London: Tuesday, 29 December 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) announces the following blocklisting six monthly return:
1. Name of applicant:
Hutchison China MediTech Limited
2. Name of scheme:
Hutchison China MediTech Limited Share Option Scheme
3. Period of return:
From 29 June 2015 to 28 December 2015
4. Balance under scheme from previous return:
472,763 ordinary shares of US$1 each
5. The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return:
Nil
6. Number of securities issued/allotted under scheme during period: 18,750 ordinary shares of US$1 each
7. Balance under scheme not yet issued/allotted at end of the period:
454,013 ordinary shares of US$1 each
8. Number and class of securities originally listed and the date of admission:
2,560,606 ordinary shares of US$1 each admitted on 26 June 2007
9. Total number of securities in issue at the end of the period: 56,533,118 ordinary shares of US$1 each
Name of contact:
Christian Hogg
Address of contact:
21/F., Hutchison House, 10 Harcourt Road, Hong Kong
Telephone number of contact:
+852 2121 8200
Ends
Chi-Med
Christian Hogg, CEO
Telephone: +852 2121 8200
Panmure Gordon (UK) Limited
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
Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. 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 (SEHK: 0001). For more information, please visit: www.chi-med.com.
London: Friday, 18 December 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, has initiated SANET-ep, a Phase III sulfatinib (HMPL-012) registration trial in China in patients with extra-pancreatic neuroendocrine tumours (“NETs”), which are all non-pancreatic NETs, including, for example, NETs originating in the lymph, lung and across the gastrointestinal tract. Preparations and site selection had begun in the middle of this year and the first patient was dosed on 17 December 2015.
SANET-ep is a randomised, double-blind, placebo-controlled, multi-centre Phase III sulfatinib registration study to treat pathologically low or intermediate grade NET patients whose disease has progressed, locally advanced or distant metastasised and for whom there is no effective therapy. Patients will be randomised at a 2:1 ratio to receive either 300 milligrams of sulfatinib orally once per day, or placebo, on every 28-day treatment cycle. The primary objective of this study is to evaluate the progression-free survival of sulfatinib as compared to that of placebo, with secondary endpoints including objective response rate (“ORR”), disease control rate, time to response, duration of response, overall survival, safety and tolerability. Approximately 270 patients will be enrolled in the SANET-ep study from more than 20 centres across China, with top-line results expected in 2018.
Additionally, the second Phase III sulfatinib registration trial, SANET-p, in pancreatic NET patients, is expected to be initiated imminently in China. SANET-p employs a similar treatment regimen and has primary and secondary endpoints similar to those for SANET-ep trial. Approximately 195 patients will be enrolled in SANET-p and is expected to start by the end of 2015, with top-line results expected in 2017.
Sulfatinib is an oral drug candidate that demonstrates dual inhibition of the tyrosine kinase activity associated with vascular endothelial growth factor receptor (“VEGFR”) and fibroblast growth factor receptor (“FGFR”) 1, a receptor kinase which also plays a role in tumour angiogenesis. In 2014, HMP completed the first-in-human Phase I clinical trial of sulfatinib in China; the detailed results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in early November 2015 (www.chi‑med.com/sulfatinib-ph1-eortc-2015/). The Phase I clinical data indicates that sulfatinib has the highest ORR reported to date in NET patients. An ORR of 44% was observed for sulfatinib in 18 evaluable patients, compared to less than 10% for sunitinib and everolimus, the two approved targeted therapies for pancreatic NET patients.
In October 2014, HMP initiated a multi-centre, single-arm, open-label Phase Ib/II study in NET patients in China to further evaluate the efficacy, safety, tolerability and pharmacokinetic characteristics of sulfatinib. This study, projected to enrol approximately 80 patients, is near to completion of patient enrolment.
Furthermore, the Phase I and Phase Ib/II studies in China provide a guide for the selection of the recommended starting dose for the Phase I study in patients with advanced solid tumours in the United States, which had the first patient enrolled in early November 2015.
In addition to these four NET studies, HMP also plans to initiate a Phase Ib study in China to evaluate the safety, pharmacokinetics and efficacy of sulfatinib in patients with both medullary and differentiated thyroid cancer by the end of 2015.
Ends
Chi-Med
Telephone: +852 2121 8200
Christian Hogg, CEO
Panmure Gordon (UK) Limited
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
Neuroendocrine tumours arise from neuroendocrine cells and develop predominantly in the digestive or respiratory tracts but can also occur in other organs of the body. Diagnosis of neuroendocrine tumours is difficult due to the small tumour size and diverse origination with patients showing varied or no symptoms. It is estimated that there are approximately 19,000 new cases of neuroendocrine tumours per year and a cumulative prevalence of approximately 141,000 cases in the United States in 2014.
