HUTCHMED's Fruquintinib (Elunate®) Approved for Market Launch in Macao as First China-Originated Innovative Oncology Drug

Recently, HUTCHMED(CHINA) LIMITED announced that its drug Aiotu (fruquintinib) has been approved for marketing in the Macao Special Administrative Region of China.

This approval is based on the latest directive of the new drug import regulations, which allows drugs that have been approved for marketing in one or more designated countries and regions to be registered and approved in Macao, China. Previously, new drug imports were required to be approved for marketing in at least two other designated countries and regions.

Aiotu is also the first innovative self-developed oncology drug in China to be approved by the National Medical Products Administration (NMPA) for marketing in Macao, China. Fruquintinib is a potent oral small-molecule inhibitor that selectively targets vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3, jointly developed by Hutchison MediPharma and Eli Lilly and Company.

Eli Lilly has the exclusive rights to commercialize fruquintinib in China and collaborates with HUTCHMED to promote the drug in China, while HUTCHMED retains all rights outside of China.

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of VEGFR-1, 2, and 3. VEGFR inhibitors play a crucial role in inhibiting tumor angiogenesis. The unique design of fruquintinib provides higher kinase selectivity, resulting in lower off-target toxicity, better tolerability, and more consistent target coverage. To date, fruquintinib has generally been well-tolerated in patients, and the low potential for drug-drug interactions observed in clinical studies suggests it may be highly suitable for combination with other cancer therapies.

Approval of Fruquintinib in China

China Metastatic Colorectal Cancer Study: Fruquintinib was approved by the National Medical Products Administration for sale in China in September 2018 and commercially launched under the brand name Elituvia in late November 2018. It was included in the National Reimbursement Drug List in January 2020. Elituvia is indicated for patients with metastatic colorectal cancer who have previously been treated with fluoropyrimidine, oxaliplatin, and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor therapy.

Editor: Eight Corners

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