London: Friday, March 31, 2017: For information purposes, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at March 31, 2017, the issued share capital of Chi-Med consisted of 60,715,323 ordinary shares of US$1.00 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 60,715,323 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Rules and Transparency Rules.
For illustrative purposes only, the 60,715,323 ordinary shares would be equivalent to 60,715,323 CREST depositary interests (each equating to one ordinary share) which are traded on AIM or, if the CREST depositary interests were converted in their entirety, equivalent to 121,430,646 American depositary shares (each equating to one-half of one ordinary share) which are traded on Nasdaq.
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.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
Introduction
The Future of Targeted Cancer Therapy In Lung Cancer
Post-POC Portfolio
Pre-POC Portfolio
Research Strategy
Transforming into a Fully Integrated Global Biopharma
| Wed. Mar 29, 9:30am – South Place Hotel, London, UK |
| » Click here to watch a replay of the event, including a keynote from Susan Galbraith, SVP of Oncology iMed, AstraZeneca |
| Thu. Mar 30, 8:30am – W Hotel, New York, NY |
| » Click here to watch a webcast of the event |
| » See press release for a description of the event |
London: Tuesday, March 28, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that on March 27, 2017, it granted share options under the Share Option Scheme adopted by Chi-Med at its Annual General Meeting on April 24, 2015 (the “Share Option Scheme”).
Chi-Med granted 150,000 share options under its Share Option Scheme to certain employees to subscribe for Ordinary Shares subject to the acceptance of the grantees. Details of such share options granted prescribed are as follows:
Date of grant: March 27, 2017
Exercise price of share options granted: GBP31.05 per Ordinary Share
Number of share options granted: 150,000 (each share option shall entitle the holders thereof to subscribe for one Ordinary Share)
Closing market price of Ordinary Shares on the date of grant: GBP31.05 per Ordinary Share
Validity period of the share options: From March 27, 2017 to March 26, 2027
100,000 of the 150,000 share options were granted to Dr Weiguo Su, Executive Director and Chief Scientific Officer, being a person discharging managerial responsibility under the EU Market Abuse Regulation.
The notification set out below is provided in accordance with the requirements of the EU Market Abuse Regulation.
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||
| a) | Name | Dr Weiguo Su | ||||||
| 2 | Reason for the notification | |||||||
| a) | Position/status | Executive Director and Chief Scientific Officer | ||||||
| b) | Initial notification/Amendment | Initial notification | ||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||
| a) | Name | Hutchison China MediTech Limited | ||||||
| b) | LEI | N/A | ||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
Option over Ordinary Share of US$1.00 Option over Ordinary Share with DI ISIN: KYG4672N1016 |
||||||
| b) | Nature of the transaction |
Grant of options in respect of 100,000 Ordinary Shares under the Share Option Scheme. The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant. |
||||||
| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2017-03-27 | ||||||
| f) | Place of the transaction | Outside a trading venue | ||||||
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. 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 announcement, whether as a result of new information, future events or circumstances or otherwise.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
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).
Ends
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
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 (“CK Hutchison”) (SEHK: 0001). For more information, please visit: www.chi-med.com.
Appointment of Director
London: Friday, March 24, 2017: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (AIM/Nasdaq: HCM) today announces that Dr Weiguo Su has been appointed as Executive Director and member of Technical Committee with effect from March 27, 2017.
Dr Su, aged 59, has been the Executive Vice President and Chief Scientific Officer of the Company since 2012. Dr Su has headed all drug discovery and research since he joined the Company, including master-minding the Company’s scientific strategy, being a key leader of the Innovation Platform, and responsible for the discovery of each and every small molecule drug candidate in the Company’s product pipeline. Prior to joining the Company in 2005, Dr Su spent 15 years with the U.S. Research and Development Department of Pfizer, Inc. with his last position as director of the Medicinal Chemistry Department.
In March 2017, Dr Su was granted the prestigious award by the China Pharmaceutical Innovation and Research Development Association (PhIRDA) as one of the Most Influential Drug R&D Leaders in China.
