VOLUNTARY ANNOUNCEMENT - EMICIZUMAB INJECTION (SYS6053) OBTAINS CLINICAL TRIAL APPROVAL IN CHINA
2026-03-04 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
Hong Kong Exchanges and Clearing Limited and The Stock Excha nge of Hong Kong Limited take no responsibility for the contents of this announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT EMICIZUMAB INJECTION (SYS6053) OBTAINS CLINICAL TRIAL APPROVAL IN CHINA The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that the Emicizumab Injection (SYS6053) (the ‘‘Product ’’) developed by the Group has obtained approval from the Natio nal Medical Products Administration of the People ’s Republic of China to conduct clinical trials in China. The Product is a modified bispecific humanized IgG4 monoclo nal antibody that can bridge coagulation factor IXa and coagulation factor X. It is a biosimilar to the originator drug Hemlibra ® and has been submitted for clinical trial application as a Class 3.3 ther apeutic biological product, for the treatment of patients with Hemophilia A. The Product was developed in accordance with the relevant gu idelines for biosimilars. Pharmaceutical and non-clinical study results indicated that the Product w as highly similar to the reference drug in terms of quality, safety and efficacy, supporting the initi ation of subsequent clinical studies. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 4 March 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. WANG Huaiy u, Dr. LI Chunlei, Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiw ei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Dir ectors.
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