dreamcatcher
- 03 Mar 2017 07:20
- 152 of 190
Positive Fruquintinib Pivotal Phase III Results
RNS
RNS Number : 4422Y
Hutchison China Meditech Limited
03 March 2017
Chi-Med Announces Positive Top-Line Results for FRESCO, its Phase III Pivotal Registration Trial of Fruquintinib in Patients with Locally Advanced or Metastatic Colorectal Cancer
- Trial met all primary and secondary endpoints -
- Safety as expected -
- Progressing to China NDA submission mid-2017 -
- Full data to be reported at an upcoming scientific meeting in mid-2017 -
London: Friday, March 3, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces top-line results from FRESCO, its Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") in China, who failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan. The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival ("OS"), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care ("BSC") as compared to patients treated with placebo plus BSC. Chi-Med is currently preparing to submit a new drug application ("NDA") for fruquintinib to the China Food and Drug Administration.
In addition to OS, a statistically significant improvement in progression-free survival ("PFS"), a key secondary endpoint, was observed. The adverse events demonstrated in FRESCO did not identify any new or unexpected safety issues. Full detailed results are subject to ongoing analysis and are expected to be disclosed at an upcoming scientific meeting in mid-2017.
Simon To, Chairman of Chi-Med, said, "Well over a decade of effort and investment has now paid-off with these compelling Phase III top-line results. They reinforce fruquintinib's potential to address major unmet clinical needs for patients in both China and around the world. They also open the way to our submitting a NDA on fruquintinib around the middle of this year."
"The success of the FRESCO trial is an important milestone not just for CRC patients and Chi-Med, but also for Chinese innovation," he added. "We believe this is one of the first home-grown, China-discovered and developed, mainstream innovation in the field of oncology to succeed in a pivotal Phase III registration trial. It shows that China has the resources, capability and perseverance to emerge as an innovator in the global oncology field. With eight small molecule drug candidates in over 30 clinical studies worldwide, Chi-Med is at the forefront of this important evolution."
"We are pleased to be working with the innovative biopharmaceutical company, Chi-Med, on the development of fruquintinib," said Kerry L. Blanchard, Senior Vice President of China Medicines Development Unit and External Innovation of Eli Lilly and Company ("Lilly") China Drug Development. "This relationship highlights our commitment to help build a vibrant innovation ecosystem in China, and we look forward to our further collaboration to bring this novel medicine to patients."
In addition to the FRESCO colorectal cancer trial, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer ("NSCLC"), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the U.S., and certain exploratory studies in combination with other oncology agents.
About VEGF and Fruquintinib
At an advanced stage, tumors secrete large amounts of vascular endothelial growth factors ("VEGF"), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGF receptors ("VEGFR") play a pivotal role in tumor-related angiogenesis, and the inhibition of the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose. It is currently under the joint development in China by Chi-Med and its partner Lilly. Two clinical studies are ongoing in lung cancer, including a late stage, pivotal Phase III registration study (FALUCA). In addition, fruquintinib is also in clinical development for the treatment of gastric cancer.
About FRESCO and Colorectal Cancer
The FRESCO trial is a randomized, double-blind, placebo-controlled, multicenter, Phase III pivotal trial in patients with locally advanced or metastatic CRC who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. No drugs have been approved in third-line CRC in China, with BSC being the general standard of care. Enrollment was completed in May 2016. 416 patients were randomized 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 BSC; or placebo plus BSC. The primary endpoint is OS, with secondary endpoints including PFS, objective response rate ("ORR"), disease control rate ("DCR") and duration of response ("DoR"). Additional details of the FRESCO study may be found at clinicaltrials.gov, using identifier NCT02314819. Full results from the FRESCO study are planned to be published at a scientific event in mid-2017.
CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to CA Cancer Journal for Clinicians 2016. There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.
About Fruquintinib in Lung and Gastric Cancer
Lung: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Enrollment began in December 2015. Patients are randomized 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 BSC; or placebo plus BSC. The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and DoR. Chi-Med plans to enroll approximately 520 patients in about 45 centers across China. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02691299. Topline results from the FALUCA study are expected to be released in early 2018.
In January 2017 Chi-Med initiated a multi-center, single-arm, open-label Phase II study of a combination therapy using fruquintinib and Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. The objectives are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy in the first-line setting for advanced or metastatic non-squamous NSCLC patients with epidermal growth factor receptor (EGFR) activating mutations. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02976116.
Gastric: Chi-Med completed a Phase I/II dose finding study of fruquintinib in combination with paclitaxel, which established a combination regimen that was well tolerated. Results of this study were published at the 2017 Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology in January 2017. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02415023. A pivotal Phase III registration study is expected to start during the first half of 2017.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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 within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, 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 enrollment 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 drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding. In addition, as certain studies rely on the use of Iressa® (gefitinib) as a combination therapeutic with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa® (gefitinib). Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. 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.
dreamcatcher
- 10 Mar 2017 18:39
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Sulfatinib Phase Ib/II Results Presented at ENETS
RNS
RNS Number : 1145Z
Hutchison China Meditech Limited
10 March 2017
Press Release
Chi-Med Presented Sulfatinib Neuroendocrine Tumors Phase Ib/II Results at the 14th Annual Conference of European Neuroendocrine Tumor Society
London: Friday, March 10, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) presented data from the ongoing Phase Ib/II clinical trial of sulfatinib in patients with advanced neuroendocrine tumors ("NET") at the 14th Annual Conference of European Neuroendocrine Tumor Society ("ENETS"), held in Barcelona, Spain from March 8 to 10, 2017. Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor ("VEGFR"), fibroblast growth factor receptor ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R"), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Five other sulfatinib clinical trials are underway in China and the US, including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.
The most recent results of the study were presented in detail as follows:
Presentation Type:
Oral Presentation, Presidential Abstract - Plenary Meeting Room
Title:
An Open-Label Phase Ib/II Study of Sulfatinib in Patients with Advanced Neuroendocrine Tumors (NCT02267967)
Presented by:
Dr. JianMing Xu
Session:
Session 2B: Medical Therapies and Goals
Date & Time:
Thursday, March 9, 2017, 11:10 AM CET
Presentation summary
The current Phase Ib/II trial is an open-label, single-arm Phase II study to assess the efficacy and safety of sulfatinib monotherapy in patients with advanced grade 1 or 2 advanced NET. 81 patients (41 pancreatic NET and 40 extra-pancreatic NET) were enrolled between November 2014 and January 2016, in seven clinical centers across China. The majority of patients had grade 2 disease (79%) and had failed previous systemic treatments (65%). As of January 20, 2017, 13 patients had confirmed partial response ("PR") and 61 patients had stable disease ("SD") corresponding to an overall objective response rate ("ORR") of 16.0% (13/81), with 17.1% (7/41) in pancreatic NET and 15.0% (6/40) in extra-pancreatic NET, and an overall disease control rate ("DCR") of 91.4%. Median overall progression-free survival ("PFS") has not been reached, but is estimated to be 16.6 months (95% CI: 13.4, 19.4) with longer median PFS in pancreatic NET estimated at 19.4 months and shorter median PFS in extra-pancreatic NET estimated at 13.4 months. Importantly, there were 12 patients who had progressed after treatment with targeted therapies (e.g. Sutent® and Afinitor®) and all benefited from sulfatinib treatment (3 PRs and 9 SDs). Sulfatinib was well tolerated with Grade ≥3 adverse events (AEs) with >5% incidence, regardless of causality, of hypertension (31%), proteinuria (14%), hyperuricemia (10%), hypertriglyceridemia (9%), diarrhea (7%) and ALT increase (6%). Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02267967.
