On April 26, Gelonghui Pharmaceutical (00013.HK) announced that its partner Takeda (TSE: 4502/ NYSE: TAK) has obtained the recommendation of the European Medicines Agency (EMA) Commission for Human Medicines (CHMP) to approve fruquintinib for the treatment of treated adult patients with metastatic colorectal cancer.
The European Commission (EC) will take the positive comments of CHMP into account when deciding on marketing licensing fruquintinib for the treatment of metastatic colorectal cancer throughout the European Union, Norway, Liechtenstein, and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR) approved in the EU to treat metastatic colorectal cancer. Takeda has exclusive global licenses to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong, and Macau.
Fruquintinib is known to be a selective oral VEGFR-1, -2, and -3 inhibitor. VEGFR inhibitors play a critical role in inhibiting tumor angiogenesis. Fruquintinib is designed to have higher kinase selectivity and is designed to reduce off-target kinase activity, thereby achieving higher drug exposure, continued target coverage, and greater flexibility when potentially used as a combination therapy. To date, fruquintinib has shown controlled safety characteristics, and research on its combined use with other anti-tumor treatments is ongoing.
Dr. Awny Farajallah, M.D., Chief Medical Officer of the Takeda Oncology Department said, “Through our partnership with Hewang Pharmaceuticals, we have made significant progress in expanding the accessibility of fruquintinib to suitable patients. With CHMP giving positive feedback on fruquintinib, we are one step closer to providing EU patients with an oral, non-chemotherapy treatment option that promises significant survival benefits. We look forward to a formal decision from the European Commission in the near future”.
Dr. Su Weiguo, CEO and Chief Scientific Officer of Hewong Pharmaceuticals, said, “Hutchison has a proven track record in developing innovative oncology drugs for patients in need. Currently, treatment options available to patients with metastatic colorectal cancer in the EU are limited, leading to poor treatment outcomes. We're excited about partner Takeda's progress in redefining the treatment landscape and addressing the significant unmet needs of patients with metastatic colorectal cancer in Europe. Over the past five years, this innovative oncology drug has had a profound impact on Chinese patients. Since we partnered with Takeda, we have seen the scope of this impact expand further, with approval and marketing in the US, and now awaiting approval from the European Commission, and we expect the drug to have a positive impact on European patients as well.”