On January 11, Gelonghui (002653.SZ) announced that the company's subsidiary Tibet Hisco Pharmaceutical Co., Ltd. recently received a “Notice of Acceptance” for HSK39297 tablets issued by the State Drug Administration.
HSK39297 is a new drug independently developed by the company to treat hemolytic diseases with independent intellectual property rights. According to the requirements for chemical drug registration classification in the notice issued by the State Drug Administration on the “Registration Classification of Chemical Drugs and Application Data Requirements” (No. 44 of 2020), this product is a chemical drug category 1. Pre-clinical research results show that this product has clear targets, accurate curative effects, and good safety. It is a small molecule drug with great potential for development. It has a high benefit/risk ratio for clinical application, and has broad clinical application prospects. It is expected to become an effective treatment for hemolytic diseases and solve the current problem of lack of clinical medication.
HSK39297 tablets obtained a clinical trial notice for primary or secondary glomerular disease indications in December 2023, and phase I clinical trials are ongoing. Clinical trial applications for hemolytic disease indications were accepted this time.