drugset / Press release

VOLUNTARY ANNOUNCEMENT - JMT202 (RECOMBINANT FULLY HUMAN ANTI-BETA KLOTHO MONOCLONAL ANTIBODY DRUG) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.

2025-05-02 · 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 JMT202 (RECOMBINANT FULLY HUMAN ANTI- βKLOTHO MONOCLONAL ANTIBODY DRUG) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. The board of directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that JMT202 (the ‘‘Product ’’), a recombinant fully human anti- βKlotho monoclonal antibody drug developed by the Group, has been approved by the U.S. Food and Drug Administration (FDA) to co nduct clinical trials in the U.S. The Product also obtained approval from the National Medical Pr oducts Administration of the People ’s Republic of China in May 2024 and is currently undergoing cli nical trials in China. The Product is an FGFR1c/ βKlotho receptor agonist that specifically activates the FG FR1c/ βKlotho receptor complex by binding to βKlotho protein, thereby mimicking the action of its natural ligand, FGF21 protein, to regulate glycolipid metabolism. The Prod uct is potentially useful for the treatment of metabolism-related diseases such as dyslipidemia, metabo lic dysfunction-associated steatohepatitis (MASH), type 2 diabetes, and obesity, and also has the potent ial to be used in combination with other targeted drugs (such as GLP-1) that regulate glycolipid met abolism. The indication for this clinical trial approval is hypertriglyceridemia (HTG). Preclinical stud ies demonstrated that with a good safety profile and long dosing intervals, the Product could signif icantly reduce triglycerides (TG) levels and have hypolipidemic effects on the liver, providing a promis ing clinical development value. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 2 May 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 ↗