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Highlights
- HUTCHMED receives US$10 million milestone payment from Takeda after FRUZAQLA®'s reimbursement approval in Spain.
- FRUZAQLA® now reimbursed for metastatic colorectal cancer patients in Spain, expanding European access.
- The approval is based on positive results from the Phase III FRESCO-2 trial published in The Lancet.
HUTCHMED (Nasdaq/AIM: HCM; HKEX:13) is pleased to announce that it will receive a US$10 million milestone payment from its partner, Takeda (TSE: 4502/NYSE: TAK), following a significant development for FRUZAQLA® (fruquintinib). In December 2024, Takeda secured a national reimbursement recommendation for FRUZAQLA® for patients with previously treated metastatic colorectal cancer (CRC) in Spain, marking the first such reimbursement recommendation for FRUZAQLA® in Europe. This milestone highlights a significant step forward in the expansion of the treatment’s accessibility across Europe.
FRUZAQLA®, which was approved by the European Commission (EC) in June 2024, has gained approval as a treatment for metastatic colorectal cancer, a leading cause of cancer-related deaths in Europe. With this approval, Takeda holds the exclusive worldwide license to develop, commercialize, and manufacture FRUZAQLA® outside of mainland China, Hong Kong, and Macau. This achievement not only enhances the availability of this innovative treatment but also strengthens the partnership between HUTCHMED and Takeda.
CEO’s Statement on Reimbursement Milestone
Dr. Weiguo Su, CEO and Chief Scientific Officer of HUTCHMED, expressed enthusiasm for both the partnership with Takeda and the positive impact this will have on CRC patients in Spain. “We are delighted for both our partner, Takeda, and patients in Spain who will now be able to receive reimbursement for this innovative treatment. This is an important step forward in improving patient access across Europe more broadly,” said Dr. Su. “It also underscores our ongoing collaboration with Takeda and reinforces our shared commitment to addressing the needs of patients with metastatic colorectal cancer.”
Regulatory Approvals and Ongoing Global Expansion
The European approval for FRUZAQLA® was based on the Phase III FRESCO-2 trial, which showed promising results in treating metastatic CRC patients. Published in The Lancet in June 2023, the trial data provided robust evidence supporting FRUZAQLA®’s effectiveness and safety. FRUZAQLA® has already been approved in various global markets, including the US (November 2023), the EU (June 2024), Switzerland (August 2024), and several other countries, such as Canada, Japan, and the UK. The company continues to push forward with regulatory applications for FRUZAQLA® in other key markets, expanding its global reach.
About Metastatic Colorectal Cancer (CRC)
Colorectal cancer (CRC) begins in the colon or rectum and remains one of the most prevalent cancers globally. According to the World Health Organization, CRC ranks as the third most common cancer worldwide, accounting for over 1.9 million new cases and 900,000 deaths in 2022. In Europe alone, CRC is the second most common cancer, leading to approximately 538,000 new cases and 248,000 deaths in 2022. Despite advances in early-stage detection and surgery, metastatic CRC remains a challenging and high-need area, with limited treatment options and a poor prognosis for patients who develop advanced disease.
For these patients, FRUZAQLA® offers a promising therapeutic option, particularly for those whose tumors lack actionable mutations, further addressing the unmet need for effective treatments in this patient population.
