Hutchison China MediTech Limited ("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 listed on the London Stock Exchange’s AIM market (AIM: HCM). It is majority owned by CK Hutchison Holdings Limited (SEHK: 0001), a leading international conglomerate committed to innovation and technology with over a quarter of a million employees in more than 50 countries and annual sales of over US$50 billion.

http://www.chi-med.com/eng/global/home.php

Presentation at 2015 European Cancer Congress
RNS
RNS Number : 9209Y
Hutchison China Meditech Limited
14 September 2015







Fruquintinib Phase II clinical results in colorectal cancer to be presented at the 2015 European Cancer Congress





London: Monday, 14 September 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, will present the detailed clinical results of its Phase II proof-of-concept ("POC") clinical trial of fruquintinib in metastatic colorectal cancer ("mCRC") at the European Cancer Congress, which will be held in Vienna, Austria from 25 to 29 September 2015.



Fruquintinib is a highly selective vascular endothelial growth factor ("VEGF") receptor inhibitor that is being evaluated across several solid tumour types in clinical trials, including colorectal cancer, non-small cell lung cancer and gastric cancer. In March 2015, Chi-Med announced that the first POC study of fruquintinib in patients with mCRC clearly met its primary endpoint of progression free survival ("PFS") by demonstrating superiority compared with placebo. Fruquintinib was well tolerated in this study, showing no major unexpected safety issues and a safety profile consistent with that of its class.



The POC study was a randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care against placebo plus best supportive care in mCRC patients who had failed at least 2 prior lines of chemotherapy, including fluoropyrimidine, oxaliplatin and irinotecan. Patients were randomised at a 2:1 ratio to receive either 5 mg of fruquintinib orally once per day on a three-weeks-on, one-week-off schedule or placebo. Treatment was given in 28-day cycles until disease progressed or non-tolerable toxicity occurred. Tumour assessments were conducted using RECIST 1.1 criteria. The primary efficacy endpoint for the trial was PFS. Secondary efficacy endpoints included objective response rate, disease control rate and overall survival. Safety endpoints included adverse events, laboratory tests, vital signs and electrocardiogram measurements. Data was analysed up to 11 February 2015, approximately six months after the last patient had been enrolled.



71 patients were enrolled in the trial, of which 47 were enrolled into the fruquintinib arm and 24 into the placebo arm. Patient baseline characteristics were similar between the two treatment arms. The median fruquintinib exposure was 84 days whereas the median was 21 days in the placebo arm. 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). The disease control rate in the fruquintinib arm was 68.1%, compared with 20.8% in the placebo arm (p<0.001). 46.8% (22/47) and 62.5% (15/24) of patients died in the fruquintinib and placebo arms, respectively, by the date of data cut-off, with median overall survival of 7.6 months and 5.5 months in the fruquintinib and placebo arms, respectively. The five most common fruquintinib treatment-related adverse events were hand-foot syndrome, hypertension, dysphonia, proteinuria and AST elevation, which is similar to those reported in this class.



The detailed study results will be presented on 27 September 2015 at the European Cancer Congress and will then be made available at http://chi-med.com/eng/irinfo/presentations.htm:



Title:
A randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial of fruquintinib in patients with metastatic colorectal cancer.



Authors:
Jin Li, et al.



Abstract:
#2111



Session:
Gastrointestinal Malignancies - Colorectal Cancer



Date & Time:
Sunday 27 September 2015, 09:15 AM-11:15 AM




The European Cancer Congress, organised by the European Society for Medical Oncology and the European Cancer Organisation this year, is the largest European multidisciplinary oncology platform for presenting data to a global audience.





Ends

Hutchison China MediTech Ltd (HCM.GB:ISD) set a new 52-week high during today's trading session when it reached 2,075. Over this period, the share price is up 18.74%.

aims-best-companies-confirmed


International company of the year


Hutchison China Meditech

Hutchison China Meditech (HCM) has finally won this category having been up for the award in 2010. For the second year running, Somero Enterprises Inc (SOM) did not win - as I thought it might this year. Hutchison is the third-largest company among the winners with a market capitalisation of more than £1.1 billion, making it one of the top ten companies on AIM. When it joined AIM in May 2006 it was valued at £141 million. The share price has risen from 275p to 2,050p over that period. Hutchison has successfully combined a revenue and cash generating healthcare business with a cash hungry drug development operation.

