括但不限於股權融資及向潛在投資者配發新股）的機會，以改善
本集團的流動資金。

假設上述計劃及措施將成功及經審閱管理層所編製本集團涵蓋自2026年6月30日起計12個月期間的現金流量預測，
董事會認為，本集團將有足夠營運資金為其營運提供資金，並能夠履行其自2026年6月30日起計12個月內到期的財
務責任。因此，董事信納按持續經營基準編製該等簡明綜合財務報表屬適當。
儘管如上文所述，本集團能否實現上述計劃及措施及繼續持續經營存在重大不明朗因素。本集團能否持續經營將視
乎下列各項而定：
1.

成功及時實施控制成本及減少支出的計劃；

2.

成功取得銀行的持續支持，以提供新銀行貸款，以及重續及延長現有銀行借款；

3.

成功與供應商及關聯方進行磋商，以延長到期應付款的還款日期；

4.

與第三方成功簽訂具約束力的協議，對外授出若干產品或產品線的許可；

5.

商業化產品的盈利能力的成功提高；及

6.

成功為本集團取得融資或資本投資。

倘本集團無法實現上述計劃及措施並持續經營，則須作出調整，將本集團資產的賬面值撇減至其可收回金額，以撥
備可能產生的任何進一步負債，並將非流動資產及非流動負債分別重新分類為流動資產及流動負債。該等調整的影
響並未於該等綜合財務報表中反映。

9

3.

新訂及經修訂國際財務報告準則的應用
編製簡明綜合中期財務報表所採納的會計政策與編製本集團截至2025年12月31日止年度的年度綜合財務報表所應用
者一致，惟就本期間的財務資料首次採納以下新訂及經修訂國際財務報告準則會計準則除外。

於本期間強制生效的新訂及經修訂國際財務報告準則會計準則
於報告期間，本集團首次應用以下由國際會計準則委員會頒佈於2026年1月1日或之後開始之年度期間強制生效之新
訂及經修訂國際財務報告準則會計準則編製本集團之簡明綜合中期財務報表：
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）
國際財務報告準則會計準則之修訂

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年度改進－第11卷

於本年度應用國際財務報告準則會計準則的修訂對本集團本期間及先前期間之財務狀況及表現及╱或此等簡明綜合
中期財務報表所載之披露概無重大影響。
4.

經營分部資料及收益
出於管理目的，本集團僅有一個可呈報的經營分部，即醫藥產品的開發、生產、市場推廣及銷售。
地域資料

來自外界客戶之收益
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
中國內地
其他地區

27,940
–

22,248
–

收益總額

27,940

22,248

上述收益資料乃基於客戶所在地點劃分。

10

非流動資產
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
中國內地
其他國家╱地區

724
48,037

773
61,250

非流動資產總額

48,761

62,023

上述非流動資產資料乃基於資產所在地點劃分。
有關主要客戶的資料
於截至2026年及2025年6月30日止六個月貢獻本集團收益10%以上的來自客戶之收益如下：
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
客戶A
客戶B
客戶C

18,174
–
7,977

16,131
6,073
–

經分拆收益資料
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
產品類別
銷售醫療產品
戰略合作收入

確認收益的時間
於某一時間點
一段時間

11

26,617
1,323

22,248
–

27,940

22,248

26,617
1,323

22,248
–

27,940

22,248

5.

其他收入及收益淨額
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）

6.

其他收入
銀行利息收入
政府補助
其他

376
–
–

4
250
116

其他收入總額

376

370

其他收益╱（虧損）淨額
租賃終止的（虧損）╱收益淨額
匯兌差額淨額
出售物業、廠房及設備收益╱（虧損）

(4)
10,971
–

101,037
1,802
936

其他收益總額

10,967

103,775

其他收入及收益總額

11,343

104,145

除稅前（虧損）╱溢利
除稅前（虧損）╱溢利乃扣除╱（計入）以下各項後達致：
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
僱員福利開支（包括董事及最高行政人員薪酬）：
工資、薪金、花紅及福利
退休金計劃供款
員工福利費用
以股份為基礎的付款開支

已售存貨成本
研發成本（不包括相關僱員福利開支、折舊及攤銷）
物業、廠房及設備折舊
使用權資產折舊
無形資產攤銷
短期租賃付款
撇銷使用權資產
撇銷物業、廠房及設備
存貨減值
捐贈

12

12,283
1,529
592
8,883

20,600
2,410
915
3,746

23,287

27,671

9,283
7,106
27
321
5,032
–
–
–
–
107

6,828
9,347
184
903
5,326
37
703
501
61
–

7.

所得稅
本集團須就在本集團成員公司成立及經營所在司法權區產生或來自該等司法權區的溢利按實體基準繳納所得稅。
於簡明綜合財務報表中並無就利得稅計提撥備，原因為於兩個期間本集團成員公司並無於其所在及經營所在司法權
區產生應評稅溢利。
開曼群島
根據開曼群島現行法律，本公司毋須就收入或資本收益繳稅。此外，本公司向其股東支付股息時不會徵收開曼群島
預扣稅。
香港
香港利得稅已就期內於香港產生的估計應評稅溢利按16.5%（2025年：16.5%）稅率計提撥備，惟本集團一家附屬公司
除外，其屬兩級制利得稅制度下的合資格實體。該附屬公司首2,000,000港元的應評稅溢利按8.25%稅率繳稅，而餘
下的應評稅溢利則按16.5%稅率繳稅。
台灣
於期內，於台灣註冊成立的附屬公司須就於台灣產生的估計應評稅溢利按20%（2025年：20%）的稅率繳納所得稅。
中國內地
根據中國企業所得稅法及有關法規（「企業所得稅法」），在中國內地經營的附屬公司須按應課稅收入的25%（2025年：
25%）繳納企業所得稅。
美利堅合眾國
於期內，於美國特拉華州註冊成立的附屬公司須按21%（2025年：21%）的稅率繳納法定美國聯邦企業所得稅。

8.

股息
本公司董事並不建議派付截至2026年6月30日止六個月的中期股息（2025年：無）。

9.

