VOLUNTARY ANNOUNCEMENT - "TG103 INJECTION" OBTAINS CLINICAL TRIAL APPROVAL FOR THE TREATMENT OF NON-ALCOHOLIC STEATOHEPATITIS
2022-09-09 · CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · original irasia.com ↗
– 1 – Hong Kong Exchanges and Clearing Limited and The Stock Exchange 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 whatsoever for any loss howsoever arising from or in reliance upon the whole or any part of the contents of this announcement. (Incorporated in Hong Kong with limited liability) (Stock code: 1093) VOLUNTARY ANNOUNCEMENT “TG103 INJECTION” OBTAINS CLINICAL TRIAL APPROV AL FOR THE TREATMENT OF NON-ALCOHOLIC STEATOHEPATITIS The board of directors (the “Board”) of CSPC Pharmaceutical Group Limited (the “Company”, together with its subsidiaries, the “Group”) is pleased to announce that “TG103 Injection”, a class 1 biological innovative drug of the Group, has been granted approval by the National Medical Products Administration of the People’s Republic of China to conduct clinical trials for the treatment of non-alcoholic steatohepatitis (NASH) in China. Non-alcoholic steatohepatitis (NASH) is an advanced stage of non-alcoholic fatty liver disease (NAFLD), and one of the leading causes of cirrhosis and liver cancer in adults. NAFLD is the most common chronic liver disease worldwide with prevalence of approximately 25% worldwide and in Asian population, and 10%-30% of NAFLD patients have NASH. Approximately 15%-25% of NASH patients may suffer from cirrhosis within 10 to 15 years. For patients with NASH, the liver-specific mortality rate is 11.77 deaths per 1,000 person-years and overall mortality rate is 25.56 deaths per 1,000 person-years. So far neither the National Medical Products Administration (NMPA) nor the U.S. Food and Drug Administration (FDA) has approved any medication for the treatment of NASH. Therefore, it is of great clinical importance to develop new drugs for NASH. TG103 Injection, an innovative long-acting recombinant human glucagon-like peptide-1 (GLP-1) Fc fusion protein, is a glucagon-like peptide-1 receptor agonist (GLP-1 RA). Studies have found that GLP-1 RA has shown significant efficacy in improving liver steatosis and inflammation as well as reversing liver fibrosis, and the preclinical studies of TG103 Injection have shown significant improvement in symptoms associated with NASH and pathologic findings. Therefore, TG103 Injection demonstrated a great clinical value in the treatment of NASH. – 2 – By order of the Board CSPC Pharmaceutical Group Limited Cai Dongchen Chairman Hong Kong, 9 September 2022 As at the date of this announcement, the Board comprises Mr. CAI Dongchen, Mr. ZHANG Cuilong, Mr. WANG Zhenguo, Mr. P AN Weidong, Mr. WANG Huaiyu, Dr. LI Chunlei, Dr. WANG Qingxi, Mr. CHAK Kin Man and Dr. JIANG Hao as executive directors; and Mr. WANG Bo, Mr. CHEN Chuan, Prof. WANG Hongguang, Mr. AU Chun Kwok Alan and Mr. LAW Cheuk Kin Stephen as independent non-executive directors.
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