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
+44 (20) 7886 2500
Corporate Information
Contents
Our Business
Highlights
Chairman’s Statement
Financial Review
Operations Review
Biographical Details Of Directors
Report Of The Directors
Corporate Governance Report
Form 20-F (Including Financial Statements)
Information For Shareholders
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
+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.
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
(For additional information, please see the attached PDF)
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Press Release
London: Friday, March 10, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) presented data from the ongoing Phase Ib/II clinical trial of sulfatinib in patients with advanced neuroendocrine tumors (“NET”) at the 14th Annual Conference of the European Neuroendocrine Tumor Society (“ENETS”), held in Barcelona, Spain from March 8 to 10, 2017. Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively targets vascular endothelial growth factor receptor (“VEGFR”), fibroblast growth factor receptor (“FGFR”) and colony-stimulating factor-1 receptor (“CSF-1R”), three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Five other sulfatinib clinical trials are underway in China and the U.S., including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.
The most recent results of the study were presented in detail as follows:
Presentation Type: Oral Presentation, Presidential Abstract – Plenary Meeting Room
Title: An Open-Label Phase Ib/II Study of Sulfatinib in Patients with Advanced Neuroendocrine Tumors (NCT02267967)
Presented by: Dr. JianMing Xu
Session: Session 2B: Medical Therapies and Goals
Date & Time: Thursday, March 9, 2017, 11:10 AM CET
The current Phase Ib/II trial is an open-label, single-arm Phase II study to assess the efficacy and safety of sulfatinib monotherapy in patients with advanced grade 1 or 2 advanced NET. 81 patients (41 pancreatic NET and 40 extra-pancreatic NET) were enrolled between November 2014 and January 2016, in seven clinical centers across China. The majority of patients had grade 2 disease (79%) and had failed previous systemic treatments (65%). As of January 20, 2017, 13 patients had confirmed partial response (“PR”) and 61 patients had stable disease (“SD”) corresponding to an overall objective response rate (“ORR”) of 16.0% (13/81), with 17.1% (7/41) in pancreatic NET and 15.0% (6/40) in extra-pancreatic NET, and an overall disease control rate (“DCR”) of 91.4%. Median overall progression-free survival (“PFS”) has not been reached, but is estimated to be 16.6 months (95% CI: 13.4, 19.4) with longer median PFS in pancreatic NET estimated at 19.4 months and shorter median PFS in extra-pancreatic NET estimated at 13.4 months. Importantly, there were 12 patients who had progressed after treatment with targeted therapies (e.g. Sutent® and Afinitor®) and all benefited from sulfatinib treatment (3 PRs and 9 SDs). Sulfatinib was well tolerated with Grade ≥3 adverse events (AEs), with >5% incidence, regardless of causality of hypertension (31%), proteinuria (14%), hyperuricemia (10%), hypertriglyceridemia (9%), diarrhea (7%) and ALT increase (6%). Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02267967.
Based on the promising Phase I and Phase II efficacy data and tolerability in patients with advanced NETs, two randomized Phase III trials are ongoing.
The presentation is available at www.chi-med.com/news/. Further information about ENETS is available at enetsconference.org.
NET arises from neuroendocrine cells and develop predominantly in the digestive or respiratory tracts but can also occur in many areas of the body. Diagnosis of NET is difficult due to the small tumor size and diverse origination with patients showing varied or no symptoms. There were approximately 20,000 new cases of NET and a cumulative prevalence of approximately 148,000 cases in the U.S. in 2016[1].
NETs can be classified according to tumor origin, as pancreatic NET representing less than 10% of the total NET patients, and extra-pancreatic NET comprising all other non-pancreatic NETs including lung, lymph and gastrointestinal tract NETs. To date, treatment options for NET patients are limited; sunitinib and everolimus are the only two approved targeted-therapies for NET, sunitinib for pancreatic NET and everolimus for NET of pancreatic, gastrointestinal or lung origin, while there is no such a choice for broad spectrum NET patients.
Sulfatinib is an oral, novel angio-immunokinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR, FGFR and CSF-1R, three key tyrosine kinase receptors involved in tumor angiogenesis and immune evasion. Inhibition of the VEGFR signaling pathway can act to stop angiogenesis, the growth of the vasculature around the tumor, and thereby starve the tumor of the nutrients and oxygen it needs to grow rapidly. Aberrant activation of the FGFR signaling pathway, which can be increased by anti-VEGFR therapy treatment, is shown to be associated with cancer progression by promoting tumor growth, angiogenesis and formation of the myeloid derived suppressor cells. Inhibition of the CSF-1R signaling pathway blocks the activation of tumor-associated macrophages, which are involved in suppressing immune responses against tumors.
In addition to the current Phase Ib/II NET trial, five sulfatinib clinical trials are underway in China and the U.S., including two Phase III studies in NET patients (SANET-p and SANET-ep), one Phase II study in thyroid cancer patients and one Phase II study in biliary tract cancer patients.
The SANET-p trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III pivotal registration trial to treat about 190 pathologically low or intermediate grade pancreatic NET patients in China whose disease has progressed, locally advanced or distant metastasized and for whom there is no effective therapy. The primary endpoint is PFS, with secondary endpoints including ORR, DCR, duration of response (“DoR”), time to response and overall survival (“OS”). Additional details of the SANET-p study may be found at clinicaltrials.gov, using identifier NCT02589821. The SANET-ep trial is similar to the SANET-p trial and is targeted at treating about 270 non-pancreatic NET patients in China. Additional details of the SANET-ep study may be found at clinicaltrials.gov, using identifier NCT02588170.
Chi-Med is conducting an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib in about 50 patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer or medullary thyroid cancer in China. The primary endpoint is ORR, with secondary endpoints including safety and tolerability, DCR, time to response and PFS. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02614495.
