London: Monday, June 29, 2020: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (AIM/Nasdaq: HCM) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | Hutchison China MediTech Limited | ||
| 2. | Name of scheme: | (a) | Share Option Scheme conditionally adopted by Hutchison China MediTech Limited in 2005 (“2005 HCML Share Option Scheme”) | |
| (b) | Share Option Scheme conditionally adopted by Hutchison China MediTech Limited in 2015 (“2015 HCML Share Option Scheme”) | |||
| 3. | Period of return: | From December 29, 2019 to June 28, 2020 | ||
| 4. |
Balance under scheme from previous return:
|
(a) | 2005 HCML Share Option Scheme: 1,738,910 ordinary shares of US$0.1 each | |
| (b) | 2015 HCML Share Option Scheme: 23,130,970 ordinary shares of US$0.1 each | |||
| 5. |
The amount by which the block scheme has been increased, if the scheme has been increased since the date of the last return:
|
(a) | 2005 HCML Share Option Scheme: Nil | |
| (b) | 2015 HCML Share Option Scheme: Nil | |||
| 6. |
Number of securities issued/allotted under scheme during period:
|
(a) | 2005 HCML Share Option Scheme: Nil | |
| (b) | 2015 HCML Share Option Scheme: Nil | |||
| 7. |
Balance under scheme not yet issued/allotted at end of the period:
|
(a) | 2005 HCML Share Option Scheme: 1,738,910 ordinary shares of US$0.1 each | |
| (b) | 2015 HCML Share Option Scheme: 23,130,970 ordinary shares of US$0.1 each | |||
| 8. |
Number and class of securities originally listed and the date of admission:
|
25,198,880 ordinary shares of US$0.1 each admitted on June 17, 2019 (to replace the Company’s previous block admission schemes following the Company’s share subdivision which took effect on May 30, 2019) | ||
| 9. | Total number of securities in issue at the end of the period: | 690,574,765 ordinary shares of US$0.1 each | ||
| Name of contact: | Christian Hogg | |||
| Address of contact: | Level 18, The Metropolis Tower, 10 Metropolis Drive, Hung Hom, Kowloon, Hong Kong | |||
| Telephone number of contact: | +852 2121 8200 | |||
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Friday, June 26, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) will be announcing its interim results for the six months ended June 30, 2020 on Thursday, July 30, 2020 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)).
Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by Chi-Med management.
The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Thursday, July 30, 2020 and will be webcast live via the company website at www.chi-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION
– Strategic investment demonstrates General Atlantic’s support of Chi-Med’s global ambitions –
– Purchase price equivalent to US$25.00 per ADS, a 10.4% premium to the 30-day volume weighted average price (“VWAP”) –
London: Thursday, June 25, 2020: Hutchison China MediTech Limited (“Chi-Med” or the “Company”) (Nasdaq/AIM: HCM) today announces that it has entered into a definitive agreement for the sale of US$100 million of shares at a price equivalent to US$25.00 per American Depositary Share (“ADS”) via a private placement to General Atlantic, a leading global growth equity firm. This fundraise could increase to US$200 million, through a warrant granted with a term of 18 months for a further US$100 million in Chi-Med shares exercisable at a price per share equivalent to US$30.00 per ADS, a 32.5% premium to the 30-day VWAP.
Chi-Med is delivering on its strategic intention to become a global oncology business. In 2020, there has been significant progress in building an innovative, global, science-focused biopharmaceutical company including three U.S. Food and Drug Administration (FDA) Fast Track Designations for fruquintinib in metastatic colorectal cancer and surufatinib for two forms of advanced neuroendocrine tumors. The submission of a New Drug Application (NDA) for surufatinib in the United States is also planned for later this year.
Chi-Med will receive all proceeds from this private placement, which will fund ongoing research and clinical development and support the further growth of its commercialization capabilities both in China and globally.
This financing also highlights the strong commitment General Atlantic is making to Chi-Med. General Atlantic has 40 years’ experience in investing in global growth equity companies, with a demonstrated history in the biopharma sector, and has approximately US$34 billion of assets under management. It has a broad portfolio of life science company investments with whom they constructively partner to support further growth.
Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said, “Over the last few months, we have made significant development, regulatory and commercial progress in several oncology programs intended for the global market. We are delighted therefore to welcome General Atlantic to our existing shareholder base and to further strengthen our balance sheet. We are confident that in this phase of material progress for Chi-Med we can deliver innovative cancer therapies to patients internationally.”
Mr. David Hodgson, Vice Chairman of General Atlantic, said, “General Atlantic is committed to supporting innovation in the global life sciences industry. Chi-Med has built a deep pipeline of assets powered by its robust research and development engine. We endorse Chi-Med’s strategy to become a leading biopharma innovator and will leverage our global organization in support of Chi-Med’s mission to deliver safe and effective therapeutics to cancer patients in need around the world.”
