Hutchmed starts rolling submission of NDA for fruquintinib
Chinese biopharma Hutchmed (AIM: HCM) has started the filing of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for fruquintinib.
The company is hopeful of gaining approval for its highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for the treatment of refractory metastatic colorectal cancer (CRC).
Hutchmed plans to complete the NDA submission in the first half of 2023, to be followed by the filing of a Marketing Authorization Application to the European Medicines Agency (EMA) and an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA).
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