Haisco Pharmaceutical Group (002653.SZ): Innovative Drug HSK42360-Na Tablets Included in Breakthrough Therapy Designation Program

Haisco Pharmaceutical Group (002653.SZ) announced that on September 24, 2026, the company learned that HSK42360-Na tablets have been officially included in the Breakthrough Therapy Designation List by the Center for Drug Evaluation (CDE) of the National Medical Products Administration. This will greatly advance the research and development of new drugs in this field and bring new hope for the treatment of glioma patients in China. It is reported that the product has excellent central nervous system permeability and has shown significant potential therapeutic advantages in both primary brain tumors and brain metastases. Clinical trials conducted to date have shown that the product has outstanding efficacy in high-grade gliomas with BRAF V600 mutations, with manageable safety, and preliminary results have been presented orally at the 2026 AACR (American Association for Cancer Research) Annual Meeting and the ESMO (European Society for Medical Oncology) Central Nervous System Tumors Special Session.