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
London: Monday, September 30, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that its shareholder CK Hutchison Holdings Limited (“CK Hutchison”) (SEHK: 1)[1] has priced an offering to sell approximately 1.3% of the total outstanding share capital in Chi-Med through an underwritten public offering, which would reduce its stake in Chi-Med from 51.1% to 49.9% (the “Offering”). The offering price was US$17.65 per American depositary share (“ADS”). Each ADS represents five ordinary shares, par value US$0.10.
CK Hutchison has previously announced that, upon completion of the Offering, it has no intention of selling additional Chi-Med shares for the foreseeable future.
Canning Fok, Group Co-Managing Director of CK Hutchison, commented: “Upon completion of the Offering, we will have achieved our previously announced objective of reducing our shareholding in Chi-Med to below 50%, and this will enable CK Hutchison to deconsolidate Chi-Med in the financial statements of CK Hutchison.”
CK Hutchison plans to maintain its shareholding in Chi-Med as a strategic investment for the long term as it continues to strive to become a global biopharmaceutical company.
About CK Hutchison
Listed on The Stock Exchange of Hong Kong Limited, CK Hutchison Holdings Limited (CK Hutchison) is a renowned multinational conglomerate committed to innovation and technology with businesses spanning the globe. With operations in over 50 countries and over 300,000 employees worldwide, CK Hutchison has five core businesses – ports and related services, retail, infrastructure, energy and telecommunications.
CK Hutchison reported turnover of approximately HKD453 billion (USD58 billion) and HKD217 billion (USD28 billion) for the year ended 31 December 2018 and for the six months ended 30 June 2019 respectively.
For more information, please visit www.ckh.com.hk
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 470 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
Information about the Offering
BofA Merrill Lynch, Goldman Sachs (Asia) L.L.C. and J.P. Morgan (in alphabetical order) are acting as joint lead bookrunners for the Offering.
The Offering will be made pursuant to a shelf registration statement on Form F-3 filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A prospectus supplement related to the Offering will be filed with the SEC and available on the SEC website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from BofA Securities, Inc, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or e-mail: dg.prospectus_requests@baml.com; or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526; or J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204 or by email at prospectus-eq_fi@jpmchase.com.
In connection with the Offering, HHHL has agreed to a 90-day lock-up on sales or transfers of Chi-Med’s ordinary shares, ADSs or equity-linked securities.
This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its and CK Hutchison’s management plans and objectives. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the possibility that the closing conditions for the Offering will not be satisfied. More information about such risks and uncertainties is contained or incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus related to the Offering filed with the SEC. 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 SEC and on AIM. None of Chi-Med, CK Hutchison, BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. or J.P. Morgan undertakes any obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Important Notice
No prospectus required for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) or admission document for the purposes of the AIM Rules for Companies will be made available in connection with the matters contained in this announcement.
In any Member State of the European Economic Area, this announcement is only addressed to and directed at persons who are “Qualified Investors” within the meaning of Article 2(e) of the Prospectus Regulation. The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with Qualified Investors. This announcement should not be acted upon or relied upon in any Member State of the European Economic Area by persons who are not Qualified Investors.
In addition, this communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at persons who (i) are outside the United Kingdom or (ii) have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). This announcement is directed only at relevant persons and must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.
CONTACTS
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
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
London: Monday, September 30, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces that its shareholder CK Hutchison Holdings Limited (“CK Hutchison”) (SEHK: 1)[1] is launching an offering to sell approximately 1.3% of the total outstanding share capital in Chi-Med’s through an underwritten public offering, which would reduce its stake in Chi-Med from 51.1% to 49.9% (the “Offering”).
CK Hutchison has announced that, upon completion of the Offering, it has no intention of selling additional Chi-Med shares for the foreseeable future.
Canning Fok, Group Co-Managing Director of CK Hutchison, commented: “Upon completion of the Offering, we will have achieved our previously announced objective of reducing our shareholding in Chi-Med to below 50%, and this will enable CK Hutchison to deconsolidate Chi-Med in the financial statements of CK Hutchison.”
