On July 28, 2020 Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM: HCM) and Eli Lilly and Company ("Lilly") reported an amendment to the 2013 License and Collaboration Agreement on Fruquintinib with Lilly Shanghai, an affiliate of Lilly (Press release, Hutchison China MediTech, JUL 28, 2020, https://www.chi-med.com/chi-med-and-lilly-to-collaborate-in-commercializing-elunate-in-china/ [SID1234562426]). The 2020 Amendment covers the expansion of Chi-Med’s role in the commercialization of Elunate (fruquintinib capsules) in China.
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Under the terms of the 2020 Amendment, Lilly will maintain the exclusive commercialization rights, and as a consequence, will continue to consolidate the sales of Elunate in China. Chi-Med will collaborate with Lilly in commercializing Elunate across China.
In a joint statement, Mr. Christian Hogg, CEO of Chi-Med and Mr. Julio Gay-Ger, President & General Manager, Lilly China, said "After many years of constructive and successful collaboration, Lilly and Chi-Med believe that this agreement now establishes the optimal structure that will allow us to leverage the full resources of both companies to maximize the potential of Elunate in China."
Starting October 1, 2020, Chi-Med will be responsible, through its commercial team in oncology of over 320 staff, for the development and execution of all on-the-ground medical detailing, promotion and local and regional marketing activities in China for Elunate. Lilly and Chi-Med will continue to collaborate, as before, in the formulation and execution of national marketing strategy and events in China for Elunate.
Chi-Med and Lilly will share gross profits linked to sales target performance. Subject to meeting pre-agreed sales targets, Lilly will pay Chi-Med an estimated total of 70% to 80% of Elunate sales in the form of royalties, manufacturing costs and service payments. There is no upfront payment by Lilly or Chi-Med relating to this amendment.
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.
About fruquintinib in metastatic colorectal cancer ("mCRC")
Fruquintinib was approved for marketing by the China National Medical Products Administration ("NMPA") in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate. Elunate is for the treatment of patients with mCRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor ("EGFR") therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with mCRC in China demonstrating improvement in overall survival, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
In December 2017, Chi-Med initiated a Phase Ib clinical study to evaluate fruquintinib in U.S. patients with advanced solid tumors. Proof-of-concept cohorts in patients with mCRC and metastatic breast cancer were added in 2019 (clinicaltrials.gov identifier: NCT03251378).
Chi-Med is initiating FRESCO-2, a randomized, double-blind, placebo-controlled, multicenter Phase III registration trial in refractory mCRC in the U.S., Europe and Japan. The primary endpoint of the study is overall survival. Over 500 patients will be enrolled from approximately 130 sites in 10 countries. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for development for mCRC patients in June 2020. The FRESCO-2 study design was also reviewed and endorsed by the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) (clinicaltrials.gov identifier: NCT04322539).
Other Fruquintinib Development
Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. The primary efficacy endpoint is overall survival. In June 2020, Chi-Med completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue (clinicaltrials.gov identifier: NCT03223376).
Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).