Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot

Fosun Pharma’s Alovatinib Enters China’s Pediatric Anti‑Tumor SPARK Pilot

The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced that Fosun Pharma’s (SHA: 600196, HKG: 2196) Alovatinib tablets will be added to the “Support Anti‑Tumor Drugs R&D for Kids (SPARK)” pilot program. The drug, a MEK1/2 selective inhibitor, is intended for the treatment of Langerhans cell histiocytosis (LCH) and low‑grade glioma in children.

What Alovatinib Brings to Pediatric Oncology

  • Targeted Mechanism – Alovatinib selectively inhibits MEK1/2, a key player in the MAPK signaling pathway that drives many pediatric tumors.
  • Prior Approvals – The NMPA approved the drug in May 2025 for adult LCH and histiocytic tumors and for pediatric/adolescent NF1 patients (≥2 years) with symptomatic, inoperable plexiform neurofibromas.
  • SPARK Inclusion – By entering the SPARK pilot, the drug gains accelerated development support, potential expedited review, and focused resources for pediatric indications.

Strategic Implications for Fosun Pharma

  • Portfolio Expansion – The move strengthens Fosun’s position in the growing pediatric oncology market, complementing its existing pipeline in solid tumors.
  • Regulatory Momentum – Participation in SPARK signals a commitment to early‑stage pediatric research, potentially attracting international collaborators and investors.
  • Market Differentiation – Alovatinib’s unique MEK1/2 profile distinguishes it from other MEK inhibitors, offering a differentiated therapeutic option for rare pediatric cancers.-Fineline Info & Tech