Dr Su received a Bachelor of Science degree in Chemistry from Fudan University in Shanghai. He completed a PhD and Post-doctoral Fellowship in Chemistry at Harvard University under the guidance of Nobel Laureate Professor E. J. Corey.
Dr Su holds 51,070 American depository shares and 300,000 share options in Chi-Med. Save for the information disclosed above, there is no other information in relation to Dr Su 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 Dr Su to the Board. His experiences in the global biopharmaceutical industry will be important to the Company.”
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.
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. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the risk that current or future appointees to Chi-Med’s board of directors are not effective in their respective positions, the difficulty in locating and recruiting suitable candidates for its board of directors and the management difficulties which may arise from changes in Chi-Med’s board of directors. 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.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
| Location: 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN |
| Time: 10am |
| The Notice of Annual General Meeting and the Proxy Form will be posted to shareholders |
Press Release
London: Tuesday, March 21, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that it will host Research & Development (“R&D”) briefings in London and New York to provide an overview of the Company’s clinical pipeline of eight novel drug candidates. The events for analysts and investors will take place in London on Wednesday, March 29, and in New York on Thursday, March 30, 2017.
Chi-Med is a China-based biopharmaceutical company focused on discovering and developing targeted therapies for oncology and immunological diseases for the global market. The Company has 30 ongoing clinical trials with eight novel drug candidates, which are expected to report a steady flow of pivotal Phase III trial results from this year onwards. Chi-Med’s first drug is targeted to launch next year in China.
The Chi-Med management team will outline the Company’s R&D strategy and discuss its drug candidate pipeline during the briefings.
| Date: | Wednesday, March 29, 2017 | Thursday, March 30, 2017 |
| City: | London | New York |
| Time: |
9:15am Registration 9:30am-12:30pm Program Presentation Lunch will be provided afterwards |
8:00am Registration & Breakfast 8:30am-11:30am Program Presentation |
| Address: | South Place Hotel, 3 South Place, London, EC2M 2AF | W Hotel, 541 Lexington Ave, New York, NY 10022 |
| Keynote Speaker: | Dr Susan Galbraith, Vice President, AstraZeneca PLC (“AstraZeneca”) |
The briefing on Wednesday, March 29, 2017 in London will begin with a keynote presentation from Dr Susan Galbraith, Vice President of Oncology Innovative Medicines and Early Development at AstraZeneca.
Mr Christian Hogg, Chief Executive Officer; Dr Weiguo Su, Executive Vice President and Chief Scientific Officer; Dr Zhenping Wu, Senior Vice President of Pharmaceutical Sciences; and Dr May Wang, Senior Vice President of Business Development & Strategic Alliances, will be presenting on Chi-Med’s research & development and partnering activities. Chi-Med currently has partnerships with AstraZeneca, Eli Lilly and Company and Nestlé Health Science S.A.
To register for the London briefing, please contact Dr Marine Perrier by telephone at +44 20 7282 1068 or by email at marine.perrier@citigatedr.co.uk.
To register for the New York briefing, please contact Matt Beck by telephone at +1 646 378 2933 or by email at mbeck@troutgroup.com.
No new material trading or financial information will be disseminated at the meeting. Following the meeting, the presentations will be made available at https://www.hutch-med.com/news/.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Monday, March 20, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has received notifications that:-
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.
The notifications set out below are provided in accordance with the requirements of the EU Market Abuse Regulation.