本公司擁有人應佔每股（虧損）╱盈利
每股基本（虧損）╱盈利金額乃根據本公司擁有人應佔六個月期內（虧損）╱溢利及期內已發行普通股加權平均數
564,114,932股（2025年：424,838,320股）計算。
概無對截至2026年6月30日止六個月的所呈列每股基本虧損作出調整，原因為尚未行使的購股權及股份獎勵的影響
對所呈列每股基本虧損具有反攤薄影響。
截至2025年6月30日止六個月，計算每股攤薄（虧損）╱盈利並無假設行使本公司購股權，原因為該等購股權行使價
高於平均市價。

13

每股基本及攤薄（虧損）╱盈利的計算乃基於：
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
（未經審核）
（未經審核）
用於計算每股基本及攤薄（虧損）╱盈利的（虧損）╱盈利

(37,094)

59,238

截至6月30日止六個月
2026年
2025年
（未經審核）
（未經審核）
股份數目
已發行普通股加權平均數

564,114,932

424,838,320

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

貿易應收款項
減值

10,853
–

15,119
–

賬面淨值

10,853

15,119

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

10,853

15,119

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

8,120
229,742

90,318
278,516

237,862

368,834

10. 貿易應收款項

信貸期一般為30日至90日。
基於發票日期，於2026年6月30日及2025年12月31日的貿易應收款項賬齡分析如下：

三個月以內
11. 貿易應付款項
以下為於報告期末貿易應付款項（基於發票日期）的賬齡分析：

6個月內
超過6個月

14

貿易應付款項為免息及一般於六個月內結算或根據與若干供應商的具體協議結算。
12. 股本
2026年
6月30日
千股
（未經審核）

2025年
12月31日
千股
（經審核）

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

5,000,000

5,000,000

350

350

2026年
6月30日

2025年
12月31日

（未經審核）

（經審核）

2026年
6月30日
人民幣千元
（未經審核）

2025年
12月31日
人民幣千元
（經審核）

已發行及繳足：
於期╱年初
已行使購股權
（附註a）
發行股份
（附註b）
發行股份
（附註c）

511,120,234
289,500
2,000,000
84,033,613

424,838,320
1,314,250
–
84,967,664

34
–*
–*
6

28
–*
–*
6

於期╱年末

597,443,347

511,120,234

40

34

法定：
每股面值0.00001美元的普通股

* 不足人民幣1,000元。
(a)

截至2026年6月30日止期間，289,500份購股權隨附的認購權已按認購價行使，導致發行2,289,500股每股面值
0.00001美元的股份，總現金代價為人民幣334,000元。於購股權獲行使後，人民幣984,000元由以股份為基礎的
付款儲備轉撥至股份溢價。

(b)

本公司於2021年11月18日採納首次公開發售後股份獎勵計劃（「該計劃」）。就該計劃項下的受限制股份單位獎勵
（「獎勵」）而言，本公司已成立一項信託，由香港中央證券信託有限公司擔任受託人。為滿足獎勵的授出及╱或
結算，本公司於截至2026年6月30日止期間向受託人配發2,000,000股本公司股份。

(c)

於2026年3月10日，本公司以認購價每股認購股份2.38港元向認購人配發及發行合共84,033,613股股份。認購事
項產生的所得款項總額為200,000,000港元（約人民幣177,571,000元）。扣除認購事項產生的相關開支後，本公
司根據該認購事項應收的所得款項淨額為約199,000,000港元（約人民幣176,683,000元）。

15

管理層討論及分析
概覽
北海康成成立於2012年，並於2021年在港交所主板上市。作為中國領先的專注於罕見疾病的全球化
生物製藥公司，公司致力於創新療法的研究、開發與商業化。截至2026年6月30日，針對市場潛力
龐大的多類常見罕見病適應症，本公司已搭建覆蓋多類藥物資產的完備產品線，包含3款已上市產品
（海芮思 ®、邁芮倍 ®、戈芮寧 ®）及1項處於臨床後期階段的候選藥物，技術類型全面覆蓋生物製劑、
小分子藥物及基因療法。在罕見病領域，本公司現佈局八款生物製劑及小分子產品，對應多類適應
症，涵蓋黏多糖貯積症II型（亨特綜合症）及其他溶酶體貯積症(LSD)、補體介導疾病、A型血友病、
代謝紊亂疾病，以及阿拉傑里綜合症(ALGS)、進行性家族性肝內膽汁淤積症(PFIC)等罕見膽汁淤積
性肝病。本公司積極投入新一代基因治療技術的研發，針對治療方案有限的罕見遺傳病開發具備潛
在治癒性的創新療法，並持續評估內外部技術與產品線機會，推動管線組合向「同類首創(FIC)」及「同
類最佳(BIC)」方向轉型，為本公司長遠發展創造更大的價值增長空間。
本公司由一支深耕罕見病領域的專業管理團隊領導，核心成員經驗貫穿研發至商業化全鏈條，且多
數具備跨國藥企的資深從業經歷，對罕見病藥物從靶點發現到上市商業化的完整產業鏈具備系統性
認知與實戰經驗。本公司創始人薛群博士為中國罕見病行業的拓荒者，多年來持續深耕中國罕見
病領域，在藥物研發、生態建設及政策推動方面均發揮了開創性作用。本公司為中國罕見病聯盟
(CHARD)創始單位之一，薛群博士擔任該聯盟副理事長，並同時兼任中國藥促會藥物研發專業委員
會副主任委員、中國藥學會罕見病藥物專委會委員及上海市罕見病防治基金會副理事長，致力於推
動罕見病行業的發展與完善。
本公司已構築覆蓋臨床前研發、臨床開發、生產及商業化的全鏈條能力，並與藥明康德、藥明生
物、百洋醫藥、泰格醫藥等CXO產業龍頭建立深度生態協同。在此基礎上，本公司積極推動「產學研
醫」深度融合，與北京協和醫院共建罕見病基因缺陷創新轉化基地，持續搭建一體化的罕見病產業生
態。

16

17

附註：

র
嫁
ࣣ

‫ش‬ӣ‫׿‬

‫ܐ‬

ׂ֜䣡ࡣ

⯎ұங‫ܐ‬檥

‫܌‬Ӳ⥃

㷚ӱ

䆝❹

ͤ

ֹஂण侙ࣣ岴ͤ

‫ۇ‬屈ࣣ
ֹण侙ࣣ岴

㬧ࠧ侢՟ࣤ

暄䤙㓬आं㓬ਵ伐堢ࣧㆂ ࣤͣ

‫ۇ‬屈ࣣͣ ֹո

悹ਸ਼㓬‫ݶ؞‬㓬剑⠶卜㾘䃼䲔ࣤͣ

୚‫❱ۿ‬ଛ侢՟ࣤͣ
ͤ

ͤ

фࢤࠧ侢՟ࣤ ͣ溒‫ॶי‬嶦䲔ࣤ ֹͤ

䤙䛁

ޫ

ޫ
‫ݰ‬坂࣓寶

該公司早期產品線包含CAN104（法佈雷病）及CAN105（A型血友病）。後續開發計劃將依據戰略優先順序進行評估。

࣒ࣿ娸⥃

‫ۇ‬吴ㅃ
ࡉ‫࣐د‬侳‫ۿ‬呵懢Ř

惻吴Ҕ
㾈榆㨓ٝࢤՌާ䆼䃎

ࡢ吴㓢
৻‫څ‬䫙懤懜懢Ř

җ惴坂ࢢ

І٠

֧ҵࣁ
䎰ҵࣁ

֧З⳪
䎰ҵࣁ

֧З⳪
䎰З⳪

旇䤙ज़ࣛ

՟Ҁ‫ݱ‬

ҵࣁ

ҵࣁ

ҵࣁ

ҵࣁ

‫ל‬З啠⦨

‫ל‬З啠⦨

֋㳰㺄Ӯ

我們的組合包括具有有效作用機制的生物製劑、小分子及基因療法解決方案，針對擁有巨大市場潛力的部分最常見的罕見病適應症。
在6項主要藥物資產中，北海康成擁有其中4項的全球權利。

