Recently, Hehuang Pharmaceuticals and Takeda announced that the US Food and Drug Administration ("FDA") has accepted the application for the launch of a new drug, fluquintinib, for the treatment of adult patients with metastatic colorectal cancer after treatment, and will prioritize its review. Furoquantinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") -1, -2, and -3. If approved, furoquantinib will become the first and only highly selective inhibitor approved in the United States for the treatment of metastatic colorectal cancer, targeting all three VEGF receptors. The target review date for the Prescription Drug User Payment Act (PDUFA) proposed by the FDA regarding the new drug's marketing application is November 30, 2023.
It is worth mentioning that by the end of last year, Hehuang Pharmaceutical had already started rolling out its application for the launch of a new drug called furoquantinib for the treatment of refractory metastatic colorectal cancer to the US FDA, and it is expected to officially complete its submission in the first half of 2023. This is the second FDA breakthrough with Huangyao Furoquantinib, which is worth looking forward to.