Hutchison China Meditech (HutchMed; HKG: 0013, NASDAQ: HCM) has announced a licensing deal with Japanese firm Takeda Pharmaceutical Co., Ltd (TYO: 4502, NYSE: TAK) to further the global development, commercialization, and manufacturing of fruquintinib in markets outside mainland China, Hong Kong, and Macau. Under the agreement, HutchMed will receive up to USD 1.13 billion, including a USD 400 million upfront fee and potential regulatory, development, and commercial sales milestone payments, plus royalties on future net sales.
Fruquintinib: Mechanism and Regulatory Milestones
Fruquintinib is a VEGFR 1/2/3 inhibitor that received its first market approval in China in September 2018 as a third-line treatment for colorectal cancer (CRC). The drug was added to China’s National Reimbursement Drug List (NRDL) in January 2020. HutchMed previously partnered with Eli Lilly & Co. for the commercialization of fruquintinib in China. The molecule is also being assessed in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction. Multiple clinical trial collaborations are ongoing between HutchMed, BeiGene, and Innovent Bio.
Global Expansion Plans
HutchMed initiated a rolling New Drug Application (NDA) for fruquintinib to the US FDA for treating refractory/metastatic colorectal cancer (CRC) in December last year. The rolling submission is expected to be completed during the first half of 2023, followed by a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) and an NDA to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).-Fineline Info & Tech