Based on the promising Phase I and Phase II efficacy data and tolerability in patients with advanced NETs, two randomized Phase III trials are ongoing.
The presentation is available at www.chi-med.com/news/. Further information about ENETS is available at enetsconference.org.
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- 13 Mar 2017 17:06
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- 15 Mar 2017 19:26
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Hutchison China MediTech Ltd (HCM:LSE) set a new 52-week high during Tuesday's trading session when it reached 2,642.80. Over this period, the share price is up 19.03%.
dreamcatcher
- 16 Mar 2017 16:21
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Grant of Awards under Long Term Incentive Plan
RNS
RNS Number : 6898Z
Hutchison China Meditech Limited
16 March 2017
Press release
Grant of Awards under Long Term Incentive Plan
London: Thursday, March 16, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) announces that on March 15, 2017, it granted conditional awards ("LTIP Awards") under the Long Term Incentive Plan ("LTIP") adopted by Chi-Med at its Annual General Meeting on April 24, 2015.
The LTIP Awards grant participating directors, persons discharging managerial responsibilities ("PDMRs") or employees a conditional right to a cash amount which is used to purchase shares in Chi-Med ("Shares"), on-market by an independent third party trustee ("Trustee").
Two different types of LTIP Awards have been granted, namely:
1. Performance-related LTIP Award for the Chi-Med Financial Years 2017-2019 ("2017-2019 LTIP") - award based on a maximum cash amount, which amount is determined by the achievement of annual performance targets for each of the financial years 2017 to 2019. The annual performance targets will be determined by the Remuneration Committee of Chi-Med based on the strategic objectives of Chi-Med. The Shares, to be purchased by the Trustee following determination of the cash amount based on actual achievement of each annual performance target, will then be held by the Trustee until the underlying LTIP Awards are vested. Vesting will occur two business days after the date of announcement of the annual results of Chi-Med for the financial year falling two years after the financial year to which the LTIP Award relates. Vesting will also depend upon the continued employment of the award holder with the Chi-Med group and will otherwise be at the discretion of the Board of Directors of Chi-Med. The LTIP Awards will cover a three-year period from 2017 to 2019.
Chi-Med has granted the following LTIP Awards for the 2017-2019 LTIP to the following PDMRs:
Award Holder
Maximum amount per annum for the 2017-2019 LTIP
Mr Christian Hogg (Executive Director and Chief Executive Officer)
US$523,615
Mr Johnny Cheng (Executive Director and Chief Financial Officer)
US$204,808
Dr Weiguo Su (Executive Vice President and Chief Scientific Officer)
US$366,255
An additional 86 senior managers and executives employed by Chi-Med and its subsidiaries have simultaneously been granted LTIP Awards under the 2017-2019 LTIP.
2. Non-performance LTIP Award ("Non-performance LTIP") - a one-off cash amount will be allocated to each grantee and used by the Trustee to purchase Shares which will be subject to a vesting period of one year. Chi-Med has granted the following LTIP Awards for the Non-performance LTIP to the following PDMRs:
Award Holder
Cash Amount for Non-performance LTIP
Mr Christian Hogg (Executive Director and Chief Executive Officer)
US$82,346
Mr Johnny Cheng (Executive Director and Chief Financial Officer)
US$25,405
Dr Weiguo Su (Executive Vice President and Chief Scientific Officer)
US$30,077
An additional 28 senior managers and executives employed by Chi-Med and its subsidiaries have simultaneously been granted LTIP Awards under the Non-performance LTIP.
Further announcements will be made in due course at the time the LTIP Awards are vested, when the number of the Shares to which each Executive Director and PDMR is entitled under such LTIP Awards will be known.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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 Statement
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
dreamcatcher
- 20 Mar 2017 15:27
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Directors' Share Dealing
RNS
RNS Number : 9126Z
Hutchison China Meditech Limited
20 March 2017
Directors' Share Dealing
London: Monday, March 20, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has received notifications that:-
1. Mr Paul Carter, Independent Non-executive Director, purchased a total of 2,800 ordinary shares of US$1.00 each in the capital of Chi-Med ("Ordinary Shares") at a price of GBP26.37 per share on March 15, 2017;
2. Dr Dan Eldar, Non-executive Director, purchased a total of 6,225 American Depositary Shares of the Company ("ADSs", each representing one half of one Ordinary Share) at an average price of US$16.85 per ADS on March 15, 2017;
3. Dr Karen Ferrante, Independent Non-executive Director, purchased a total of 2,540 ADSs at an average price of US$19.77 per ADS on March 16, 2017; and
4. Ms Edith Shih, Non-executive Director and Company Secretary, purchased a total of 10,000 ADSs at an average price of US$19.10 per ADS on March 16, 2017.
Following the above purchases, Mr Carter is interested in 2,800 Ordinary Shares, representing approximately 0.005% of the current issued share capital of Chi-Med; Dr Eldar is interested in 6,225 ADSs, representing approximately 0.005% of the current issued share capital of Chi-Med; Dr Ferrante is interested in 2,540 ADSs, representing approximately 0.002% of the current issued share capital of Chi-Med; and Ms Shih is interested in 50,741 ADSs and 60,000 Ordinary Shares, representing approximately 0.14% of the current issued share capital of Chi-Med.
dreamcatcher
- 27 Mar 2017 12:50
- 158 of 190
2016 Annual Report and Notice of AGM
RNS
RNS Number : 5450A
Hutchison China Meditech Limited
27 March 2017
2016 Annual Report and
Notice of Annual General Meeting
London: Monday, March 27, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that its 2016 Annual Report together with the Notice of Annual General Meeting and the Form of Proxy have been posted to shareholders. The documents can be accessed from the website of Chi-Med (www.chi-med.com).
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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.
dreamcatcher
- 18 May 2017 17:37
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Chi-Med Presents Clinical Data at ASCO 2017
RNS
RNS Number : 5131F
Hutchison China Meditech Limited
18 May 2017
Press Release
Chi-Med Presents Clinical Data at ASCO 2017 Annual Meeting
- FRESCO Phase III trial results for fruquintinib in colorectal cancer in an oral presentation -
- Five abstracts in total accepted for fruquintinib, savolitinib and sulfatinib -
London: Thursday, May 18, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that new clinical data on three of its novel tyrosine kinase inhibitors, fruquintinib, savolitinib and sulfatinib, will be presented at the 2017 American Society of Clinical Oncology ("ASCO") Annual Meeting, to be held in Chicago, Illinois from June 2 to 6, 2017.
The five presentations, one oral presentation and four poster presentations, cover the following studies:
Fruquintinib:
· The full results of the FRESCO Phase III study in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") will be highlighted in an oral presentation on June 5, 2017. Primary endpoint median overall survival was 9.30 months for fruquintinib versus 6.57 months in the control group, with a hazard ratio of 0.65 and p< 0.001. Fruquintinib was well tolerated, with manageable on-target treatment related adverse events consistent with previous studies.
