VOLUNTARY ANNOUNCEMENT - SACUBITRIL VALSARTAN SODIUM TABLETS OBTAINS DRUG REGISTRATION APPROVAL
2023-08-24 · 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 SACUBITRIL VALSARTAN SODIUM TABLETS OBTAINS DRUG REGISTRATION APPROVAL The board of directors (the “Board”) of the CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that the Sacubitril Valsartan Sodium Tablets (50mg, 100mg, 200mg) (the “Product”) developed by CSPC Ouyi Pharmaceutical Co., Ltd.* (石藥集團歐意藥業有限公司), a subsidiary of the Company, has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China, and is deemed to have passed the consistency evaluation of quality and efficacy of generic drugs. The Product contains a neprilysin inhibitor, sacubitril, and an angiotensin receptor blocker, valsartan. The Product inhibits neprilysin via LBQ657, the active metabolite of the prodrug sacubitril, and blocks the angiotensin II type-1 receptor via valsartan, thereby exerting its vasodilatory, preventive and reversal effects on cardiovascular remodeling and urinary sodium excretion. The Product is indicated (1) to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure (NYHA Class II-IV, LVEF ≤ 40%) with reduced ejection fraction; and (2) for the treatment of essential hypertension. The approval of the Product will further enrich the Group’s product portfolio for cardio- cerebrovascular diseases. - 1 - By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 24 August 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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