FOSUN PHARMA's (600196.SH) Subsidiary Receives Acceptance for Luvo Mertinib Tablets Drug Registration Application

Stock News11-21

FOSUN PHARMA (600196.SH) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., has received acceptance from the National Medical Products Administration (NMPA) for the drug registration application of Fumaining® (generic name: Luvo Mertinib Tablets) for treating Langerhans cell histiocytosis (LCH) in pediatric patients aged 2 years and above. The application has been included in the priority review process.

Luvo Mertinib Tablets, a self-developed innovative small-molecule chemical drug, acts as a selective MEK1/2 inhibitor. As of November 21, 2025, the drug has already been approved in China for two indications: (1) treating LCH and histiocytic neoplasms in adult patients, and (2) treating pediatric and adolescent patients aged 2 years and above with symptomatic, inoperable plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1).

Additionally, the drug is currently in Phase III clinical trials in China for treating adult NF1 and pediatric low-grade gliomas, while its Phase II clinical trials for treating extracranial arteriovenous malformations are ongoing. Notably, the drug's application for treating inoperable or residual/recurrent NF1-related plexiform neurofibromas in adult patients has been included in the NMPA's Breakthrough Therapy Designation program.

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