我們的全面及多元化產品線

產品線

業務回顧
本公司在核心藥物產品線及業務營運方面取得重大進展，包括以下里程碑及成就。
海芮思®（艾度硫酸酯酶β注射液，前稱為CAN101）
海芮思 ®是中國首款獲批用於治療亨特綜合症(MPS II)的酶替代療法(ERT)，引進自韓國合作夥伴GC
Biopharma（前稱GC Pharma，原Green Cross Corporation），根據與GC Biopharma合作協議，北海康
成擁有海芮思 ®於大中華區的獨家開發與商業化權利。該產品已於全球超過10個國家完成上市，具備
扎實的臨床應用基礎與成熟的國際市場驗證。
黏多糖貯積症(MPS)是一組由於溶酶體中缺乏降解糖胺聚糖（黏多糖，GAGs）的水解酶而導致多系
統受累的罕見疾病。其中，黏多糖貯積症II型(MPS II)屬X連鎖隱性遺傳，體內缺乏艾度糖醛酸-2－
硫酸酯酶(IDS)，從而導致GAG在溶酶體中積聚。患者主要為男性（女性罕見），亞洲人群發病率約
0.84/100,000。主要症狀的中位始發年齡大多在5歲前。臨床表現包括嚴重的氣道阻塞、骨骼畸形、
心肌病等，大多數患者會出現神經功能下降，生活品質低下。未接受治療的患者病情進展迅速，中
位死亡年齡約13.4歲。MPS於2018年被納入中國《第一批罕見病目錄》。各國指南及共識均推薦酶
替代療法作為MPS II型的標準治療，海芮思可提供外源性IDS供細胞溶酶體攝取，分解代謝積累的
GAG。海芮思®作為國內唯一獲批的MPS II的ERT藥物，具備明確的臨床剛需與獨家市場地位。
•

®
2020年9月，北海康成成功獲得國家藥監局(NMPA)對海芮思（作為在中國治療MPS
II的首個且
唯一ERT療法）的上市批准。

•

2021年5月，北海康成在中國商業化推出海芮思 ®，並進入非醫保市場。自推出以來，患者識別
速度加快，截至2026年6月30日已累計識別921名患者，我們已在142個城市實施商業保險計劃
（惠民保），覆蓋中國6.26億人口。

•

2026年8月，海芮思®已獲得台灣衛生福利部食品藥物管理署(TFDA)頒發的藥品上市許可證。

18

邁芮倍®（氯馬昔巴特口服溶液，前稱為CAN108）
邁芮倍 ®（Livmarli ® ╱氯馬昔巴特口服溶液）是一種幾乎不被吸收的回腸膽汁酸轉運蛋白(IBAT)抑
制劑，減少膽汁酸腸肝循環，降低肝內和血清中的膽汁酸水準，減少由此介導的肝臟損傷，以及
緩解膽汁淤積性瘙癢（極度瘙癢）。邁芮倍 ®引進自我們的美國合作夥伴Mirum Pharmaceuticals, Inc.
（「Mirum」），根據與Mirum的協議，北海康成擁有邁芮倍®在大中華區開發和商業化以及在特定條件
下生產的獨家授權。
邁芮倍 ®適用於阿拉傑里綜合症(ALGS)及進行性家族性肝內膽汁淤積症(PFIC)等罕見遺傳性膽汁淤
積性肝病。ALGS是一種常染色體顯性遺傳的多系統疾病，以肝內膽管缺乏為特徵，可導致膽汁淤
積、嚴重瘙癢及進行性肝損傷，發病率約1/30,000至1/50,000，於2023年被納入中國《第二批罕見病
目錄》。PFIC是一組罕見的遺傳性肝病，因肝細胞轉運蛋白缺陷導致肝內膽汁淤積，從嬰兒期起表現
為嚴重瘙癢、黃疸和肝功能衰竭，70-80%的患者最終需要肝移植，發病率約1/50,000至1/100,000。
邁芮倍®已獲美國食品藥品監督管理局(FDA)授予ALGS及PFIC II型的突破性療法認定，以及ALGS及
PFIC之孤兒藥資格認定。在歐洲，邁芮倍®已獲歐洲藥品管理局(EMA)授予ALGS及PFIC之孤兒藥資
格認定。在台灣，邁芮倍®已獲台灣衛生福利部食品藥物管理署(TFDA)授予孤兒藥認定，並享有十年
市場獨佔期。
•

截至2024年12月31日，邁芮倍 ®獲得在中國內地、香港及台灣的治療ALGS上市批准，並獲得在
台灣用於治療PFIC的批准。邁芮倍 ®廣泛獲得上市批准，成為該地區首個且是唯一獲批上市的治
療ALGS患者膽汁淤積性瘙癢的產品。

•

2024年5月，邁芮倍®在中國內地的適用範圍從1歲擴展至三個月及以上的患者。

•

2024年12月，邁芮倍 ® 在台灣獲准上市，用於治療三個月及以上的PFIC患者的膽汁淤積性瘙癢
症。

•

於2024年12月，邁芮倍®在台灣的適用範圍從1歲擴展至兩個月及以上的ALGS患者。

•

2024年1月，北海康成在中國商業化推出邁芮倍 ®，並進入非醫保市場。自推出以來，患者識別
速度加快，截至2026年6月30日，我們已累計識別920名ALGS患者，已在64個城市實施商業保險
計劃（惠民保），覆蓋中國2.99億人口。

•

2026年8月14日，邁芮倍®已獲台灣健保署核准納入健保支付，相關健保支付將於2026年9月1日
正式生效。邁芮倍 ®是台灣地區首個獲批用於治療ALGS與PFIC的治療藥物，兩項適應症同步納
入台灣健保報銷，是當地患者的重大利好，也是本公司罕見病商業化佈局的重要里程碑。這一
舉措的落地將大幅減輕台灣病患家庭長期承受的經濟壓力。

