NMPA Grants Conditional Approval for Tunlametinib Capsules

Update: 12 Feb,2026 Source: Haiou Health Views: 108

On March 15, 2024, the National Medical Products Administration (NMPA) granted conditional approval for Tunlametinib Capsules (brand name: Keluping), a Class 1 innovative drug developed by Shanghai Kezhou Pharmaceutical Research & Development Co., Ltd., via the priority review and approval procedure. The drug is indicated for patients with NRAS-mutated advanced melanoma who have failed prior anti-PD-1/PD-L1 therapy.

Tunlametinib is a selective mitogen-activated protein kinase kinase 1 and 2 (MEK1/2) inhibitor that exerts anti-tumor effects by inhibiting the activity of MEK1/2 kinases. The launch of this drug provides a new therapeutic option for patients with NRAS-mutated advanced melanoma who have failed anti-PD-1/PD-L1 therapy.

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