VOLUNTARY ANNOUNCEMENT - JMT203 (ANTI-GFRAL MONOCLONAL ANTIBODY) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S.
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 JMT203 (ANTI-GFRAL MONOCLONAL ANTIBODY) 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 the antibody drug JMT203 (the ‘‘Product ’’) independently developed by Shanghai JMT-BIO Technology C o., Ltd.* ( 上海津曼特生物 科技有限公司), a subsidiary of the Company, has been approved by the U.S. F ood and Drug Administration (FDA) to conduct clinical trials in the U.S. Previously, the Product obtained approval from the National Medical Products Administration of the Pe ople ’s Republic of China in June 2023 and is currently undergoing clinical trials in China. The Product independently developed by the Group is a recomb inant humanised monoclonal antibody against GDNF family receptor alpha like (GFRAL), which can e ffectively antagonise the GDF15- GFRAL/RET signal and regulate appetite and metabolism. It c an potentially reverse or alleviate symptoms of cachexia, such as weight loss, anorexia and musc ular atrophy caused by tumors and chemotherapy drugs, thereby effectively improving the qua lity of life of tumor patients. The indication for this approval is cancer cachexia. Preclinical studies d emonstrated that the Product had good safety profile and was able to significantly inhibit weight loss, i ncrease non-fasting blood glucose and improve the forepaw grip strength of cachectic mice, thereb y relieving the cachexia symptoms and improving the tumor-bearing survival rate of cachectic mic e, and significantly increased treatment tolerance and extended survival in combination with anti-t umor therapies. Currently, there are no GDF15 or GFRAL-targeted drugs avail able on the market worldwide. The Product has the potential to become an effective drug for the treatment of cancer cachexia, providing a promising clinical development value. By order of the Board CSPC Pharmaceutical Group Limited CAI Dongchen Chairman Hong Kong, 22 April 2025 – 1 – 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. * For identification purposes only – 2 –
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