Fosun Pharma (600196.SH / 02196.HK) Receives Acceptance for Additional Indication of Luvometinib Tablets

Bulletin Express02-05

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”) announced that its subsidiary Shanghai Fosun Pharmaceutical Industrial Development Company Limited recently had its drug registration application for an additional indication of 复迈宁® (generic name: Luvometinib Tablets) accepted by the National Medical Products Administration and included in the List of Priority Review.

According to the announcement dated February 5, 2026, this application covers the treatment of adult patients with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) not amenable to complete resection. Luvometinib, a MEK1/2 selective inhibitor, has already been approved in China for treating adult patients with Langerhans cell histiocytosis (LCH) and histiocytic neoplasms, as well as pediatric patients aged two years or older with NF1 and symptomatic PN.

In addition to the newly accepted indication, a separate pediatric indication for LCH is currently under review with priority status, while pediatric low-grade glioma and extracranial arteriovenous malformations are under clinical trials in China.

Fosun Pharma has invested approximately RMB663 million (unaudited) in research and development of Luvometinib as of December 2025. According to IQVIA MIDAS™, the global sales of MEK1/2 selective inhibitors reached around US$2,068 million in 2024. The new indication will require official marketing approval before commercialization, and its impact on Fosun Pharma’s current financial results remains limited.

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(“Fosun Pharma”) announced that its subsidiary Shanghai Fosun Pharmaceutical Industrial Development Company Limited recently had its drug registration application for an additional indication of 复迈宁® (generic name: Luvometinib Tablets) accepted by the National Medical Products Administration and included in the List of Priority Review.</p>\n<p>According to the announcement dated February 5, 2026, this application covers the treatment of adult patients with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) not amenable to complete resection. 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(“Fosun Pharma”) announced that its subsidiary Shanghai Fosun Pharmaceutical Industrial Development Company Limited recently had its drug registration application for an additional indication of 复迈宁® (generic name: Luvometinib Tablets) accepted by the National Medical Products Administration and included in the List of Priority Review.</p>\n<p>According to the announcement dated February 5, 2026, this application covers the treatment of adult patients with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) not amenable to complete resection. 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