Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma) announced that China’s National Medical Products Administration (NMPA) has approved an additional indication for Luvometinib Tablets (trade name: Fumaining, project No. FCN-159). The MEK1/2 selective inhibitor, developed by wholly owned unit Shanghai Fosun Pharmaceutical Industrial Development Co., is now cleared to treat adult patients with neurofibromatosis type 1 (NF1) suffering from symptomatic plexiform neurofibromas (PN) that cannot be completely resected.

Luvometinib, an oral chemical drug (Class 2.4) available in 4 mg and 1 mg strengths under approval numbers H20250025 and H20250026, is among Fosun Pharma’s flagship in-house innovations. Prior to the latest clearance, the therapy already held three domestic approvals: (1) adult Langerhans cell histiocytosis (LCH) and histiocytic neoplasms, (2) pediatric NF1-PN in patients aged ≥2 years, and (3) pediatric relapsed or refractory LCH in patients aged ≥2 years. Ongoing studies include Phase III trials for pediatric low-grade glioma and Phase II trials for extracranial arteriovenous malformations and KRAS-mutant advanced non-small cell lung cancer in combination with anlotinib.

Cumulative R&D spending on Luvometinib reached approximately RMB714.00 million as of July 2026 (unaudited). Market prospects are supported by 2025 global sales of MEK1/2 selective inhibitors, which totaled about US$2.36 billion, according to IQVIA MIDAS data.

Management expects the new adult NF1-PN indication to broaden Luvometinib’s clinical reach and reinforce its competitive position. Nevertheless, the company cautions that post-launch sales will depend on factors such as patient demand, competitive dynamics and distribution capabilities, introducing inherent uncertainty.