Savolitinib:
· c-MET amplification ("amp") is a major acquired resistance ("AR") pathway to Tagrisso® (osimertinib). AstraZeneca PLC ("AstraZeneca") will highlight an analysis of 23 EGFR-mutant non-small-cell lung cancer ("NSCLC") patients with AR to Tagrisso®. Analysis shows that about 30% (7/23 patients) of AR is c-MET amp and that among the 7 patients with c-MET amp, 3 patients received combination Tagrisso®/savolitinib therapy; all 3 had partial response ("PR") under RECIST (Response Evaluation Criteria in Solid Tumors) guidelines.
· Savolitinib included in PAPMET Phase II study (sponsored by NIH/NCI) of multiple c-MET and vascular endothelial growth factor receptor ("VEGFR") tyrosine kinase inhibitors in metastatic papillary renal cell carcinoma patients. PAPMET will evaluate four therapies in a 1:1:1:1 randomization, sunitinib, cabozantinib, crizotinib and savolitinib in an about 275-patient study which began in 2016 and as at January 30, 2017 had registered 26 patients. PAPMET will study efficacy, safety and correlation of clinical outcome with tumor molecular driver alterations such as c-MET.
· Update on the VIKTORY trial, a biomarker-based umbrella trial in gastric cancer. From June 2014 to January 2017, a total of 432 metastatic gastric cancer patients were enrolled in VIKTORY, a total of 23 patients (5.3%) were guided into savolitinib monotherapy treatment (4/23 patients) or savolitinib/docetaxel combination therapy (19/23) based on molecular screening outcomes.
Sulfatinib:
· Preliminary results of a Phase II study in advanced medullary thyroid cancer ("MTC") and radioiodine ("RAI")-refractory differentiated thyroid cancer ("DTC"). Sulfatinib is an oral, novel angio-immuno kinase inhibitor that selectively targets VEGFR, fibroblast growth factor receptor-1 ("FGFR") and colony-stimulating factor-1 receptor ("CSF-1R"). As at December 31, 2016 a total of 18 patients had been enrolled with 1/6 MTC patients and 3/12 RAI-DTC patients reporting confirmed PRs, and all other patients stable disease, under RECIST.
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- 18 May 2017 17:42
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12:30 18/05/2017
Broker Forecast - Panmure Gordon issues a broker note on Hutchison China Meditech Ltd
Panmure Gordon today reaffirms its buy investment rating on Hutchison China Meditech Ltd (LON:HCM) and raised its price target to 3530p (from 2900p). Story provided by StockMarketWire.com
dreamcatcher
- 13 Jun 2017 19:20
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Fruquintinib NDA for Advanced CRC Filed with CFDA
RNS
RNS Number : 7715H
Hutchison China Meditech Limited
12 June 2017
Chi-Med Submits New Drug Application to CFDA for Fruquintinib in Advanced Colorectal Cancer
- Application accepted by CFDA for technical review by the Center for Drug Evaluation -
- Triggers RMB30.8 million milestone payment from Eli Lilly and Company ("Lilly") -
London: Monday, June 12, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that the China Food and Drug Administration ("CFDA") has acknowledged acceptance of the New Drug Application ("NDA") for fruquintinib for the treatment of patients with advanced colorectal cancer, which triggers a milestone payment of RMB30.8 million (US$4.5 million) from Lilly to Chi-Med. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer ("CRC") in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017.
About CRC
CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to National Central Cancer Registry of China. There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.
About Fruquintinib
Fruquintinib is a highly selective small molecule drug candidate that has been shown to inhibit vascular endothelial growth factor receptor ("VEGFR") 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy.
At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
Fruquintinib is currently under joint development in China by Chi-Med and its partner Lilly. Chi-Med and Lilly jointly announced top-line results from the FRESCO CRC trial on March 3, 2017. In addition, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer ("NSCLC"), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the United States, and certain exploratory studies in combination with other oncology agents.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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 within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, 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 enrollment 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 drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication 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. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. 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.
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- 16 Jun 2017 17:52
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dreamcatcher
- 22 Jun 2017 17:08
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Chi-Med starts clinical trial in China
StockMarketWire.com
Hutchison China MediTech has initiated a phase I/II clinical trial of HMPL‑453 in China.
Chi-Med said HMPL‑453 was a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptor and the first drug dose was administered on 19 June.
It said this study would complement the first-in-human phase I clinical trial in Australia that was initiated earlier this year.
At 9:22am: (LON:HCM) Hutchison China Meditech Ltd share price was 0p at 3600p
Story provided by StockMarketWire.com
dreamcatcher
- 29 Jun 2017 16:52
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Start of Savolitinib Global PRCC Phase III Trial
RNS
RNS Number : 5372J
Hutchison China Meditech Limited
29 June 2017
Chi-Med and AstraZeneca Initiate SAVOIR, a Global Phase III Trial of Savolitinib in Papillary Renal Cell Carcinoma
London: Thursday, June 29, 2017: Chi-Med and AstraZeneca today announce that they have initiated a global pivotal Phase III, open-label, randomized multi-center registration study of the highly selective inhibitor of c-MET receptor tyrosine kinase, savolitinib, in c-MET-driven papillary renal cell carcinoma ("PRCC"). This is the first pivotal study ever conducted in c-MET-driven PRCC and the first molecularly selected trial in renal cell carcinoma ("RCC").
"The launch of the SAVOIR trial, designed to support product registration in the U.S. and Europe, continues to advance our strategy to deliver innovative medicines to major markets worldwide," said Christian Hogg, Chief Executive Officer of Chi-Med. "Based on the results of our Phase II study, we believe savolitinib has the potential to bring meaningful clinical benefit to patients with c-MET-driven PRCC. We also expect to further understand the correlations between c-MET alterations and patient outcomes through epidemiological analyses using our newly developed companion diagnostic assay."
Susan Galbraith, SVP IMED Oncology, AstraZeneca commented that "It is exciting to achieve this milestone in savolitinib's development. The data building across our early development studies are encouraging, that savolitinib has the potential to be an important treatment option for c-MET driven cancers including kidney, lung and gastric cancers."
The initiation of this Phase III trial has triggered a US$5 million milestone payment to Hutchison MediPharma Limited (a 99.8% subsidiary of Chi-Med) from AstraZeneca under the terms of the license and collaboration agreement signed between them in 2011 (as amended).
In addition to SAVOIR, Chi-Med and AstraZeneca are conducting a number of Phase Ib and II studies of savolitinib in kidney cancer, lung cancer and gastric cancer. These studies involve savolitinib as a monotherapy or in combination with other targeted therapy, such as Tagrisso® (osimertinib) or Iressa® (gefitinib). Additional studies combining with Imfinzi® (durvalumab) and Taxotere® (docetaxel) are also in progress.
About SAVOIR
SAVOIR is a global Phase III, open-label, randomized, controlled trial evaluating the efficacy and safety of savolitinib, compared with sunitinib, in patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC. Approximately 180 patients will be randomized at 50 to 75 sites across five to ten countries. c-MET status is confirmed by the novel targeted next-generation sequencing (NGS) assay developed for savolitinib. Patients will be randomized in a 1:1 ratio to receive either continuous treatment with savolitinib 600 mg (400 mg if <50 kg) orally, once daily, or intermittent treatment with sunitinib 50 mg orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.