CK Hutchison plans to maintain its shareholding in Chi-Med as a strategic investment for the long term as it continues to strive to become a global biopharmaceutical company.
About CK Hutchison
Listed on The Stock Exchange of Hong Kong Limited, CK Hutchison Holdings Limited (CK Hutchison) is a renowned multinational conglomerate committed to innovation and technology with businesses spanning the globe. With operations in over 50 countries and over 300,000 employees worldwide, CK Hutchison has five core businesses – ports and related services, retail, infrastructure, energy and telecommunications.
CK Hutchison reported turnover of approximately HKD453 billion (USD58 billion) and HKD217 billion (USD28 billion) for the year ended 31 December 2018 and for the six months ended 30 June 2019 respectively.
For more information, please visit www.ckh.com.hk
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 470 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
Information about the Offering
BofA Merrill Lynch, Goldman Sachs (Asia) L.L.C. and J.P. Morgan (in alphabetical order) are acting as joint lead bookrunners for the Offering.
The Offering will be made pursuant to a shelf registration statement on Form F-3 filed by Chi-Med with the United States Securities and Exchange Commission (“SEC”) that became automatically effective on April 3, 2017. A prospectus supplement related to the Offering will be filed with the SEC. Before you invest, you should read the registration statement, prospectus supplement and other documents the issuer has filed with the SEC for more complete information about Chi-Med and the Offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the Offering may be obtained from BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or e-mail: dg.prospectus_requests@baml.com; or Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526; or J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204 or by email at prospectus-eq_fi@jpmchase.com.
In connection with the Offering, HHHL has agreed to a 90-day lock-up on sales or transfers of Chi-Med’s ordinary shares, American depositary shares (“ADSs”) or equity-linked securities.
This announcement is not directed to, or intended for distribution or use by, any person or entity that is a citizen or resident or located in any locality, state, country or other jurisdiction where such distribution, publication, availability or use would be contrary to law or regulation or which would require any registration or licensing within such jurisdiction.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014. In addition, market soundings (as defined in MAR) were taken in respect of the Offering with the result that certain persons became aware of inside information (as defined in MAR), as permitted by MAR. This inside information is set out in this announcement. Therefore, those persons that received inside information in a market sounding are no longer in possession of such inside information relating to Chi-Med and its securities.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its and CK Hutchison’s management plans and objectives. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the possibility that the closing conditions for the Offering will not be satisfied. More information about such risks and uncertainties is contained or incorporated by reference in the preliminary prospectus supplement and the accompanying prospectus related to the Offering filed with the SEC. 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 SEC and on AIM. None of Chi-Med, CK Hutchison, BofA Securities, Inc., Goldman Sachs (Asia) L.L.C. or J.P. Morgan undertakes any obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Important Notice
No prospectus required for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) or admission document for the purposes of the AIM Rules for Companies will be made available in connection with the matters contained in this announcement.
In any Member State of the European Economic Area, this announcement is only addressed to and directed at persons who are “Qualified Investors” within the meaning of Article 2(e) of the Prospectus Regulation. The ADSs are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with Qualified Investors. This announcement should not be acted upon or relied upon in any Member State of the European Economic Area by persons who are not Qualified Investors.
In addition, this communication, in so far as it constitutes an invitation or inducement to enter into investment activity (within the meaning of s21 Financial Services and Markets Act 2000 as amended) in connection with the securities which are the subject of the Offering described in this announcement or otherwise, is being directed only at persons who (i) are outside the United Kingdom or (ii) have professional experience in matters relating to investments falling within Article 19(5) (investment professionals) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”) or (iii) are persons falling within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iv) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Financial Services and Markets Act 2000) in connection with the issue or sale of any securities may otherwise lawfully be communicated or caused to be communicated (all such persons in (i) to (iv) together being referred to as “relevant persons”). This announcement is directed only at relevant persons and must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Monday, September 30, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at September 30, 2019, the issued share capital of Chi-Med consisted of 666,786,450 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 666,786,450 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 666,786,450 ordinary shares would be equivalent to 666,786,450 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 133,357,290 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. For more information, please visit: www.chi-med.com.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
| Announcement released: September 29, 2019 (Sun) |
| >> View Announcement << |
| Presentation webcast & call: September 30, 2019 (Mon) 2pm CEST (1pm BST/8am EDT/8pm HKT) |
To participate by phone, please use one of the following numbers. The conference ID for the calls is “Chi-Med“.