Neuroendocrine tumours can be classified according to tumour origin, as pancreatic NET representing less than 10% of the total NET patients, and extra-pancreatic NET comprising all other non-pancreatic NETs including lung, lymph and gastrointestinal tract NETs. To date, treatment options for NET patients are limited; sunitinib and everolimus are the only two approved targeted-therapies for pancreatic NET, while there is no such a choice for extra-pancreatic NET patients.
At an advanced stage, tumours secrete large amounts of vascular endothelial growth factor (“VEGF”), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumour in order to provide greater blood flow, oxygen, and nutrients to fuel the rapid growth of the tumour. Anti-angiogenesis drugs have demonstrated benefits in a wide variety of tumour types. VEGF and other ligands can bind to VEGF receptors, which have been shown to play a role in angiogenesis. Inhibition of the VEGF/VEGFR signalling pathway can act to stop the growth of the vasculature around the tumour and thereby starve the tumour of the nutrients and oxygen it needs to grow rapidly.
Fibroblast cell growth factor (“FGF”) also plays a key role in tumour angiogenesis. Aberrant activation of the FGF/FGFR signalling pathway is shown to be associated with cancer progression by promoting growth, survival, migration and invasion of the tumour. There is evidence that anti-VEGF therapy treatment could increase FGFR pathway activation, leading to drug resistance to anti-VEGF therapies. It is believed that simultaneously targeting VEGFR and FGFR could be an attractive approach to improve clinical efficacy.
HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of over 280 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China. HMP is a subsidiary of Chi-Med. For more information, please visit: www.hmplglobal.com.
Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. 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 (SEHK: 0001). For more information, please visit: www.chi-med.com.
Forward-Looking Statements
This announcement contains forward-looking statements that reflect Chi-Med’s current expectations regarding future events, including its plans to initiate clinical studies for its drug candidates in the targeted indications, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrolment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of a drug candidate to meet the primary or secondary endpoint of a study, the ability of a drug candidate to obtain regulatory approval in different jurisdictions, the ability of a drug candidate to gain commercial acceptance after obtaining regulatory approval and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
Press Release
London: Wednesday, 9 December 2015: Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that Shanghai Hutchison Pharmaceuticals Limited (“SHPL”), its 50:50 joint venture with a subsidiary of Shanghai Pharmaceuticals Holding Co., Limited, has today entered into an agreement (the “Agreement”) with the Shanghai government for the surrender of SHPL’s remaining 36 years land-use rights on its approximately 58,000 square metres old factory site at 2098 Zhennan Road, Taopu Town, Putuo District, Shanghai (the “Site”).
The Site is located in an area of Shanghai 12 kilometres from the city centre, which was re-zoned in 2014 from industrial use into usage as a new science and technology, commercial and residential development area called Smart City.
The Agreement signed between SHPL and (i) Land Development Centre of Putuo District of Shanghai Municipality and (ii) Shanghai Taopu Smart City of Science and Technology Development and Construction Company Limited (together the “Acquirers”) provides that SHPL will return the Site to the Acquirers in consideration for cash compensation of approximately US$105 million (the “Compensation”). Under the Agreement, SHPL will receive the Compensation in three stages over a period of approximately one year as the transaction progresses to completion.
The re-zoning of the Site prompted SHPL to develop plans to build a new factory, 40 kilometres south of Shanghai city centre, in Fengpu District. Due to the strong growth of SHPL which recorded first half sales in 2015 of US$103.9 million, up nine-fold versus the same period in 2005, the new factory was designed to accommodate an approximately three-fold production capacity increase compared to the old factory. SHPL began construction on this new factory in 2014 and the full transition of production from the old factory to the new factory is expected to complete by mid-2016. The cost of the new factory, expected to total approximately US$100 million, has already been over 80% incurred and funded to-date through SHPL cash reserves and bank borrowings of US$38 million as at 30 November 2015.
Christian Hogg, CEO of Chi-Med, said, “This is good news. The move to our new factory in Fengpu has been a major effort for the SHPL team and positions us well for the future with a tripling of production capacity. This modern facility will support continued business expansion and further scale efficiency at SHPL. Meanwhile, we plan to use the cash compensation to pay off debt, retain cash for working capital and look to pay dividends to the shareholders of SHPL.”
Ends
Chi-Med
Telephone: +852 2121 8200
Christian Hogg, CEO
Panmure Gordon (UK) Limited
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
SHPL is one of the key companies in the Commercial Platform of Chi-Med which engages in the manufacture and sale of prescription drugs. SHPL operates a commercial organisation of over 1,800 medical sales representatives across about 300 cities and towns in China detailing both its own prescription drug products as well as those of third party companies such as Seroquel® (AstraZeneca) and Concor® (Merck Serono).
Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. 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 (SEHK: 0001). For more information, please visit: www.chi-med.com.