Enrolment complete in Savolitinib Phase II trial
RNS
RNS Number : 0214C
Hutchison China Meditech Limited
13 October 2015





Press Release

Savolitinib completes enrolment for Phase II clinical trial in Papillary Renal Cell Carcinoma





London: Tuesday, 13 October 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, and AstraZeneca AB (publ) ("AstraZeneca") have completed enrolment in a global Phase II study of savolitinib (AZD6094), a potent and highly selective mesenchymal epithelial transition factor ("c-Met") inhibitor. This is a Phase II study to evaluate the efficacy and safety of savolitinib monotherapy (600 mg once daily) in papillary renal cell carcinoma ("PRCC") in the United States, Canada and Europe. PRCC represents about 14% of all new cases of kidney cancer.



Savolitinib is a potential global first-in-class inhibitor of c-Met, receptor tyrosine kinase, an enzyme which exhibits aberrant behaviour (e.g. gene amplification, over-expression and mutation) in many types of solid tumours. Savolitinib was developed as a potent and highly selective oral c-Met inhibitor that was designed to address renal toxicity, the primary issue that has to-date prevented other selective c-Met inhibitors from gaining regulatory approval. In Phase I/Ib clinical studies, savolitinib has shown promising signs of clinical efficacy, causing tumour size reduction, in c-Met aberrant patients in PRCC, non-small cell lung cancer, colorectal cancer and gastric cancer.



This Phase II study is an open-label, single-arm, multicentre study designed to evaluate the efficacy and safety of savolitinib in patients with locally advanced or metastatic PRCC. A total of 90 patients have been enrolled in 22 centres, making it the largest prospective clinical study in PRCC ever conducted. The primary objective of this study is to assess the anti-tumour activity of savolitinib in patients with PRCC, with secondary assessment objectives including progression free survival, duration of response, safety and tolerability and pharmacokinetics and pharmacodynamics. Importantly, tumour samples from each patient are concurrently being subjected to molecular analysis to determine c-Met status in order to better understand the relationship between c-Met aberration and clinical outcome.



The interim data of the Phase II trial is expected to be published at the American Society of Clinical Oncology meeting in 2016.







Ends

Chi-Med files Nasdaq Registration Statement
RNS
RNS Number : 5322C
Hutchison China Meditech Limited
16 October 2015





Press Release

Hutchison China MediTech Limited Files Registration Statement for Potential Nasdaq Stock Market Listing





London: Friday, 16 October 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) announces that it has publicly filed today a registration statement on Form F-1 (the "Registration Statement") with the United States Securities and Exchange Commission (the "SEC") in relation to a potential listing of American depositary shares ("ADSs") representing its ordinary shares on the Nasdaq Stock Market (the "Offering"). As of the date of this press release, Chi-Med has not yet set a definite timetable or decided on further details of the potential Offering, and there can be no assurance that the potential Offering will be completed. Accordingly, the number of ADSs which may be offered and the offering price of the potential Offering have not yet been determined. The directors of Chi-Med will assess various factors, including market conditions, in considering whether to formally launch the transaction.



Bank of America Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering.



The Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective. The Registration Statement and all subsequent amendments may be accessed through the SEC's website at www.sec.gov.



The Offering, if it does proceed, will be made only by means of a prospectus that will form part of the effective Registration Statement. Copies of the preliminary prospectus, when available, may be obtained from (in alphabetical order) (i) Bank of America Merrill Lynch, Attn: Prospectus Department, 222 Broadway, New York, NY 10038, or by email at dg.prospectus_requests@baml.com, or (ii) Deutsche Bank Securities Inc., Attn: Prospectus Group, 60 Wall Street, New York, NY 10005, or by email at prospectus.cpdg@db.com.



This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.



Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.





Ends

Proactive investor -

Hutchison China MediTech (LON:HCM) up 5.5%. The Remuneration Committee has granted conditional awards under the Long Term Incentive Plan to the chief executive and the chief financial officer.

Director Deals - Hutchison China Meditech Ltd (HCM)
BFN
Christopher Nash, Non Executive Director, bought 4,512 shares in the company on the 19th October 2015 at a price of 2195.00p. The Director now holds 36,442 shares.

Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com

Milestone Payment from Lilly Triggered
RNS
RNS Number : 2160D
Hutchison China Meditech Limited
23 October 2015







Proof-of-concept study of fruquintinib in non-small cell lung cancer triggers milestone payment


London: Friday, 23 October 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, is set to receive a US$10 million milestone payment, in the fourth quarter of 2015, from its partner Eli Lilly and Company ("Lilly").



The milestone payment was triggered by the positive proof-of-concept ("POC") Phase II study of fruquintinib in the treatment of patients with advanced non-squamous non-small cell lung cancer ("NSCLC") in China. Last month, top line results of this POC Phase II study were reported showing fruquintinib met the primary endpoint of progression free survival ("PFS"). The adverse events demonstrated in the POC study are consistent with the known safety profile for fruquintinib. Full details of the NSCLC Phase II POC results will be presented at a global medical conference in 2016.



Pursuant to the fruquintinib licensing, co-development, and commercialisation agreement entered into by HMP and Lilly in October 2013, HMP will receive reimbursements for costs associated with further clinical development in China for NSCLC according to a pre-specified cost-sharing rate. We now intend to initiate a pivotal Phase III study of fruquintinib in non-squamous NSCLC in China.



Including this US$10 million NSCLC POC milestone payment, HMP will have received a total of US$31.7 million from Lilly so far this year.





Ends

Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during today's trading session when it reached 2,792.5. Over this period, the share price is up 140.73%.

Clinical results presented
RNS
RNS Number : 9704D
Hutchison China Meditech Limited
30 October 2015









Press Release




Sulfatinib clinical results and fruquintinib-savolitinib combination preclinical results to be presented at the 2015 AACR‑NCI‑EORTC Molecular Targets and Cancer Therapeutics conference




London: Friday, 30 October 2015: Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, will present further scientific data on sulfatinib (HMPL‑012), fruquintinib (HMPL‑013) and savolitinib (AZD6094, HMPL‑504) at the International Conference on Molecular Targets and Cancer Therapeutics, which will be held in Boston, Massachusetts, USA from 5 to 9 November 2015. Sulfatinib, fruquintinib and savolitinib were all discovered by HMP and are currently being evaluated in clinical trials for the treatment of various cancers.



Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), a receptor for a protein which also plays a role in tumour growth. HMP will present clinical data from its Phase I trial in China, focusing on neuroendocrine tumour ("NET") patients. In this study, sulfatinib's objective response rate among the 18 efficacy-evaluable NET patients was 44.4% and disease control rate was 100%. By comparison, sunitinib and everolimus, the two approved single agent therapies for neuroendocrine tumours, achieve objective response rates of less than 10% in their pivotal clinical trials. Furthermore, neuroendocrine tumour responses to sulfatinib have been observed to improve gradually with time.



Savolitinib is an inhibitor of the c-Met receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumours, and fruquintinib is a highly selective inhibitor of VEGFR1, 2 and 3. In clear cell renal cell carcinoma ("ccRCC"), c-Met activation has emerged as one of the mechanisms for resistance to anti-VEGF/VEGFR therapies, implying that inhibition of the c-Met and VEGFR pathways in a combination therapy could produce additional clinical benefit. HMP will present data from a preclinical study to assess the effect of savolitinib and fruquintinib combined in ccRCC xenograft models. In this study, while single-agent treatment at clinically relevant doses only exhibited mild to moderate tumour growth inhibition, a significantly increased anti-tumour effect was observed for the group receiving combination therapy.



Preclinical data will also be presented regarding savolitinib in non-small cell lung cancer ("NSCLC") and mechanisms of acquired savolitinib resistance.

Completion of Phase I clinical trial of HMPL 523
RNS
RNS Number : 9695D
Hutchison China Meditech Limited
30 October 2015







Completion of Phase I clinical trial of novel Syk Inhibitor HMPL‑523 for autoimmune diseases in healthy volunteers




London: Friday, 30 October 2015: Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has successfully completed its first-in-human Phase I clinical trial of HMPL‑523. HMPL‑523 is a novel, highly selective and potent small molecule inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling.