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||
| a) | Name | Mr Paul Carter | ||||||
| 2 | Reason for the notification | |||||||
| a) | Position/status | Independent Non-executive Director | ||||||
| b) | Initial notification/Amendment | Initial notification | ||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||
| a) | Name | Hutchison China MediTech Limited | ||||||
| b) | LEI | N/A | ||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
Ordinary Share of US$1.00 each DI ISIN: KYG4672N1016 ADS ISIN: US44842L1035 |
||||||
| b) | Nature of the transaction | Acquisition of 2,800 Ordinary Shares on March 15, 2017 at a price of GBP26.37 per share | ||||||
| c) | Price(s) and volume(s) |
|
||||||
| d) | Aggregated information
|
N/A | ||||||
| e) | Date of the transaction | 2017-03-15 | ||||||
| f) | Place of the transaction | London Stock Exchange (XLON) | ||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||||||||||
| a) | Name | Dr Dan Eldar | ||||||||||||||||
| 2 | Reason for the notification | |||||||||||||||||
| a) | Position/status | Non-executive Director | ||||||||||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||||||||||
| b) | LEI | N/A | ||||||||||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||||||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||||||||||
| b) | Nature of the transaction | Acquisition of 6,225 ADSs on March 15, 2017 at an average price of US$16.85 per ADS | ||||||||||||||||
| c) | Price(s) and volume(s) |
|
||||||||||||||||
| d) | Aggregated information
|
N/A | ||||||||||||||||
| e) | Date of the transaction | 2017-03-15 | ||||||||||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||||||||||
| a) | Name | Dr Karen Ferrante | ||||||||||||||||
| 2 | Reason for the notification | |||||||||||||||||
| a) | Position/status | Independent Non-executive Director | ||||||||||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||||||||||
| b) | LEI | N/A | ||||||||||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||||||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||||||||||
| b) | Nature of the transaction | Acquisition of 2,540 ADSs on March 16, 2017 at an average price of US$19.77 per ADS | ||||||||||||||||
| c) | Price(s) and volume(s) |
|
||||||||||||||||
| d) | Aggregated information
|
N/A | ||||||||||||||||
| e) | Date of the transaction | 2017-03-16 | ||||||||||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Ms Edith Shih | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Non-executive Director and Company Secretary | ||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||
| b) | LEI | N/A | ||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||
| a) |
Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 10,000 ADSs on March 16, 2017 at an average price of US$19.10 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
N/A | ||||||||
| e) | Date of the transaction | 2017-03-16 | ||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
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.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
Press Release
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.
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.
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.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Monday, March 13, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today published the Form 20-F for the financial year ended December 31, 2016 per attached and also available for viewing on the Company’s website at www.chi-med.com.
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 (“CK Hutchison”) (SEHK: 0001). For more information, please visit: www.chi-med.com.
Christian Hogg, CEO
+852 2121 8200
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Richard Gray / Andrew Potts
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Hutchison China MediTech Limited (“Chi-Med”) Reports Final Results for the Year Ended December 31, 2016 and Updates Shareholders on Key Clinical Programs
Group: Record revenue, net income and clinical investment in 2016
Innovation Platform: First successful pivotal Phase III outcome with launch now targeted for 2018
Commercial Platform: High-performance drug marketing and distribution platform covers ~300 cites/towns in China with >3,300 sales people. High value products and household-name brands
Strengthened cash position: Expected to be sufficient to progress full pipeline well into 2019
Catalysts targeted for 2017:
References in this announcement to adjusted research and development expenses, consolidated net income attributable to Chi-Med from our Commercial Platform, consolidated operating profit 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 (5:00 p.m. HKT) – at Citigate Dewe Rogerson, Third Floor, 3 London Wall Buildings, London, EC2M 5SY. Investors may participate in the call 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 U.S. call, please dial +1-212-999-6659. For all dial-in numbers please use conference ID “Chi-Med.”
London: Monday, March 13, 2017: 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 final results for the year ended December 31, 2016.
Simon To, Chairman of Chi-Med, said: “Chi-Med has had an important year in 2016, making progress at both the operating and strategic levels, in both the Innovation and Commercial Platforms.
Our Innovation Platform has eight drug candidates in 30 active clinical trials, delivering a flow of pivotal Phase III trial results from this year onwards, with its first drug targeted to launch next year. This is a sequence of potential new drugs capable of delivering meaningful benefit to patients and value for shareholders. Chi-Med has a solid cash position to fund the pipeline, fueled by its increasingly valuable and cash generative Commercial Platform, a flow of property compensation profits, clinical and regulatory milestone payments and the proceeds of the Nasdaq listing.
On March 3, Chi-Med and its partner Eli Lilly and Company (“Lilly”), announced that fruquintinib had convincingly met all the primary and secondary endpoints of its Phase III pivotal study, the FRESCO study, in third-line CRC. The NDA will be submitted in China in mid-2017 and, subject to approval, fruquintinib will be launched in 2018. This will be a first for the China biotech industry – fruquintinib is the first new mainstream cancer drug, with global best-in-class positioning, to be discovered and developed in China. Chi-Med believes fruquintinib has the potential to become one of the largest drugs in China, if successful in the many other solid tumor indications that it is pursuing. This year, U.S. trials are being initiated, aiming to introduce fruquintinib to the global as well as the China market.