Mr. Lefei Sun, Managing Director and Head of Healthcare for China at General Atlantic, continued, “We believe Chi-Med is a pioneer of the Chinese biotech market in bringing advanced oncology therapies to the world. We are delighted to partner with Chi-Med to help unlock future value.”
Chi-Med has agreed to issue the equivalent of 4,000,000 ADSs in a private placement to General Atlantic at a price equivalent to US$25.00 per ADS, resulting in aggregate gross proceeds of US$100 million to Chi-Med. The purchase price represents a 10.4% premium to the 30-day VWAP. The Company has also granted a warrant to General Atlantic to purchase up to an additional equivalent of 3,333,334 ADSs, at an exercise price equivalent to US$30.00 per ADS, and a term of 18 months.
Each ADS represents five ordinary shares, par value US$0.10 each (the “Shares”). The new Shares to be issued by Chi-Med including shares issuable upon exercise of the warrant, pursuant to the private placement will, when issued, be credited as fully paid and will rank pari passu in all respects with the existing ordinary shares of Chi-Med.
The securities to be sold in the private placement will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Subject to certain conditions, the Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Shares sold in the private placement and the Shares issuable upon exercise of the warrant to facilitate future resales by General Atlantic. Any offering of the securities under the resale registration statement will only be made by means of a prospectus. General Atlantic has the right to appoint an observer or a representative director to the board of directors of the Company upon achieving certain ownership thresholds in the future.
This announcement, including any information included or incorporated by reference in this announcement, is for information purposes only and shall not constitute nor form part of, and should not be construed as, an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. No public offering of the securities referred to in this announcement is being made in the United States or elsewhere.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
The private placement of 20,000,000 Shares (equivalent to 4,000,000 ADSs) to General Atlantic will comprise the issuance of 18,700,000 Shares (“First Tranche Shares”) and the issuance of 1,300,000 Shares (“Second Tranche Shares”). Application will be made to the London Stock Exchange for the First Tranche Shares and the Second Tranche Shares to be admitted to the AIM market operated by the London Stock Exchange (“Admission”). It is expected that admission of the First Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 3, 2020 and admission of the Second Tranche Shares will become effective at 8:00 a.m. British Summer Time on July 6, 2020.
Following admission of the First Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 709,274,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. Following admission of the Second Tranche Shares to trading on AIM, the issued share capital of Chi-Med will consist of 710,574,765 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. The figure of 709,274,765 (following admission of the First Tranche Shares but prior to admission of the Second Tranche Shares) and the figure of 710,574,765 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 Guidance and Transparency Rules.
For illustrative purposes only, if the 710,574,765 ordinary shares were converted in their entirety, they would be equivalent to 142,114,953 Nasdaq-traded ADSs (each equating to five ordinary shares).
In addition, the Company will apply for the block listing of up to 16,666,670 new ordinary shares in accordance with the block listing process under Rule 29 of the AIM Rules for Companies to cover the potential exercise of the warrant. The new ordinary shares subject to the block admission will not be allotted immediately, but rather will be issued and allotted on exercise of the warrant from time to time. The Company will make six-monthly announcements of the utilization of the block listing, in line with its obligations under Rule 29 of the AIM Rules for Companies. The expected effective date of admission of these securities to AIM is on July 6, 2020.
General Atlantic is a leading global growth equity firm providing capital and strategic support for growth companies. Established in 1980, General Atlantic combines a collaborative global approach, sector specific expertise, a long-term investment horizon and a deep understanding of growth drivers to partner with great entrepreneurs and management teams to build exceptional businesses worldwide. The firm’s global Life Sciences portfolio includes Adagene, CANbridge, Ginkgo Bioworks, Immunocore, Motif FoodWorks, Ocumension, PathAI, and Royalty Pharma. General Atlantic has more than 150 investment professionals based in New York, Amsterdam, Beijing, Greenwich, Hong Kong, Jakarta, London, Mexico City, Mumbai, Munich, Palo Alto, São Paulo, Shanghai, and Singapore. For more information on General Atlantic, please visit the website: www.generalatlantic.com.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. 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 regarding the use of proceeds from the transaction and potential proceeds to be received upon exercise of the warrant as well as Chi-Med’s clinical development and regulatory plans for its drug candidates and Chi-Med’s overall business strategy. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the exercise of the warrant, the funding necessary for Chi-Med’s future clinical development plans, 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 timing and ability of Chi-Med to raise additional funding as needed for continued operations, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. 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.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Europe – Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Thursday, June 18, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track Designation for the development of fruquintinib, for the treatment of patients with metastatic colorectal cancer (“mCRC”) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy.
