VOLUNTARY ANNOUNCEMENT - OMALIZUMAB FOR INJECTION OBTAINS MARKETING APPROVAL GRANTED BY NMPA
2024-10-08 · 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 OMALIZUMAB FOR INJECTION OBTAINS MARKETING APPROVAL GRANTED BY NMPA The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that Omalizumab for Injection (brand name: Enyitan ®) (the ‘‘Product ’’) developed by the Group has obtained marketing approval granted by the National Med ical Products Administration (NMPA) of the People ’s Republic of China. Enyitan ® is a humanised anti-immunoglobulin E (IgE) recombinant mon oclonal antibody and is the first biosimilar drug of Xolair ® (omalizumab for injection) developed as Class 3.3 therapeutic biological product in China. It is indicated fo r adults and adolescents (12 years of age and older) with chronic spontaneous urticaria who rem ain symptomatic despite H1 antihistamine treatment. The Product was developed in acco rdance with the research guidelines for biosimilar drugs and the principle of step-b y-step progression. Head-to-head clinical pharmacokinetics and clinical safety and efficac y comparison trials were conducted, on the basis of the comprehensive pharmaceutical and non-cl inical comparison studies completed, proving that the Product is highly similar to the originator drug (Xolair ®) in terms of quality, safety and efficacy, with no clinically me aningful differences. The originator drug has been approved in China for the indicatio ns of allergic asthma and chronic spontaneous urticaria in adults and adolescents (1 2 years of age and older) who remain symptomatic despite H1 antihistamine treatment, wi th its efficacy and safety being widely recognised. – 1 – The approval of the Product will further enrich the Group ’s product portfolio for autoimmune diseases, and the marketing approval of another indication is also being actively promoted. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 8 October 2024 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 direct ors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, M r. LAW Cheuk Kin Stephen and Ms. LI Quan as independent non-executive direct ors. – 2 –
The release as fetched from its publisher. irasia.com ↗