CHENGDU, China , Sept. 22, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the " Company ") announced that a new drug application (NDA) for the Company's small molecule rearranged during transfection (RET) kinase inhibitor A400 (also known as EP0031) was accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China 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 the 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.

Cohort 1 and 2, the Phase 2 stage of the KL400-I/II-01 study, evaluate the ef

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