Haisco Pharmaceutical Group (002653.SZ): Innovative drug HSK44459 tablet receives approval for new indication clinical trial.

Haisco Pharmaceutical Group (002653.SZ) announced that the company recently received a "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. After review, the clinical trial application for HSK44459 tablets, accepted in November 2024, meets the relevant requirements for drug registration, and the drug is approved to conduct clinical trials. The announcement states that Behcet's disease, also known as Behcet's disease, is a chronic, recurrent autoimmune/inflammatory disease based on vasculitis-related pathological changes. It is mainly characterized by recurrent oral ulcers, genital ulcers, uveitis, and skin lesions, and can also affect surrounding blood vessels, heart, nervous system, gastrointestinal tract, joints, lungs, kidneys, and other organs. It was included in the second batch of rare disease list in China in 2023. There is currently no recognized effective cure for Behcet's disease, and the main treatment goal is to rapidly suppress inflammation. Apremilast is currently the only PDE4 inhibitor approved for the treatment of Behcet's disease, but it has significant adverse reactions. Based on the current clinical status of Behcet's disease, there is still a significant clinical need for drugs with better efficacy and safety. HSK44459 tablets are a new drug developed independently by the company with proprietary intellectual property for the treatment of Behcet's disease. Preclinical study results indicate that this drug has a clear target, definite efficacy, and good safety. It is a highly promising small molecule drug with a high benefit/risk ratio for clinical application, with broad prospects for clinical use. It is expected to become an effective treatment for Behcet's disease and address the current lack of clinical medications. According to the regulations on the classification and submission requirements of chemical drug registration issued by the National Medical Products Administration in Announcement No. 44 of 2020, this drug belongs to Class 1 of chemical drugs. HSK44459 received a clinical trial approval notice for the indication of "interstitial lung disease" in August 2024 (announcement number: 2024-072) and has completed Phase I clinical research. The approved indication for this application is Behcet's disease.