Shanghai-based Thederma has announced that its drug candidate TAN-118 has obtained tacit clinical approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. This follows the clearance received from the US FDA in October of the previous year, indicating that TAN-118, an AhR candidate drug with a new structure, is set to enter multi-center clinical trials globally.
High Activity and Selectivity of TAN-118
TAN-118 is characterized by its high activity, high selectivity, and intestinal restriction. It has demonstrated significantly higher efficacy in animal efficacy models compared to established products such as mesalazine and tofacitinib. The drug’s primary enrichment in the gastrointestinal tract after administration, with extremely low exposure in plasma, suggests that it is well-suited for local efficacy in the colon while minimizing potential risks to other organs, leading to a higher safety profile.
Potential Clinical Value in Autoimmune Inflammatory Diseases
TAN-118’s ability to regulate the secretion of various Th1, Th2, and Th17 inflammatory factors positions it as a potential therapeutic option for a range of autoimmune inflammatory diseases beyond inflammatory bowel disease (IBD). The drug’s unique characteristics and potential to achieve clinical value in these disease areas underscore the importance of its global clinical trial initiative.-Fineline Info & Tech