19

戈芮寧®（注射用維拉苷酶β，前稱為CAN103）
®
戈芮寧 （注射用維拉苷酶β）
已於2025年5月獲中國藥監局上市批准，是國內首個自主研發適用於12
歲及以上青少年和成人I型及III型戈謝病患者的長期酶替代療法。戈謝病是由葡萄糖腦苷脂酶（酸性
β－葡萄糖苷酶）缺乏引起的，這種酶有助於分解溶酶體內一種被稱作葡萄糖腦苷脂（葡糖神經酰胺）
的細胞膜鞘脂。葡萄糖腦苷脂主要積聚在某些器官內的單核巨噬細胞中，形成典型的戈謝細胞，導
致脾腫大，肝腫大，貧血，血小板減少症，骨痛和骨折，嚴重的戈謝病類型（圍產期致死型，II型和
III型），早期可出現神經系統症狀。戈謝病於2018年被納入中國「第一批罕見病目錄」。

戈芮寧 ®通過靜脈輸注特異性地補充戈謝病患者體內溶酶體中缺乏的葡萄糖腦苷脂酶。本公司持有該
產品開發及商業化的全球專有權利。戈芮寧®作為生物創新藥，可完全替代同類進口產品，且治療費
用預計顯著降低，有望大幅減輕患者長期治療的經濟負擔，提升全球戈謝病患者用藥的可及性與可
持續性。
•

2025年3月，本公司的全資附屬公司－北海康成（上海）生物科技有限公司為持有人的戈芮寧®順利
通過了對分段生產試點品種開展的註冊核查與上市前GMP符合性檢查。戈芮寧®是中國首個通過
生物製品分段生產檢查的創新生物藥。

•

®
2025年5月，戈芮寧（用於治療I型及III型戈謝病的生物創新藥）
在中國獲批上市。

•

2025年12月，戈芮寧®納入中國第一版商保創新藥目錄。

•

自推出以來，患者識別速度加快，截至2026年6月30日，我們已累計識別42名戈謝病患者，已在
40個城市實施商業保險計劃（惠民保），覆蓋中國1.75億人口。

•

2026年7月，本公司已全面啟動戈芮寧 ®在北非重點市場的註冊申報流程及商業化籌備工作，上
市各項準備工作也在全面推進中。出海北非市場是戈芮寧 ®佈局全球戈謝病市場的首個重要里程
碑。北非地區戈謝病市場規模可觀且持續增長，存在大量未被滿足的臨床需求。

•

此外，本公司亦正積極推進戈芮寧®於香港地區的註冊申報工作。

•

2026年8月，本公司正開展一項獲NMPA批准的註冊臨床試驗，將戈芮寧 ®的適用人群擴展至2至
12歲的兒童。

20

CAN106歐莫撲拜單抗
•

CAN106是一種針對補體C5的新型長效重組單克隆抗體，其開發用於治療補體介導的疾病，包
括陣發性睡眠性血紅蛋白尿症(PNH)、重症肌無力(MG)及其他補體相關的適應症。根據臨床數
據，CAN106表現出良好的PK/PD特徵、安全性及耐受性，顯示CAN106具有有效抑制PNH患者
C5的潛力，給藥便利，只需每四週給藥一次。

•

本公司分別於2019年及2020年自WuXi Biologics Ireland Limited及Privus Biologics, LLC獲得在
PNH以及涉及激活C5蛋白的其他補體介導疾病中開發、製造及商業化CAN106的全球權利。

•

CAN106已被FDA授予孤兒藥資格認證，用於治療MG，這是一種導致肌肉無力的自身免疫性神
經肌肉疾病。CAN106享有《孤兒藥法案》的福利，包括符合條件的臨床試驗可享受50%的稅收抵
免、豁免監管申請費、獲得聯邦研究資助的資格，以及獲得MG上市許可後7年的市場獨佔保護
期。

•

於2023年6月，本公司宣佈正在中國進行的CAN106用於治療PNH的1b期研究的正面初步結果。
中國北京的北京協和醫院血液內科主任醫師韓冰教授為該項研究的牽頭研究者。CAN106顯示出
與劑量成比例的藥代動力學暴露特徵，可在24小時內迅速降低游離C5水平，並呈現劑量依賴性
減少，隊列3所有受試者均保持在完全C5抑制的0.5微克╱毫升閾值以下。CAN106在所有劑量下
均展現良好安全性與耐受性，所有藥物相關不良事件均為短暫且輕度至中度，無受試者因此退
出研究，亦無發生嚴重不良事件、過敏反應或腦膜炎感染病例。

•

可使用抗C5抗體預防治療的補體介導疾病仍廣受關注，表明CAN106在PNH以外的多種適應症中
皆具有潛力。

•

本公司認為CAN106是治療多種補體介導疾病的強力候選藥物。我們正積極探索獨立推進或對外
合作等多元路徑，致力於將CAN106推向具備顯著商業潛力的後期臨床開發階段。

21

CAN204基因療法
腺相關病毒(AAV)作為基因轉染工具之治療方法，具備成為多種遺傳疾病安全、一次性持久療法之
潛力，為北海康成重點開發領域之一。杜興氏肌肉萎縮症(DMD)為最常見之進行性肌肉萎縮症，已
被納入中國「國家第一批罕見病目錄」
（2018年，第98號）。該疾病為X染色體連鎖遺傳性神經肌肉罕見
病，主要發病於男孩，患者通常因心肌及肺肌無力於20多歲時離世，中國約有5萬名DMD患者，全
球存在大量未被滿足之臨床需求。
本公司之下一代雙腺相關病毒(AAV)載體DMD基因療法(CAN204)，依托自Scriptr Global授權之
StitchR ™ RNA組裝雙載體技術平台，透過兩組獨立AAV載體實現大容量基因片段之高保真與高效遞
送，所編碼之midi-Dystrophin蛋白長度較第一代基因療法之micro-Dystrophin提升逾兩倍，並於蛋白
設計上模擬臨床表現較輕之貝克型肌肉萎縮症，從生物學角度降低失敗風險。該療法有望成為治療
DMD之顛覆性療法。
•

於2024年11月，北海康成與Scriptr已於《科學》期刊上發表論文，報告StitchR™技術之發現及其於
治療肌肉萎縮症之應用；

•

截至2025年12月，我們已順利完成小鼠體內概念驗證研究，並取得DMD臨床前關鍵數據；

•

2026年上半年，我們持續推進多種AAV病毒衣殼的篩選與評估，以優化StitchR™對肌肉及心臟組
織的遞送效率，並同步完成治療載荷的改進與非人靈長類動物實驗的前期籌備。臨床前數據正
穩步累積，為DMD基因療法邁向人體臨床驗證奠定堅實基礎。

