ELUNATE receives commercial approval in Macau
pharmafile | March 1, 2022 | News story | Manufacturing and Production |
HUTCHMED has received approval to market fruquintinib (ELUNATE in China), a selective and potent oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, in the Macau Special Administrative Region.
The approval comes after the latest update to the provisions on new drug importation, which allows drugs that have been approved in one or more specified areas, to be authorised for use in Macau. Fruquintinib was approved in Mainland China by the National Medical Products Administration in September 2018, for the treatment of metastatic colorectal cancer (CRC). ELUNATE will become the first homegrown innovative oncoogy drug, to be marketed in Macau.
Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, -2, and -3. VEGFR inhibitors play a pivotal role in blocking tumour angiogenesis. It was designed to improve kinase selectivity to minimise off-target toxicities, improve tolerability, and provide more consistent target coverage
Dr Karen Atkin, Chief Operating Officer of HUTCHMED, commented, “With the rapid pace of innovation in China’s biotech sector in recent years, more homegrown innovative drugs are being developed and launched in China. We are encouraged by the Macau government’s policy for registration of novel therapies, such as ELUNATE, based on China clinical trial data. We now look forward to patients in Macau having full access to ELUNATE in the coming months.”
In June 2020, the FDA granted Fast Track Designation for the development of fruquintinib for the treatment of patients with metastatic CRC. A Phase III registration study of fruquintinib, for the treatment of patients with metastatic CRC, is currently ongoing in the US, Europe, Japan, and Australia.
Lina Adams
