drugset / Press release

VOLUNTARY ANNOUNCEMENT - SYS6041 (ANTIBODY-DRUG CONJUGATE) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2025-04-14 · 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 SYS6041 (ANTIBODY-DRUG CONJUGATE) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. 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 Investigational New Drug (IND) application for SYS6041 (Antibody-Drug Conjugate) ( the ‘‘Product ’’) developed by the Group has been approved by the U.S. Food and Drug Administration (F DA) to conduct clinical trials in the United States. The Product has also obtained approval from t he National Medical Products Administration of the People ’s Republic of China in January 2025 to conduct clinical trial s in China. The Product is a monoclonal antibody-drug conjugate that bi nds to specific receptors on the tumor surface, entering the cells through endocytosis to release toxins and kill the tumor cells. The indication for this approval is advanced solid tumors. Preclinical stu dies demonstrated that the Product had good anti-tumor effects on a variety of cancers, providing a prom ising clinical development value. A number of patent applications for the Product have been submitted i n China and overseas. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 14 April 2025 As at the date of this announcement, the Board comprises Mr. C AI Dongchen, 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 dir ectors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. L AW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors.

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