VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTANCE OF BIOLOGIC LICENSE APPLICATION OF OMALIZUMAB FOR INJECTION
2023-06-26 · 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 BIOLOGIC LICENSE APPLICATION OF OMALIZUMAB 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 biologic license application of Omalizumab for Injection (brand name: Kelingda (可令達)) (the “Product”) 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. The Product, a humanized monoclonal antibody against human immunoglobulin E (IgE), is a biosimilar to XOLAIR®. It is applied as a Class 3.3 therapeutic biological product for the indication of chronic spontaneous urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment. The originator drug has obtained approval in China for the indications of allergic asthma and chronic spontaneous urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment, with its efficacy and safety being widely recognized. Through a series of progressive studies in pharmaceutical, non-clinical, clinical pharmacokinetics, and clinical efficacy and safety according to the relevant research guidelines for biosimilars, the Product has been scientifically, rigorously and completely proven to be highly similar to the originator reference drug in terms of quality, safety and efficacy, with no clinically meaningful differences. - 1 - By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 26 June 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 - 2 -
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