Chi-Med is initiating a Phase III registration study, known as the FRESCO-2 study, in refractory mCRC in the U.S., Europe and Japan (clinicaltrials.gov identifier: NCT04322539). FRESCO-2 is expected to start enrolling patients in mid-2020. The U.S. FDA acknowledged that the totality of the fruquintinib clinical data, including the FRESCO-2 study, if positive; the prior positive Phase III FRESCO study demonstrating improvement in overall survival that led to fruquintinib approval for mCRC in China in 2018; and additional completed and ongoing supporting studies in mCRC; could support a New Drug Application (“NDA”) for the treatment of patients with mCRC in the third-line setting. The adequacy of the data to support a specific indication will be assessed during the review of a New Drug Application.
The FDA Fast Track Designation is one of several approaches utilized by the U.S. FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the U.S. FDA on drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review.1
CRC is the third most common cancer worldwide, causing more than 880,000 deaths in 2018.2 In the U.S., CRC is the fourth most common cause of new cancer cases, but the second leading cause of cancer deaths.3 It is estimated that in 2020, 147,950 people will be diagnosed with CRC and 53,200 people will die from CRC in the U.S.4
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company (“Lilly”) in China.
Fruquintinib was approved for marketing by the China National Medical Products Administration (“NMPA”) in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate®. Elunate® is for the treatment of patients with mCRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with mCRC in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
In December 2017, Chi-Med initiated a multi-center, open-label, Phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors (clinicaltrials.gov identifier: NCT03251378). The study progressed into proof-of-concept trials in 2019, including patients with mCRC and metastatic breast cancer. In February 2020, an End of Phase II (EOP2) meeting was held with the U.S. FDA, and regulatory interactions with the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) are also underway.
Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376. In June 2020, Chi-Med completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue.
Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt® (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. 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 regarding the potential future benefits of Fast Track Designation and the anticipated clinical development of fruquintinib in CRC in the United States as well as Chi-Med’s clinical development plans for fruquintinib in other jurisdictions and indications. 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 fruquintinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, its ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of such combination therapeutics. 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.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Tuesday, June 9, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited (“HBYS”), its 50:50 joint venture with Guangzhou Baiyunshan Pharmaceutical Holdings Company Limited, has today entered into an agreement (the “Agreement”) with the Guangzhou government for the planned return of HBYS’s remaining 34 years land-use rights on its approximately 30,000 square meters unused site (“HBYS Plot 2”) at Guang Cong Road, Tong He Town, Baiyun District, Guangzhou (the “Site”).
The Site is located in an area of Guangzhou approximately six kilometers from the city center, which will be rezoned from industrial use to commercial and residential usage.
The Agreement signed between HBYS and the Land Development Centre of Guangzhou provides that HBYS will return the Site to the government in consideration for cash compensation of up to US$95 million (the “Compensation”). Under the Agreement, HBYS will receive the Compensation in several stages over a period of approximately one year as all surrender procedures are met and the transaction progresses to completion.
The return of HBYS Plot 2 has no impact on the operations of HBYS. The joint venture continues to operate manufacturing facilities at a second, 59,000 square meter, nearby site in Baiyun District, Guangzhou (HBYS Plot 1) as well as a large new factory, on a 230,000 square meter site, in Bozhou, Anhui Province.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. 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 and can be identified by words like: “will,” “expects,” “believes” or similar terms, or by express or implied 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. Such risks and uncertainties include, among other things, the risk that the land-use rights transaction described above does not proceed to completion or HBYS does not receive the cash compensation, in whole or in part, owed for the surrender of its land-use rights. 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.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Thursday, June 4, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that the Independent Data Monitoring Committee (IDMC) of the FRUTIGA study of fruquintinib has completed a planned interim data review. Based on the preset criteria, the IDMC recommended that the trial continue.
FRUTIGA is a Phase III trial in China of fruquintinib in combination with paclitaxel (Taxol®) in the treatment of patients with advanced gastric adenocarcinoma or gastroesophageal junction (“GEJ”) adenocarcinoma who have progressed after first-line standard chemotherapy.
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial factor receptor (“VEGFR”) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may be highly suitable for combinations with other anti-cancer therapies.
FRUTIGA is a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. Patients will be randomized at a 1:1 ratio and stratified according to factors such as stomach vs. GEJ tumor type and performance status. The primary efficacy endpoint is overall survival. Secondary efficacy endpoints include progression-free survival (as defined by RECIST 1.1), objective response rate, disease control rate, duration of response, and quality-of-life score (EORTC QLQ-C30, version 3.0). Biomarkers related to the antitumor activity of fruquintinib will also be explored.
Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03223376.
FRUTIGA was initiated following the results of an open label, multi-center Phase Ib dose finding/expansion study of fruquintinib in combination with paclitaxel (Taxol®) as a second-line treatment in patients with advanced gastric cancer (clinicaltrials.gov identifier NCT02415023).
