VOLUNTARY ANNOUNCEMENT - DUPILUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA
2025-08-19 · 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 DUPILUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHI NA The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that Dupilumab Injection (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, a recombinant fully human monoclonal antibody drug targeting IL-4R α, is a biosimilar to Dupixent ® that has been applied for as a Class 3.3 therapeutic biologic al product and is indicated for the treatment of moderate-to-severe atopic dermatitis in a dults. The Product was developed in accordance with the relevant re search guidelines for biosimilars. Results from pharmaceutical and non-clinical studies demonstrate d that the Product was highly similar to the reference drug in terms of quality, safety and efficacy, sup porting the initiation of subsequent clinical studies. For and on behalf of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 19 August 2025 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chu nlei, Dr. YAO Bing, Mr. CAI Xin and Mr. CHEN Weiping as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Steph en and Ms. LI Quan as independent non-executive directors.
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