Fosun Pharma (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration (NMPA) has accepted its marketing application for luvometinib with Priority Review status for the treatment of pediatric patients aged 2 years and older with Langerhans Cell Histiocytosis (LCH), expanding the MEK inhibitor’s reach into ultra‑rare pediatric oncology.
Regulatory Milestone
Item
Detail
Product
Luvometinib (MEK1/2 inhibitor)
Company
Fosun Pharma (600196.SH; 2196.HK)
Agency
NMPA (China)
Application Type
Marketing authorization with Priority Review
Indication
Pediatric LCH (age ≥2 years)
Previous Approvals
May 2025: Adult LCH/histiocytic neoplasms; Pediatric/adolescent NF1‑PN
Special Designation
Included in SPARK project (Sep 2025) for pediatric anti‑tumor drug R&D
Drug Profile
Mechanism: Selective MEK1/2 inhibitor that blocks MAPK pathway signaling
Innovation: First MEK inhibitor approved in China for LCH and histiocytic neoplasms; extends to pediatric population
Formulation: Oral tablet for pediatric use
Clinical Path: Phase III trial for pediatric low‑grade glioma initiated July 2025; SPARK program inclusion accelerates review
Clinical Development Pipeline
Study
Indication
Status
Next Milestone
LCH Pediatric
Langerhans Cell Histiocytosis (age ≥2)
Priority Review (Nov 2025)
Approval expected Q2 2026
NF1‑PN
Plexiform neurofibromas (NF1)
Approved (May 2025)
Commercial launch Q4 2025
Low‑grade glioma
Pediatric brain tumors
Phase III initiated (Jul 2025)
Data readout H2 2027
Market Context & Outlook
Metric
Value
China LCH Prevalence
~500‑800 pediatric patients
Current Standard
Chemotherapy (cladribine, cytarabine); no approved targeted therapy
Pricing
Expected ¥200,000‑300,000/year (aligns with rare disease biologics)
Peak Sales Forecast
¥80‑120 million (US$11‑16 million) by 2028
Market Share Target
60‑70% of eligible pediatric patients
Competition
Only MEK inhibitor in China for LCH; SPARK program provides regulatory fast‑track
SPARK Program: Inclusion provides expedited review, pediatric‑specific guidance, and potential pricing benefits under China’s rare disease policy
Reimbursement Path: Rare disease designation likely to secure NRDL inclusion within 12‑18 months post‑approval
Strategic Value: Strengthens Fosun’s pediatric oncology portfolio and demonstrates capability in ultra‑rare disease development
Forward‑Looking Statements This brief contains forward‑looking statements regarding luvometinib’s regulatory review, market potential, and SPARK program benefits. Actual results may differ materially due to risks including NMPA approval timelines, pricing negotiations, and competitive dynamics.-Fineline Info & Tech
By Fineline Cube 