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NMPA Approves Merck's Belzutifan for Advanced Paraganglioma and Pheochromocytoma

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China's NMPA has approved Merck's HIF-2α inhibitor Welireg (belzutifan) for adolescents and adults aged 12 and older with locally advanced, unresectable or metastatic paraganglioma and pheochromocytoma (PPGL). The indication was placed on the priority review list in January 2026 and has now cleared approval. Belzutifan was already approved in China for adults with VHL disease-associated renal cell carcinoma, CNS hemangioblastoma or pancreatic neuroendocrine tumors not requiring immediate surgery, and the PPGL approval extends its use to a new patient population, including younger patients. Open questions include uptake and pricing details for the new indication, which the approval announcement itself does not address.

Written by a model from the reports · updated 2 hours ago

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Oct 22
  1. mp.weixin.qq.comPick
    NMPA Approves Merck's HIF-2α Inhibitor Welireg (Belzutifan) for PPGL Indication

    Merck's Welireg (belzutifan) has been approved by the NMPA for adolescents and adults aged 12 and older with locally advanced, unresectable or metastatic PPGL. The drug was previously approved in China for adults with VHL disease-associated RCC, CNS hemangioblastoma or pNET not requiring immediate surgery. The new PPGL indication was placed on the priority review list in January 2026.

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CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org