The licensing agreement for fruquintinib, which provides a potential new treatment option for patients with refractory metastatic colorectal cancer, is expected to strengthen Takeda’s growing oncology portfolio


Fruquintinib is a highly selective oral cancer drug. (Credit: James Yarema on Unsplash)

Takeda has signed an exclusive licensing agreement with HUTCHMED and its subsidiary to further develop and commercialise the latter’s cancer drug fruquintinib outside China.

Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, 2 and 3 and was approved in China in 2018.

The orally administered drug has the potential to be used across subtypes of refractory metastatic colorectal cancer (CRC), regardless of biomarker status.

Under the terms of the agreement, the Japanese drugmaker will obtain exclusive an license to develop and commercialise fruquintinib in all indications and territories excluding mainland China, Hong Kong, and Macau.

HUTCHMED will receive an upfront of $400m, additional potential milestone payments of up to $730m, along with royalties on net sales of the drug.

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.

“Working with HUTCHMED will enable us to expand our oncology portfolio, bringing us one step closer to achieving our aspiration to cure cancer.”

Takeda said that it is committed to developing new medicines for cancer patients who have limited or ineffective treatment options.

Fruquintinib offers a potential new treatment option for patients with refractory metastatic CRC to improve the lives of people living with cancer.

The drug showed positive results in the Phase 3 FRESCO-2 clinical trial, which met its primary endpoint of improving overall survival (OS) in patients with metastatic CRC.

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

In December last year, HUTCHMED initiated a rolling submission of a New Drug Application (NDA) with the US FDA, which is expected to be completed in the first half of this year.

HUTCHMED executive director, chief executive officer and chief scientific officer Weiguo Su said: “We are pleased to be partnering with a company that shares our mission to improve treatment outcomes for cancer patients and has the scale and expertise in global drug development and commercialization to advance fruquintinib globally outside of China.”