| China Toll Free | 4001 200558 |
| Hong Kong Toll Free | 800 900 476 |
| New York | +1 212 999 6659 |
| Italy Toll Free | 800 986 477 |
| Singapore Toll Free | 800 120 4789 |
| Standard International Access | +44 (0) 20 3003 2666 |
| Switzerland Toll Free | 0800 800 038 |
| UK Toll Free | 0808 109 0700 |
| USA Toll Free | 1 866 966 5335 |
|
Title:
|
Efficacy and Safety of Surufatinib in Patients with Well-Differentiated Advanced Extrapancreatic Neuroendocrine Tumors: Results from the Randomized Phase III Study (SANET-ep) |
| Presenting Author: | Jianming Xu, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA |
| Abstract #: | LBA76 |
| Date & Time: | Sunday, September 29, 2019, 16:30 CEST |
| Location: | Tarragona Auditorium (Hall 7), Fira de Barcelona Gran Via Conference Centre |
Press Release
– Surufatinib achieved primary endpoint, reducing the risk of progression or death by 67% in patients with non-pancreatic neuroendocrine tumors (“NET”) in the Phase III SANET-ep study –
– Preparations underway for the potential submission of surufatinib New Drug Application (“NDA”) by year end 2019 for non-pancreatic NET tumors in China –
– Treatment options are limited for the 90% of all global NET patients whose tumors originate outside of the pancreas. Surufatinib represents an important potential advancement for these patients –
– Conference call and webcast to be held on Monday, September 30, 2 p.m. Barcelona time to review surufatinib data –
London: Sunday, September 29, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today presented the results of the Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic (SANET-ep) at the 2019 European Society for Medical Oncology Congress (“ESMO”). The study has met the pre-defined primary endpoint of progression free survival (“PFS”) early. Patients treated with surufatinib were 67% less likely to see their disease progress or die as compared to patients on placebo control, assessed by local investigators.
Chi-Med is holding an investor conference call and webcast on Monday, September 30, to review the SANET-ep data. In addition, safety and tolerability data presented from an ongoing U.S. Phase Ib study of surufatinib in pancreatic NET patients who are refractory to Sutent® and Afinitor® will also be discussed.
As announced in June 2019, the independent Data Monitoring Committee (“IDMC”) for the trial recommended that the study stop early because it had met the pre-defined primary endpoint of PFS during a planned interim analysis. Preparations are now underway for the potential NDA submission by year end 2019 for this indication in China.
At data cut-off as of March 31, 2019, 198 patients were randomized 2:1 to treatment with either 300 mg of surufatinib orally daily (N=129) or placebo control (N=69), on a 28-day cycle. Median PFS per investigator assessment was 9.2 months for patients treated with surufatinib, as compared to 3.8 months for patients in the placebo group (hazard ratio [“HR”] 0.334; 95% confidence interval [“CI”] 0.223-0.499; p<0.0001).
The efficacy of surufatinib was seen across all subgroups, and supported by statistically significant improvement as measured by secondary efficacy endpoints including objective response rate (“ORR”), disease control rate (“DCR”), time to response (“TTR”), duration of response (“DoR”), safety, and tolerability. Efficacy was also supported by Blinded Independent Image Review Committee (“BIIRC”) assessment. Overall survival (“OS”) data was not mature, with only 18.7% OS events at data cut-off. Surufatinib was generally well-tolerated in this study and the safety profile is consistent with observations in prior clinical studies.
