Takeda Pharmaceutical will acquire an exclusive worldwide license, excluding China, of fruquintinib from Hutchmed (China) and its subsidiary Hutchmed to strengthen its oncology portfolio.

Under the licensing agreement, the Japanese pharmaceutical company will further develop and market the VEGFR1/2/3 tyrosine kinase inhibitor in all indications and territories outside of mainland China, Hong Kong, and Macau.

Takeda will make an upfront payment of $400 million to Hutchmed, besides additional potential payments of up to $730 million based on regulatory, development, and commercial sales milestones, as well as royalties on net sales.

Fruquintinib, which was approved in China in 2018, is orally administered and offers a potential new treatment option for patients with refractory metastatic colorectal cancer (CRC), despite biomarker status.

Teresa Bitetti — Takeda Global Oncology Business Unit President 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 utilizing 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 anticipates filing marketing authorization application for fruquintinib in the US, the European Union (EU), and Japan this year.

The transaction is subject to customary closing conditions and completion of antitrust reviews.

In 2020, the US Food and Drug Administration (FDA) granted fast track designation for fruquintinib while in December 2022, Hutchmed started a rolling submission of a new drug application with the FDA, which is expected to be complete in the first half of 2023.

Colorectal cancer is the third most common cancer worldwide, with 935,000 deaths in 2020, according to the International Agency for Research on Cancer.

  Colorectal cancer, fruquintinib, HUTCHMED (China), Japan, Metastatic colorectal cancer, Oncology, Takeda, Takeda Pharmaceutical, Teresa Bitetti