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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Brad Miles, BMC Communications
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David Dible, Citigate Dewe Rogerson
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david.dible@citigatedr.co.uk
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：和黄医药在2017年3月8日至10日于西班牙巴塞罗那举行的第14届欧洲神经内分泌肿瘤学会年会（ENETS）上公布了索凡替尼正在进行的治疗晚期神经内分泌瘤的Ib/II期临床试验结果。索凡替尼是一种新型口服血管免疫激酶抑制剂，能够有效地抑制与VEGFR, FGFR与CSF-1R靶点相关的酪氨酸激酶活性，这三种酪氨酸激酶受体参与了肿瘤新生血管的生成以及免疫逃逸。索凡替尼在中国和美国另有5项临床研究正在进行中，包括治疗神经内分泌瘤的两项III期临床试验（SANET-p和 SANET-ep），一项治疗甲状腺癌的的II期临床试验以及一项治疗胆管癌的II期临床试验。
该研究最新的研究结果如下：
| 公布方式： | 口头报告 |
| 标题： | 索凡替尼治疗晚期神经内分泌瘤的开放标签Ib/II期临床试验（NCT02267967） |
| 报告人： | 徐建明博士 |
| 目录： | 2B：医学疗法和目标 |
| 时间： | 2017年3月9日，星期四，11：10欧洲中部时间 |
目前索凡替尼正在进行的Ib / II期试验是一项开放标签的单臂II期研究，旨在评估索凡替尼单药治疗晚期1级或2级神经内分泌瘤患者的疗效和安全性。 2014年11月至2016年1月期间，在中国7个临床中心共入组了81名受试者（41例胰腺神经内分泌瘤和40例胰腺外神经内分泌瘤）。大多数受试者疾病等级为2级（79％），此前的系统治疗失败（65％）。截至2017年1月20日，13名受试者证实得到部分缓解（PR），61名受试者疾病稳定（SD），而客观缓解率（ORR）为16.0％（13/81例），胰腺神经内分泌瘤中为17.1％（7/41例），胰腺外神经内分泌瘤中为15.0％（6/40例），总体疾病控制率（DCR）为91.4％。中位总体无进展生存期（PFS）数据尚未成熟，但估计总体为16.6个月（95％CI：13.4,19.4），其中胰腺神经内分泌瘤中位无进展生存期较长，估计为19.4个月，而胰腺外神经内分泌瘤为13.4个月。值得一提的是，有12名受试者在此前接受靶向疗法（例如Sutent®和Afinitor®）治疗后疾病进展，但全部受益于索凡替尼的治疗（3例部分缓解，9例疾病稳定）。索凡替尼总体耐受良好， 3级及以上的不良事件发生率为>5%包括，高血压（31％），蛋白尿（14％），高尿酸血症（10％），高甘油三酯血症（9％），腹泻7％）和ALT升高（6％）。该研究的详情请登陆 clinicaltrials.gov, 检索 NCT02267967查看。
索凡替尼治疗晚期神经内分泌瘤的I期和II期临床研究结果显示出良好药效和耐受性，受此鼓舞，两项III期随机临床试验正在进行中。
详细的发布内容可参见www.chi-med.com/news/。更多关于欧洲神经内分泌肿瘤学会（ENETS）的信息请登陆enetsconference.org。
神经内分泌瘤是起源于神经内分泌细胞的肿瘤，可以发生在体内很多部位，但最常见的是消化道及呼吸道的神经内分泌瘤。神经内分泌瘤因肿瘤小，患者症状各异，导致诊断难度大。2016年，美国大约有20,000例神经内分泌肿瘤新发病例，患者总数约为148,000例。
神经内分泌瘤可以根据肿瘤起源的部位进行分类，其中胰脏神经内分泌瘤占神经内分泌瘤患者总数少于10％，而胰腺外神经内分泌瘤则包括所有其他非胰腺神经内分泌瘤，包括肺，淋巴和胃肠道神经内分泌瘤。 迄今为止，神经内分泌瘤患者的治疗方案有限; 舒尼替尼和依维莫司是仅有的两种获批的针对神经内分泌瘤的靶向疗法，舒尼替尼用于治疗胰腺神经内分泌瘤，而依维莫司用于治疗胰腺，胃肠道或肺源的神经内分泌瘤，但广谱神经内分泌瘤患者仍缺乏有效的治疗手段。
