2019 was a year in which we laid the foundations for a new era for Chi-Med, “primed” by our latestage clinical successes – particularly with our novel drug candidates surufatinib, savolitinib and Elunate® (fruquintinib) – and our expansion of these candidates into further global development.
Our first launched drug, Elunate®, is set to broaden patient access this year due to its recent addition to the NRDL in China. Elunate®’s outstanding efficacy and safety profile will now be affordable for many more colorectal cancer patients.
We have several launches anticipated for 2020 and 2021 from recently filed or imminent NDA submissions on surufatinib and savolitinib.
We are scaling up our oncology commercial team in preparation for the potential launch of surufatinib, our first unpartnered oncology drug candidate, late this year in non-pancreatic NET. Our first NDA for surufatinib was granted Priority Review following our submission in late 2019, and preparation for a second NDA in pancreatic NET is underway. These successes have put surufatinib on course to potentially be the first targeted therapy to address NET of all origins.
Savolitinib’s first NDA in lung cancer is expected to be submitted in early 2020, supported by our Phase II registrational study in China. If approved, this could be the first launch for savolitinib worldwide.
Based on extensive clinical data, we also expect to initiate multiple global registration studies this year.
For both fruquintinib and surufatinib, we are engaged with regulators in the U.S., Europe and Japan. The global FRESCO-2 Phase III registration study of fruquintinib in colorectal cancer is expected to begin enrollment in mid-2020. Similar forthcoming discussions are expected to clarify the registration pathway for surufatinib in NET. Global registration studies for savolitinib are also being evaluated with AstraZeneca in several indications.
China registration studies with certain of our hematological malignancy assets are also in planning. Our selective Syk inhibitor HMPL-523 and our selective PI3Kδ inhibitor HMPL-689 are both in advanced Phase Ib dose expansion studies which we expect to inform our China registration study decisions in late 2020.
We believe that the potential launches of multiple new oncology products will address a broad range of unmet medical needs and benefit a large number of patients across the globe, propelling Chi-Med rapidly forward.
Mar 3, 2020