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  • KeChow Pharma’s New Drug Application for Tunlametinib Capsules for Advanced NRAS-Mutant Melanoma Accepted by NMPA

    2023-02-13

    On February 13, 2023, Beijing time, the National Medical Products Administration (NMPA) accepted the marketing authorization application for our independently developed Class 1 innovative drug, Tunlametinib Capsules (R&D code: HL-085 Capsules). This application targets patients with advanced NRAS-mutant melanoma who have previously undergone immunotherapy. Advanced NRAS-mutant melanoma is known for its high malignancy and rapid progression, with no current effective treatment options available in the clinic. Tunlametinib Capsules is poised to be the first targeted drug approved globally for this condition, potentially filling a critical gap in treatment. 

    About KeChow Pharma

    KeChow Pharma is dedicated to developing innovative treatments for tumors, free radical-related diseases, and other therapeutic areas. Its pipeline includes MEK inhibitor, chemoprotective agents, KRASG12C inhibitor, pan-RAF inhibitor, and multiple other tumor-targeted inhibitors. Notably, its MEK inhibitor, Tunlametinib (HL-085), has submitted a new drug application in China and is included in the CSCO guidelines. Another novel drug, a chemoprotective agent, demonstrates superior efficacy and safety compared to current clinical counterparts. All research efforts aim to address unmet clinical needs globally and within China by developing original small molecule drugs with “best-in-class” potential, bridging domestic gaps and fulfilling scientific aspirations to enhance quality of life.