索凡替尼是一种新型口服血管免疫激酶抑制剂，能够有效地抑制与VEGFR, FGFR与CSF-1R靶点相关的酪氨酸激酶活性，这三种酪氨酸激酶受体参与了肿瘤新生血管的生成以及免疫逃逸。通过抑制VEGFR信号通路能够阻断肿瘤组织周围过度的脉管系统的生成（血管生成），从而切断了肿瘤快速增长所需营养及氧气的供给。抗VEGFR疗法可能会加剧FGFR信号通路的异常激活，从而导致因肿瘤增长而产生的疾病进展，肿瘤周围的血管生成以及髓系衍生抑制细胞的形成。抑制CSF-1R信号通路可阻断肿瘤相关巨噬细胞的活化，巨噬细胞参与抑制针对肿瘤的免疫应答。
现阶段，除了治疗神经内分泌瘤的Ib/II期临床试验，索凡替尼在中国和美国另有5项临床研究在进行中，包括治疗神经内分泌瘤的两项III期临床试验（SANET-p和 SANET-ep），一项治疗甲状腺癌的的II期临床试验以及一项治疗胆管癌的II期临床试验。
SANET-p试验是一项随机双盲安慰剂对照多中心的关键III期注册研究，计划在中国招募并治疗190例疾病已进展，局部晚期或远处转移且缺乏有效疗法的病理性轻度或中度胰腺神经内分泌瘤患者。 该研究的主要终点是无进展生存期（PFS），次要终点包括客观缓解率（ORR），疾病控制率（DCR），缓解持续时间（DoR），响应时间和总生存期（OS）。 SANET-p研究的详细内容可登录clinicaltrials.gov，检索NCT02589821查看。 SANET-ep试验与SANET-p试验相似，计划在中国招募并治疗约270例非胰腺神经内分泌瘤患者。 SANET-ep研究的详细内容可登陆clinicaltrials.gov，检索NCT02588170查看。
和黄医药正在中国进行的索凡替尼一项开放标签的II期临床试验以50名局部晚期或转移性放射性碘难治性分化型甲状腺癌或甲状腺髓样癌患者为目标受试者，旨在评估该药的药效和安全性。该试验的主要终点是客观缓解率（ORR），次要终点包括安全性，耐受性，疾病控制率，响应时间以及无进展生存期 。关于该研究的更多信息请登陆clinicaltrials.gov，检索NCT02614495查看。
同时，索凡替尼的另一项中国开放标签II期临床试验以32名经历过一轮系统治疗失败的晚期或转移性胆管癌患者为目标受试者，旨在评估该药的药效和安全性。该试验的主要终点是接受治疗16周时的无进展生存期，次要终点包括客观缓解率，疾病控制率，缓解持续时间，无进展生存期，总生存期和安全性。关于该研究的更多信息请登陆clinicaltrials.gov，检索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.
–达到首要和次要终点 –
– 安全性及疗效达到预期 –
–计划于2017年中递交中国新药上市申请–
–完整详细的试验结果将在2017年中通过肿瘤学术大会公布–
2017年3月3日：和黄医药今天宣布呋喹替尼（HMPL-013）的III期关键注册临床试验“FRESCO”取得成功。参与试验的416名受试者为既往至少接受过2轮化疗（包括氟尿嘧啶、奥沙利铂类药物及伊立替康）失败的转移性结肠癌患者，这项试验成功地达到了主要终点：相较于接受安慰剂联合最佳支持治疗（“BSC”），接受呋喹替尼联合最佳支持治疗（“BSC”）的患者的总体生存（“OS”）时间达到了具有统计学和临床意义的显著延长。和黄医药将准备向中国食品药品监督管理局递交呋喹替尼的新药上市申请（“NDA”）。
除了延长总生存时间，研究结果也显示呋喹替尼显著延长了病人的无进展生存期(“PFS”) ，成功达到了这一关键的次要终点。研究过程中并未出现新的或超出预期的重大安全性问题。详细的研究结果待分析完成后将适时公布于2017年年中的肿瘤年会上。
和黄中国医药科技有限公司董事长杜志强先生表示：“经过十多年不懈的努力和巨大的投入，我们欣慰地宣布呋喹替尼的III期临床试验FRESCO获得成功，这不仅是结直肠癌症患者的福音，也是和黄医药更是中国医药创新的重要里程碑。我们相信这是一个为数不多的由中国本土药企设计，合成，并成功完成关键III期注册临床试验的肿瘤创新药。这也标志着在国际肿瘤药物创新领域，中国有资源、有能力、有毅力坚持创新。和黄医药现有八个临床期小分子候选药物，正在全球多个国家积极开展30多个临床研究，其始终走在医药创新这一重要领域的前沿。”
