VOLUNTARY ANNOUNCEMENT - SYS6043 (ANTIBODY-DRUG CONJUGATE) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.
2025-01-16 · 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 SYS6043 (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 SYS6043 (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 trial in the U.S. Previously, the Product has obtained clinical trial ap proval from the National Medical Products Administration of the People ’s Republic of China in December 2024 to conduct clinical tria ls in China. The Product is a monoclonal antibody-drug conjugate which c an bind to specific receptors on the tumor surface and achieve tumor cell killing by entering the cells through endocytosis and releasing toxins. The indication for this approval is advanced/metastatic so lid tumors, and the Product is expected to be indicated for the treatment of small cell lung cancer, esoph ageal squamous cell carcinoma, head and neck squamous cell carcinoma, prostate cancer and hepatoce llular carcinoma. Preclinical studies demonstrated that the Product had good anti-tumor effects o n a variety of cancers, providing a promising clinical development value. A number of patent ap plications of the Product have been submitted in China and overseas. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 16 January 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 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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