— First NDA filing of savolitinib globally —
—  Chi-Med seeking first-in-class Chinese marketing authorization for a selective MET inhibitor —LONDON, May 29, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announced that the New Drug Application (“NDA”) for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations has been accepted for review by the China National Medical Products Administration (NMPA).The NDA is supported by data from an open-label, Phase II registration study.  Interim data were presented on the first 50 treated patients at the Chinese Society of Clinical Oncology Annual Meeting in September 2019.  An updated analysis with 70 patients in the study will be presented by Professor Shun Lu as part of the American Society of Clinical Oncology (“ASCO”) 2020 Virtual Scientific Meeting, available on May 29, 2020 at 8:00 a.m. Eastern Time (“Phase II Study of Savolitinib in Patients with Pulmonary Sarcomatoid Carcinoma and Other Types of Non-Small Cell Lung Cancer Harboring MET Exon 14 Skipping Mutations”, abstract #9519). “With today’s NDA acceptance, savolitinib is one step closer to benefitting a specific group of NSCLC patients who have limited treatment options today and we are very proud of that. After many years of collaboration with AstraZeneca, we hope that this NDA is the first of many globally for savolitinib.” Mr Christian Hogg, Chief Executive Officer of Chi-Med, commented. It is estimated that 2-3% of NSCLC patients have MET Exon 14 skipping mutations, which predicts poor prognosis.¹  Annual incidence of lung cancer in China accounted for 37.0% of the world’s annual incidence of lung cancer in 2018.²In 2011, Chi-Med entered into a global licensing and joint development and commercialization agreement with AstraZeneca (LSE, STO, NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes NSCLC and kidney cancer, and additional MET-driven tumors are being explored.About SavolitinibSavolitinib is a small molecule inhibitor of MET, a receptor tyrosine kinase enzyme which has been shown to function abnormally in many types of solid tumors.  It was developed as a potent and highly selective oral inhibitor.  In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.Savolitinib in NSCLC:Phase II in MET Exon 14 deletion NSCLC (NCT02897479) – NDA accepted and data to be presented at ASCO 2020.
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