HUTCHMED to Get First Milestone Payment After FRUZAQLA® Sales Exceed $200 Million

HUTCHMED (China) Limited has announced that it will receive a milestone payment of US$20 million from its partner Takeda. This payment is triggered by Takeda surpassing US$200 million in sales of FRUZAQLA® (fruquintinib) for metastatic colorectal cancer (CRC). Metastatic CRC is the second leading cause of cancer-related deaths in the US. Globally, there are approximately 840,000 new cases of CRC annually in the US, Europe, and Japan combined.

Takeda reported US$203 million in net sales of FRUZAQLA® for the nine months ending September 2024. This milestone payment is a significant first for HUTCHMED, marking the company’s initial commercial milestone payment. Takeda holds an exclusive global license to develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong, and Macau, where it is marketed under the FRUZAQLA® brand. Approvals for FRUZAQLA® have been secured in the US, EU, Switzerland, Canada, Japan, UK, Argentina, Australia, and Singapore as of 2024, with ongoing regulatory applications in other regions.

Dr. Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, highlighted that reaching the US$200 million sales mark reflects Takeda's strong commercial capabilities and the clinical advantages of fruquintinib. The US$20 million payment will aid HUTCHMED in broadening the application of fruquintinib to new indications, supporting their global partnership strategy.

CRC originates in the colon or rectum and is the third most prevalent cancer worldwide, with over 1.9 million new cases and 900,000 deaths reported in 2022 according to the International Agency for Research on Cancer/World Health Organization. In the US, an estimated 153,000 new CRC cases and 53,000 deaths are expected in 2024. Europe saw approximately 538,000 new cases and 248,000 deaths in 2022, while Japan reported 146,000 new cases and 60,000 deaths. Although early-stage CRC can be treated surgically, metastatic CRC remains a serious condition with poor outcomes and limited treatment options. Personalized therapeutic strategies based on molecular characteristics might benefit some metastatic CRC patients, but most lack actionable mutations.

Fruquintinib has received global regulatory approvals based on data from two significant Phase III trials: the global FRESCO-2 trial and the China-based FRESCO trial, involving a combined total of 734 patients. The safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023, with the FRESCO trial results appearing in JAMA. In mainland China, Hong Kong, and Macau, fruquintinib is co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was added to China’s National Reimbursement Drug List in January 2020, and over 100,000 colorectal cancer patients have been treated with fruquintinib since its launch in China.

Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2, and -3), playing a critical role in blocking tumor angiogenesis. Designed for enhanced selectivity, fruquintinib limits off-target kinase activity, enabling sustained target inhibition and potential use in combination therapies.

HUTCHMED is a commercial-stage biopharmaceutical company focused on discovering, globally developing, and commercializing targeted therapies and immunotherapies for cancer and immunological diseases. The company boasts a workforce of around 5,000, with approximately 1,800 personnel dedicated to oncology and immunology. Since its inception, HUTCHMED has been dedicated to advancing cancer drug candidates from in-house discovery to global markets, with its first three medicines marketed in China and one approved in the US, Europe, and Japan.