Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced the completion of a rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its oral inhibitor of VEGFR-1, -2, and -3, fruquintinib. The drug is proposed for the treatment of refractory metastatic colorectal cancer (CRC), with the NDA bolstered by data from the global Phase III multi-regional FRESCO-2 study, which included participation from the US, Europe, Japan, and Australia. The study compared fruquintinib plus best supportive care (BSC) against placebo plus BSC in patients with refractory metastatic CRC. Additionally, the filing included data from the FRESCO study conducted in China. HutchMed intends to pursue approval filings with the European Medicines Agency (EMA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) later this year.
Fruquintinib’s Market Approval and Reimbursement
Fruquintinib, a vascular endothelial growth factor receptor (VEGFR) 1/2/3 inhibitor, received its initial market approval in China in September 2018 for use as a third-line treatment for CRC. The drug was subsequently added to the National Reimbursement Drug List (NRDL) at the start of 2020. HutchMed has partnered with Eli Lilly & Co. for the commercialization of fruquintinib in China.
Clinical Trials and Global Partnerships
Fruquintinib is also under assessment for the treatment of advanced gastric cancer or adenocarcinoma of the gastroesophageal junction (GC/GEJ). HutchMed has established multiple clinical trial collaborations for this molecule with BeiGene and Innovent Bio. In a significant move in March this year, HutchMed entered into a licensing agreement worth USD 1.13 billion with Japanese firm Takeda Pharmaceutical Co., Ltd (TSE:4502, NYSE:TAK) to advance the global development, commercialization, and manufacturing of fruquintinib in markets outside of mainland China, Hong Kong, and Macau.-Fineline Info & Tech
