VOLUNTARY ANNOUNCEMENT - HIGH-CONCENTRATION HYDROXOCOBALAMIN HYDROCHLORIDE INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA FOR THE TREATMENT OF METHYLMALONIC ACIDEMIA (MMA)
2025-07-03 · 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 HIGH-CONCENTRATION HYDROXOCOBALAMIN HYDROCHLORIDE INJECTION OBTAINS CLINICAL TRIAL APPROVAL IN CHINA FOR THE TREATMENT OF METHYLMALONIC ACIDEMIA (MMA) The Board of Directors (the ‘‘Board ’’) of CSPC Pharmaceutical Group Limited (the ‘‘Company ’’, together with its subsidiaries, the ‘‘Group ’’) is pleased to announce that high-concentration hydroxocobalamin hydrochloride injection (the ‘‘Product ’’) developed by 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 for the treatment of methyl malonic acidemia ( ‘‘MMA’’). MMA is an autosomal recessive disorder of organic acid metab olism that may manifest as early as in the neonatal period and has already been included in the Firs t List of Rare Diseases jointly formulated by five departments, including the National Health Commiss ion, in China. Hydroxocobalamin injection is the first-line recommendation for the treatment of vitam in B12-responsive MMA, and lifelong use is required. Currently, no hydroxocobalamin injection targe ting the indication of MMA has been approved for marketing either domestically or internationally, and there remains an urgent unmet medical need for patients with MMA. The indication for this clinical approval is methylmalonic acidemia with elevated homocysteine level (cbl C type) in children. The Product has become the first hyd roxocobalamin injection approved in China for clinical trials in MMA and its development is expec ted to offer a new treatment option for patients with MMA, providing a promising clinical developm ent value. By order of the Board CSPC Pharmaceutical Group Limited CAI Dong Chen Chairman Hong Kong, 3 July 2025 – 1 – As at the date of this announcement, the Board comprises Mr. C AI Dong Chen, 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 ↗