London: Tuesday, July 30, 2019: Hutchison China MediTech Limited (“Chi-Med“) (AIM/Nasdaq: HCM) today announces its unaudited financial results for the six months ended June 30, 2019 and provides updates on key clinical programs.
Highlights include:
- Positive surufatinib China Phase III study in non-pancreatic neuroendocrine tumors (“NET”) – Interim analysis of SANET-ep study confirmed to have met primary endpoint and the Independent Data Monitoring Committee (“IDMC”) recommended the study be un-blinded, a year ahead of schedule. New Drug Application (“NDA”) is now being prepared for submission during 2019;
- Early progress on Elunate® (fruquintinib capsules) with China in-market sales in colorectal cancer (“CRC”) of $11.4 million1 (RMB77.1 million) during H1 2019; Discussions in progress for potential inclusion in the China National Reimbursement Drug List (“NRDL”) at the next update in Q4 2019;
- Potential for first savolitinib NDA targeted for H1 2020 – for MET2 Exon 14 deletion non-small cell lung cancer (“NSCLC”) in China. Oral presentations of savolitinib data made at scientific conferences in H1 2019 in lung cancer (monotherapy and combination with Tagrisso®) and kidney cancer (combination with Imfinzi®).
Video webcast presentation at 9:00 a.m. BST and additional conference call at 9:00 a.m. EDT.
“Chi-Med’s business is progressing well on all fronts.” said Simon To, Chairman, Chi-Med. “All major clinical readouts in the first half were encouraging, with the stand-out results being surufatinib’s positive Phase III outcome in non-pancreatic NET and savolitinib’s preliminary data in MET Exon 14 deletion NSCLC along with the completion of enrollment of its registration study. We believe these accomplishments have the potential to support Chi-Med’s next two NDA submissions, surufatinib later this year and savolitinib early next year.”
“Highly encouraging preliminary data was also reported for the savolitinib / Tagrisso® combination in NSCLC, which led to the initiation of a global registration intent trial by AstraZeneca AB (publ) (“AstraZeneca”), the SAVANNAH study, early this year. Also, recently released preliminary data for the savolitinib / Imfinzi® combination in kidney cancer is promising.”
“Our first approved oncology drug, Elunate®, is making progress, with first six-month revenue well ahead, at the same stage, of the five small molecule VEGFR3 inhibitors previously launched by multinational companies in China. In our view, with time and inclusion in the China NRDL, Elunate®’s well documented efficacy and safety profile will make it a formidable competitor.”
“Business is as usual for our Commercial Platform, which generated 9% net income growth on a CER4 basis versus same period last year. This income helps significantly to fund our clinical development programs as well as our discovery engine which produced yet another exciting oncology asset, our ninth, with the IND5 submission of our novel IDH 1/2 inhibitor6 HMPL-306.”
“Our organization is expanding rapidly, with our New Jersey-based international clinical and regulatory team scaling up to manage global registration studies on surufatinib and fruquintinib and early development on our B-cell malignancy assets. Our in-house oncology commercial team in China is also growing fast, managing medical affairs and getting ready for the potential launch of surufatinib late next year.”
“Looking ahead at the next two years, we expect to accelerate our transformation into a fully integrated and globally-facing biopharmaceutical company with capability to discover, develop and launch multiple novel drug innovations aimed at addressing a broad range of unmet medical needs and benefiting a large number of patients.” hutchison-china