Haisco Pharmaceutical Group (002653.SZ): Innovative drug HSK31679 tablet included in breakthrough therapy program.

Haisco Pharmaceutical Group (002653.SZ) announced that on March 12, 2026, they were informed that HSK31679 tablets have officially been included in the "Breakthrough Therapy List" by the National Medical Products Administration Drug Evaluation Center (CDE), making it the first domestically developed THR- agonist to be included in breakthrough therapy. Currently, there are no approved medications for the treatment of non-alcoholic steatohepatitis (NASH) in China. The inclusion of HSK31679 tablets in the "Breakthrough Therapy List" will greatly promote the development of new drugs in this field and bring new hope for the treatment of NASH patients in China. HSK31679 tablets are a highly selective thyroid hormone receptor (THR-) agonist developed independently by the company. By binding with the thyroid hormone receptor, it affects key steps in lipid metabolism, reducing blood lipids and liver fat. It is clinically intended for the treatment of NASH. Phase II clinical studies on the efficacy and safety of HSK31679 tablets in Chinese NASH patients have been completed, with results showing positive liver tissue pathology endpoints after 52 weeks of continuous treatment. It has demonstrated significant clinical value, as well as good overall safety and tolerability, laying a solid foundation for its inclusion in breakthrough therapy and entry into Phase III pivotal clinical trials.