VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF ENLONSTOBART FOR INJECTION
2023-03-10 · 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. (Incorpor ated in H ong Kong with limi ted liabi lity) (Stock co de: 1093) VOLUNTARY ANNOUNCEMENT NMPA ACCEPTANCE OF APPLICATION FOR MARKETING APPROVAL OF ENLONSTOBART FOR INJECTION 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 application for marketing approval of enlonstobart for injection (brand name: Enshuxing) of CSPC Megalith Biopharmaceutical Co., Ltd* (石藥集團巨石生物製藥有限公司), a subsidiary of the Company, has been accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China with eligibility for the conditional approval pathway. Enlonstobart for injection is a recombinant fully human anti-PD-1 monoclonal antibody developed by the Group, belonging to IgG4 monoclonal antibody drug. It is applied as a Class 1 therapeutic biological product for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1 expression who have failed to respond to first-line platinum-based chemotherapy. A Phase III confirmatory clinical trial of the product for the first-line treatment of cervical cancer has also been initiated with approval granted by the NMPA. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 10 March 2023 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, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive directors. * For identification purposes only
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