For the complete release, please download the PDF.
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London: Tuesday, 28 July 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM), the China-based healthcare group, today announces its unaudited financial results for the six months ended 30 June 2015.
Results are reported in US dollar currency unless otherwise stated.
Christian Hogg, CEO of Chi-Med, said: “Chi-Med has made great progress on all fronts so far this year. Our vision is to become a major China-based pharmaceutical company – we believe we will achieve this by being an important innovator in the global targeted therapy arena. In line with this, during the first half, Chi-Med and its partners invested over $30 million pushing our oncology and immunology clinical pipeline as hard and fast as we could.
We now have 17 clinical trials (H1 2014: 10) underway, with a further seven to start in the second half – and we expect to be enrolling four pivotal Phase III oncology studies by year end. Almost all of our drug candidates have global first-in-class or best-in-class potential, and many are being tested in potential Breakthrough Therapy indications. Our drug candidates have all been designed in-house over the last decade and are highly selective, allowing for high drug exposure, potent target coverage and minimal off-target toxicity. This has resulted in some of the highest clinical response rates ever seen in the tumour types we are studying. Most importantly, we are closing in on approvals, with our first drug candidates targeting New Drug Application (“NDA”) submissions next year in the US and China.
Our Commercial Platform continues to grow rapidly with strong profit growth and cash flow. Our focus today is the commercialisation of our own-brand as well as third party prescription drugs through a powerful network of over 1,800 medical sales staff, covering about 13,500 hospitals and detailing our products to over 80,000 doctors. Soon however, we intend to leverage this organisation to commercialise our own Innovation Platform drugs once they are approved in China.
With our high potential clinical pipeline, our efficient and highly productive discovery engine and our powerful, profitable, high growth commercial and distribution platform, we believe Chi-Med is uniquely positioned to achieve its vision and to generate considerable shareholder value this year and beyond.”
Innovation Platform: Across the board clinical trial progress – now expect to be enrolling four pivotal Phase III oncology studies by year end – two on fruquintinib and two on sulfatinib.
1. Kidney Cancer: First-line papillary renal cell carcinoma (“PRCC”) global Phase II study progressing as expected, now over 50 patients enrolled and will complete in late-2015. We are seeing obvious efficacy in patients with high levels of c-Met amplification and plan to report results at the American Society of Clinical Oncology (“ASCO”) meeting in mid-2016;
2. Lung cancer: Results of the Phase Ib dose finding study (“TATTON”) in combination with AZD9291 (T790M inhibitor) were reported at the ASCO meeting in mid-2015. We published astonishing tumour shrinkage visuals and very encouraging efficacy data – a 55% objective response rate (“ORR”), in second-line gefitinib/erlotinib refractory non-small cell lung cancer (“NSCLC”). The TATTON study is now being expanded (30 patients) and is expected to complete enrolment in early-2016 and, subject to continued high ORR, could then move directly to Phase III;
3. Gastric cancer: Four clinical trials are underway in c-Met aberrant gastric cancer patients. During H1 2015 we observed clear response to savolitinib monotherapy, for the first time, in the c-Met amplified gastric cancer setting;
4. Immunotherapy combinations planned: AstraZeneca is an important innovator in the immunotherapy field with MEDI4736/durvalumab (PD-L1) particularly in the use of this immunotherapy agent in combination with other anti-cancer agents. In H2 2015 we intend to start three further clinical studies in kidney cancer, two of which will combine savolitinib with MEDI4736.
1. Colorectal cancer (third-line): Clearly met Phase II study primary endpoint, Progression Free Survival (“PFS”), triggering $18 million milestone and reimbursement payments from Lilly. Full Phase II results to report at European Society of Medical Oncology meeting in September 2015. We have now enrolled over 120 patients in the FRESCO pivotal Phase III study and expect completion in early 2016 and NDA submission in China in late 2016;
2. NSCLC (third-line): Phase II study completed enrolment in March 2015 and we will report top-line results in Q3-2015, and if positive, we intend to start a pivotal Phase III study in late 2015;
3. Gastric cancer (second-line): Fruquintinib in combination with chemotherapy (paclitaxel) – Phase Ib dose-finding study 3mg fruquintinib dose was shown safe and tolerable and we are now in 4mg cohort (a dose that provides full target inhibition). We expect to start a Phase II/III study in late 2015 which will be used to prove combinability with chemotherapy, the key to much broader indications and hence fruquintinib’s global potential.
1. Neuroendocrine tumours (“NET”) (first-line): Reported 35% ORR in our Phase I study, which is about four times the ORR of current approved therapies, then started Phase Ib study in China in NET (over 50patients already enrolled). We have submitted a Phase II/III clinical trial application in China and upon clearance in late 2015 we will start two pivotal Phase III studies in China, one in pancreatic NET and a second in advanced carcinoid patients;
2. Thyroid cancer: We expect to initiate a Phase Ib study in China in Q3 2015;
3. US Development: Sulfatinib is the first wholly-owned cancer drug candidate that we are developing in the US. Our US Investigational New Drug application was cleared in early 2015 and, after a dose confirmation study in Caucasians, we expect to start a US Phase II NET study in early 2016.
1. Immunology: Phase I single ascending dose section completed with 800mg single dose showing no material toxicities in healthy volunteers – with higher doses providing drug exposures well above expected efficacious dose. The 14-day multiple ascending dose section of the Phase I study is now underway with 200mg daily cohort successfully complete – we expect to determine Phase II dose for rheumatoid arthritis by the end of 2015;
2. Hematological Cancer: Phase I, primarily in lymphoma and leukemia patients, set to start in Australia in H2-2015, the fastest route to a possible efficacy signal for HMPL-523 by early 2016.
1. Epitinib (HMPL-813): Emerging early human efficacy data in Phase Ib study of NSCLC patients with brain mets. Seeing clear partial responses in both primary lung and metastasised brain lesions;
2. Theliatinib (HMPL-309): Phase I dose-escalation study nearing completion with dose well above efficacious dose already qualified;
3. HMPL-689: Our selective PI3Kδ inhibitor is set to start Australian Phase I study in hematological cancer patients in late 2015;
4. HMPL-453: Our selective FGFR 1-3 inhibitor is set to start Australian Phase I study in solid tumour patients in early 2016.
Commercial Platform: Focus on broadening scope and capacity of higher margin Prescription Drugs business.
Ends
Chi-Med
Telephone: +852 2121 8200
Christian Hogg, CEO
Panmure Gordon
Telephone: +44 20 7886 2500
Richard Gray
Andrew Potts
Citigate Dewe Rogerson
Telephone: +44 20 7638 9571
Anthony Carlisle – Mobile: +44 7973 611 888
David Dible – Mobile: +44 7967 566 919
An analyst presentation will be held at 9:00 am today at Citigate Dewe Rogerson, Third Floor, 3 London Wall Buildings, London, EC2M 5SY.
About Chi-Med
Chi-Med is a China-based healthcare group focused on researching, developing, manufacturing and selling pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases. Its Commercial Platform manufactures, markets and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (“CK Hutchison”) (SEHK: 0001). For more information, please visit: www.chi-med.com.
Please download the PDF for the full text of our interim announcement.