康诺亚-B：康悦达前三季产品收入约6.6亿元同比+227%，NMPA批准青少年中重度特应性皮炎新适应症

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contents of this announcement.

Keymed Biosciences Inc.
康諾亞生物醫藥科技有限公司

(Incorporated in the Cayman Islands with limited liability)

(Stock Code: 2162)

INSIDE INFORMATION ANNOUNCEMENT
(1) UPDATE ON PRODUCT REVENUE FOR
THE FIRST THREE QUARTERS OF 2026
AND
(2) NATIONAL MEDICAL PRODUCTS
ADMINISTRATION APPROVES THE NEW
INDICATION MARKETING APPLICATION
FOR STAPOKIBART FOR THE TREATMENT
OF MODERATE-TO-SEVERE ATOPIC
DERMATITIS IN ADOLESCENTS
This announcement is made by Keymed Biosciences Inc. (the “ Company ” , together with its
subsidiaries, the “Group”) pursuant to Rule 13.09 of the Rules Governing the Listing of Securities
on The Stock Exchange of Hong Kong Limited (the “Listing Rules”) and Part XIVA of the
Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong).
The board of directors of the Company (the “Board”) is pleased to inform the shareholders of the
Company (the “Shareholders”) and potential investors that:
(1)

UPDATE ON PRODUCT REVENUE FOR THE FIRST THREE QUARTERS OF 2026
It recorded a revenue generated from the Company’s product Kangyueda® (康悅達 ®) (IL-4Rα
monoclonal antibody, Stapokibart) of approximately RMB660 million during the first three
quarters of 2026, representing a year-on-year increase of approximately 227%. The core
drivers are genuine market demand and the sharp increase in the number of hospitals with
market access. Benefiting from the support of national policies, since January 1, 2026, all
three approved indications of Kangyueda®, namely moderate-to-severe Atopic Dermatitis
(AD) in adults, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Seasonal Allergic
Rhinitis (SAR), as well as its two packaging formats of vial and pre-filled autoinjector,
have been included in China’s National Reimbursement Drug List, with a medical insurance
payment standard of RMB1,039 per unit for the 300 mg/2 mL specification, significantly
enhancing the affordability of the product for patients in China. Meanwhile, in July 2026,
Kangyueda® (康悅達 ®) was officially included in the National Essential Medicines List (2026
Edition), which took effect on September 1, 2026. Pursuant to the relevant administrative
requirements for essential medicines, public medical institutions at all levels nationwide are
required to procure and give priority to the use of medicines included in the list. This further
broadens terminal prescription settings and enhances the accessibility of medicines.

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As of September 30, 2026, the commercialization team had grown to more than 550 members,
with market access initiatives progressing rapidly. It covers 30 provinces and nearly
290 cities, including more than 2,200 hospitals. There are approximately 2,200 hospitals
with consistent prescription output and more than 1,300 hospitals for in-hospital drug
administration. Furthermore, it has stable partnerships with nearly 60 primary distributors,
with presence in nearly 700 pharmacies.
(2)

NATIONAL MEDICAL PRODUCTS ADMINISTRATION APPROVES THE
NEW INDICATION MARKETING APPLICATION FOR STAPOKIBART FOR
THE TREATMENT OF MODERATE-TO-SEVERE ATOPIC DERMATITIS IN
ADOLESCENTS
The National Medical Products Administration of China (the “NMPA”) has recently approved
the marketing application for a new indication of stapokibart (an anti-IL-4Rα monoclonal
antibody; trade name: Kangyueda (康悅達); development code: CM310) for the treatment of
moderate-to-severe atopic dermatitis (AD) in adolescents. Both the vials (300 mg [2 ml]/vial)
and the pre-filled auto-injector pens (300 mg [2 ml]/pen) have been approved.
This marketing approval of Stapokibart was based on a randomised, double-blind, placebocontrolled Phase III clinical study evaluating the efficacy and safety in 180 adolescent
patients aged 12 or elder but younger than aged 18. The study results indicated that, at Week
18 of treatment, up to 73.9% of patients achieved an EASI-75 response, significantly higher
than the placebo group (43.3%, P<0.0001). Up to 57.1% of patients achieved IGA response,
significantly superior to the placebo group (25.0%, P<0.0001). In addition, the PP-NRS
of patients in the Stapokibart group improved by up to 49.5% from baseline. In terms of
safety, the incidence rates of treatment-emergent adverse events (TEAEs) in the Stapokibart
group and the placebo group were comparable, and most were mild to moderate in severity.
Furthermore, compared with the results of studies in adults, the safety profile in adolescent
patients with moderate-to-severe AD was favourable, with no new safety signals identified.
About Stapokibart
Stapokibart is a humanized and highly potent antibody against interleukin-4 receptor
α-subunit (IL-4Rα). It is the first domestically-developed IL-4Rα antibody that received
marketing application approval from the NMPA and is also the world’s first IL-4Rα antibody
approved for the treatment of Seasonal allergic rhinitis (SAR) indications. By targeting
IL-4Rα, Kangyueda (康悅達 ® ) can lead to dual-blockade of interleukin-4 (IL-4) and
interleukin-13 (IL-13) signaling. IL-4 and IL-13 are two critical cytokines for initiating type 2
inflammation. In March 2026, the marketing application for Stapokibart injection for prurigo
nodularis (PN) was also accepted by the NMPA. As of the date of this announcement, the
Company are advancing a randomized, double-blinded, placebo-controlled Phase III clinical
study to evaluate the efficacy and safety of Stapokibart in child subjects with moderate-tosevere AD, and patient enrollment is in progress. Meanwhile, in July 2026, the Company
initiated a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study
evaluating the efficacy and safety of Stapokibart injection under background therapy for the
treatment of adolescent patients with SAR.

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The financial information contained in this announcement has been prepared based on the
internal management records of the Group and has not been audited or reviewed by the external
auditor. Accordingly, such information is provided for investors’ reference only. Due to various
uncertainties arising in the process of collecting and compiling such information, it may differ
from the information to be disclosed in the audited or unaudited consolidated financial statements
to be published by the Company, including but not limited to information contained in annual or
interim disclosures.
There is no assurance that the Company will ultimately market and/or commercialize
Stapokibart for other indications under development. Shareholders and potential investors of
the Company are advised to exercise caution when dealing in the shares of the Company.
By order of the Board
Keymed Biosciences Inc.
Dr. Bo CHEN
Chairman
Hong Kong, October 16, 2026

As at the date of this announcement, the Board of Directors of the Company comprises Dr. Bo
CHEN, Dr. Changyu WANG and Dr. Gang XU as executive Directors; Mr. Qi CHEN and Mr.
Yilun LIU as non-executive Directors; and Prof. Xiao-Fan WANG, Prof. Yang KE and Mr. Cheuk
Kin Stephen LAW as independent non-executive Directors.

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