Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its RET inhibitor A400/EP0031 in the treatment of RET fusion-positive solid tumors. A400 is a next-generation selective RET inhibitor (SRI) with broad activity against common RET gene fusions and mutations, showing potential to overcome resistance to first-generation SRIs.
In preclinical studies, A400 demonstrated strong inhibitory activity against RET kinase, and in animal models, it showed good blood-brain barrier penetration. The drug is currently undergoing a pivotal study in China for advanced RET-positive non-small cell lung cancer. In March 2021, Kelun-Biotech entered into a licensing agreement with Ellipses Pharma, granting the UK oncology specialist exclusive rights to A400 in the US and certain European countries, while retaining rights in Greater China, South Korea, Singapore, and Malaysia. The drug received clearance for a Phase I/II study in the US to treat RET mutation malignant tumors in June 2022.- Flcube.com
