Core Viewpoint - The approval of the clinical trial for the biosimilar Y225 marks a significant advancement for the company in the treatment of Hemophilia A, potentially filling a gap in the domestic market for high-barrier bispecific monoclonal antibody biosimilars [1][2] Group 1: Product Development - The clinical trial for Y225, a biosimilar to the drug Shuyou Lile® (Emicizumab injection), has been approved by the National Medical Products Administration (NMPA) of China, with the trial set to begin on December 23, 2025 [1] - Y225 is designed to treat Hemophilia A, a condition caused by a deficiency in coagulation factor VIII, which leads to bleeding disorders [1] - The original drug Shuyou Lile® is the only bispecific antibody approved for preventive treatment in patients with or without factor VIII inhibitors, but its high cost limits patient access [1] Group 2: Competitive Advantage - The company has innovatively overcome the formulation patent of the original drug, allowing Y225 to potentially launch seven years earlier than expected, making it the first biosimilar of Shuyou Lile® to enter the domestic market [1] - The existing patents for Shuyou Lile® extend its protection until 2038, creating a significant barrier to entry for competitors [1] Group 3: Strategic Partnerships - A strategic cooperation agreement was signed with Hubei Jiangxia Laboratory on June 17, 2025, to leverage the laboratory's research capabilities alongside the company's experience in antibody drug development [2] - The collaboration will focus on innovative antibody molecule design, efficient production process development, and clinical research, with Y225 as the first project [2] - This partnership aims to enhance the overall research and development efficiency and long-term industrialization potential of the company's pipeline [2]

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，概不對因本公告全部 或任何部份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。 自願公告 WUHAN YZY BIOPHARMA CO., LTD. Y225「艾美賽珠單抗注射液」取得NMPA的IND批准 本 公 告 由 武 漢 友 芝 友 生 物 製 藥 股 份 有 限 公 司（「本 公 司」， 連 同 其 附 屬 公 司 ， 統 稱 「本 集團」）自 願作 出 ，以 告知 本 公司 股東 及 潛在 投 資者 有關 本 公司 的 最新 業務 發 展情況。 本公司欣然宣佈，於2025年12月23日，其生物類似藥Y225的臨床試驗（「IND」）申 請已獲中華人民共和國國家藥品監督管理局（「NMPA」）批准。 武 漢 友 芝 友 生 物 製 藥 股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2496） 香港聯合交易所有限公司證券上市規則第18A .05條規定的示警聲明：本公司無法 保證能 ...