The primary objective is to evaluate the primary efficacy endpoint progression free survival ("PFS") of savolitinib as compared with sunitinib. Secondary endpoints include overall survival, objective response rate ("ORR"), duration of response, best percentage change in tumor size, disease control rate, and safety and tolerability. The impact of savolitinib compared with sunitinib on disease symptoms and quality of life, along with the pharmacokinetics of savolitinib will also be assessed. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03091192.
About Savolitinib
Savolitinib (AZD6094/HMPL-504) is a potential first-in-class selective inhibitor of c-MET (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with other selective c-MET inhibitors, such as renal toxicity.
Savolitinib was discovered by Chi-Med and is being developed in collaboration with AstraZeneca. Savolitinib is currently being studied in multiple tumor types worldwide including kidney, lung and gastric cancers, both as a monotherapy or in combination with other targeted and immunotherapy agents.
About c-MET-Driven PRCC
Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. However, the biology and molecular characteristics of PRCC are different from those of clear cell RCC ("ccRCC"). Multiple studies indicate that PRCC is c-MET-driven in 40-70% of patients.
There are no therapies approved for patients with PRCC, who currently receive treatments approved for RCC such as sunitinib. These RCC agents were mostly approved on the basis of studies where the majority of subjects were ccRCC patients and where the benefits to the PRCC minority were more modest. Currently the National Comprehensive Cancer Network Guidelines advise PRCC patients to enter clinical trials.
About Savolitinib in PRCC
In February 2017, the results of a global Phase II multicenter study in advanced PRCC was presented at the 2017 American Society of Clinical Oncology Genitourinary Cancers Symposium, which indicated a clear efficacy signal with savolitinib monotherapy in c-MET-driven patients. Median PFS of 6.2 months in c-MET-driven patients as compared with 1.4 months (p<0.0001) in c-MET-independent patients. ORR was 18.2% in c-MET-driven patients vs. 0% (p=0.002) in c-MET independent patients. An encouraging durable response and safety profile were reported in savolitinib treated patients. Further details are available at www.chi-med.com/asco-gu-2017-savolitinib-ph2-in-prcc-pres/.
Studies of c-MET-driven disease in gastric cancer and lung cancer suggest that c-MET amplification and/or overexpression can be a negative prognostic for disease progression. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-MET alterations and patient outcomes, including any predictive biomarkers.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance new oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.
By harnessing the power of four scientific platforms - immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates - and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology, cardiovascular & metabolic diseases and respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med's current expectations regarding future events, including its expectations for the clinical development of savolitinib, plans to initiate clinical studies for savolitinib, 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 enrollment 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 drug candidate savolitinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of savolitinib for a targeted indication 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. For further discussion of these and other risks, see Chi-Med's filings with the U.S. Securities and Exchange Commission and on AIM. 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.
dreamcatcher
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Chi-Med Reports 2017 Interim Results
RNS
RNS Number : 5072M
Hutchison China Meditech Limited
31 July 2017
Chi-Med Reports 2017 Interim Results and Updates Shareholders on Key Clinical Programs
London: Monday, July 31, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM), the China-based biopharmaceutical company focused on discovering and developing targeted therapies for oncology and immunological diseases for the global market, today announces its unaudited financial results for the six months ended June 30, 2017.
Group: Record revenue; continued investment in clinical pipeline
· Group revenue up 21% to $126.6 million (H1 2016: $104.5m).
· Net income attributable to Chi‑Med of $1.7 million (H1 2016: $0.5m), including $37.5 million in research and development expenses on an as adjusted basis (H1 2016: $36.0m).
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 or completing; three more preparing to start
· Deep clinical pipeline of novel small molecule tyrosine kinase inhibitors ("TKIs"):
o Eight clinical drug candidates now in 31 active or completing clinical trials (H1 2016: 25) around the world; over 3,100 subjects dosed in our trials to date, with over 300 dosed in the first half of 2017.
· Fruquintinib - Highly selective TKI of vascular endothelial growth factor receptor ("VEGFR")-1/2/3:
o Positive outcome in Phase III study, the FRESCO study, in third-line colorectal cancer ("CRC") patients in China;
o Potentially best-in-class in terms of both efficacy and safety relative to Stivarga® (regorafenib);
o 2017 American Society of Clinical Oncology ("ASCO") oral presentation;
o NDA submitted in third-line CRC to the Center for Drug Evaluation of the China Food and Drug Administration ("CFDA").
· Savolitinib - Highly selective TKI of the mesenchymal epithelial transition factor ("c-MET"):
o Presented positive Phase II data in c-MET-driven papillary renal cell carcinoma ("PRCC") at the ASCO Genitourinary Cancers Symposium;
o 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;
o Initiated a global epidemiology study in c-MET-driven PRCC to demonstrate the importance of treatment with a c-MET inhibitor.
· Presented positive proof-of-concept data on:
o Fruquintinib in gastric cancer in combination with Taxol® (paclitaxel);
o Sulfatinib in neuroendocrine tumors ("NET") as well as preliminary data in thyroid cancer.
· Progressing multiple Phase I dose escalation studies in Australia and China on:
o HMPL-523 against spleen tyrosine kinase ("Syk");
o HMPL-453 against fibroblast growth factor receptor 1/2/3 ("FGFR");
o HMPL-689 against phosphoinositide 3-kinase delta ("PI3Kδ");
o Theliatinib against epidermal growth factor receptor ("EGFR") wild-type;
o Expect to complete dose escalation and initiate proof-of-concept expansion trials on these drug candidates towards end of 2017 or early 2018.
Commercial Platform: High-performance drug marketing and distribution platform covers ~300 cities/towns in China with >3,300 sales people. High value products and household name brands
· Total consolidated sales up 26% to $103.9 million (H1 2016: $82.3m).
· Total sales of non-consolidated joint ventures were $253.1 million (H1 2016: $249.6m) mainly due to a price increase on a key product in late 2016; a relatively quiet influenza season; and -5% currency effect. Dividends paid to Chi-Med Group level from non-consolidated joint ventures totaled $42.6 million in first half of 2017 (H1 2016: $15.9m).
· Total consolidated net income attributable to Chi-Med up 14% to $25.2 million (H1 2016: $22.1m).
Solid cash position:
· Cash resources of $192.5 million at Chi-Med Group level as of June 30, 2017 ($173.7m as of December 31, 2016), including cash and cash equivalents, short-term investments and unutilized bank facilities.
Potential major milestones targeted for rest of 2017 and into 2018
· Savolitinib in non-small cell lung cancer ("NSCLC"):
o Data from Phase II studies to be presented later in 2017 at a major scientific conference:
1) Savolitinib in combination with Tagrisso® (osimertinib) in second- and third-line NSCLC;
2) Savolitinib in combination with Iressa® (gefitinib) in second-line NSCLC;
o Subject to the strength of Phase II data, global Phase III registration and potential Breakthrough Therapy strategy for NSCLC will be determined.
