VOLUNTARY ANNOUNCEMENT - GLP-1/GIP RECEPTOR DUAL-BIASED AGONIST POLYPEPTIDE LONG-ACTING INJECTION (SYH2082 INJECTION) OBTAINS CLINICAL TRIAL APPROVAL IN CHINA
2026-03-20 · 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 GLP-1/GIP RECEPTOR DUAL-BIASED AGONIST POLYPEPTIDE LONG-ACTING INJECTION (SYH2082 INJECTION) OBTAINS 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 the Group has obtained approval from the National Medical Products Administratio n of the People ’s Republic of China to conduct clinical trials in China with GLP-1/GIP receptor du al-biased agonist polypeptide long-acting injection (SYH2082 Injection) ( ‘‘SYH2082 ’’) developed by the Group. SYH2082 also obtained approval from the U.S. Food and Drug Administration (FDA) in February 2026 to conduct clinical trials in the U.S. SYH2082 has the potential to become a leading long-acting GL P-1/GIP receptor dual-biased agonist in clinical development, administered once a month. SYH2082 u tilizes the Group ’s long-acting formulation technology platform to achieve monthly dosing that is designed to improve patient compliance and convenience. SYH2082 selectively activates the cAMP pathway to reduce β-arrestin recruitment, thereby decreasing receptor internalization and desensitization, enhancing drug efficacy, and extending the durability of effect. Furthermore, through the integration of long half- life modification platform technology and long-acting formulation platform technology, SYH2082 aim s to support sustained weight loss over the dosing interval. In preclinical studies, SYH2082 demonstr ated superior efficacy on long-term weight loss and maintenance compared to similar marketed products , supporting a once-a-month dosing schedule. SYH2082 was well-tolerated, with no significant adverse reactions observed in toxicology studies. – 1 – The indication for the approved clinical trial is weight man agement for individuals with obesity or overweight and at least one weight-related comorbidity. In addition, SYH2082 also has the potential to improve glycemic control in adults with type 2 diabetes mell itus (T2DM), providing clinical benefits. This clinical trial approval is an important achievement fo r the Group in the field of metabolism in terms of the development of innovative long-acting product s and lays a solid foundation for future development of additional innovative products. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 20 March 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, Mr. QU Zhiyong and Mr. ZHANG Yiw ei as Executive Directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan, Mr. LAW Cheuk Kin Stephen and Ms. LI Quan as Independent Non-executive Dir ectors. – 2 –
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