友芝友生物-B(2496.HK)公告Y225(艾美赛珠单抗/Hemlibra生物类似药)I期临床试验完成首例受试者给药

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announcement.

WUHAN YZY BIOPHARMA CO., LTD.
武漢友芝友生物製藥股份有限公司
(A joint stock company incorporated in the People’s Republic of China with limited liability)

(Stock Code: 2496)

VOLUNTARY ANNOUNCEMENT
THE FIRST PATIENT DOSED IN PHASE I CLINICAL TRIAL OF
Y225 FOR TREATMENT OF HEMOPHILIA A
This announcement is made by Wuhan YZY Biopharma Co., Ltd. (the ‘‘Company’’) on a
voluntary basis to inform the shareholders of the Company and potential investors of the
latest business updates of the Company.
The board of directors of the Company (the ‘‘Board’’) is pleased to announce that the first
patient has been dosed in the Phase I clinical study of Y225, an emicizumab biosimilar
under development by the Company in the PRC. This Phase I clinical trial is a randomized,
double-blind, single-dose, parallel-group study designed to evaluate the bioequivalence of
Y225 and the reference drug Hemlibra® (emicizumab injection) in healthy adult male
subjects, and to provide a basis for subsequent clinical development of Y225. This marks the
project’s entry into the human clinical research stage.
ABOUT Y225 AND BACKGROUND ON RELATED DISEASES
Y225 is a bispecific antibody drug candidate developed by the Company using Hemlibra® as
the reference drug and in accordance with the requirements for biosimilar development, and
is intended for the prophylactic treatment of hemophilia A. Emicizumab bridges activated
coagulation factor IX (FIXa) and coagulation factor X (FX) to mimic part of the cofactor
function of activated coagulation factor VIII. The originator drug has been approved in
China for routine prophylaxis in adult and pediatric patients with hemophilia A with
coagulation factor VIII inhibitors, and in adult and pediatric patients with severe hemophilia
A without such inhibitors. It is administered subcutaneously, and during the maintenance
period, the dosing regimen may be selected as once weekly, once every two weeks or once
every four weeks according to medical advice.

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Hemophilia A is a hereditary bleeding disorder. Patients face risks of recurrent bleeding and
joint damage due to deficiency or insufficient function of coagulation factor VIII, making
long-term regular prophylactic treatment of great significance. According to public
information, as of February 2025, 53,177 patients with hemophilia had been registered in
China; an expert interview published in June 2026 further disclosed that, as of 2025, over
60,000 patients had been registered in the National Hemophilia Case Information
Management System. The above figures represent the total number of registered patients
with different types of hemophilia. The expansion of the registered patient population
further highlights the need for long-term standardized diagnosis and treatment and improved
treatment accessibility.
The Company is advancing the research and development of Y225 to expand treatment
options for patients with hemophilia A and to create conditions for improving the
accessibility and affordability of long-term prophylactic treatment. The Company has been
granted a Chinese patent authorization for the antibody formulation technology related to
Y225 and will steadily advance subsequent research and evaluation work in accordance with
the requirements for biosimilar development.
On June 17, 2025, the Company entered into a strategic cooperation agreement with Hubei
Jiangxia Laboratory (湖北江夏實驗室) to jointly establish an Antibody Drug Development
and Achievement Transformation Center. Y225 is one of the first cooperation projects
between both parties. Both parties will combine their respective scientific research
resources, antibody drug R&D and industrialization capabilities to continuously advance
relevant R&D and achievement transformation.
Cautionary statement required by Rule 18A.05 of the Rules Governing the Listing of
Securities on The Stock Exchange of Hong Kong Limited: The Company cannot
guarantee that Y225 will ultimately be successfully developed and marketed. Shareholders
of the Company and potential investors are advised to exercise caution when dealing in the
shares of the Company.
By order of the Board
Wuhan YZY Biopharma Co., Ltd.
Dr. Zhou Pengfei
Chairman of the Board,
Executive Director and Chief Executive Officer
Wuhan, PRC, October 16, 2026
As of the date of this announcement, the Board comprises Dr. Zhou Pengfei and Mr. Wen
Zhicheng as executive Directors; Dr. Yuan Qian, Dr. Zhou Hongfeng, Mr. Pang Zhenhai,
Dr. Hui Xiwu and Mr. Xie Shouwu as non-executive Directors; and Dr. Cheng Bin, Ms. Fu
Lili, Dr. Deng Yuezhen and Dr. Chen Bin as independent non-executive Directors.

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