drugset / Press release

VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN, DAPAGLIFLOZIN AND METFORMIN EXTENDED-RELEASE TABLETS OBTAIN CLINICAL TRIAL APPROVAL IN CHINA

2025-12-29 · 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 PRUSOGLIPTIN, DAPAGLIFLOZIN AND METFORMIN EXTENDED-RELE ASE TABLETS OBTAIN CLINICAL TRIAL APPROVAL IN CHINA The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that Prusogliptin, Dapagliflozin a nd Metformin Extended-Release Tablets (the ‘‘Product ’’) developed by the Group have obtained approval from the National Medical Products Administration of the Pe ople ’s Republic of China to conduct clinical trials in China. The Product is the world ’s first clinically approved triple-drug combination formu lation consisting of prusogliptin, dapagliflozin and metformin hydrochloride . Prusogliptin is a dipeptidyl peptidase-4 (‘‘DPP-4 ’’) inhibitor that elevates the level of endogenous active glu cagon-like peptide-1 (GLP-1) by inhibiting DPP-4, thereby enhancing the sensitivity of β-cells and α-cells towards glucose, increasing glucose-stimulated insulin secretion, and strengthening the inhibitory effect of glucose on glucagon secretion, which in turn improves hyperglycemia. Dapaglif lozin is a sodium-glucose co-transporter 2 (‘‘SGLT2 ’’) inhibitor that reduces reabsorption of filtered glucose b y inhibiting SGLT2, thereby promoting urinary glucose excretion. Metformin is a biguan ide drug that improves glucose tolerance in patients with type 2 diabetes mellitus and lowers both basal blood glucose and postprandial blood glucose. – 1 – The indication for this clinical trial approval is: ‘‘The Product is used as an adjunct to diet and exercise for adult patients with type 2 diabetes mellitus who have ina dequate glycemic control with metformin hydrochloride monotherapy. The triple-drug combination f ormulation has complementary mechanisms of action that cover multiple pathophysiological mechanis ms of diabetes, enabling effective glycemic control with a favorable safety and tolerability profile. I n addition, it can reduce the number of drugs taken, simplify antihyper glycemic regimen, and improve pa tient adherence, demonstrating high clinical development value. The Product will provide a new treatment option for patients with type 2 diabetes mellitus and further enrich the Group ’s pipeline in the field of metabolic diseases. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 29 December 2025 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 –

The release as fetched from its publisher. irasia.com ↗