Changchun High-Tech Industry (000661.SZ) subsidiary GenSci's application for registering clinical trials for 145 domestically produced drugs has been accepted.

Changchun High-Tech Industry (000661.SZ) announced that its subsidiary Changchun Gensai Pharmaceutical Co., Ltd. (referred to as "Gensai Pharmaceutical") has received the acceptance notice issued by the National Medical Products Administration for the registration clinical trial application of GenSci145 tablets. GenSci145 tablets, a new type of selective PI3K inhibitor independently developed by Gensai Pharmaceutical, has been confirmed in preclinical studies to have strong selective inhibitory activity against various hotspot mutations in the PIK3CA helical and kinase domains. It has also demonstrated clear efficacy and good safety characteristics in animal models. Based on its highly relevant mechanism of action to the target indication and the development experience and validation results of other products targeting the same pathway, GenSci145 tablets have clear clinical development value and potential differentiation advantages, and are expected to provide a better clinical treatment option for patients with locally advanced or metastatic solid tumors carrying PIK3CA mutations.