Takeda has signed an exclusive licence agreement with HUTCHMED (China) and its subsidiary Hutchmed to develop and market the latter’s fruquintinib.

Under the deal terms, the company will have an exclusive global licence for the development and commercialisation of fruquintinib for all indications and territories outside of mainland China, Macau, and Hong Kong.

Fruquintinib is an oral vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor.

It has been designed to improve kinase selectivity to reduce off-target toxicities and offer more consistent target coverage and improve tolerability.

The VEGFR inhibitor has the potential to be utilised across metastatic colorectal cancer (CRC) subtypes, irrespective of biomarker status.

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018.

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It was commercially launched in the country in the same year under ELUNATE brand name.

As per the terms of the agreement, HUTCHMED will receive an upfront payment of $400m on the closing of the deal, along with additional potential payments of up to $730m in regulatory, development and commercial sales milestones and royalties on net sales.

Takeda Global Oncology Business Unit president Teresa Bitetti said: “Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options.

“We look forward to utilising our development and commercial capabilities to expand the potential of this innovative medicine to patients beyond China.

“We have a strong track record of working with companies that share our focus on bringing transformative medicines to patients around the globe who need them.”

The company stated that the transaction is subject to the completion of antitrust regulatory reviews and other customary closing conditions.

In 2020, fruquintinib received Fast Track designation from the US Food and Drug Administration (FDA) to treat metastatic CRC patients.

HUTCHMED commenced a rolling submission of a New Drug Application (NDA) to the US FDA for fruquintinib in December last year. The submission is planned to be completed in the first half of this year.