drugset / Press release

VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN AND METFORMIN EXTENDED-RELEASE TABLETS OBTAINS CLINICAL TRIAL APPROVAL

2025-04-22 · 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 AND METFORMIN EXTENDED-RELEASE TABLETS OBTAINS CLINICAL TRIAL 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 Prusogliptin and Metformin Extended-Release Tablets (the ‘‘Product ’’) developed by the Group has obtained approval from the National Medical Products Administration of the People ’s Republic of China to conduct clinical trials in China. The Product is the world ’s first fixed-dose combination formulation of prusoglipti n and metformin hydrochloride approved for clinical trials. Prusogliptin is a dipeptidyl peptidase-IV (DPP-4) inhibitor that elevates the level of endogenous active glucagon-like peptide-1 (GLP-1) by inhibiting DPP-4 and thus enhances the sensitivity of β-cells and α-cells towards glucose, leading to increased glucose- stimulated insulin secretion and enhanced inhibitory effe ct of glucose on glucagon secretion, thereby improving hyperglycemia. Metformin is a biguanide drug tha t improves glucose tolerance in patients with type 2 diabetes mellitus and lowers both basal blood glu cose and postprandial blood glucose. The indication for this clinical trial approval is for use as an adjunct to diet and exercise in the treatment of adult patients with type 2 diabetes mellitus wh o have inadequate control with metformin monotherapy or who are currently receiving combination the rapy with prusogliptin and metformin. Compared with monotherapy products for type 2 diabetes mell itus, the Product demonstrates a favorable safety and tolerability profile, providing a pro mising clinical development value. By Order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 22 April 2025 As at the date of this announcement, the Board comprises Mr. C AI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. PAN Weidong, Mr. WANG Huaiyu, Dr. LI Chu nlei, Dr. YAO Bing, Mr. CAI Xin and Mr. CHEN Weiping as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Steph en and Ms. LI Quan as independent non-executive directors.

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