Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (the Company) announced that its subsidiary, Shanghai Fosun Pharmaceutical Industrial Development Company Limited, has obtained approval from the National Medical Products Administration to conduct a Phase II clinical trial of 复迈宁® (Luvometinib Tablets) in combination with Anlotinib for patients with KRAS-mutant advanced non-small cell lung cancer.

Luvometinib, an innovative MEK1/2 selective inhibitor developed by the Company, is already approved in China for two indications: adult patients with Langerhans cell histiocytosis and histiocytic neoplasms, and pediatric patients aged two years or above with neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas not amenable to complete resection. Two further indications have been accepted by the regulator and included in the Priority Review list, and additional trials are ongoing in children’s low-grade glioma and extracranial arteriovenous malformations.

As of January 2026, research and development investment in Luvometinib had reached approximately 668.00 million renminbi. According to IQVIA MIDAS™, sales of MEK1/2 selective inhibitors globally amounted to around US$2,068 million in 2024.

The Company highlighted that further clinical confirmation and regulatory approvals are required before the new indication can be brought to market.