· Fruquintinib:
o Potential NDA approval and launch in China, via our partner Eli Lilly and Company ("Lilly"), as the first approved treatment for third-line CRC patients;
o Completion of enrollment in the FALUCA study, an approximately 520 patient Phase III registration study in third-line NSCLC in China;
o Initiation of Phase III registration study of fruquintinib in combination with Taxol® in second-line gastric cancer in China.
· 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): Potential presentation of preliminary efficacy data from Phase I dose escalation study in hematological cancer.
References in this announcement to adjusted research and development expenses, consolidated net income attributable to Chi-Med from our Commercial Platform and consolidated net income attributable to Chi-Med from our Prescription Drugs business 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 (4:00 p.m. HKT) - at Panmure Gordon & Co, One New Change, London EC4M 9AF, 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/.
U.S. Conference Call Scheduled Today at 9:00 a.m. EDT - to participate in the call from the United States, please dial 1 866 966 5335.
Additional dial-in numbers are also available at Chi-Med's website. For both calls and all dial-in numbers, please use conference ID "Chi-Med."
Simon To, Chairman of Chi-Med, said: "Chi-Med's consistent strategy over the past 16 years has generated considerable shareholder value, and we believe it is now poised to deliver substantially more.
In our Innovation Platform, we have progressed our deep portfolio of eight clinical drug candidates, now in 31 active or completing clinical trials around the world. In the process we have achieved two particularly important milestones: the formal NDA submission for fruquintinib in third-line CRC in China; and the initiation of our first global Phase III registration study of savolitinib in c-MET-driven metastatic PRCC. We also presented positive Phase Ib/II data at major scientific conferences in early 2017 on savolitinib in PRCC, fruquintinib in gastric cancer, and sulfatinib in NET and thyroid cancer.
Now, subject to approval, we expect to launch fruquintinib in China in 2018 with our commercial partner, Lilly. Importantly also, later in 2017, we will present eagerly-awaited Phase II clinical trials data on savolitinib in combination with Tagrisso® and Iressa® in NSCLC thereby allowing AstraZeneca AB (publ) ("AstraZeneca") to clarify their plans for potential global Phase III registration. Furthermore, we are also now preparing to initiate Phase III registration studies in China of fruquintinib in gastric cancer and of epitinib in NSCLC patients with brain metastasis. The progress of our pipeline is testament to the quality of our in-house research organization, which has discovered all eight of our clinical drug candidates. It also demonstrates that global quality drug discovery is now very much possible in China.
At the same time, regulatory reform is moving at speed in China, improving transparency and raising the standards of clinical data reliability. This helps us, since, at Chi-Med we have always run all our clinical trials to global standards, be they inside or outside China. Fruquintinib is now set to establish an important new reference point, under the reformed regulatory framework in China, for both quality and rigor of clinical trials and for speed to approval. Change is also underway on the National Drug Reimbursement List ("NDRL") in China, with the first steps having been taken this month to include multiple innovative cancer drugs for some level of reimbursement in a clear move to broaden accessibility.
In parallel, our Commercial Platform continues to grow sales and profits showing resilience against the normal pressures of dynamic and competitive markets. During late 2016 and early 2017, we increased prices in our Prescription Drugs business; and moved our Consumer Health factory over 1,400 kilometers to a lower-cost, larger capacity site in central China. Both had short-term effects; but both are now set to benefit our businesses materially. There were also market pressures on our Consumer Health business, with rapid raw material price increases, a relatively quiet influenza season and around a 5% fall in the Chinese RMB, which affected our U.S. dollar stated financial results. Despite this, net income attributable to Chi-Med from our Commercial Platform increased by 14% to $25.2 million, and we expect to meet full year guidance on core operations. We see this as a measure of the strength of our brands, teams and operations.
Our consistent commercial and scientific strategy, and our pragmatic approach to managing finance and risk, have led to the strength of both our position today and our prospects. The first of our new drug candidates, led by fruquintinib, and including savolitinib, sulfatinib and epitinib, are all progressing towards potential registration and launch in major markets with the balance of our pipeline of drug candidates including theliatinib, HMPL-523, HMPL-689 and HMPL-453 now mostly in proof-of-concept studies.
In addition, our discovery platform is generating a third wave of innovation with a strong focus on immunotherapy. Combining this innovation pipeline with our China marketing and distribution platform, our international partners and our financial stability, all lead Chi-Med to view our future with great confidence."
FINANCIAL HIGHLIGHTS:
Consolidated financial results of the Group are reported under U.S. generally accepted accounting principles ("U.S. GAAP") and in U.S. dollar currency unless otherwise stated. Chi-Med also conducts its business through three non-consolidated joint ventures, which are accounted for under the equity accounting method as non-consolidated entities in our consolidated financial statements. Within this announcement, certain financial results reported by such non-consolidated joint ventures are referred to, which are based on figures reported in their respective consolidated financial statements prepared pursuant to International Financial Reporting Standards (as issued by the International Accounting Standards Board). Unless otherwise indicated, references to "subsidiaries" mean the consolidated subsidiaries and joint ventures (excluding non-consolidated joint ventures) of Chi-Med.
Group Results
· Consolidated revenue up 21% to $126.6 million (H1 2016: $104.5m).
· Net income attributable to Chi-Med of $1.7 million (H1 2016: $0.5m).
· Solid cash position: Available cash resources of $192.5 million as of June 30, 2017 (December 31, 2016: $173.7m) at the Chi-Med Group level, including cash and cash equivalents, short-term investments and unutilized banking facilities. During the first half of 2017, Chi-Med received dividends from its non-consolidated joint ventures of $42.6 million (H1 2016: $15.9m).
Innovation Platform - a deep broad, risk-balanced global oncology/immunology pipeline
· Consolidated revenue of $22.7 million (H1 2016: $22.3m) from milestone payments from Lilly ($4.5m, fruquintinib NDA filing) and AstraZeneca ($5.0m, savolitinib Phase III initiation) and service fee payments from Lilly, AstraZeneca and Nutrition Science Partners Limited ("NSP"), our 50/50 joint venture with Nestlé Health Science S.A. ("Nestlé").
· Net loss attributable to Chi-Med of $14.8 million (H1 2016: -$13.7m) driven by $31.6 million (H1 2016: $31.2m) in research and development expenses, or $37.5 million (H1 2016: $36.0m) on an as adjusted (non-GAAP) basis, spent on our 31 active or completing clinical trials, five of which are pivotal Phase III studies on fruquintinib, sulfatinib and savolitinib.
Commercial Platform - a deeply established, cash-generative, pharmaceutical business in China - a platform to commercialize our Innovation Platform candidate drugs
· Total consolidated sales up 26% to $103.9 million (H1 2016: $82.3m) mainly resulting from growth in our Prescription Drug commercial services business.
· Total sales of non-consolidated joint ventures were $253.1 million (H1 2016: $249.6m) resulting from flat sales on She Xiang Bao Xin ("SXBX") pill due to a price increase that we implemented in December 2016; and a relatively quiet influenza season on the over-the-counter ("OTC") drug business.
