Fosun Pharma drug for pediatric LCH gets priority review

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has had a drug registration application accepted by the National Medical Products Administration (NMPA) and included in the List of Priority Review. The application is for an additional indication: the treatment of pediatric patients aged 2 years and older with Langerhans cell histiocytosis (LCH).

The drug, a self-developed MEK1/2 selective inhibitor, is already approved for marketing in China for two indications, including LCH and histiocytic neoplasms in adults, and neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) in pediatric patients aged 2 years and older. As of October 2025, the Group had invested approximately RMB 638m (unaudited) in the R&D of the drug at this stage.

According to IQVIA MIDAS™2 data, worldwide sales of MEK1/2 selective inhibitors reached approximately $2,068m in 2024. While this acceptance does not materially impact the Group's results at this stage, the company cautions investors to be aware of inherent investment risks due to market factors affecting sales performance post-launch.