drugset / Press release

VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE SYS6023 OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2024-07-08 · 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 announcemen t, make no representation as to its accuracy or completeness and expressly disclaim any lia bility whatsoever for any loss howsoever arising from or in reliance upon the whole or any pa rt of the contents of this announcement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT ANTIBODY-DRUG CONJUGATE SYS6023 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 antibody-drug conjugate SYS6023 (the ‘‘Product ’’) developed by CSPC Megalith Biopharmaceutical Co., Ltd.* ( 石藥集團巨石生物製藥有限公司), a subsidiary of the Group, has obtained approval of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States (the ‘‘U.S. ’’). Previously, the Product has obtained clinical trial approv al granted by the National Medical Products Administration of the People ’s Republic of China to conduct clinical trials in China in March 2024. SYS6023 is a monoclonal antibody-drug conjugate which can b ind to specific receptors on the tumor surface and achieve tumor cell killing by entering the cells through endocytosis and releasing toxins. The indications for this clinical tri al approval are advanced solid tumors. Preclinical studies have demonstrated that the Pro duct has good anti-tumor effects on a variety of cancers, providing promising clinical devel opment values. A number of patent applications of the Product have been submitted. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 8 July 2024 – 1 – 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 Chunlei, Dr. JIANG Hao, Dr. YAO Bing and Mr. CAI Xin as executive directors ; 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 direct ors. * for identification purpose only – 2 –

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