Sichuan Kelun-Biotech Biopharmaceutical Co Ltd, a holding subsidiary of Kelun Pharmaceutical (SZ:002422), announced on Monday that the new drug application (NDA) for its small molecule rearranged during transfection (RET) kinase inhibitor A400 (EP0031) has been accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).

The product is intended for the treatment of adult patients with RET-fusion positive locally advanced, or metastatic non-small cell lung cancer (NSCLC).

This acceptance for review is based on positive results from the two pivotal Phase 2 cohorts of the KL400-I/II-01 study for both 1L and 2L+ advanced RET-fusion positive NSCLC.