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HONG KONG - HUTCHMED (China) Limited (Nasdaq/AIM:HCM; HKEX:13) will receive a $10 million milestone payment from Takeda (TSE:4502/NYSE:TAK) following the first national reimbursement recommendation in Europe for its colorectal cancer drug FRUZAQLA® (fruquintinib). This announcement comes after the drug's approval by the European Commission in June 2024 and subsequent reimbursement approval in Spain this month.
FRUZAQLA® is notable for being the first novel oral targeted therapy for metastatic colorectal cancer in the European Union that is not contingent on biomarker status, a significant development for patients in over a decade. Takeda, which holds the exclusive license to develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau, has achieved this milestone as part of its partnership with HUTCHMED.
Dr. Weiguo Su, CEO and Chief Scientific Officer of HUTCHMED, expressed satisfaction with the progress and emphasized the importance of the collaboration with Takeda in addressing the needs of metastatic colorectal cancer patients.
The decision for reimbursement is based on the results from the Phase III FRESCO-2 trial, which demonstrated the drug's efficacy and safety. These findings were published in The Lancet in June 2023. FRUZAQLA® has also been approved in the United States in November 2023, followed by approvals in Switzerland, Canada, Japan, the United Kingdom (TADAWUL:4280), Argentina, Australia, and Singapore throughout 2024.
Colorectal cancer is the second leading cause of cancer-related deaths in Europe, with approximately 248,000 fatalities in 2022. The approval of FRUZAQLA® represents a significant advancement in the therapeutic options available for this disease, which has limited treatment alternatives for metastatic cases.
Fruquintinib, the active ingredient in FRUZAQLA®, is a selective inhibitor of vascular endothelial growth factor receptors, which play a critical role in tumor angiogenesis. The drug's design allows for enhanced selectivity and the potential for use in combination therapies.
The drug has already been included in the National Reimbursement Drug List in China since January 2020 and has treated over 100,000 colorectal cancer patients in the country. HUTCHMED, a biopharmaceutical company, continues to focus on the discovery and development of targeted therapies for cancer and immunological diseases.
This milestone payment is a testament to the ongoing collaboration between HUTCHMED and Takeda and underscores the potential of fruquintinib in improving patient outcomes. The information is based on a press release statement.
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