“我们目前正在积极准备呋喹替尼新药上市申请（NDA）的递交，大约在今年年中完成。”他补充道。“FRESCO研究数据揭示了呋喹替尼的巨大潜力，增强了我们对呋喹替尼满足中国乃至全球患者治疗需求的信心。”
礼来中国药物开发及外部创新高级副总裁薄科瑞（Kerry L. Blanchard）博士表示：“我们非常高兴能够与和黄医药这个专注创新药研发的生物制药公司合作开发呋喹替尼，这不仅标志着我们共同致力于打造一个充满活力的中国医药创新的生态环境，更期待双方进一步的合作以将这个创新药物造福更多的患者。”
除了以结直肠癌为适应症的FRESCO研究，呋喹替尼正在进行另一个以晚期非小细胞肺癌为适应症的III期注册临床研究，该试验被命名为“FALUCA”。另有其他几个研究正在进行或计划中，包括与紫杉醇联合用药治疗胃癌的一项III期临床研究，与其他抗肿瘤药物联合用药的探索性研究，以及在美国准备开展的新研究。
癌症进入到晚期，肿瘤会分泌大量的蛋白配体-血管内皮生长因子(VEGF)，以促进肿瘤组织周围过度的脉管系统的生成(血管生成)，为肿瘤细胞的生长提供更多的血流，氧气和营养。VEGF和其受体VEGFR在肿瘤的血管生成中起到了至关重要的作用，因此，对VEGF/VEGFR相关通路的抑制就成为了阻断新生血管形成，防止肿瘤增长和侵入的一种重要的治疗策略。
呋喹替尼是一种新型的高选择性小分子候选药物，临床研究证实：通过一日一次的口服剂量即可有效的抑制血管内皮生长因子受体（VEGFR），且无未知脱靶毒性。目前呋喹替尼正由和黄医药及其合作伙伴礼来在中国共同合作开发。呋喹替尼现有两个分别针对结直肠癌及肺癌的关键III期临床试验正在进行中。此外，呋喹替尼联合其他药物治疗胃癌及肺癌的临床研究也在进行中。
呋喹替尼的III期临床试验“FRESCO”为随机双盲安慰剂对照的多中心临床试验，目标受试者为至少经过2轮化疗／治疗 （包括奥沙利铂和氟尿嘧啶类药物及伊立替康）失败的转移性结直肠癌患者。2016年5月，FRESCO完成416名受试者的入组，受试者按照2：1的比例随机接受每天口服一次5毫克呋喹替尼，周期为服药三周/停药一周，联合最佳支持治疗；或安慰剂联合最佳支持治疗。主要试验终点为总体生存率 （OS），次要终点包括无进展生存期 （PFS）、客观缓解率（ORR）、疾病控制率和缓解时间。有关呋喹替尼的III期临床试验“FRESCO”的更多信息，请访问clinicaltrials.gov，检索NCT02314819。FRESCO详细的研究结果将适时公布于2017年的相关的肿瘤年会上。
结直肠癌为中国第二大常见癌症类型，根据CA Cancer Journal for Clinicians 2016年的报道，中国结直肠癌新发病例数约为38万。而全球2015年的结直肠癌新发病例数大约为150万，根据Frost & Sullivan报道，预计到2020年这个数字会增加到170万每年。
肺癌：FALUCA为随机双盲安慰剂对照的多中心III期注册临床试验，目标受试者为晚期非鳞状非小细胞肺癌患者，这些受试者至少经过2轮化疗／治疗的失败。FALUCA于2015年12月正式开始。受试者以2: 1的比例随机接受每天口服一次5毫克的呋喹替尼（服药三周/停药一周为一周期）联合最佳支持治疗（BSC）或安慰剂联合最佳支持治疗。此研究的主要试验终点为总生存期（OS），次试验终点包括无进展生存期 (PFS)，客观缓解率 (ORR)，疾病控制率和缓解持续时间。此次临床研究计划在全国近45家研究中心展开，预计入组约520名受试者。有关该研究的更多信息，请访问clinicaltrials.gov，检索NCT02691299。FALUCA研究结果预计将于2018年揭晓。
2017年1月和黄医药开展了呋喹替尼与吉非替尼联合用药治疗肺癌患者的多中心开放单臂II期试验，目标受试者为晚期或转移性非鳞状非小细胞肺癌患者。此项试验的主要目的是研究呋喹替尼与吉非替尼联合用药方案在患者中的安全性，耐受性和初步药效。有关该研究的更多信息，请访问clinicaltrials.gov，检索NCT02976116。
胃癌：呋喹替尼与紫杉醇联合用药治疗二线胃癌患者的Ib期研究已接近尾声，该研究为后续的临床研究提供了良好耐受的联合用药方案。相关信息请访问clinicaltrials.gov，检索NCT02415023。此项Ib期试验研究结果已于2017年初在ASCO-GI年会上发表。基于此，以呋喹替尼与紫杉醇联合用药治疗胃癌的关键注册性三期临床研究预计将于2017年上半年开展。