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Press Release

Hutchison China MediTech Limited (“Chi-Med”) Reports Final Results for the Year Ended December 31, 2017 and Updates Shareholders on Key Clinical Programs

Hutchison China MediTech Limited
Posted on: 13 Mar 18

 

Group:  Year of major progress; results in line with guidance

·         Group revenue up 12% to $241.2 million (2016: $216.1m);

·         Net loss attributable to Chi‑Med $26.7 million (2016: Net profit $11.7m), including $88.0 million in research and development expenses on an adjusted (non-GAAP) basis (2016: $76.1m).

 

Strengthened cash position:  Expected to be sufficient to accelerate and broaden pipeline into 2020

·         Cash resources of $479.6 million at Group level as of December 31, 2017 ($173.7m as of December 31, 2016), including cash and cash equivalents, short-term investments and unutilized bank facilities;

·         Completed Nasdaq follow-on offering, raising net proceeds of $292.7 million in late 2017.

 

Innovation Platform:  Submitted first China New Drug Application (“NDA”) on fruquintinib; initiated first global Phase III registration study on savolitinib; five other pivotal Phase III studies underway and more preparing to start; and discovery engine aiming to produce 1-2 novel clinical drug candidates per year

·         Deep clinical pipeline of novel small molecule tyrosine kinase inhibitors (“TKIs”):

Eight clinical drug candidates now in active or completing clinical trials in 36 target patient populations (“TPP”) (2016: 30) around the world; over 3,500 subjects dosed in trials to date, over 700 in 2017;

Stream of second-generation immunotherapy compounds advancing through pre-clinical development.

 

·         Savolitinib – Highly selective TKI of the mesenchymal epithelial transition factor (“c-MET”) – Global Phase III studies underway or in planning in kidney and lung cancer with Phase I/Ib studies in over a dozen exploratory TPPs in multiple further cancer indications:

Presented positive Phase Ib/II data in second- and third-line non-small cell lung cancer (“NSCLC”), combination of savolitinib and Tagrisso® or Iressa® at the 2017 World Conference on Lung Cancer (“WCLC”); AstraZeneca AB (publ) (“AstraZeneca”) have now agreed to proceed with development in second-line NSCLC with the initiation of multiple studies including a global randomized, chemotherapy-doublet controlled study of savolitinib plus Tagrisso® in first-generation epidermal growth factor receptor (“EGFR”)-TKI refractory, c-MET gene amplified, T790M negative NSCLC patients;

Presented positive Phase II data in c-MET-driven papillary renal cell carcinoma (“PRCC”) at the ASCO Genitourinary Cancers Symposium; then initiated global Phase III study, the SAVOIR study, in c-MET-driven PRCC in a head-to-head comparison with current standard therapy Sutent® (sunitinib), the first Phase III study ever conducted with molecularly selected patients in renal cell carcinoma (“RCC”).

 

·         Fruquintinib – Highly selective TKI of vascular endothelial growth factor receptor (“VEGFR”)-1/2/3 – Likely to be Chi-Med’s first China Food and Drug Administration (“CFDA”)-approved TKI, Phase III studies in colorectal cancer (“CRC”), lung and gastric cancer in China either complete or enrolling and global development now underway:

Positive outcome in Phase III study, the FRESCO study, in third-line CRC patients in China; 2017 American Society of Clinical Oncology (“ASCO”) oral presentation; Potentially best-in-class in terms of both efficacy and safety relative to Stivarga® (regorafenib); NDA submitted to the Center for Drug Evaluation of the CFDA in June 2017 and technical reviews and inspections are ongoing;

Completed enrolment in early 2018 of a 527 patient Phase III study, the FALUCA study, in third-line NSCLC in China;

Presented positive Phase Ib data, at the 2017 ASCO Gastrointestinal Cancers Symposium, for fruquintinib in combination with Taxol® (paclitaxel) in second-line gastric cancer; then initiated the FRUTIGA study, an over 500 patient Phase III study in China;

Initiated Phase I development of fruquintinib in the United States in late 2017.

