VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE "SYSA1801" OBTAINS CLINICAL TRIAL APPROVAL IN CHINA
2021-06-16 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
Hong Kong Exchanges and Clearing Limited and The Stock Exchange 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 whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. CSPC PHARMACEUTICAL GROUP LIMITED ʮ ̡ (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT ANTIBODY-DRUG CONJUGATE “SYSA1801” 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 “SYSA1801” (the “Product ”), an antibody-drug conjugate developed by the Group, has obtained approval granted by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials in China. Patent applications of the Product have been submitted in China and overseas. SYSA1801 is an anti-Claudin 18.2 monoclonal antibody-drug conjugate. Preclinical in vitro and in vivo animal studies have demonstrated that SYSA1801 can effectively target tumor cells through anti-Claudin 18.2 antibody and trigger endocytosis, bringing the small molecule toxin into tumor cells to achieve anti-tumor effects. The indication for this clinical trial approval is solid tumor with Claudin 18.2 expression. The preclinical studies have shown that SYSA1801 has excellent in vivo and in vitro activity and good safety for gastric cancer, pancreatic cancer and lung cancer, providing a promising prospect of demonstrating good efficacy in clinical trials. Gastric cancer and lung cancer have a high incidence rate in China, while the case fatality rate of pancreatic cancer is also on an increasing tread, presenting a huge demand for new therapeutic targets and new medicines. The Group will endeavor to push forward the clinical trials of the Product and strive to launch the Product as soon as possible. By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 16 June 2021 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.
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