全球新管線：CAN301新一代可穿透血腦屏障戈謝病酶替代療法候選藥物
我們已啟動新一代戈謝病療法管線CAN301的自主研發。CAN301是一款具備中樞神經系統靶向能力
的葡糖腦苷脂酶(GCase)酶替代療法，是本公司首個依託中樞神經系統大分子遞送技術平台的研發項
目，旨在針對性解決III型戈謝病中樞神經系統相關表現的未滿足臨床需求，可作為本公司已上市產
®
品戈芮寧（前稱CAN103）
的迭代升級候選藥物。目前，我們正穩步推進平台搭建、新型分子篩選及
體內概念驗證等系列臨床前研發工作，並同步推進知識產權保護及該中樞遞送平台在其他疾病領域
的拓展應用。
作為繼戈芮寧®之後的第二代中樞靶向療法，CAN301與現有一代上市產品形成協同互補的產品矩
陣，填補中樞病變治療空白，拓寬整體目標患者人群，提升本公司在戈謝病及相關疾病領域的市場
覆蓋度。

22

藥明生物戰略入股
2026年2月15日，本公司與WuXi Biologics HealthCare Venture訂立股份認購協定（藥明生物間接全資
附屬投資實體），配發84,033,613股新股，認購價格為每股2.38港元，募集資金總額約2.0億港元。所
募集的資金當中，60%用於清償集團貿易應付款，28%用於現有產品管線的研發開支，12%用於營運
資金及已商業化產品的註冊維護。交易完成後藥明生物關聯方持股16.27%，躍升為本公司第二大股
東。
藥明生物作為全球領先的生物藥一體化CRDMO服務商，與本公司擁有多年深度業務合作。本次股權
合作實現產業資本與業務合作深度協同，持續夯實本公司於國內罕見病生物藥賽道領先優勢。
罕見病行業的市場機遇
全球罕見病藥物賽道具備獨特產業屬性與長期成長潛力。絕大多數罕見病源於基因突變，發病機制
相對明確，顯著提升候選療法研發成功率；行業銷售場景高度聚焦，僅需針對少量專科醫師與定點
醫院開展學術推廣，營運效率突出。全球多地配套完善激勵監管機制，以美國《孤兒藥法案》、快速
審評通道為代表，透過市場獨佔、審批提速等政策降低研發與商業化門檻。據IMARC報告預測，全
球孤兒藥市場規模將由2023年之2,148億美元增長至2032年之5,413億美元 1，成長確定性充足。與發
達市場相比，發展中國家因篩診體系尚未完善，罕見病藥物市場滲透率仍處低位，後續提升空間巨
大。
預計中國罕見病產業將持續受惠於國家層面多維度監管與保障扶持政策，行業發展環境持續優化。
監管端持續簡化罕見病藥物研發及上市申報流程，開設專屬審批通道，允許企業直接採納境外全球
多中心臨床試驗數據作為國內註冊支撐，搭配優先審評、附條件批准等激勵機制，大幅縮短罕見病
創新藥上市週期；病種規範管理方面，國家先後於2018年發布第一批《國家罕見病目錄》收錄121種罕
見病，並在2023年推出第二批目錄新增86種病種，兩批合計覆蓋207種罕見病，為罕見病篩查診斷、
臨床研發及市場商業化建立清晰標準框架。

1

https://www.imarcgroup.com/orphan-drugs-market

23

支付保障體系亦迎來重大升級，國家醫保局於2025年1月公布2025年醫保目錄調整規劃，首次增設
商業健康保險創新藥丙類目錄，作為甲、乙類基本醫保的重要補充，專門收錄創新度高、臨床價值
突出但定價偏高的罕見病特效藥、基因療法等前沿品類，依託商業健康險搭建補充支付渠道，並配
套豁免自付考核、不納入集采監測等扶持政策，拓寬罕見病創新藥支付通路。創新研發激勵層面，
2026年5月正式實施的新版《藥品管理法實施條例》首次設立罕見病藥市場獨佔保護制度，對於符合條
件、且承諾穩定保障藥品供應的罕見病治療新藥，可享有最長7年的市場獨佔期，期間不再批准相同
品種上市，有效保障企業研發投入回報，充分調動產業研發罕見病療法的積極性。
據弗若斯特沙利文數據，約80%罕見病為遺傳性疾病 2，基因療法可針對疾病根源實現根治潛力，是
行業前景極為廣闊的創新治療方向；伴隨病毒載體、基因編輯等技術迭代升級，全球已有多款基因
療法實現商業化。我們前瞻佈局DMD雙載體基因治療等前沿管線，正是緊扣罕見病致病機理，以根
源性治療方案填補臨床未被滿足的醫療需求。

未來展望
展望未來，本公司將充分把握罕見病領域龐大的市場機遇及持續向好的政策環境，持續深化研發與
商業化雙輪驅動戰略：
1)

商業銷售層面，本公司依托合同銷售組織百洋，持續推動海芮思 ®、邁芮倍 ®、戈芮寧 ®三款已上
市產品於國內市場的銷售擴張與患者用藥可及性提升，並有序推進自研產品戈芮寧 ®的海外市場
佈局與商業拓展。隨著邁芮倍 ®納入台灣健保給付範圍，台灣市場有望迎來業績放量增長，為本
公司整體業績提供堅實支撐。

2)

創新研發層面，本公司持續推進全球化BD合作，充分釋放自研管線的商業潛力，同時持續拓寬
技術平台矩陣、推動現有產品迭代升級，並前瞻佈局全球首創(First-in-class)前沿技術與創新藥
品種。

憑藉本公司在罕見病賽道的先發優勢、全產業鏈CXO龍頭資源的深度協同優勢，以及國家層面持續
利好的產業政策支持，北海康成將加速完成企業價值重估，為股東帶來長期、穩定、可持續的投資
回報。