 

·         In addition, presented positive preliminary proof-of-concept efficacy and safety data on multiple drug candidates over last year, including:

Savolitinib in c-MET-driven gastric cancer;

Fruquintinib in combination with Iressa® in first-line EGFR mutation positive NSCLC;

Sulfatinib against VEGFR, fibroblast growth factor receptor 1/2/3 (“FGFR”) and colony stimulating factor 1 receptor (“CSF-1R”),  in neuroendocrine tumors (“NET”) as well as thyroid cancer;

Theliatinib in EGFR wild-type esophageal cancer.

 

·         Initiated early/proof-of-concept development on multiple drug candidates over last year, including:

Savolitinib in combination with Imfinzi® (durvalumab), AstraZeneca’s anti-programmed death-ligand 1 (“PD-L1”) antibody – Phase II in PRCC and clear cell renal cell carcinoma (“ccRCC”) in Europe;

Savolitinib – Phase II study in pulmonary sarcomatoid carcinoma in China;

Savolitinib – Phase II study in prostate cancer in Canada;

Sulfatinib – Phase II in second-line biliary tract cancer in China; 

Epitinib – Phase Ib/II in EGFR gene amplified glioblastoma in China;

HMPL-523 against spleen tyrosine kinase (“Syk”) – Phase I in hematological cancer in China;

HMPL-453 against FGFR 1/2/3 – Phase I in all comer solid tumors in Australia and China;

HMPL-689 against phosphoinositide 3-kinase delta (“PI3Kδ”) – Phase I in hematological cancer in China;

Theliatinib against EGFR wild-type – Phase Ib in esophageal cancer in China.

 

Commercial Platform: High-performance drug marketing and distribution platform covers ~300 cites/towns in China with approximately 3,300 sales people.  High-value products and household-name brands

·         Total consolidated sales up 13% to $205.2 million (2016: $180.9m);

·         Total sales of non-consolidated joint ventures up 6% to $472.0 million (2016: $446.5m);

·         Total consolidated net income attributable to Chi-Med up 25% to $37.5 million (2016: $29.9m) on an adjusted (non-GAAP) basis which excludes one-time gains.

 

Potential milestones targeted for 2018

·         Savolitinib: 

Second-line NSCLC – Initiation of a global randomized, chemotherapy-doublet controlled study of savolitinib plus Tagrisso® in first-generation (Iressa®/Tarceva®) EGFR-TKI refractory, c-MET gene amplified, T790M negative NSCLC along with multiple supporting studies;

Third-line NSCLC – AstraZeneca to decide global registration strategy in third-generation (Tagrisso®) EGFR-TKI refractory NSCLC;

AstraZeneca/Chi-Med agreement on registration strategy in China for savolitinib plus Iressa®  combination in second-line NSCLC;

Release of results of global PRCC molecular epidemiology study (“MES”) and review of the potential Breakthrough Therapy opportunity in c-MET-driven PRCC.

·         Fruquintinib:

NDA approval and launch in China, with our partner Eli Lilly and Company (“Lilly”), in advanced CRC;

Release of top-line results for the FALUCA Phase III study in third-line NSCLC in late 2018.

·         Epitinib (EGFR):  Initiation of Phase III registration study in first-line NSCLC patients with EGFR activating mutations with brain metastasis in China;

·         HMPL-523 (Syk):  Presentation of preliminary safety and efficacy data from Phase I/Ib dose escalation and dose expansion study in hematological cancer in Australia and China.

 

Use of Non-GAAP Financial Measures – References in this announcement to adjusted research and development expenses, adjusted consolidated net income attributable to Chi-Med from the Commercial Platform, adjusted consolidated net income attributable to Chi-Med from our Prescription Drugs business and adjusted revenue of HBYS are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

 

U.K. Analysts Meeting and Webcast Scheduled Today at 9:00 a.m. BST (5:00 p.m. HKT) – at Citigate Dewe Rogerson, 3 London Wall Buildings, London, EC2M 5SY, U.K.. Investors may participate in the call at +44 20 3003 2666 or access a live video webcast of the call via Chi-Med’s website at www.chi-med.com/investors/event-information/.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 13/03/2018

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