Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China

HONG KONG and FLORHAM PARK, N.J., July 28, 2020 (GLOBE NEWSWIRE) — Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announced that the China National Medical Products Administration (“NMPA”) has granted Priority Review status to the New Drug Application (“NDA”) for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations.  This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.
With over 774,000 new cases every year, China accounted for 37% of the world’s annual incidence of lung cancer in 2018.¹  Approximately 80-85% of lung cancer cases are NSCLC.²  It is estimated that 2-3% of NSCLC patients have MET Exon 14 skipping mutations; these mutations lead to poor prognosis.³  The annual incidence of MET Exon 14 skipping mutation NSCLC is estimated to be 12,000 to 20,000 in China.About Priority Review in ChinaThe NMPA’s Priority Review procedure encourages research and development of potential new medicines with clear clinical value, medicines or vaccines that address urgent clinical needs, as well as medicines that address serious infectious diseases, certain rare diseases, and select pediatric conditions or formulations.  A potential new medicine may have clear clinical value if it is being developed for serious conditions that are life threatening, debilitating, or impact quality of life.  NDAs undergoing Priority Review would receive preferential allocation of NMPA resources during the review process.⁴About SavolitinibSavolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis.  Savolitinib has been studied in over 1,000 patients to date.  In clinical studies it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile.In 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.Savolitinib development in NSCLC:Phase II in MET Exon 14 mutation NSCLC (NCT02897479) – In May 2020, data from an ongoing open-label, Phase II registration study was presented as part of the American Society of Clinical Oncology 2020 Virtual Scientific Program (“ASCO 2020”).  In patients with MET Exon 14 skipping mutation NSCLC in the efficacy evaluable population, savolitinib demonstrated a 49.2% objective response rate (“ORR”), a 93.4% disease control rate (DCR) and a 9.6 months duration of response (DoR).  36% of patients in the study have pulmonary sarcomatoid carcinoma (PSC), an aggressive subtype of NSCLC.  Data were not yet mature for DoR, progression-free survival (PFS) or overall survival (“OS”).  Clinical data indicated an acceptable safety profile, with a low adverse event (AE) related discontinuations rate of 14.3%.  This data supported the China NDA acceptance in May 2020.