drugset / Press release

VOLUNTARY ANNOUNCEMENT - DARATUMUMAB INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA

2025-12-23 · 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 DARATUMUMAB INJECTION 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 Daratumumab 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 human monoclonal IgG1 antibody binding to ADP -ribosyl cyclase (CD38), is a biosimilar to the originator drug Darzalex ® and has been submitted for clinical trial application as a Class 3.3 therapeutic biological product, for the treatmen t of adult patients with multiple myeloma. The Product was developed in accordance with the relevant re search guidelines for biosimilars. Pharmaceutical and non-clinical study results indicated t hat the Product was highly similar to the original reference drug in terms of quality, safety and effi cacy, supporting the initiation of subsequent clinical studies. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 23 December 2025 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 and Mr. QU Zhiyong, as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Directors.

The release as fetched from its publisher. irasia.com ↗