The proof-of-concept data presented over the past twelve months on savolitinib, fruquintinib in combination with Taxol®, epitinib, and sulfatinib as well as the Phase I data on HMPL-523, Chi-Med’s Syk inhibitor was all positive. This high rate of success is believed to result from the superior kinase selectivity and unique pharmacokinetic (“PK”) properties of these drug candidates. In 2017, data up-dates on four further proof-of-concept studies will be released, and it is anticipated that there will be multiple clinical and regulatory milestones.
In parallel, the Commercial Platform continues to perform well. In addition to growing sales and profits, it provides a very strong China marketing and distribution platform for the drugs to come from the Innovation Platform if approved. It is also now well positioned to benefit from the tripled production capacity of its new factories and the substantial flow of land compensation profits, which started last year and is set to continue into 2018. Its brands are household names in China and many products hold market leading positions, representing a set of very valuable and highly sought after assets.
All this, and the proceeds of the Nasdaq listing, mean cash and available resources at year-end were $173.7 million, up by about $135 million, despite the sharp increase in clinical investment, and expected to be sufficient to cover development needs well into 2019. This financial strength has also allowed for re-negotiation of the collaboration agreement with AstraZeneca AB (publ) (“AstraZeneca”), enabling Chi-Med to take a greater share in the potential long-term economic value of savolitinib in return for increasing its investment.
Over fifteen years of consistent commercial and scientific strategies, along with a pragmatic approach to finance and risk management, has led Chi-Med to today’s position. The first wave of new drug candidates, led by fruquintinib, and including savolitinib, sulfatinib and epitinib, are progressing towards potential registration and launch in major markets. The second wave of novel drug candidates including theliatinib, HMPL-523, HMPL-689 and HMPL-453 are now mostly in proof-of-concept studies. In addition Chi-Med’s discovery platform is generating a third wave of innovation with a strong immuno-oncology focus. Combining this innovation pipeline with a valuable China marketing and distribution platform, important international partners and a robust cash position lead Chi-Med to view the future with confidence.”
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
Innovation Platform – a broad, risk-balanced, global oncology/immunology pipeline
Commercial Platform – a deeply established, cash-generative, pharmaceutical business in China – a commercialization framework for our Innovation Platform candidate drugs
Innovation Platform: First positive Phase III read-out, fruquintinib in third-line CRC, reported on March 3, 2017 – a major achievement for Chi-Med and the biotech industry in China. Multiple opportunities for near-term pivotal success: three further Phase III studies underway and four more planned to start in 2017 with multiple read-outs expected over the next three years.
Commercial Platform: Continued strong growth in cash flow and profit – representing a stable financial base that underpins a significant portion of Chi-Med’s current market value.
2017 CATALYSTS: We target to present multiple clinical data updates during 2017, including:
We target to achieve multiple clinical and regulatory milestones during 2017, including:
FINANCIAL GUIDANCE: The over-performance in actual 2016 revenue and net income, as compared to our most recent guidance, provided in our interim results announcement for the six months ended June 30, 2016 dated August 2, 2016, reflects the general strength of our Commercial Platform performance including the scale of property compensation received. We provide reconciliation of 2016 guidance versus actual performance and full year 2017 financial guidance, as detailed below:
| Group Level: | 2016 Guidance[1] | 2016 Actual | 2017 Guidance |
| · Consolidated revenue | $190-205 million | $216.1 million | $225-240 million |
| · Admin., interest & tax | $(16)-(18) million | $(17.9) million | $(18)-(19) million |
| · Net income/(loss)[2] | $0-5 million | $11.7 million | $(13)-(28) million |
| Innovation Platform: | |||
| · Consolidated revenue | $35-40 million | $35.2 million | $35-40 million |
| · Adjusted R&D expenses | $(80)-(85) million | $(76.1) million | $(85)-(90) million |
| Commercial Platform: | |||
| · Sales (consolidated) | $155-165 million | $180.9 million | $190-200 million |
| · Sales of non-consol. JVs[3] | $430-440 million | $446.5 million | $480-500 million |
| · One-time property gains[2] | $35-37 million | $40.4 million | $14-16 million |
| · Net income[2] | $63-66 million | $70.3 million | $46-50 million |
Notes: [1] Company Guidance August 2, 2016; [2] Attributable to Chi-Med; [3] Joint ventures.