· Total consolidated net income attributable to Chi-Med up 14% to $25.2 million (H1 2016: $22.1m) or up 2% to $22.7 million on an adjusted basis to exclude $2.5 million one-time government subsidies; strong Prescription Drug net income growth was offset by short-term pressures in OTC drugs caused by our factory move and certain raw material price increases.
· Both top- and bottom-line growth were reduced by -5% in U.S. dollar terms during the first half of 2017 as a result of the weakening of the Chinese RMB as compared to the same period in 2016.
KEY H1 2017 OPERATIONAL HIGHLIGHTS:
Innovation Platform: In June this year, we both completed our first NDA submission, for fruquintinib in third-line CRC, and initiated our first global Phase III study in oncology, for savolitinib in PRCC. Each triggered milestone payments from our partners Lilly and AstraZeneca, and each represents major achievements for Chi-Med and for the biotech industry in China.
· Savolitinib: Potential first-in-class selective c-MET inhibitor currently in 12 active clinical studies worldwide in multiple tumor types including kidney, lung and gastric cancers as a monotherapy or in combination with other targeted and immunotherapy agents. Developing globally in partnership with AstraZeneca:
1. Kidney cancer:
a. Presented Phase II global multicenter study in advanced PRCC at the 2017 ASCO Genitourinary Cancers Symposium showing robust efficacy with savolitinib monotherapy in c-MET-driven patients. Median progression free survival ("PFS") of 6.2 months in patients with c-MET-driven tumors as compared with 1.4 months (p<0.0001) in c-MET-independent patients. Objective response rate ("ORR") was 18.2% in c-MET-driven patients vs. 0% (p=0.002) in c-MET independent patients. Encouraging durable response and a tolerable safety profile were reported in savolitinib treated patients. The full article has now been published in the Journal of Clinical Oncology.
b. A global Phase III study, the SAVOIR study, was initiated in late June 2017. The SAVOIR study is an open-label, randomized, controlled trial evaluating the efficacy and safety of savolitinib, compared with Sutent®, in patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC. Approximately 180 patients will be randomized in the United States and Europe; c-MET-driven PRCC patients will be selected through the use of a companion diagnostic kit.
c. Confirmed combination dose of savolitinib in combination with anti-programmed death-ligand 1 ("PD-L1") antibody, Imfinzi® (durvalumab), via Phase Ib study in clear cell renal cell carcinoma ("ccRCC") patients. A ccRCC expansion phase is now underway.
2. Lung cancer:
a. Continued enrollment of Phase II studies in NSCLC patients with EGFR mutations who have progressed following first-line EGFR TKI therapy and harbor c-MET gene amplification. We are preparing to present data on the following studies at major scientific conferences later in 2017: (1) a Phase II study, the TATTON study (Part B), of savolitinib in combination with Tagrisso® in second-line or third-line EGFR TKI refractory NSCLC patients; and (2) a Phase II study of savolitinib in combination with Iressa® in second-line EGFR TKI refractory NSCLC patients.
· Fruquintinib: Designed to be a best-in-class selective inhibitor of VEGFR 1/2/3 - we are developing outside of China and in partnership with Lilly within China:
1. CRC (third-line or above): Reported in March 2017 that fruquintinib convincingly met the primary endpoint of median overall survival ("OS"), 9.30 months versus 6.57 months (p<0.001), and all secondary endpoints in the FRESCO Phase III study as a monotherapy among third-line CRC patients in China; further, that the adverse events ("AEs") demonstrated in FRESCO did not identify any new or unexpected safety issues; then presented the full FRESCO data-set in an oral presentation at ASCO and completed submission of our China NDA in June 2017. Subject to CFDA approval, fruquintinib is expected to launch in China in 2018. Based on the patient population in third-line CRC in China, as well as the sales performance of TKIs launched in recent years in China, we estimate peak fruquintinib revenues, in third-line CRC alone, could reach between $110-160 million annually resulting in peak net income to Chi-Med of around $20-35 million.
2. NSCLC (third-line): Continue to enroll a Phase III study, named FALUCA, with a primary endpoint of OS, to evaluate fruquintinib in third-line NSCLC patients in China; expect to complete enrollment in early 2018; top-line Phase III data expected to be reported in late 2018; subject to positive FALUCA outcome, we target to submit a second China NDA shortly thereafter.
3. Gastric cancer (second-line): Presented positive interim results in the Phase I/Ib dose finding/expansion study in early 2017 at the ASCO Gastrointestinal Cancers Symposium. Established a well-tolerated combination dose of 4mg fruquintinib with 80mg/m2 weekly of Taxol® with encouraging efficacy, including ORR of 36%; Disease Control Rate ("DCR") of 68%; ≥16 week PFS of 50% and ≥7 month OS of 50%. On track now to initiate a Phase III registration study in China in 2017.
4. NSCLC (first-line): In January 2017, we initiated a Phase II study of fruquintinib in combination with Iressa® in first-line NSCLC patients with EGFR activating mutations in China.
5. Production facility in Suzhou, China operated by Chi-Med is now ready to support commercial launch of fruquintinib in 2018.
6. Planning to initiate global development of fruquintinib in 2017, initially through a Phase I dose confirmation study in Caucasian patients in the United States.
· Sulfatinib: A unique angio-immuno TKI therapy with high potency against VEGFR, FGFR1 and colony stimulating factor-receptor 1 ("CSF-1R") with emerging strong efficacy in multiple solid tumor settings - enrolling two pivotal Phase III studies:
1. NET:
a. Presented positive Phase II study at the European Neuroendocrine Tumor Society ("ENETS") conference in early 2017. Established that sulfatinib was well tolerated with highly encouraging efficacy in both pancreatic NET (ORR 17.1%; DCR 90.2%; and median PFS 19.4 months) and non-pancreatic NET (ORR 15.0%; DCR 92.5%; and median PFS 13.4 months) with 100% DCR in twelve patients who had disease progression on targeted therapies such as Sutent® and Afinitor® (everolimus); now enrolling two Phase III studies in China, named SANET-p (in pancreatic NET patients) and SANET-ep (in non-pancreatic NET patients), with primary endpoint median PFS.
b. U.S. Phase I dose confirmation study in Caucasian patients is near completion, and a Phase II expansion study in the United States is expected to be initiated in late 2017 or early 2018.
2. Thyroid cancer: Presented Phase II data at ASCO in June 2017 in patients with locally advanced or metastatic radioactive iodine ("RAI")-refractory differentiated thyroid cancer ("DTC") or medullary thyroid cancer ("MTC") in China. Preliminary data in 18 patients showing an ORR of 25% in RAI-DTC and an ORR of 17% in MTC patients, with all other patients reporting stable disease ("SD").
3. Biliary tract cancer: Initiated a Phase II proof-of-concept study in China in January 2017.
· Epitinib: Highly differentiated EGFR TKI designed for optimal blood-brain barrier penetration allowing for higher drug exposure in the brain than currently marketed first generation EGFR TKIs:
1. NSCLC with brain metastasis: Epitinib has been shown to be well tolerated with encouraging efficacy with an overall ORR (lung and brain) of 62% in all EGFR TKI naïve NSCLC patients (those patients not previously treated with an EGFR TKI) and an ORR of 70%, including both confirmed and unconfirmed partial responses ("PRs"), in EGFR TKI naïve NSCLC patients who also had measurable brain metastasis and were c-MET negative. Based on these data we are preparing to initiate a Phase III registration study in China in late 2017 or early 2018.
