By Fineline Cube 
Shanghai-based Fosun Pharmaceutical (Group) Co., Ltd.’s (HKG: 2196, SHA: 600196) in-house developed Category 1 drug Fumaining (luvometinib) has been prescribed in multiple regions across China, marking the official clinical launch of this rare disease treatment.
Drug Profile and Approval
Fumaining is China’s first and currently only targeted drug approved for dual indications: adult Langerhans cell histiocytosis (LCH) and histiocytic neoplasms, as well as neurofibromatosis type 1 (NF1) in pediatric and adolescent patients aged 2 years and above.
Mechanism of Action
Luvometinib, a small-molecule targeted drug with independent intellectual property rights, highly selectively inhibits MEK1/2 protein activity. This action blocks the abnormal activation of the MAPK signaling pathway, suppressing tumor cell proliferation and inducing apoptosis.
Clinical Trial Results
In a Phase II clinical study for NF1-related plexiform neurofibromas (PN), with a median follow-up of 15.1 months, the objective response rate (ORR) reached 60.5%, and the median time to response (TTR) was 4.7 months. This demonstrates the drug’s rapid efficacy, good tolerability, and clear antitumor activity. Additionally, the Phase II study for luvometinib in histiocytic neoplasms showed an ORR of 82.8% in 29 patients, with a median time to response of just 2.9 months and a favorable safety profile.
Future Clinical Trials
Luvometinib is also undergoing clinical trials for low-grade gliomas, extracranial arteriovenous malformations, and pediatric LCH. There is potential for the drug to expand into more disease areas in the future.-Fineline Info & Tech