drugset / Press release

VOLUNTARY ANNOUNCEMENT - INDICATION FOR ACUTE ISCHEMIC STROKE OF MINGFULE (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION) OBTAINS MARKETING APPROVAL

2024-02-05 · 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 INDICATION FOR ACUTE ISCHEMIC STROKE OF MINGFULE (明復樂 ®) (RECOMBINANT HUMAN TNK TISSUE-TYPE PLASMINOGEN ACTIVATOR FOR INJECTION) OBTAINS MARKETING APPROVAL The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that Mingfule (明復樂 ®) (recombinant human TNKtissue-type plasminogen activator forinjection) (rhTNK-tPA) (1.0×107 IU/ 16 mg/injection) (the “Product”) developed by CSPC Recomgen Pharmaceutical (Guangzhou) Co., Ltd.* (石藥集團明復樂藥業 (廣州) 有限公司), asubsidiary ofthe Company, has obtained marketing approval granted bytheNational Medical Products Administration ofthePeople’s Republic ofChina forthenewindication ofthrombolytic treatment inpatients withacute ischemic stroke (onset <4.5h). It is the first approval for this indication of this product type in China, and is the second approved indication of the Product in China following its indication for acute myocardial infarction. The approval of this new indication is based on the efficacy and safety results of a well-designed, large-scale pivotal phaseIIIclinical trial.Theresults ofthestudyhavebeenpublished inTheLancet, a top-level international medical journal. The Product, a third-generation thrombolytic drug, is a recombinant protein produced by genetic engineering using mammalian cells. Compared with alteplase (rt-PA), the Product has a longer half- life, stronger antagonistic capability of plasminogen activator inhibitor-1 (PAI-1) and stronger fibrin binding ability. Theadministration oftheProduct isconvenient bysingle bolus intravenous injection within 5-10 seconds, which enables a faster intravenous thrombolytic treatment and a shorter transit timeforpatients withacuteischemic stroke, demonstrating significant clinical application advantages. - 1 - Theapproval ofthis newindication adds another keyproduct totheGroup’s portfolio inthefield of cerebrovascular disease, offers a new treatment option for patients with acute ischemic stroke (onset <4.5h) and improves drug accessibility, bringing benefits to more patients. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 5 February 2024 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 purpose only. - 2 -

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