FINANCIAL STATEMENTS: Chi-Med will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.
Annual General Meeting:
The Annual General Meeting of Chi-Med will be held at 4th Floor, Hutchison House, 5 Hester Road, Battersea, London SW11 4AN on Thursday, April 27, 2017 at 10:00 a.m.
Christian Hogg, CEO
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Anthony Carlisle, Citigate Dewe Rogerson
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Richard Gray / Andrew Potts
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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 (“CK Hutchison”) (SEHK: 0001). For more information, please visit: www.chi-med.com.
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “Chi-Med,” “Chi-Med Group,” “we,” “us” and “our” mean Chi-Med and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.
The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. 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 can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “believe,” “first-in-class,” “best-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. 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 is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
In addition, this announcement contains statistical data and estimates that Chi-Med obtained from industry publications and reports generated by third-party market research firms, including Frost & Sullivan, an independent market research firm, and publicly available data. All patient population, market size and market share estimates are based on Frost & Sullivan research, unless otherwise noted. Although Chi-Med believes that the publications, reports and surveys are reliable, Chi-Med has not independently verified the data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Ends
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2017 年3 月10 日：和黃醫藥在2017 年3 月8 日至10 日於西班牙巴塞羅那舉行的第14 屆歐洲神經內分泌腫瘤學會年會（ENETS）上公佈了索凡替尼正在進行的治療晚期神經內分泌瘤的Ib /II 期臨床試驗結果。索凡替尼是一種新型口服血管免疫激酶抑製劑，能夠有效地抑制與VEGFR, FGFR 與CSF-1R 靶點相關的酪氨酸激酶活性，這三種酪氨酸激酶受體參與了腫瘤新生血管的生成以及免疫逃逸。索凡替尼在中國和美國另有5 項臨床研究正在進行中，包括治療神經內分泌瘤的兩項III 期臨床試驗（SANET-p 和SANET-ep），一項治療甲狀腺癌的的II 期臨床試驗以及一項治療膽管癌的II 期臨床試驗。
該研究最新的研究結果如下：
| 公佈方式： | 口頭報告 |
| 標題： | 索凡替尼治療晚期神經內分泌瘤的開放標籤Ib /II 期臨床試驗（NCT02267967 ） |
| 報告人： | 徐建明博士 |
| 目錄： | 2B ：醫學療法和目標 |
| 時間： | 2017 年3 月9 日，星期四，11 ：10 歐洲中部時間 |