2. Glioblastoma: Planning underway to start a Phase II study in glioblastoma, a primary brain cancer that harbors high levels of EGFR gene amplification, in 2017.
· HMPL-523: Potential first-in-class Syk inhibitor in oncology and immunology:
Hematological cancer: Currently enrolling Phase I dose escalation studies in Australia and China in patients with hematologic malignancies. Dose escalation continues to evaluate both once daily ("QD") and twice daily regimes and will begin dose expansion with single agent HMPL-523 in due course. We target to present proof-of-concept data in 2018.
· HMPL-689: Potential best-in-class, highly selective PI3Kδ inhibitor, which we believe should have meaningful safety and tolerability advantages over Zydelig® (idelalisib):
Hematological cancer: Completed Phase I study in healthy volunteers in Australia, now preparing to start Phase I in patients with lymphomas in China where we received IND clearance in early 2017.
· Theliatinib: EGFR inhibitor, with high binding affinity to wild-type EGFR protein, with potential in patients with solid tumors presenting EGFR gene amplification or protein over-expression:
Esophageal cancer: Phase I dose escalation study is continuing and a Phase II expansion in esophageal cancer patients with a high level of EGFR activation, including gene amplification and protein over-expression was initiated in early 2017.
· HMPL-453: Potential first-in-class and/or best-in-class selective FGFR 1/2/3 inhibitor:
Solid tumors: During the first half of 2017, we initiated Phase I dose escalation studies in both Australia and China.
Commercial Platform: Net profit increased 14% to $25.2 million (H1 2016: $22.1m) with strong Prescription Drugs growth and $2.5 million in one-time government subsidies more than offsetting the effect of challenging conditions in the OTC business; as well as the -5% weakening of the Chinese RMB.
· Prescription Drugs business continuing profit growth - consolidated sales up 27% to $85.8 million (H1 2016: $67.6m); total sales of non-consolidated Prescription Drugs joint venture flat at $129.7 million (H1 2016: $126.8m); and total consolidated net income attributable to Chi-Med up 27% to $19.4 million (H1 2016: $15.3m).
1. Shanghai Hutchison Pharmaceuticals Limited ("SHPL") - our large-scale non-consolidated Prescription Drugs joint venture - Continued progress on SXBX pill, our most important commercial product, a prescription vasodilator that accounts for about 12% of China's over $1.5 billion botanical coronary artery disease prescription drug market. SXBX pill is a proprietary product with full patent protection through 2029. During late 2016 and early 2017, we have been able to effectively implement a pricing strategy that provides an important foundation for future margin improvement and profit growth.
2. Shanghai government subsidy - SHPL was awarded a significant one-time increase in its regular government research and development subsidies. This totaled $5.9 million, equivalent to $2.5 million in net income attributable to Chi-Med.
3. Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Limited ("Hutchison Sinopharm") - our Prescription Drugs commercial services business - Continued commercial success in the first half of 2017 on Seroquel® (bi-polar disorder/schizophrenia), which grew sales by 10% to $18.9 million (H1 2016: 17.2m), and Concor® (hypertension/high blood pressure) where strong results, 75% year-on-year growth, recently led Merck Serono to expand Hutchison Sinopharm's exclusive territory by over 70% to now cover a total of six provinces/municipalities with a population of over 360 million people.
· Consumer Health business stable despite challenging conditions - consolidated sales up 24% to $18.1 million (H1 2016: $14.6m); total sales of non-consolidated Consumer Health joint venture flat at $123.4 million (H1 2016: $122.7m); and total consolidated net income attributable to Chi-Med down 16% to $5.8 million (H1 2016: $6.8m).
Short-term OTC profit pressure - capacity constraint and depreciation costs - caused by regulatory hiatus before the start of production at our new factory; an increase in certain key raw material prices; and the quietest influenza season since 2014.
2017 AND EARLY 2018 MILESTONES: We target to present multiple clinical data updates during the balance of 2017 and early 2018, including:
· Savolitinib:
1. Phase II data in second- and third-line NSCLC in combination with Tagrisso®;
2. Phase II data in second-line NSCLC in combination with Iressa®;
3. Molecular epidemiology study (n >300) in PRCC.
· Fruquintinib: Phase III FRESCO study full data sub-group analysis in third-line CRC.
· HMPL-523 (Syk): Preliminary efficacy data from Phase I dose escalation study in hematological cancer.
· HMPL-689 (PI3Kδ): Phase I dose escalation data in healthy volunteers.
We hope to achieve multiple clinical and regulatory milestones during 2017 and early 2018, including:
· Savolitinib: Potential decision on Phase III registration and potential Breakthrough Therapy strategy in NSCLC in combination with Tagrisso®/Iressa®.
· Fruquintinib:
1. Potential NDA approval and launch in third-line CRC in China;
2. Complete enrollment of Phase III FALUCA study in third-line NSCLC;
3. Initiate China Phase III study in second-line gastric cancer;
4. Initiate U.S. Phase I dose confirmation study in Caucasian patients.
· Epitinib:
1. Initiate China Phase III study in first-line EGFR-mutant NSCLC patients with brain metastasis;
2. Initiate China Phase II study in glioblastoma (primary brain cancer).
· Sulfatinib: Initiate Phase II expansion study in NET patients in the United States.
· HMPL-523 (Syk): Initiate Australia and China dose expansion proof-of-concept studies in hematological cancer.
· HMPL-689 (PI3Kδ): Initiate Phase I dose escalation study in China in hematological cancer patients.
FINANCIAL GUIDANCE: Our updated guidance for 2017, compared to the most recent guidance in our full year results announcement for the year ended December 31, 2016 dated March 13, 2017, reflects no overall change to estimated net income/(loss) for the Chi-Med Group. The only adjustment that we would highlight is the potential for deferral, into 2018, of the one-time property gains resulting from Guangzhou government policy. Full year 2017 financial guidance is detailed below:
Group Level:
2017 Previous
Guidance[1]
2017 Current
Guidance
Adjustment
· Consolidated revenue
$225-240 million
$225-240 million
none
· Admin., interest & tax
$(18)-(19) million
$(18)-(19) million
none
· Net income/(loss)[2]
$(13)-(28) million
$(13)-(28) million
none
Innovation Platform:
· Consolidated revenue
$35-40 million
$35-40 million
none
· Adjusted R&D expenses
$(85)-(90) million
$(85)-(90) million
none
Commercial Platform:
· Sales (consolidated)
$190-200 million
$190-200 million
none
· Sales of non-consol. JVs[3]
$480-500 million
$480-500 million
none
· One-time property/R&D gains[2]
$14-16 million[4]
$3-16 million[4]
$0-11 million less[4]
· Net income[2]
$46-50 million
$35-50 million
$0-11 million less
Notes: [1] Company Guidance March 13, 2017; [2] Attributable to Chi-Med; [3] Joint ventures; [4] timing subject to Guangzhou government policy.
dreamcatcher
- 07 Aug 2017 19:07
- 166 of 190
Director Deals - Hutchison China Meditech Ltd (HCM)
BFN
Dr Dan Eldar, Non Executive Director, bought 1,900 shares in the company on the 2nd August 2017 at a price of 3493.00p. The Director now holds 5,012 shares.
