GeneScience Pharmaceutical gets approval for GenSci145 clinical trial in solid tumors

Changchun GeneScience Pharmaceutical, a subsidiary of Changchun High & New Technology Industry Group, has received approval from the National Medical Products Administration for its clinical trial application for GenSci145 tablets. The drug is intended for the treatment of locally advanced or metastatic solid tumors carrying PIK3CA mutations.

GenSci145 is a novel, selective PI3Kα inhibitor developed in-house by GeneScience Pharmaceutical. Pre-clinical studies have demonstrated its strong selective inhibitory activity against various hotspot mutations in the PIK3CA helical and kinase domains, showing clear efficacy and good safety in animal models. The drug aims to provide a new treatment option for patients with HR+/HER2- breast cancer and other solid tumors that have PIK3CA mutations and have developed resistance to existing therapies.

The company anticipates that a successful clinical trial will expand its business structure, optimize its product portfolio, and enhance its core competitiveness. However, the company also cautioned investors about the inherent risks associated with pharmaceutical research and development, including long development cycles and various uncertainties in the clinical trial process.