China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct separate clinical trials for its Category 1 biologic product TG103 in non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease (AD). This marks a significant step forward in the development of TG103, highlighting its potential therapeutic applications in two distinct but critical areas.
TG103: A Novel GLP-1 Receptor Agonist
TG103 is a novel, long-acting recombinant glucagon-like peptide-1 (GLP-1) with an extended half-life due to its Fc-fusion characteristic. CSPC obtained clinical development and commercial promotion rights to the drug, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), through an RMB 150 million (USD 21.6 million) deal with China-based I-Mab in 2018. GLP-1 RAs have shown significant effects in improving liver steatosis and inflammation, reversing liver fibrosis, and preclinical studies of TG103 have demonstrated its potential to significantly improve NASH-related symptoms and pathological outcomes.
Potential Benefits in Alzheimer’s Disease
Preclinical animal experiments and clinical studies of drugs targeting the same pathway have shown that GLP-1 receptor agonists can improve pathological changes related to AD and have positive effects on brain metabolism and cognitive function in AD patients. TG103 is expected to delay the progression of AD and bring clinical benefits to patients.-Fineline Info & Tech
