Haisco Pharmaceutical Group (002653.SZ): The innovative drug HSK42360 tablets have been included in the pilot project of the "Children's Antitumor Drug Research and Development Incentive Pilot Program (Starlight Plan)"

Haisco Pharmaceutical Group (002653.SZ) announced on April 8, 2026 that their drug HSK42360 tablets have been officially included in the "Starlight Plan", a pilot project for the development of pediatric anti-tumor drugs, by the China Drug Evaluation Center (CDE) of the National Medical Products Administration. HSK42360 tablets are a small molecule inhibitor developed independently by the company, targeting the BRAFV600 mutation and possessing brain penetrability. It is clinically intended for late-stage solid tumors with BRAFV600 mutation. BRAF mutation is one of the key driving factors for gliomas, the most common central nervous system tumors in children. There is currently no approved targeted therapy for pediatric gliomas with BRAFV600 mutation in China, leading to a significant unmet clinical need in this indication area. According to the announcement "Chemical Drug Registration Classification and Declaration Data Requirements" issued by the National Medical Products Administration (No. 44 of 2020), this drug belongs to Class 1 of chemical drugs. HSK42360 tablets are currently undergoing two Phase I clinical studies, one for adult solid tumor patients and the other for pediatric malignant brain tumor patients aged 6 and <18 years. The inclusion of HSK42360 tablets in the "Starlight Plan" for the development of pediatric anti-tumor drugs will greatly advance the research and development process of new drugs in this field, promote the independent development of innovative drugs in China, and bring new hope for the treatment of Chinese pediatric brain glioma patients.