drugset / Press release

VOLUNTARY ANNOUNCEMENT - PHASE II CLINICAL TRIAL OF SYH2069 INJECTION FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS IN ADULT PATIENTS OFFICIALLY INITIATED AT THE FIRST CENTRE IN CHINA

2026-09-16 · 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 PHASE II CLINICAL TRIAL OF SYH2069 INJECTION FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS IN ADULT PATIENTS OFFICIALLY INITIATED AT THE FIRST CENTRE IN C HINA 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 Phase II clinical trial (SYH2069-003) of SYH2069 Injection (the ‘‘Product ’’) developed by the Group for the treatment of type 2 diabetes mellitus in adult patients has been official ly initiated at the first centre in China. The Product is a novel fatty acid-modified polypeptide long -acting glucagon-like peptide-1 receptor (‘‘GLP-1R ’’) and glucose-dependent insulinotropic polypeptide recep tor ( ‘‘GIPR ’’) dual-target dual- biased agonist. It is designed to selectively activate GLP- 1R and GIPR to promote insulin secretion in a glucose-dependent manner, with expected effects to suppre ss appetite, delay gastric emptying, increase satiety and reduce caloric intake, thereby synergisticall y exerting glucose-lowering and weight-reducing effects. Furthermore, by selectively activating the cyclic adenosi ne monophosphate (cAMP) signalling pathway downstream of GLP-1R and GIPR, the Product avoids receptor i nternalisation and desensitisation caused by β-arrestin recruitment, thereby enhancing its activity and extending the durability of effect. Preclinical studies showed that the Product demonstrated p romising target activity and a manageable safety profile. The Group obtained the Notice of Approval for Clinical Trial of Drug issued by the National Medical Products Administration of the People ’s Republic of China (the ‘‘NMPA ’’) for the Product for the indication of overweight or obesity in December 2025, and in itiated the relevant Phase I clinical trials following the approval; these trials demonstrated the Prod uct’s preliminary safety, tolerability, and pharmacokinetic and pharmacodynamic profile in humans. Su bsequently, the Group obtained the Notice of Approval for Clinical Trial of Drug issued by the NMPA for t he Product for the indication of type 2 diabetes mellitus in April 2026, and the Product is expected to demonstrate durable glucose-lowering effects and clinical benefits in adult patients with type 2 d iabetes mellitus in China. – 1 – The initiated clinical trial is a multicentre, randomised, double-blind, placebo- and active-controlled, parallel-group Phase II clinical trial, aimed at evaluatin g the efficacy and safety of the Product under different dosing regimens in adult patients with type 2 diab etes mellitus. The recruitment and screening of participants for this Phase II clinical trial are activel y underway. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 16 September 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, Dr. LI Chunlei , Dr. YAO Bing, Mr. CAI Xin, Mr. CHEN Weiping, Mr. QU Zhiyong and Mr. ZHANG Yiwei 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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