Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational RET inhibitor, A400/EP0031. This drug is being developed for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).
A400 represents a next-generation selective RET inhibitor (SRI) designed to effectively target common RET gene fusions and mutations, with the potential to address resistance observed with first-generation SRIs. In March 2021, Kelun-Biotech entered into a licensing agreement with Ellipses Pharma, granting the UK oncology specialist exclusive rights to A400 in the U.S. and select European markets, while retaining rights in Greater China, South Korea, Singapore, and Malaysia. The drug received clearance for Phase I/II trials in the U.S. for RET mutation malignant tumors in June 2022 and was granted orphan drug designation (ODD) by the FDA in November 2023 for RET fusion-positive solid tumors. A400 is currently undergoing a pivotal study for RET-positive NSCLC in China.- Flcube.com