The first-in-human Phase I study of HMPL‑523 was a dose-escalating study conducted to assess the safety, tolerability and pharmacokinetics of both single and repeat doses of HMPL‑523 in healthy volunteers in Australia. The study began in June 2014, and completed ten single dose cohorts, with eight patients per cohort, from 5mg single dose through 800mg single dose. In April 2015, the multiple ascending dose section of the Phase I study commenced in which HMPL‑523 was administered once daily for 14 consecutive days. Four dose cohorts have now completed this section of the study, again with eight patients per cohort, from 200mg multiple dose through to 400mg multiple dose. At 400mg daily, HMPL‑523 drug exposures are believed to be well above the predicted efficacious dose level and, consequently, there is no intention to escalate further in healthy volunteers.



The preliminary safety profile of HMPL‑523 was in-line with our expectations. No material off-target toxicities such as hypertension and severe diarrhoea were observed with HMPL‑523 in this study. Furthermore, HMPL‑523 exhibited a linear pharmacokinetic profile and a dose dependent suppression of B-cell activation. Full results of the Phase I study will be published in due course.



Christian Hogg, CEO of Chi‑Med, said, "We have now established what we believe is a dose range for the further development of HMPL‑523. This will now allow Chi-Med to move this important, potentially first-in-class compound into global Phase II proof-of-concept studies against multiple indications both in autoimmune diseases and oncology."







Ends

2 Nov Beaufort... N/A Buy

Chi-Med initiates sulfatinib U.S. clinical trials
RNS
RNS Number : 7256E
Hutchison China Meditech Limited
06 November 2015







Chi-Med initiates sulfatinib U.S. clinical trials


London: Friday, 6 November 2015: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated the Phase I clinical trial of sulfatinib (HMPL-012) in the United States. Its U.S. Investigational New Drug application was submitted and cleared earlier this year and the first patient was dosed on 4 November 2015. HMP is also planning to initiate two Phase III registration studies for the treatment of neuroendocrine tumours ("NET") and a Phase Ib study for the treatment of thyroid cancer with sulfatinib in China by the end of 2015.



This Phase I dose escalation study is to assess the safety and tolerability of sulfatinib in U.S. patients with advanced solid tumours. A U.S. Phase II study in NET is expected to be initiated based on the conclusion of this Phase I dose escalation study.



Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor ("VEGFR") and fibroblast growth receptor ("FGFR"), a receptor for a protein which also plays a role in tumour growth. In a Phase I clinical trial in China focusing on NET patients, sulfatinib's objective response rate among the 18 efficacy-evaluable NET patients was 44.4%. By comparison, sunitinib and everolimus, the two approved single agent therapies for pancreatic NET, achieved objective response rates of less than 10% in their pivotal clinical trials. Furthermore, NET responses to sulfatinib have been observed to improve gradually with time. Results of the Phase I trial in China will be reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in November 2015 and will be made available at www.chi‑med.com/news/.



Sulfatinib is the first oncology candidate that HMP has taken through proof-of-concept in China and expanded to a U.S. clinical study without a partner.





Ends

Second Public Filing of Registration Statement
RNS
RNS Number : 6812F
Hutchison China Meditech Limited
13 November 2015

NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, TO U.S. NEWSWIRE SERVICES OR FOR RELEASE, PUBLICATION OR DISSEMINATION IN OR INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION







Second Public Filing of Registration Statement on Form F‑1 for potential Nasdaq Stock Market Listing



London: Friday, 13 November 2015: Further to its announcement on 16 October 2015, Hutchison China MediTech Limited ("Chi‑Med") (AIM: HCM) announces that it has publicly filed today a second draft of the registration statement on Form F-1 (the "Form F-1 Registration Statement") with the United States Securities and Exchange Commission (the "SEC") in relation to a potential listing of American depositary shares ("ADSs") representing its ordinary shares on the Nasdaq Stock Market (the "Offering"). As of the date of this announcement, Chi-Med has not yet set a definite timetable or decided on further details of the potential Offering and there can be no assurance that the potential Offering will be completed. Accordingly, the number of ADSs which may be offered and the offering price of the potential Offering have not yet been determined. The directors of Chi-Med will assess various factors, including market conditions, in considering whether formally to launch the transaction.

Bank of America Merrill Lynch and Deutsche Bank Securities (in alphabetical order) are acting as joint global coordinators and joint bookrunners for the potential Offering.