Chi-Med is also conducting an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib in about 32 patients with advanced or metastatic biliary tract cancer who failed one prior systemic therapy in China. The primary endpoint is PFS at 16 weeks, with secondary endpoints including the ORR, DCR, DoR, PFS, OS and safety. Additional details of this study may be found at clinicaltrials.gov, using identifier NCT02966821.
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. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of sulfatinib, including plans for further clinical studies of sulfatinib in NET, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate sulfatinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of sulfatinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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
[1] According to Frost & Sullivan.
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.
– Trial met all primary and secondary endpoints –
– Safety as expected –
– Progressing to China NDA submission mid-2017 –
– Full data to be reported at an upcoming scientific meeting in mid-2017 –
London: Friday, March 3, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces top-line results from FRESCO, its Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer (“CRC”) in China, who failed at least two prior chemotherapies, including fluoropyrimidine, oxaliplatin and irinotecan. The trial met its primary endpoint of demonstrating a clinically meaningful and a statistically significant increase in overall survival (“OS”), in the intention-to-treat (ITT) population of patients treated with fruquintinib plus best supportive care (“BSC”) as compared to patients treated with placebo plus BSC. Chi-Med is currently preparing to submit a new drug application (“NDA”) for fruquintinib to the China Food and Drug Administration.
In addition to OS, a statistically significant improvement in progression-free survival (“PFS”), a key secondary endpoint, was observed. The adverse events demonstrated in FRESCO did not identify any new or unexpected safety issues. Full detailed results are subject to ongoing analysis and are expected to be disclosed at an upcoming scientific meeting in mid-2017.
Simon To, Chairman of Chi-Med, said, “Well over a decade of effort and investment has now paid-off with these compelling Phase III top-line results. They reinforce fruquintinib’s potential to address major unmet clinical needs for patients in both China and around the world. They also open the way to our submitting a NDA on fruquintinib around the middle of this year.”
“The success of the FRESCO trial is an important milestone not just for CRC patients and Chi-Med, but also for Chinese innovation,” he added. “We believe this is one of the first home-grown, China-discovered and developed, mainstream innovation in the field of oncology to succeed in a pivotal Phase III registration trial. It shows that China has the resources, capability and perseverance to emerge as an innovator in the global oncology field. With eight small molecule drug candidates in over 30 clinical studies worldwide, Chi-Med is at the forefront of this important evolution.”
“We are pleased to be working with the innovative biopharmaceutical company, Chi-Med, on the development of fruquintinib,” said Kerry L. Blanchard, Senior Vice President of China Medicines Development Unit and External Innovation of Eli Lilly and Company (“Lilly”) China Drug Development. “This relationship highlights our commitment to help build a vibrant innovation ecosystem in China, and we look forward to our further collaboration to bring this novel medicine to patients.”
In addition to the FRESCO colorectal cancer trial, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer (“NSCLC”), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the U.S., and certain exploratory studies in combination with other oncology agents.
At an advanced stage, tumors secrete large amounts of vascular endothelial growth factors (“VEGF”), a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGF receptors (“VEGFR”) play a pivotal role in tumor-related angiogenesis, and the inhibition of the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
Fruquintinib (HMPL-013) is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose. It is currently under the joint development in China by Chi-Med and its partner Lilly. Two clinical studies are ongoing in lung cancer, including a late stage, pivotal Phase III registration study (FALUCA). In addition, fruquintinib is also in clinical development for the treatment of gastric cancer.
The FRESCO trial is a randomized, double-blind, placebo-controlled, multicenter, Phase III pivotal trial in patients with locally advanced or metastatic CRC who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. No drugs have been approved in third-line CRC in China, with BSC being the general standard of care. Enrollment was completed in May 2016. 416 patients were randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC. The primary endpoint is OS, with secondary endpoints including PFS, objective response rate (“ORR”), disease control rate (“DCR”) and duration of response (“DoR”). Additional details of the FRESCO study may be found at clinicaltrials.gov, using identifier NCT02314819. Full results from the FRESCO study are planned to be published at a scientific event in mid-2017.
CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to CA Cancer Journal for Clinicians 2016. There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.
Lung: The FALUCA trial is a randomized, double-blind, placebo-controlled, multi-center, Phase III registration study targeted at treating patients with advanced non-squamous NSCLC, who have failed two lines of systemic chemotherapy. Enrollment began in December 2015. Patients are randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC. The primary endpoint is OS, with secondary endpoints including PFS, ORR, DCR and DoR. Chi-Med plans to enroll approximately 520 patients in about 45 centers across China. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02691299. Topline results from the FALUCA study are expected to be released in early 2018.
In January 2017 Chi-Med initiated a multi-center, single-arm, open-label Phase II study of a combination therapy using fruquintinib and Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. The objectives are to evaluate the safety and tolerability as well as preliminary efficacy of the combination therapy in the first-line setting for advanced or metastatic non-squamous NSCLC patients with epidermal growth factor receptor (EGFR) activating mutations. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02976116.
Gastric: Chi-Med completed a Phase I/II dose finding study of fruquintinib in combination with paclitaxel, which established a combination regimen that was well tolerated. Results of this study were published at the 2017 Gastrointestinal Cancers Symposium sponsored by the American Society of Clinical Oncology in January 2017. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT02415023. A pivotal Phase III registration study is expected to start during the first half of 2017.
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, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding. In addition, as certain studies rely on the use of Iressa® (gefitinib) as a combination therapeutic with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa® (gefitinib). Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Investor Enquiries
Christian Hogg, CEO +852 2121 8200
International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile) / anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile) / bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile) / sduffy@bmccommunications.com
Investor Relations
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
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500