This announcement contains forward-looking statements that reflect Chi-Med’s current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that the land-use rights transaction described above does not proceed to completion or is completed for a different amount of compensation, or the new factory in Fengpu District incurs additional costs or does not begin production as scheduled. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
London: Tuesday, 8 December 2015: Hutchison China MediTech Limited (“Chi‑Med”) (AIM: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, has initiated FALUCA, a Phase III registration study for fruquintinib (HMPL‑013) in third-line non-squamous non-small cell lung cancer (“NSCLC”) patients in China. Fruquintinib is an investigational small molecule which selectively inhibits vascular endothelial growth factor receptors (“VEGFR”). Preparations and site selection began in August this year, with the first patient dosed on 8 December 2015.
FALUCA is a randomised, double-blind, placebo-controlled, multi-centre, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Patients will be randomised at a 2:1 ratio to receive either 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus best supportive care (“BSC”); or placebo plus BSC. The primary endpoint is overall survival, with secondary endpoints including progression free survival, objective response rate, disease control rate and duration of response. HMP plans to enrol approximately 520 patients in about 45 centres across China, with top-line results expected in 2017.
In September this year, Chi-Med announced that the Phase II proof-of-concept (“POC”) trial of fruquintinib in patients with third-line non-squamous NSCLC in China had successfully achieved the primary endpoint of progression free survival (“PFS”) with no unexpected safety issues. The detailed results of this Phase II study will be presented in a global scientific conference in 2016.
Ends
Chi-Med
Telephone: +852 2121 8200
Christian Hogg, CEO
Panmure Gordon (UK) Limited
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
Fruquintinib is designed as a highly selective and potent oral inhibitor of VEGFR, namely VEGFR1, VEGFR2, and VEGFR3. Angiogenesis is an important mechanism in tumour pathogenesis, and inhibition of VEGF-mediated angiogenesis has been important in the treatment of a variety of cancers.
In addition to the FALUCA Phase III registration study in third-line non-squamous NSCLC detailed above, fruquintinib is being developed in metastatic colorectal cancer (“mCRC”) and gastric cancer:
Metastatic colorectal cancer fruquintinib monotherapy – HMP reported full results of the first POC Phase II study of fruquintinib in a randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial targeted at patients with third-line mCRC. This Phase II study showed fruquintinib had clearly met the primary endpoint of PFS with no unexpected safety issues. 71 patients were enrolled in the trial, and median PFS was 4.73 months in the fruquintinib arm compared with 0.99 month in the placebo arm, with a hazard ratio of 0.30 (p<0.001).
As a result, HMP initiated FRESCO, a Phase III registration study in patients with mCRC who have failed at least two prior systemic cancer therapies, including flouropyrimidine, oxaliplatin and irinotecan. HMP plans to enrol more than 400 patients in about 25 centres across China for this study, with top-line results expected in 2016.
Gastric cancer fruquintinib combination with paclitaxel – HMP is nearing completion of a Phase Ib dose-finding study of fruquintinib, in combination with paclitaxel, in second-line gastric cancer patients and plans to initiate a Phase II POC study in early 2016.
Pursuant to the fruquintinib licensing, co-development, and commercialisation agreement entered into by HMP and Eli Lilly and Company in October 2013, HMP will receive reimbursements for costs associated with both FRESCO and FALUCA according to a pre-specified cost-sharing rate.
At an advanced stage, tumours secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumour in order to provide greater blood flow, oxygen, and nutrients to the tumour. VEGF and VEGF receptors play a pivotal role in tumour-related angiogenesis, and inhibition of the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumours to grow and invade.
Lung cancer is one of the leading malignant causes of death in the world, and there were an estimated 1.9 million new cases of lung cancer diagnosed worldwide in 2014, of which approximately 36% were from China. The very high prevalence of lung cancer in China as compared to the rest of the world is thought to be linked in part to the high incidence of cigarette smoking in the country. The number of new cases annually is expected to grow and reach an estimated 2.3 million globally by 2020. There are two major types of lung cancer: small cell lung cancer and NSCLC. NSCLC is a disease in which malignant cancer cells form in the tissues of the lung, and can be further classified based on cancer cell types with the most common ones including squamous cell carcinoma, large cell carcinoma and adenocarcinoma.
To date, several anti-VEGF/VEGFR agents have shown clinical efficacy against a number of tumour types. Given the scale and growth in the China oncology market, the market for VEGF/VEGFR inhibitors in China is expected to develop quickly in the next few years.
Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. 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 (SEHK: 0001). For more information, please visit: www.chi-med.com.
This announcement contains forward-looking statements that reflect Chi-Med’s current expectations regarding future events, including its plans to initiate clinical studies for its drug candidates in the targeted indications, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrolment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of a drug candidate to meet the primary or secondary endpoint of a study, the ability of a drug candidate to obtain regulatory approval in different jurisdictions, the ability of a drug candidate to gain commercial acceptance after obtaining regulatory approval and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.