Coron Bo Tai Biology-B (06990.HK): A400/EP0031 new drug application for market approval accepted by the National Medical Products Administration.

The Zhitong Finance APP news, Colombo Biotechnology-B (06990.HK) announced that the new drug application (NDA) for A400 (also known as EP0031), a re-arranged (RET) small molecule kinase inhibitor project in the company's transfection process, has been accepted by the China National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) for the treatment of RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients. This acceptance is based on the positive results of two key phase 2 cohorts in the KL400-I/II-01 study, treating 1L and 2L and above RET fusion-positive NSCLC patients.