On January 8, Fosun Pharma announced that its subsidiary, Fosun Wanbang, had its drug registration application for Furetinib Succinate Capsules accepted by the National Medical Products Administration. The indication for this application is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Furetinib is a highly effective ALK/ROS1 inhibitor with high CNS penetration . It has demonstrated good efficacy in clinical studies, showing significant efficacy against central nervous system metastases, and exhibiting a good safety profile . In March 2025, Fosun Pharma initially submitted a marketing application for Furetinib, but voluntarily withdrew it in October, citing the need to further refine the registration materials according to the latest technical requirements of the National Medical Products Administration (NMPA).
Interim analysis results from the Phase II REMARK study showed that the progression-free survival (PFS) in the fosetinib (160 mg once daily) group was significantly prolonged compared to the crizotinib (250 mg twice daily) group (NR vs 13.93 months, P<0.0001) , reducing the risk of disease progression or death by 77% (HR=0.23), indicating that fosetinib is a highly promising innovative drug for the treatment of ALK-positive NSCLC. Furthermore, compared to crizotinib, fosetinib significantly reduced the risk of CNS progression.The median time to CNS progression (CNS-TTP) was 19.32 months in the crizotinib group, while it had not yet been reached in the fosetinib group (HR=0.04). Furthermore, fosetinib showed a trend toward improved overall survival (OS) (HR=0.60). The results also showed an objective response rate (ORR) of 92.8% in the fosetinib group, a 12% improvement compared to the crizotinib group (P=0.0035); and for patients with baseline brain metastases, the intracranial ORR reached 100% in the fosetinib group, compared to 50% in the crizotinib group.In addition to the indications for which this application was submitted, another indication for Furetinib — ROS1 -positive NSCLC— has also completed a Phase II clinical trial in mainland China (excluding Hong Kong, Macau, and Taiwan).As of November 2025, Fosun Pharma 's cumulative R&D investment in this new drug is approximately RMB 480 million (unaudited). According to statistics, in 2024, the sales of major drugs used to treat ALK- positive NSCLC in China were approximately RMB 3.367 billion.

https://bydrug.pharmcube.com/news/detail/707920bfb41cfd6e5d72dbe1cc575ab8