Fosun Pharma's Remetinib drug application for pediatric LCH granted priority review

Shanghai Fosun Pharmaceutical Group announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., has had its drug registration application for Remetinib (Remetinib Tablets) accepted by the National Medical Products Administration (NMPA). The application, seeking a new indication for treating Langherhans Cell Histiocytosis (LCH) in pediatric patients aged two years and older, has also been granted priority review status.

Remetinib is an innovative small molecule chemical drug and a selective MEK1/2 inhibitor developed by the group. The drug has already received marketing approval in mainland China for two indications, including LCH and Histiocytic Neoplasm in adults, and pediatric patients with symptomatic, inoperable plexiform neurofibromas (PN) associated with Neurofibromatosis Type 1 (NF1).

As of October 2025, the cumulative R&D investment for Remetinib by the group is approximately RMB 638m. According to IQVIA MIDAS™ data, the global sales of MEK1/2 selective inhibitors reached approximately $2.068bn in 2024. The company cautioned that the new indication still requires regulatory approval before commercialization and that future sales are subject to market factors.