- HUTCHMED (China) Limited HCM has entered into an exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited TAK to further the global development, commercialization, and manufacture of fruquintinib outside China.
- Fruquintinib is orally administered and can potentially be used across subtypes of metastatic colorectal cancer (CRC), regardless of biomarker status.
- Results of the FRESCO-2 Phase 3 trial of fruquintinib in refractory metastatic CRC were presented at the European Society for Medical Oncology Congress in September 2022. FRESCO-2 met its primary endpoint of improving overall survival in patients with metastatic CRC and was generally well tolerated.
- Takeda will receive an exclusive worldwide license to develop and commercialize fruquintinib from HUTCHMED Limited in all indications and territories outside mainland China, Hong Kong, and Macau.
- HUTCHMED Limited will be eligible to receive up to $1.13 billion, including $400 million upfront and up to $730 million in additional potential payments relating to regulatory, development and commercial sales milestones, as well as royalties on net sales.
- Marketing authorization submissions in the U.S., Europe, and Japan are planned to complete in 2023, with the rolling submission to the FDA planned to complete in the first half of 2023.
- Price Action: HCM shares are up 8.55% at $18.80 during the premarket session on the last check Monday.
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