2

https://www.frostchina.com/content/news/detail/68afe91c2cd88e5f3d93f806

24

生產
於2025年3月，我們宣佈全資附屬公司－北海康成（上海）生物科技有限公司為持有人的戈芮寧 ®順利
通過了對分段生產試點品種開展的註冊核查與上市前GMP符合性檢查。戈芮寧®是中國首個通過生物
製品分段生產檢查的創新生物藥。
我們已獲得選定的許可引進項目的生產產能，包括來自藥明生物、GC Biopharm及Mirum等第三方合
作夥伴的產能。我們旨在平衡成本效益及控制藥物產品及╱或候選藥物的質量。為推進我們基因療
法的產品線，我們正研究適用於基因療法的生產策略，在實現高品質的同時兼顧資本效益，並預計
委聘CDMO合作，推進基因療法產品的後續開發工作。
商業化
於2025年8月，北京百洋智合醫學成果轉化服務有限公司（「百洋智合」，為百洋醫藥之附屬公司）成為
本公司獨家合同銷售組織，以於中國內地、香港及澳門推廣我們的三款核心商業化產品海芮思®、邁
芮倍 ®及戈芮寧 ®，且根據協定約定，如應百洋智合提出要求，本公司將委任其聯屬公司作為中國內
地的獨家分銷商。截至2025年末，本公司已順利完成向百洋轉讓推廣及分銷安排，確保營運流程的
連續性與效率。
2026年上半年，我們的合同銷售組織百洋智合正式啟動三款產品的商業化運營，雙方團隊緊密配
合，不僅協同推進三款產品的國家級及地方市場准入工作，亦在市場營銷、渠道管理及患者服務等
多個環節形成合力，加速推動新患者的早期識別與治療轉化，力求將疾病知曉率的提升切實轉化為
患者的用藥可及性。截至2026年6月30日，百洋醫藥關聯方持有本公司股份比例增至17.07%，體現了
戰略股東對本公司長期價值的認可。
於中國內地市場外，本公司的商業化團隊亦積極拓展台灣、香港及海外市場的商業化佈局，各項舉
措已取得積極進展，詳情請見各產品線具體描述。

25

報告期間後的重要事件
除本公告所披露者外，本公司概無報告期間後的重要事件須提請本公司股東（「股東」）垂注。

財務回顧
概覽
以下討論乃基於本公告其他部分所載財務資料及附註作出，並應與該等財務資料及附註一併閱讀。
收益
我們的收益由截至2025年6月30日止六個月的人民幣22.2百萬元增加人民幣5.7百萬元至截至2026年6
月30日止六個月人民幣27.9百萬元，主要由於Hunterase與邁芮倍的銷售增長。
銷售成本
我們的銷售成本由截至2025年6月30日止六個月的人民幣6.8百萬元增加人民幣2.5百萬元至截至2026
年6月30日止六個月人民幣9.3百萬元，主要歸因於商業化產品的銷售額增加導致產生的成本增加。
毛利及毛利率
我們的毛利由截至2025年6月30日止六個月的人民幣15.4百萬元增加人民幣3.2百萬元至截至2026年6
月30日止六個月人民幣18.7百萬元。我們截至2026年6月30日止六個月的毛利率為66.8%（截至2025年
6月30日止六個月：69.3%）。
其他收入及收益
我們的其他收入及收益由截至2025年6月30日止六個月的人民幣104.1百萬元減少人民幣92.8百萬元至
截至2026年6月30日止六個月的人民幣11.3百萬元，主要由於截至2025年6月30日止六個月美國租賃
終止產生的收益人民幣101.0百萬元。由於承租人（本公司的全資附屬公司）與美國租賃物業的業主於
2025年2月24日訂立終止協議，以提前終止與美國租賃物業有關的租約，自2025年2月28日起生效，
因此產生收益。由於截至2024年12月31日與美國租賃物業相關的使用權資產已悉數撇銷，截至2025
年6月30日止六個月，分別終止確認租賃負債及其他應付款項約人民幣97.7百萬元及人民幣3.3百萬
元，且計入損益。

26

銷售及分銷開支
我們的銷售及分銷開支由截至2025年6月30日止六個月的人民幣22.7百萬元增加人民幣8.2百萬元至截
至2026年6月30日止六個月人民幣30.9百萬元，主要由於投資於新產品（即戈芮寧®）的商業化推出以及
由自營銷售模式轉為專業合同銷售模式所產生的一次性成本。
行政開支
我們的行政開支由截至2025年6月30日止六個月的人民幣16.6百萬元增加人民幣6.7百萬元至截至2026
年6月30日止六個月人民幣23.3百萬元，主要由於新授出股權激勵導致股份為基礎的付款開支增加以
及與融資活動相關的專業服務費用上升。
研發開支
我們的研發開支由截至2025年6月30日止六個月的人民幣18.0百萬元減少人民幣5.5百萬元至截至2026
年6月30日止六個月人民幣12.5百萬元，主要由於先前臨床試驗完成令營運成本下降，以及新研發項
目於2026年第二季度剛啟動。
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元

研發開支
員工成本
測試及臨床試驗開支
許可費
折舊及攤銷
其他開支

5,392
4,162
–
6
2,944

8,629
6,818
–
14
2,529

合計

12,504

17,990

其他開支
我們的其他開支由截至2025年6月30日止六個月的人民幣1.3百萬元減少人民幣1.2百萬元至截至2026
年6月30日止六個月人民幣0.1百萬元，主要由於並無使用權資產及物業、廠房及設備的減值撥備。

27

融資成本
我們的融資成本由截至2025年6月30日止六個月的人民幣1.8百萬元減少人民幣1.6百萬元至截至2026
年6月30日止六個月人民幣0.2百萬元，主要由於銀行貸款利息開支及租賃負債利息減少。
非國際財務報告準則計量
除根據國際財務報告準則呈列之本集團的綜合財務報表之外，本公司亦使用國際財務報告準則並無
規定或並非按國際財務報告準則呈列之期內經調整虧損作為附加財務計量方法。我們呈列該財務計
量方式是由於我們的管理層使用此方法通過消除我們認為不能反映業績之項目的影響，評估我們的
財務表現。本公司認為，該等經調整計量方法為投資者及其他人士提供額外資料，以助其以與管理
層相同的方式了解及評估我們的綜合經營業績，從而有助於在適用的情況下比較不同期間及不同公
司的經營表現。
我們將期內經調整溢利╱虧損界定為期內溢利╱（虧損），不包括股份為基礎的付款開支、撇銷使用
權資產及租賃終止的收益╱（虧損）的影響。國際財務報告準則並無界定期內經調整溢利╱虧損一
詞。該非國際財務報告準則計量方式用作分析工具存在局限性， 閣下不應視其為獨立於或可代替
本集團根據國際財務報告準則所呈報經營業績或財務狀況的分析。
下表載列於所示期間期內經調整溢利╱虧損的對賬：
截至6月30日止六個月
2026年
2025年
人民幣千元
人民幣千元
期內（虧損）╱溢利
加：
以股份為基礎的付款開支(1)
撇銷使用權資產(2)
減：
租賃終止的（虧損）╱收益(3)

(37,094)

59,238

8,883
–

3,746
703

(4)

101,037

期內經調整虧損

(28,207)

(37,350)

28

附註：
(1)

此項代表以發行股份、購股權（與股價掛鉤）作為僱員服務的報酬。該開支乃根據國際財務報告準則第2號入賬，並
於歸屬期內按授出日期公平值於損益表中確認。此項目屬非現金性質，預期不會導致本集團未來現金流入或流出，
故作出調整。

