Takeda to acquire exclusive worldwide (ex-China) license of Hutchmed’s fruquintinib.
Takeda announced that it has entered into an exclusive licensing agreement with Hutchmed (China) Limited and its subsidiary Hutchmed Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau
Approved in China in 2018, fruquintinib is a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3. Fruquintinib is orally administered and has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status.
Positive results of FRESCO-2, the Phase III multi-regional clinical trial of fruquintinib in refractory metastatic CRC were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC and was generally well tolerated..
The FDA granted Fast Track designation for the development of fruquintinib for the treatment of patients with metastatic CRC in 2020. In December 2022, Hutchmed initiated a rolling submission of a New Drug Application (NDA) for fruquintinib with the FDA, which is planned to be completed in the first half of 2023. This will be followed by planned submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and a JNDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
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