目前索凡替尼正在進行的Ib / II期試驗是一項開放標籤的單臂II期研究，旨在評估索凡替尼單藥治療晚期1 級或2 級神經內分泌瘤患者的療效和安全性。2014年11月至2016年1月期間，在中國7個臨床中心共入組了81名受試者（41例胰腺神經內分泌瘤和40例胰腺外神經內分泌瘤）。大多數受試者疾病等級為2 級（79％），此前的系統治療失敗（65％）。截至2017年1月20日，13名受試者證實得到部分緩解（PR），61名受試者疾病穩定（SD），而客觀緩解率（ORR）為16.0％（13/81例），胰腺神經內分泌瘤中為17.1％（7/41例），胰腺外神經內分泌瘤中為15.0％（6/40例），總體疾病控制率（DCR）為91.4％。中位總體無進展生存期（PFS）數據尚未成熟，但估計總體為16.6個月（95％CI：13.4,19.4），其中胰腺神經內分泌瘤中位無進展生存期較長，估計為19.4個月，而胰腺外神經內分泌瘤為13.4個月。值得一提的是，有12名受試者在此前接受靶向療法（例如Sutent ®和Afinitor ®）治療後疾病進展，但全部受益於索凡替尼的治療（3例部分緩解，9例疾病穩定）。索凡替尼總體耐受良好，3 級及以上的不良事件發生率為>5%包括，高血壓（31％），蛋白尿（14％），高尿酸血症（10％），高甘油三酯血症（9％），腹瀉7％）和ALT升高（6％）。該研究的詳情請登陸clinicaltrials.gov , 檢索NCT02267967查看。
索凡替尼治療晚期神經內分泌瘤的I期和II期臨床研究結果顯示出良好藥效和耐受性，受此鼓舞，兩項III期隨機臨床試驗正在進行中。
詳細的發佈內容可參見www.chi-med.com/news/。更多關於歐洲神經內分泌腫瘤學會（ENETS）的信息請登陸enetsconference.org。
神經內分泌瘤是起源於神經內分泌細胞的腫瘤，可以發生在體內很多部位，但最常見的是消化道及呼吸道的神經內分泌瘤。神經內分泌瘤因腫瘤小，患者症狀各異，導致診斷難度大。2016年，美國大約有20,000例神經內分泌腫瘤新發病例，患者總數約為148,000例。
神經內分泌瘤可以根據腫瘤起源的部位進行分類，其中胰臟神經內分泌瘤佔神經內分泌瘤患者總數少於10％，而胰腺外神經內分泌瘤則包括所有其他非胰腺神經內分泌瘤，包括肺，淋巴和胃腸道神經內分泌瘤。迄今為止，神經內分泌瘤患者的治療方案有限;舒尼替尼和依維莫司是僅有的兩種獲批的針對神經內分泌瘤的靶向療法，舒尼替尼用於治療胰腺神經內分泌瘤，而依維莫司用於治療胰腺，胃腸道或肺源的神經內分泌瘤，但廣譜神經內分泌瘤患者仍缺乏有效的治療手段。
索凡替尼是一種新型口服血管免疫激酶抑製劑，能夠有效地抑制與VEGFR, FGFR與CSF-1R靶點相關的酪氨酸激酶活性，這三種酪氨酸激酶受體參與了腫瘤新生血管的生成以及免疫逃逸。通過抑制VEGFR信號通路能夠阻斷腫瘤組織周圍過度的脈管系統的生成（血管生成），從而切斷了腫瘤快速增長所需營養及氧氣的供給。抗VEGFR 療法可能會加劇FGFR信號通路的異常激活，從而導致因腫瘤增長而產生的疾病進展，腫瘤周圍的血管生成以及髓系衍生抑制細胞的形成。抑制CSF-1R信號通路可阻斷腫瘤相關巨噬細胞的活化，巨噬細胞參與抑製針對腫瘤的免疫應答。
現階段，除了治療神經內分泌瘤的Ib /II期臨床試驗，索凡替尼在中國和美國另有5 項臨床研究在進行中，包括治療神經內分泌瘤的兩項III期臨床試驗（SANET-p和SANET-ep），一項治療甲狀腺癌的的II期臨床試驗以及一項治療膽管癌的II期臨床試驗。
SANET-p 試驗是一項隨機雙盲安慰劑對照多中心的關鍵III期註冊研究，計劃在中國招募並治療190例疾病已進展，局部晚期或遠處轉移且缺乏有效療法的病理性輕度或中度胰腺神經內分泌瘤患者。該研究的主要終點是無進展生存期（PFS），次要終點包括客觀緩解率（ORR），疾病控制率（DCR），緩解持續時間（DoR ），響應時間和總生存期（OS）。SANET-p研究的詳細內容可登錄clinicaltrials.gov，檢索NCT02589821查看。SANET-ep 試驗與SANET-p 試驗相似，計劃在中國招募並治療約270例非胰腺神經內分泌瘤患者。SANET-ep研究的詳細內容可登陸clinicaltrials.gov，檢索NCT02588170查看。
和黃醫藥正在中國進行的索凡替尼一項開放標籤的II期臨床試驗以50名局部晚期或轉移性放射性碘難治性分化型甲狀腺癌或甲狀腺髓樣癌患者為目標受試者，旨在評估該藥的藥效和安全性。該試驗的主要終點是客觀緩解率（ORR），次要終點包括安全性，耐受性，疾病控制率，響應時間以及無進展生存期。關於該研究的更多信息請登陸clinicaltrials.gov，檢索NCT02614495查看。
同時，索凡替尼的另一項中國開放標籤II期臨床試驗以32名經歷過一輪系統治療失敗的晚期或轉移性膽管癌患者為目標受試者，旨在評估該藥的藥效和安全性。該試驗的主要終點是接受治療16週時的無進展生存期，次要終點包括客觀緩解率，疾病控制率，緩解持續時間，無進展生存期，總生存期和安全性。關於該研究的更多信息請登陸clinicaltrials.gov，檢索NCT02966821查看。
Authors: J.M. Xu, J. Li, C.M. Bai, N. Xu, Z.W. Zhou, Z.P. Li, C.C. Zhou, W. Wang, J. Li, C. Qi, Y. Hua, W.G. Su
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. sunitinib and everolimus) 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.
