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“TG103 INJECTION” OBTAINS CLINICAL TRIAL APPROVAL FOR THE TREATMENT OF NON-ALCOHOLIC STEATOHEPATITIS

September 13, 2022

“TG103 Injection”, a class 1 biological innovative drug of the Group, has been granted approval by the National Medical Products Administration of the PRC 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.

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