(2)

此項代表租賃物業提前終止或預期不再為本集團帶來未來經濟利益。此項目屬非現金性質，預期不會導致本集團未
來現金流入或流出，故作出調整。

(3)

此項代表於租賃提前終止時確認財務收益╱（虧損），即使用權資產賬面值與租賃負債之間的差額。此項目屬非現金
性質，預期不會導致本集團未來現金流入或流出，故作出調整。

資本管理
本集團資本管理的主要目標為保障本集團持續經營的能力並維持穩健的資本比率，以支持其業務及
獲得最大的股東價值。
本集團因應經濟狀況的變化及相關資產的風險特徵管理其資本結構，並對其作出調整。為維持或調
整資本結構，本集團可能會調整向股東派付的股息、向股東返還資本或發行新股。本集團並無重大
季節性借款要求。
流動資金及財務資源
截至2026年6月30日，我們的現金及銀行結餘為人民幣88.1百萬元，其中人民幣29.8百萬元、人民
幣41.0百萬元、人民幣16.3元及人民幣1.0百萬元分別以人民幣、美元、港元及新台幣計值。與截至
2025年12月31日的人民幣66.6百萬元相比，現金及銀行結餘增加主要歸因於來自認購及銀行貸款的
融資。我們的現金主要用於為研發、里程碑付款及營運資金以及其他一般企業用途提供資金。
融資及財務政策
本集團採納審慎的融資及財務政策，力求維持最佳財務狀況及最低財務風險。為支持其業務營運及
其研發、業務營運及拓展計劃，本集團定期審閱融資要求以維持充足的財務資源。截至2026年6月30
日止六個月，我們主要通過銷售商業化產品所得收益、股份認購及債務融資為營運提供資金。
我們密切注意現金及現金等價物的使用情況，確保以最具成本效益和效率的方式使用財務資源。我
們亦考慮及將根據本集團資金需求努力尋求各種資金來源。

29

銀行貸款及其他借款
截至2026年6月30日，我們的銀行貸款及其他借款為人民幣28.0百萬元（2025年12月31日：人民幣15.0
百萬元）。截至2026年6月30日，所有銀行貸款及其他借款均以人民幣計值，附帶固定票面年利率為
2.65%至3.45%。
流動比率
截至2026年6月30日，本集團的流動比率（按流動資產除以流動負債計算）為42.9%（2025年12月31日：
24.2%）。流動比率增加乃主要由於截至2026年6月30日現金及銀行結餘增加及貿易應付款項減少。
資產負債比率
截至2026年6月30日，本集團的資產負債比率（按計息借款總額除以總資產計算）為14.5%（2025年12月
31日：9.1%）。
外幣風險
我們面臨交易性貨幣風險。我們的若干現金及銀行結餘、貿易應收款項及其他應收款項以及貿易及
其他應付款項均以非功能性貨幣計值，且面臨外幣風險。
我們目前並無外幣對沖政策。然而，管理層監控外幣風險，並將於有需要時考慮對沖重大外幣風
險。
或然負債
截至2026年6月30日，我們並無任何重大或然負債。
資本開支及承擔
本集團截至2026年6月30日止六個月的資本開支主要與購買物業、廠房及設備有關。截至2026年6月
30日止六個月，本集團產生資本開支人民幣84,000元。
本集團資產抵押
截至2026年6月30日，本集團並無任何資產抵押。
持有之重大投資
截至2026年6月30日，本集團並無任何重大投資。
30

附屬公司、聯營公司及合營企業之重大收購及出售事項
於報告期間，本集團並無任何附屬公司、聯營公司及合營企業之重大收購及出售事項。截至本公告
日期，除招股章程另有披露外，本集團並無任何有關重大投資或資本資產的具體未來計劃。
股份計劃

首次公開發售前股權激勵計劃
本公司於2019年7月25日採納2019年股權激勵計劃（「首次公開發售前股權激勵計劃」），並於2021年6
月11日作出修訂。
根據首次公開發售前股權激勵計劃授出及出售的獎勵可能涉及的本公司股本中普通股（「股份」）最高
數目為54,549,230股及其中已授出可認購55,708,000股股份的購股權（包括其後已失效或已悉數行使的
購股權）。於本公司上市後，概無根據首次公開發售前股權激勵計劃授出購股權。
於報告期間，並無購股權已獲行使，及886,000份購股權已失效。截至2026年6月30日，本公司
20,767,760份購股權尚未行使。

首次公開發售後受限制股份單位計劃
本公司已通過日期為2021年11月18日的股東決議案有條件採納首次公開發售後受限制股份單位計劃
並於2024年6月27日作出修訂（「首次公開發售後受限制股份單位計劃」）。
於2024年6月27日，首次公開發售後受限制股份單位計劃的計劃上限已予更新。因此，就根據首次公
開發售後受限制股份單位計劃可能授出的所有獎勵可配發及發行的最高股份數目，與根據任何其他
股份計劃可能授出的有關股份的購股權或獎勵的最高股份數目相加，不得超過截至2024年6月27日
（或本公司股東批准更新10%上限之日）本公司同類已發行股本（不包括任何庫存股份）的10%。就計算
計劃上限而言，於2024年6月27日之前授出的所有尚未行使受限制股份單位，以及根據首次公開發售
後受限制股份單位計劃條款失效的獎勵，不得計算在內。

31

於報告期間，本公司根據首次公開發售後受限制股份單位計劃，於2026年1月12日向28名承授人授
出6,372,575份受限制股份單位，以及於2026年4月10日向薛博士授出6,372,574份受限制股份單位。
向薛博士授出受限制股份單位已於2026年6月23日舉行的股東週年大會上獲獨立股東批准。因此，
經計及根據任何其他股份計劃已授出的有關股份的購股權或獎勵的股份數目，根據首次公開發售
後受限制股份單位計劃可供授出的受限制股份單位最高數目（即可供配發及發行的最高股份數目）為
30,432,790份，佔於2026年6月30日已發行股份總數（不包括庫存股份）約5.09%。
於報告期間，748,107份受限制股份單位已失效。截至2026年6月30日，本公司16,578,792份受限制股
份單位尚未行使。