– 達到首要和次要終點–
–安全性及療效達到預期–
– 計劃於2017年中遞交中國新藥上市申請–
–完整詳細的試驗結果將在2017年中通過腫瘤學術大會公佈–
2017年3月3日：和黃醫藥今天宣布呋喹替尼（HMPL-013）的III 期關鍵註冊臨床試驗“ FRESCO”取得成功。參與試驗的416名受試者為既往至少接受過2 輪化療（包括氟尿嘧啶、奧沙利鉑類藥物及伊立替康）失敗的轉移性結腸癌患者，這項試驗成功地達到了主要終點：相較於接受安慰劑聯合最佳支持治療（“BSC”），接受呋喹替尼聯合最佳支持治療（“BSC”）的患者的總體生存（“OS”）時間達到了具有統計學和臨床意義的顯著延長。和黃醫藥將準備向中國食品藥品監督管理局遞交呋喹替尼的新藥上市申請（“NDA”）。
除了延長總生存時間，研究結果也顯示呋喹替尼顯著延長了病人的無進展生存期(“PFS”) ，成功達到了這一關鍵的次要終點。研究過程中並未出現新的或超出預期的重大安全性問題。詳細的研究結果待分析完成後將適時公佈於2017年年中的腫瘤年會上。
和黃中國醫藥科技有限公司董事長杜志強先生表示：“ 經過十多年不懈的努力和巨大的投入，我們欣慰地宣布呋喹替尼的III期臨床試驗FRESCO 獲得成功，這不僅是結直腸癌症患者的福音，也是和黃醫藥更是中國醫藥創新的重要里程碑。我們相信這是一個為數不多的由中國本土藥企設計，合成，並成功完成關鍵III期註冊臨床試驗的腫瘤創新藥。這也標誌著在國際腫瘤藥物創新領域，中國有資源、有能力、有毅力堅持創新。和黃醫藥現有八個臨床期小分子候選藥物，正在全球多個國家積極開展30多個臨床研究，其始終走在醫藥創新這一重要領域的前沿。”
“我們目前正在積極準備呋喹替尼新藥上市申請（NDA）的遞交，大約在今年年中完成。”他補充道。“FRESCO研究數據揭示了呋喹替尼的巨大潛力，增強了我們對呋喹替尼滿足中國乃至全球患者治療需求的信心。”
禮來中國藥物開發及外部創新高級副總裁薄科瑞（Kerry L. Blanchard）博士表示：“ 我們非常高興能夠與和黃醫藥這個專注創新藥研發的生物製藥公司合作開發呋喹替尼，這不僅標誌著我們共同致力於打造一個充滿活力的中國醫藥創新的生態環境，更期待雙方進一步的合作以將這個創新藥物造福更多的患者。”
除了以結直腸癌為適應症的FRESCO研究，呋喹替尼正在進行另一個以晚期非小細胞肺癌為適應症的III期註冊臨床研究，該試驗被命名為“FALUCA” 。另有其他幾個研究正在進行或計劃中，包括與紫杉醇聯合用藥治療胃癌的一項III期臨床研究，與其他抗腫瘤藥物聯合用藥的探索性研究，以及在美國準備開展的新研究。
癌症進入到晚期，腫瘤會分泌大量的蛋白配體-血管內皮生長因子(VEGF)，以促進腫瘤組織周圍過度的脈管系統的生成(血管生成)，為腫瘤細胞的生長提供更多的血流，氧氣和營養。VEGF和其受體VEGFR在腫瘤的血管生成中起到了至關重要的作用，因此，對VEGF/VEGFR相關通路的抑制就成為了阻斷新生血管形成，防止腫瘤增長和侵入的一種重要的治療策略。
