On November 18, 2023, Haisco Pharmaceutical Group (002653.SZ) announced that the company recently received a "Notice of Acceptance" issued by the National Medical Products Administration, accepting the clinical trial registration for the domestic production of HSK44459 tablets.
HSK44459 tablets are a new drug independently developed by the company with independent intellectual property rights for the treatment of Behçet's disease. According to the National Medical Products Administration's announcement on the "Classification of Chemical Drug Registration and Documentation Requirements" (No. 44, 2020), this product is classified as a Class 1 chemical drug.
Preclinical research results indicate that this product has clear targets, confirmed efficacy, and good safety, making it a highly promising small molecule drug with a high benefit/risk ratio for clinical applications, broad clinical application prospects, and the potential to become an effective treatment for Behçet's disease, addressing the current shortage of clinically available medications.