Story provided by StockMarketWire.com
Director deals data provided by www.directorsholdings.com
dreamcatcher
- 07 Aug 2017 19:08
- 167 of 190
14:05 07/08/2017
Director Deals - Hutchison China Meditech Ltd (HCM)
Paul Carter, Non Executive Director, bought 724 shares in the company on the 2nd August 2017 at a price of 3425.00p. The Director now holds 3,524 shares. Story provided by StockMarketWire.com Director deals data provided by www.directorsholdings.com
dreamcatcher
- 29 Aug 2017 20:52
- 168 of 190
Start of HMPL 689 Phase I Trial in China
RNS
RNS Number : 1286P
Hutchison China Meditech Limited
29 August 2017
Chi‑Med Initiates a Phase I Clinical Trial of Selective PI3Kδ Inhibitor HMPL‑689 in Lymphoma Patients in China
London: Tuesday, August 29, 2017: Hutchison China MediTech Limited ("Chi‑Med") (AIM/Nasdaq: HCM) has initiated a Phase I clinical trial of HMPL‑689 in China. HMPL-689 is a novel, highly selective and potent small molecule inhibitor targeting phosphoinositide-3 kinase delta isoform ("PI3Kδ"), a key component in the B-cell receptor ("BCR") signaling pathway.
This Phase I study is a multi‑center, open‑label, two‑stage study to evaluate safety, tolerability, pharmacokinetics ("PK") and preliminary efficacy of HMPL-689 monotherapy in relapsed and/or refractory non-Hodgkin lymphoma patients. During the initial dose-escalation stage, the primary objective is to determine the maximum tolerated dose (MTD) or the recommended Phase II dose ("RP2D"). Safety, tolerability and preliminary efficacy of HMPL-689 at the RP2D will be further studied in a subsequent dose-expansion stage in which several subtypes of lymphoma patients will be evaluated. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03128164.
About HMPL-689
PI3K signaling is mediated by four different catalytic isoforms (p110α, β, ɣ, δ). The δ (delta) isoform is the most critical isoform and a proven target in the BCR signaling pathway. This isoform is restricted to hematopoietic cells and is highly expressed in lymphoid cells.
HMPL-689 is a novel, potential best-in-class, highly selective and potent small molecule inhibitor targeting the isoform PI3Kδ. HMPL-689 was designed for superior PI3Kδ isoform selectivity, in particular to not inhibit PI3Kɣ (gamma), to minimize the risk of serious infection caused by immune suppression. In preclinical PK studies, HMPL-689's PK properties have been found to be favorable with expected good oral absorption, moderate tissue distribution and low clearance. HMPL-689 is also expected to have low risk of drug accumulation and drug-to-drug interaction and is highly potent, particularly at the whole blood level.
A Phase I, first-in-human, dose escalation study in healthy adult volunteers in Australia to evaluate the PK and safety profile following single oral dosing HMPL-689 was completed in 2016. Results were as expected with linear PK properties and good safety profile. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02631642.
About Chi‑Med
Chi‑Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, 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 press release contains forward‑looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward‑looking statements reflect Chi‑Med's current expectations regarding future events, including its expectations for the clinical development of HMPL‑689, plans to initiate further clinical studies for HMPL‑689, 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 enrollment 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 drug candidate HMPL‑689 to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL‑689 for a targeted indication 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. For further discussion of these and other risks, see Chi‑Med's filings with the U.S. Securities and Exchange Commission and on AIM. Chi‑Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
dreamcatcher
- 31 Aug 2017 16:34
- 169 of 190
Director's Share Dealing
RNS
RNS Number : 4283P
Hutchison China Meditech Limited
31 August 2017
Director's Share Dealing
London: Thursday, August 31, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) has received notifications that Mr Simon To, Executive Director and Chairman, through Dynamic Drive Limited, a person closely associated with Mr To, purchased a total of 14,748 American Depositary Shares of the Company ("ADSs", each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med) on August 28 and 29, 2017 at an average price of US$24.40 per ADS. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust (the "DDT") which has been established for the benefit of Mr To's family members, of which Mr To is the settlor.
Following the above purchases, Mr To is interested in 133,237 ADSs (in DDT and Wencheng Trust of which his family members are the beneficiaries) and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in DDT of which his family members are the beneficiaries), representing in aggregate approximately 0.41% of the current issued share capital of Chi-Med.
dreamcatcher
- 03 Oct 2017 17:59
- 170 of 190
Going into orbit. :-))
dreamcatcher
- 12 Oct 2017 18:36
- 171 of 190
Appointment of Director
RNS
RNS Number : 4095T
Hutchison China Meditech Limited
12 October 2017
Appointment of Director
London: Thursday, October 12, 2017: Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that Professor Mok, Shu Kam Tony has been appointed as Independent Non-Executive Director and member of the Technical Committee with effect from October 12, 2017.
Professor Mok, aged 57, has more than 30 years of experience in clinical oncology with his main research interest focusing on biomarker and molecular targeted therapy in lung cancer. He is currently Li Shu Fan Medical Foundation Named Professor and Chairman of Department of Clinical Oncology at The Chinese University of Hong Kong. He co-founded the Lung Cancer Research Group and has led a number of important multinational clinical trials, which include the IPASS, FASTAST 2, IMPRESS and PROFILE 1014 that contributed to the current standard of practice on management of advanced stage lung cancer.
Professor Mok has contributed to over 200 articles in international peer-reviewed journals, including the New England Journal of Medicine, Science, Lancet and Journal of Clinical Oncology, and contributed to multiple editorials and textbooks. He is Past Chair of the American Society of Clinical Oncology (ASCO) International Affairs Committee, a member of the ASCO Publications Committee and Vice Secretary of the Chinese Society of Clinical Oncology (CSCO).
Professor Mok is closely affiliated with the oncology community in China and has been awarded an Honorary Professorship at Guangdong Province People's Hospital, Guest Professorship at Peking University School of Oncology and Visiting Professorship at Shanghai Jiao Tong University and West China School of Medicine/West China Hospital, Sichuan University.
He received his Bachelor of Medical Science degree and Doctor of Medicine from University of Alberta, Canada. He is also a Fellow of Royal College of Physicians and Surgeons of Canada, Hong Kong College of Physicians, Hong Kong Academy of Medicine, Royal College of Physicians of Edinburgh and American Society of Clinical Oncology.
Professor Mok is currently a member of the board of directors of Sanomics Limited, the Chinese Lung Cancer Research Fund and the International Association for the Study of Lung Cancer (ISALC). He is also Chairman of The Hong Kong Cancer Therapy Society.
Professor Mok holds 10,002 American Depositary Shares of Chi-Med (each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med), representing approximately 0.008% of the current issued share capital of Chi-Med. Save for the information disclosed above, there is no other information in relation to Professor Mok that is required to be disclosed pursuant to Rule 17 and Schedule 2(g) of the AIM Rules for Companies.
Mr Simon To, Chairman of Chi-Med said, "We welcome Professor Mok to the Board. His renowned expertise and extensive experience in clinical oncology, with particular emphasis in lung cancer, will be important to the Company."