Koren Pharmaceuticals (002422.SZ): The new drug A400/EP0031 has been accepted for review by the National Medical Products Administration for market approval.

Zhixin Finance APP News, Kelun Pharma (002422.SZ) announced that the company recently learned that its controlling subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd. (hereinafter referred to as "Kelun Botai"), has had a new drug marketing application (NDA) for the RET kinase inhibitor project A400 (also known as EP0031) developed during the transfection process 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 the KL400-I/II-01 study in two key phase 2 cohorts (1L and 2L and above) treating RET fusion-positive NSCLC.