首次公開發售後購股權計劃
本公司已通過日期為2021年11月18日的股東決議案有條件採納首次公開發售後購股權計劃並於2024
年6月27日作出修訂（「首次公開發售後購股權計劃」）。
於2024年6月27日，首次公開發售後購股權計劃的計劃上限已予更新。因此，根據首次公開發售後購
股權計劃可能授出的所有購股權可配發及發行的最高股份數目，與根據任何其他股份計劃可能授出
的有關股份的購股權或獎勵的最高股份數目相加，不得超過截至2024年6月27日（或本公司股東批准
更新10%上限之日）本公司同類已發行股本（不包括庫存股份）的10%。就計算計劃上限而言，於2024
年6月27日之前授出的所有尚未行使購股權，以及根據首次公開發售後購股權計劃條款失效的購股
權，不得計算在內。
於報告期間，本公司根據首次公開發售後購股權計劃，於2026年1月12日按每股2.32港元的行使價向
30名承授人授出6,372,575份購股權，以及於2026年4月10日按每股2.724港元的行使價向薛博士授出
6,372,574份購股權。向薛博士授出購股權已於2026年6月23日舉行的股東週年大會上獲獨立股東批
准。因此，經計及根據任何其他股份計劃已授出的有關股份的購股權或獎勵的股份數目，根據首次
公開發售後購股權計劃可供授出的購股權最高數目（即可供配發及發行的最高股份數目）為30,346,915
份，佔於2026年6月30日已發行股份總數（不包括庫存股份）約5.08%。
於報告期間，289,500份購股權已獲行使，及863,232份購股權已失效。截至2026年6月30日，本公司
20,341,917份購股權尚未行使。

32

企業管治及其他資料
遵守企業管治守則（「企業管治守則」）
本公司致力於維持高標準企業管治，以維護股東權益、提升企業價值、制定其業務策略及政策以及
提高其透明度及問責制。本公司已遵守及採納上市規則附錄C1所載的企業管治守則的原則及守則條
文，作為其本身的企業管治守則。
董事會認為，除下文所披露偏離企業管治守則第C.2.1條外，本公司於報告期間已遵守企業管治守則
的所有準則及所有適用守則條文。
我們並無區分董事會主席與首席執行官的職責。薛博士自2012年6月起擔任北海康成（北京）醫藥科技
有限公司的董事會主席兼總經理，並自本公司於2018年1月成立以來擔任董事會主席、董事兼首席執
行官。薛博士為本集團創始人，於本集團的業務營運及管理方面擁有豐富經驗。董事會認為，考慮
到其經驗、個人履歷及於本公司的職位，薛博士為識別策略機會及作為董事會核心的最適合董事，
因為其作為首席執行官對我們的業務有廣泛的了解。董事會亦認為，董事會主席及首席執行官由同
一人士兼任可促進策略倡議的有效執行，並便利管理層與董事會之間的資訊溝通。董事認為，權力
及權限的平衡不會因此項安排而受損。此外，所有重大決策均經諮詢董事會成員（包括相關董事委員
會）及四名獨立非執行董事後作出。
董事會將不時檢討企業管治架構及常規，並於董事會認為適當時作出必要安排。
遵守標準守則
本公司已就董事進行證券交易採納一套操守守則，其條款不遜於上市規則附錄C3上市發行人董事進
行證券交易的標準守則（「標準守則」）所載之規定標準。經向全體董事作出具體查詢後，全體董事已
確認彼等於報告期間一直遵從標準守則。

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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概無購買、出售或贖回本公司任何上市證券（包括出售庫存
股份（定義見上市規則）
）。於2026年6月30日，本公司並無持有任何庫存股份。
僱員及薪酬政策
截至2026年6月30日，本集團擁有39名僱員（2025年12月31日：41名僱員）及15名外部顧問。本集團的
僱員薪酬包括薪金、花紅、股份激勵計劃、僱員公積金及社會保險供款以及其他福利付款。根據中
國及其他有關司法權區的適用法律，我們為本集團僱員的社保基金（包括養老保險、失業保險、工傷
保險、醫療保險及生育保險）及住房公積金作出供款。
我們定期進行新員工培訓，以指導新僱員並幫助彼等適應新的工作環境。此外，除在職培訓外，我
們定期向僱員提供線上及面對面的正式及全面的公司層面和部門層面培訓。我們亦鼓勵僱員參加外
部研討會及講習班，以豐富彼等的技術知識及開發能力和技能。
於報告期間內，員工成本總額（包括董事薪酬）約為人民幣23.3百萬元（截至2025年6月30日止六個月：
人民幣27.7百萬元）。

中期股息
董事會已決議不宣派截至2026年6月30日止六個月的中期股息（截至2025年6月30日止六個月：無）。

審核委員會及中期業績審閱
董事會審核委員會（「審核委員會」）有三名成員，包括陳炳鈞先生（主席）、James Arthur Geraghty先生
及Richard Arthur Moscicki博士，其職權範圍符合上市規則。
審核委員會已審議及審閱本集團截至2026年6月30日止六個月的未經審核中期業績與中期報告以及本
集團採納的會計原則及常規，並與管理層及外部核數師就（其中包括）財務報告相關事項進行討論。
審核委員會認為，本集團截至2026年6月30日止六個月的未經審核中期業績符合相關會計準則、法律
法規的規定。

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此外，本集團截至2026年6月30日止六個月的未經審核中期簡明綜合財務資料已由本公司核數師國衛
會計師事務所有限公司（「國衛」）按照香港會計師公會頒佈的香港審閱委聘準則第2410號「由實體的獨
立核數師執行中期財務資料審閱」
（「香港審閱委聘準則第2410號」）進行審閱。

有關中期財務資料的獨立審閱報告的摘錄
以下為國衛審閱報告的摘錄。
結論
根據吾等的審閱，吾等並無發現任何事項致使吾等相信簡明綜合財務報表在所有重大方面未按照國
際會計準則第34號編製。
與持續經營有關的重大不確定性
吾等提請注意簡明綜合財務報表附註2，當中指出 貴集團截至2026年6月30日止六個月產生虧損淨
額為人民幣37,094,000元，及於2026年6月30日，貴集團的流動負債淨額及負債淨額分別為人民幣
193,377,000元及人民幣195,930,000元。該等情況連同簡明綜合財務報表附註2所載其他事項，顯示存
在重大不確定性，可能對 貴集團持續經營的能力構成重大疑問。吾等的結論並無就該事項作出修
訂。
上述簡明綜合財務報表附註2於本公告附註2中披露。

刊載中期業績及中期報告
本業績公告刊登於本公司網站(www.canbridgepharma.com)及聯交所網站(www.hkexnews.hk)。

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本公司的2026中期報告（包含所有上市規則所規定的相關資料）將於2026年9月刊載於上述網站。
承董事會命
北海康成製藥有限公司
董事長
薛群博士
香港，2026年8月28日

於本公告日期，董事會包括執行董事薛群博士；非執行董事趙瑋女士及王廷偉先生；以及獨立非執
行董事Richard Arthur Moscicki博士、James Arthur Geraghty先生、陳炳鈞先生及胡瀾博士。

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