The second draft of the Form F-1 Registration Statement relating to the ADSs has been filed with the SEC but has not yet become effective. The ADSs may not be sold, nor may offers to buy be accepted, prior to the time the Form F-1 Registration Statement becomes effective. The Form F-1 Registration Statement and all subsequent amendments may be accessed through the SEC's website at www.sec.gov.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Shareholders and potential investors should note that the potential Offering may or may not proceed, and accordingly are advised to exercise caution when dealing in the securities of Chi-Med.


Presentation of Financial Information

As announced by Chi-Med on 16 October 2015, the consolidated financial statements of Chi-Med included in the Form F‑1 Registration Statement have been prepared in accordance with U.S. GAAP, while the historical consolidated financial statements of Chi-Med published prior to the potential Offering were prepared in accordance with IFRS. The second draft of the Form F-1 Registration Statement filed with the SEC today supplementally contains the unaudited condensed consolidated financial statements of Chi-Med as of and for the nine months ended 30 September 2015 and 30 September 2014. In addition, the second draft of the Form F-1 Registration Statement filed today supplementally contains unaudited condensed consolidated accounts for the three non-consolidated joint ventures of Chi-Med, namely, Shanghai Hutchison Pharmaceuticals Limited, Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited and Nutrition Science Partners Limited, as of and for the nine months ended 30 September 2015 and 30 September 2014, which are prepared in accordance with IFRS. Such unaudited condensed consolidated financial statements are set out in the Appendix to this announcement.

Ends

Initiation of fruquintinib Phase 3 trial in NSCLC
RNS
RNS Number : 3100I
Hutchison China Meditech Limited
08 December 2015







Initiation of fruquintinib Phase III registration trial in non-small cell lung cancer


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

US$105 m Shanghai land compensation agreement
RNS
RNS Number : 4611I
Hutchison China Meditech Limited
09 December 2015



Press Release

US$105 million Shanghai land compensation agreement



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."

Initiation sulfatinib Phase III registration study
RNS
RNS Number : 4500J
Hutchison China Meditech Limited
18 December 2015

-





Initiation of sulfatinib Phase III registration study in neuroendocrine tumour patients


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 (http://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 initiates HMPL-523 Phase I clinical trial
RNS
RNS Number : 9858L
Hutchison China Meditech Limited
15 January 2016







Initiation of HMPL-523 Phase I clinical trial in haematological cancer in Australia


London: Friday, 15 January 2016: Hutchison China MediTech Limited ("Chi-Med") (AIM: HCM) today announces that Hutchison MediPharma Limited ("HMP"), its drug R&D subsidiary, has initiated a Phase I trial in Australia in patients with haematological malignancies. HMPL‑523 is a novel, highly selective and potent small molecule oral inhibitor targeting spleen tyrosine kinase, also known as Syk, a key component in B-cell receptor signalling. Preparations and site selection began in late 2015 and the first patient was dosed on 13 January 2016. This trial follows the successful completion of a first-in-human Phase I clinical trial in healthy volunteers in October 2015.



The new study is a Phase I, open-label, dose escalation study of HMPL‑523 as monotherapy administered orally to patients with relapsed or refractory haematological malignancies who are unable to tolerate standard therapy or for whom there is no effective therapy. Two stages for this study are planned: a dose escalation stage and a dose-expansion stage. The primary objectives of the study are to evaluate safety and tolerability, and to determine the maximum tolerated dose and/or recommended Phase II dose of HMPL‑523 in this patient population. Other objectives include the evaluation and characterisation of the pharmacokinetics of HMPL‑523 and its metabolites, and to make preliminary assessments of the anti-tumour activity of HMPL‑523 in certain sub-populations in the dose expansion phase of the trial.



The successful completion of the first-in-human study in healthy volunteers in 2015 has established the safety profile of HMPL‑523. HMP now hopes that this Phase I study in haematological malignancies could provide clinical proof-of-concept that modulation of the B-cell signalling pathway through inhibition of Syk will provide patients with a clinical benefit.





Ends

Chi-Med schedules FY results
StockMarketWire.com
Hutchison China MediTech will announce its final results for the year ended 31 December on 1 March.

At 8:08am: (LON:HCM) Hutchison China Meditech Ltd share price was 0p at 2247.5p


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