Hutchmed China Ltd on Thursday said its new drug application for the combination of fruquintinib and sintilimab has been accepted for review by the China National Medical Products Administration. The Hong Kong-based developer of treatments for cancer and immunological diseases said the drug combination was intended for the treatment of patients with locally advanced or metastatic renal cell carcinoma who have failed prior treatment with one tyrosine kinase inhibitor. The combination was developed jointly with China-based Innovent Biologics Inc, and the application was supported by data from the Frusica-2 study. ‘Kidney cancer continues to pose significant challenges in China, with limited treatment options for patients who fail first-line therapies. Submitting this NDA for the fruquintinib and sintilimab combination for advanced renal cell carcinoma marks an important step in our efforts to address this unmet need,’ said Michael Shi, head of Research & Development and chief medical officer at Hutchmed. ‘We are dedicated to making this combination therapy available to patients with renal cell carcinoma. At the same time, through ongoing research, we remain focused on exploring the full potential of this combination, as well as advancing our broader pipeline across multiple cancer types, to provide more patients with new and effective treatment options.’ The combination of fruquintinib and sintilimab in December 2024 won conditional approval from the China NMPA for the treatment of patients with advanced mismatch repair proficient endometrial cancer who have failed prior systemic therapy and are not candidates for curative surgery or radiation, based on data from the Frusica-1 study. Shares in Hutchmed China were up 0.9% at 226.00 pence each in London on Thursday morning. The stock is down 22% over the past year. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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