呋喹替尼是一種新型的高選擇性小分子候選藥物，臨床研究證實：通過一日一次的口服劑量即可有效的抑制血管內皮生長因子受體（VEGFR），且無未知脫靶毒性。目前呋喹替尼正由和黃醫藥及其合作夥伴禮來在中國共同合作開發。呋喹替尼現有兩個分別針對結直腸癌及肺癌的關鍵III期臨床試驗正在進行中。此外，呋喹替尼聯合其他藥物治療胃癌及肺癌的臨床研究也在進行中。
呋喹替尼的III期臨床試驗“FRESCO” 為隨機雙盲安慰劑對照的多中心臨床試驗，目標受試者為至少經過2 輪化療／治療 （包括奧沙利鉑和氟尿嘧啶類藥物及伊立替康）失敗的轉移性結直腸癌患者。2016年5月，FRESCO完成416名受試者的入組，受試者按照2：1的比例隨機接受每天口服一次5毫克呋喹替尼，週期為服藥三週/停藥一周，聯合最佳支持治療；或安慰劑聯合最佳支持治療。主要試驗終點為總體生存率（OS），次要終點包括無進展生存期（PFS）、客觀緩解率（ORR）、疾病控制率和緩解時間。有關呋喹替尼的III 期臨床試驗“ FRESCO”的更多信息，請訪問clinicaltrials.gov，檢索NCT02314819。FRESCO 詳細的研究結果將適時公佈於2017年的相關的腫瘤年會上。
結直腸癌為中國第二大常見癌症類型，根據CA Cancer Journal for Clinicians 2016年的報導，中國結直腸癌新發病例數約為38萬。而全球2015年的結直腸癌新發病例數大約為150萬，根據Frost & Sullivan 報導，預計到2020年這個數字會增加到170萬每年。
肺癌：FALUCA 為隨機雙盲安慰劑對照的多中心III期註冊臨床試驗，目標受試者為晚期非鱗狀非小細胞肺癌患者，這些受試者至少經過2 輪化療／治療的失敗。FALUCA於2015年12月正式開始。受試者以2: 1的比例隨機接受每天口服一次5毫克的呋喹替尼（服藥三週/停藥一周為一周期）聯合最佳支持治療（BSC）或安慰劑聯合最佳支持治療。此研究的主要試驗終點為總生存期（OS），次試驗終點包括無進展生存期(PFS)，客觀緩解率(ORR)，疾病控制率和緩解持續時間。此次臨床研究計劃在全國近45家研究中心展開，預計入組約520名受試者。有關該研究的更多信息，請訪問clinicaltrials.gov，檢索NCT02691299。FALUCA研究結果預計將於2018年揭曉。
2017年1月和黃醫藥開展了呋喹替尼與吉非替尼聯合用藥治療肺癌患者的多中心開放單臂II期試驗，目標受試者為晚期或轉移性非鱗狀非小細胞肺癌患者。此項試驗的主要目的是研究呋喹替尼與吉非替尼聯合用藥方案在患者中的安全性，耐受性和初步藥效。有關該研究的更多信息，請訪問clinicaltrials.gov，檢索NCT02976116 。
胃癌：呋喹替尼與紫杉醇聯合用藥治療二線胃癌患者的Ib 期研究已接近尾聲，該研究為後續的臨床研究提供了良好耐受的聯合用藥方案。相關信息請訪問clinicaltrials.gov，檢索NCT02415023。此項Ib 期試驗研究結果已於2017年初在ASCO-GI年會上發表。基於此，以呋喹替尼與紫杉醇聯合用藥治療胃癌的關鍵註冊性三期臨床研究預計將於2017年上半年開展。