VOLUNTARY ANNOUNCEMENT - NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR PRUSOGLIPTIN AND METFORMIN EXTENDED-RELEASE TABLETS
2026-01-12 · 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 announcement, make no representation as to its accuracy or completeness and expressly disclaim any liability whatsoe ver for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this ann ouncement. CSPC PHARMACEUTICAL GROUP LIMITED (Incorporated in Hong Kong with limited liability) (Stock Code: 1093) ʮ ̡ VOLUNTARY ANNOUNCEMENT NMPA ACCEPTS MARKETING AUTHORISATION APPLICATION FOR PRUSOGLIPTIN AND METFORMIN EXTENDED-RELEASE TABLETS 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 marketing authorisation application for Prusogliptin and Metformin Extended-Rele ase Tablets (the ‘‘Product ’’) developed by the Group has been accepted by the National Medical Products Administration (the ‘‘NMPA ’’) of the People ’s Republic of China. The Product is a fixed-dose extended-release combination o f the Group ’s Class 1 innovative drug, prusogliptin, and metformin hydrochloride, and has been ap plied for as a Class 2.3 chemical drug under the registration classification of chemical drugs. The pro posed indication is: ‘‘The Product is used as an adjunct to diet and exercise for adult patients with type 2 di abetes mellitus ( ‘‘T2DM ’’) who have inadequate glycemic control on metformin monotherapy or wh o are already receiving combination therapy with prusogliptin and metformin ’’. Prusogliptin is a dipeptidyl peptidase-4 ( ‘‘DPP-4 ’’) inhibitor that can increase endogenous active GLP-1 levels by inhibit ing DPP-4, thereby enhancing glucose- stimulated insulin secretion and strengthening the inhibi tory effect of glucose on glucagon secretion, resulting in improved glycemic control. Metformin is a bigu anide that reduces hepatic glucose production, inhibits intestinal glucose absorption, and e nhances insulin sensitivity by increasing peripheral glucose uptake and utilisation. In Phase III clinical trials conducted in treatment-naive T 2DM patients and in T2DM patients with inadequate glycemic control on metformin monotherapy, pru sogliptin demonstrated favourable efficacy and safety. Compared with metformin monotherapy, the combi nation of prusogliptin and metformin exhibits significant and sustained glucose-lowering effe cts with a lower incidence of hypoglycemia and a favourable safety profile. In addition, the Product has a l ow potential for drug-drug interactions with other medications, and no dose adjustment is required in pat ients with mild to moderate renal impairment. Compared with coadministration of the two sing le-agent formulations, the fixed-dose combination can simplify treatment regimens and significa ntly enhance patient adherence, thereby achieving glycemic control more effectively. – 1 – Currently, the Group is also actively advancing the clinica l development of a triple drug combination consisting of prusogliptin, dapagliflozin, and metformin hydrochloride, with the aim of benefiting more patients. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 12 January 2026 As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, Dr. CAI Lei, Mr. WEI Qingjie, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. WANG Huaiy u, Dr. LI Chunlei, Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping and Mr. QU Zhiyong, as Executive Directors; 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 Directors. – 2 –
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