drugset / Press release

VOLUNTARY ANNOUNCEMENT - ACCEPTANCE OF NEW INDICATION APPLICATION FOR MARKETING APPROVAL OF MINGFULE (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION)

2022-11-16 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗

– 1 – 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. (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT ACCEPTANCE OF NEW INDICATION APPLICATION FOR MARKETING APPROV AL OF MINGFULE (თూᆀ®) (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIV ATOR 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 new indication application for marketing approval of Mingfule ( თూᆀ®) (recombinant human TNK tissue-type plasminogen activator for injection) (rhTNK-tPA) developed by CSPC Recomgen Pharmaceutical (Guangzhou) Co., Ltd.* (ూᆀᖹุ (ᄿψ)ʮ̡), a subsidiary of the Company, for the thrombolytic treatment in patients with acute ischemic stroke has been officially accepted by the National Medical Products Administration (NMPA) of the People’s Republic of China. Mingfule, a third-generation recombinant human tissue-type plasminogen activator (rt-PA) product, is a mutant of rt-PA. Compared with rt-PA, Mingfule is the latest type of rt-PA thrombolytic drug with a longer half-life period, stronger antagonistic capability of plasminogen activator inhibitor-1 (PAI-1) and stronger fibrin binding ability. Compared with rt-PA products which are administered by intravenous injection followed by continuous intravenous infusion for 1 hour, Mingfule can be administered by a single bolus intravenous injection within 5-10 seconds, which is convenient and allows patients to complete intravenous thrombolytic treatment in a shorter time, demonstrating significant clinical application advantages. Mingfule obtained marketing approval from the NMPA in 2015 for the first indication of thrombolytic treatment in patients with acute myocardial infarction. Based on the characteristics of the mechanism of action and the existing clinical data of Mingfule, the Group plans to continue the development of Mingfule in combination with endovascular therapy of bridging therapy in ischemic stroke and other indications including deep vein thrombosis, pulmonary embolism and central retinal artery occlusion. – 2 – By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 16 November 2022 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. P AN 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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