Fosun Pharma secures NMPA nod for Luvometinib’s pediatric LCH indication, lifting rare-tumor portfolio

Bulletin Express06-15 20:40

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) has received National Medical Products Administration approval for an additional indication of its self-developed MEK1/2 inhibitor, Luvometinib Tablets (trade name “复迈宁”, project FCN-159). The drug is now authorised in China to treat pediatric patients aged two years and above with relapsed or refractory Langerhans cell histiocytosis (LCH) following systemic therapy.

The latest green light follows two prior China approvals: 1) treatment of adult LCH and other histiocytic neoplasms; 2) treatment of pediatric patients (≥2 years) with neurofibromatosis type 1 (NF1) and symptomatic plexiform neurofibromas (PN) not suitable for complete resection.

Regulatory pipeline: • Adult NF1-PN indication—accepted by the NMPA and granted priority review status. • Ongoing trials include a Phase III study in pediatric low-grade glioma, and two Phase II studies targeting extracranial arteriovenous malformations and KRAS-mutant advanced non-small-cell lung cancer (in combination with anlotinib).

R&D investment in Luvometinib has reached approximately RMB 699.00 million (unaudited) as of May 2026. According to IQVIA MIDAS™, global sales of MEK1/2 selective inhibitors totalled US$2.36 billion in 2025, underscoring the commercial potential of the class.

Management expects the new pediatric LCH indication to address unmet needs in rare tumors and strengthen the drug’s competitive positioning. However, future sales will depend on market demand, competitive dynamics and channel penetration, introducing inherent uncertainty.

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(Fosun Pharma) has received National Medical Products Administration approval for an additional indication of its self-developed MEK1/2 inhibitor, Luvometinib Tablets (trade name “复迈宁”, project FCN-159). 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