drugset / Press release

VOLUNTARY ANNOUNCEMENT - PRUSOGLIPTIN TABLETS OBTAINS MARKETING APPROVAL GRANTED BY NMPA

2025-01-13 · 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 TABLETS OBTAINS MARKETING APPROVAL GRANTED BY NMPA 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 Tablets (brand name: Shanzeping ( 善澤平)) (the ‘‘Product ’’), a Class 1 new chemical drug developed by the Group, has obtained marketing approval granted by the National Med ical Products Administration (NMPA) of the People ’s Republic of China. The Product is a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor which is highly selective and strongly inhibitory towards DPP-4. By inhibiting DPP-4, th e Product elevates the level of endogenous active glucagon-like peptide-1 (GLP-1) and thus enhances t he sensitivity of b-cells and a-cells towards glucose, leading to increased glucose-stimulated insulin secretion and enhanced inhibitory effect of glucose towards glucagon secretion, thereby lowering bloo d glucose levels. The Product is indicated for the improvement of glycemic control in adults with type 2 dia betes, including monotherapy and combination therapy when metformin hydrochloride alone do es not provide adequate glycemic control. The results of the two pivotal phase III clinical trials supp orting the approval of the Product (a phase III trial of prusogliptin tablets as monotherapy and a phase III trial of prusogliptin tablets in combination with metformin hydrochloride) have demonstra ted that the Product has a long-lasting glucose-lowering effect and is not prone to inducing hypogl ycemia and weight gain. In addition, the Product has a low incidence of adverse reactions and drug int eractions. No dosage adjustment is required when the Product is used in patients with mild to mod erate renal impairment. Type 2 diabetes is the most common type of diabetes in adults. According to the International Diabetes Federation, there were approximately 540 million adults (a ged 20 –79 years) with diabetes worldwide in 2021, with approximately 140 million in China, and the numbe r of adults with diabetes in China was estimated to increase to 174 million by 2045. – 1 – The approval of the Product will provide a new treatment opti on for patients with type 2 diabetes and further enrich the Group ’s product portfolio in metabolism. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 13 January 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. – 2 –

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