Fruquintinib was approved for marketing in China by the NMPA in September 2018 and commercially launched by Eli Lilly and Company (“Lilly”) in late November 2018 under the brand name Elunate®. Elunate® is for the treatment of patients with metastatic colorectal cancer that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-EGFR therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with colorectal cancer (“CRC”) in China, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.
Global development of fruquintinib in CRC: We are initiating a Phase III registration study, known as the FRESCO-2 study, in the U.S., Europe and Japan in CRC. FRESCO-2 is expected to start enrolling patients in mid-2020. Based on our agreement with the U.S. Food and Drug Administration (FDA), the FRESCO and FRESCO-2 studies, if positive, could support our New Drug Application (NDA).
Immunotherapy combinations: We have entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt® (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. 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 fruquintinib in gastric cancer and other indications, the ability of fruquintinib to gain commercial acceptance in China and the potential market of fruquintinib for patients with metastatic CRC who have failed two prior treatments in China. 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 fruquintinib, including as a combination therapy, to meet the primary or secondary endpoint of a study, Chi-Med’s ability to obtain or maintain regulatory approval in different jurisdictions and that that no unidentified side effects will occur which could result in the NMPA pulling fruquintinib from the market, fruquintinib’s ability to gain commercial acceptance in China, including the sufficiency of funding to support commercialization of fruquintinib in metastatic CRC and that the benefits obtained from fruquintinib during clinical trials will be the same for all patients who are prescribed fruquintinib. In addition, as certain studies rely on the use of Taxol®, tislelizumab, Tyvyt® or geptanolimab as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Taxol®, tislelizumab, Tyvyt® and geptanolimab. 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.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
| Announcement released: May 29, 2020 (Fri) |
| >> View Announcement << |
| Presentation webcast & call: June 1, 2020 (Mon) |
| 1pm GMT/ 8am EDT/ 8pm HKT |
London: Monday June 1, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has held its pre-New Drug Application (“NDA”) meeting with the U.S. Food and Drug Administration (“FDA”) for surufatinib for the treatment of patients with advanced neuroendocrine tumors (“NET”). Chi-Med has reached an agreement with the FDA that the completed SANET-ep (non-pancreatic NET) and SANET-p (pancreatic NET) studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients, could form the basis to support a U.S. NDA submission.
The FDA granted Fast Track Designation status to surufatinib for the non-pancreatic and pancreatic NET development programs in April 2020. Chi-Med has initiated preparatory work for the U.S. NDA and intends to utilize a rolling submission under Fast Track Designation Status. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. Filing acceptance of the NDA is subject to FDA review of the complete application. The planned start of the NDA submission is late 2020.
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.
Chi-Med currently retains all rights to surufatinib worldwide.
NET in the U.S., Europe and Japan: In the U.S., surufatinib was granted Fast Track Designations for development in pancreatic and non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan Drug Designation for pancreatic NET in November 2019. A U.S. FDA NDA submission is being prepared. Regulatory interactions in Europe and Japan are also underway to confirm the clinical development strategy and potential path to registration. All such interactions are based on the robust data from the two positive Phase III studies of surufatinib in NET in China, and the ongoing multi-cohort Phase Ib study in the U.S. that began in November 2015 (clinicaltrials.gov identifier: NCT02549937).
Non-pancreatic neuroendocrine tumors in China: In November 2019, a NDA for surufatinib for the treatment of patients with advanced non-pancreatic NET was accepted for review by the China National Medical Products Administration (NMPA) and granted Priority Review status in December 2019. The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in patients with advanced non-pancreatic neuroendocrine tumors in China for whom there is no effective therapy. A 198-patient interim analysis was conducted in June 2019, leading the Independent Data Monitoring Committee (“IDMC”) to determine that the study met the pre-defined primary endpoint of progression-free survival (“PFS”) and should be stopped early. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress (clinicaltrials.gov identifier: NCT02588170).
Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic NET in China. A second NDA for surufatinib for the treatment of patients with advanced pancreatic NET is being prepared for submission, following an interim analysis review conducted in January 2020 by the IDMC that recommended the registrational study be terminated early as the pre-defined primary endpoint of PFS had already been met (clinicaltrials.gov identifier: NCT02589821). Study results will be submitted for presentation at an upcoming scientific conference.
Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532).
Immunotherapy combinations: We have entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi® (toripalimab) and Tyvyt® (sintilimab), which are approved in China.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. 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 regarding the submission of an NDA for surufatinib for the treatment of NET with the U.S. FDA and the timing of such submission, the therapeutic potential of surufatinib for the treatment of patients with NET, the further clinical development of surufatinib in this and other indications, 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 the sufficiency of its data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S. and China or other jurisdictions such as the E.U. or Japan, its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, its ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi®, and Tyvyt® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. 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.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500