Dr. Jianming Xu, co-lead investigator for the SANET-ep study, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the People’s Liberation Army in Beijing, said: “The SANET-ep results showed that surufatinib meaningfully benefited Chinese patients with progressive, advanced extra-pancreatic NET, across multiple measures of efficacy and was generally well tolerated. Importantly, these positive results were achieved in patients regardless of tumor origin and in patients who received prior systematic treatment for their disease.”
Dr. Lin Shen, co-lead investigator for the SANET-ep study, Vice President of the Beijing Cancer Hospital and Head of its Department of Gastroenterological Oncology, said: “NET is a disease that many oncologists encounter in their practices. Both in China and globally, options are limited for NET patients whose tumors originate outside of the pancreas. These patients account for over 90% of all NET cases. The SANET-ep results represent an important potential advancement in clinical practice for these patients.”
|
Surufatinib (n=129) |
Placebo (n=69) |
Hazard Ratio (95% CI), p-value | |
| Primary endpoint: | |||
| PFS (investigator assessment) | 9.2 months | 3.8 months | 0.334 (0.223-0.499), p<0.0001 |
| Secondary endpoints: | |||
| ORR | 10.3% | 0% | (5.6%-17.0%), p=0.0051 |
| DCR | 86.5% | 65.6% | Odds Ratio 3.3 (1.5-7.3), p=0.0022 |
| TTR | 3.7 months | (1.8, 5.5) | |
| DoR | 5.6 months | (2.0, 17.5) |
Participating on the webcast will be members of the Chi-Med management team as well as Dr. James Yao, Chair of Gastrointestinal Oncology at MD Anderson Cancer Center and one of the lead investigators for Chi-Med’s ongoing Phase I/Ib surufatinib study in NET. Toll-free dial-in numbers are as follows: U.K. 0808 109 0700; U.S. 1 866 966 5335; Mainland China 4001 200558; and Hong Kong 800 900 476.
Presentation slides will be posted before the call begins. Additional numbers and the slides will be available at www.chi-med.com/event-information/, and a replay will also be available shortly after the event.
Additional details may be found at clinicaltrials.gov, using identifier NCT02588170. A copy of the presentation will be available at www.chi-med.com.
Safety and tolerability data of surufatinib in western patients were presented at ESMO 2019 as a poster on Sunday, September 29, including data on 15 patients (12 efficacy evaluable) with heavily treated pancreatic NET. The study confirmed 300mg as the recommended Phase 2 dose (RP2D), the same as that used in the China studies. Preliminary data shows promising anti-tumor activity in the pancreatic NET patients, with ORR of 13.3% and DCR of 73.3%. Additional details may be found at clinicaltrials.gov, using identifier NCT02549937.
Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or other neuroendocrine tumors. Approved targeted therapies include Sutent® and Afinitor® for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.
According to Frost and Sullivan, there were 19,000 newly diagnosed cases of neuroendocrine tumors in the U.S. in 2018. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with neuroendocrine tumors in the U.S. in 2018 of which over 90%, or approximately 132,000, were non-pancreatic neuroendocrine tumor patients.
In China there were approximately 67,600 newly diagnosed neuroendocrine patients in 2018 and, considering the U.S. incidence to prevalence ratio, potentially as many as 300,000 patients living with the disease.
Discovered and developed solely by Chi-Med, surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral drug candidate 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, as well as colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib’s unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies. Surufatinib is in proof-of-concept clinical trials in the U.S. and several proof-of-concept and late-stage clinical trials in China, for indications such as neuroendocrine tumors and biliary tract cancer.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. 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 surufatinib, plans to initiate clinical studies for surufatinib, 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 surufatinib, including in combination therapies, 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 surufatinib 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
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
– Late-Breaking Abstract of the positive SANET-ep Phase III trial of surufatinib in patients with non-pancreatic neuroendocrine tumors (“NET”) to be presented –
– Conference call and webcast with lead trial investigators to be held on Monday, September 30 to review surufatinib data –
– Data from ongoing international clinical trials with surufatinib and fruquintinib to be presented –
London: Wednesday, September 25, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) will showcase data from its proprietary clinical programs at the 2019 European Society for Medical Oncology Congress (“ESMO”) on September 27 to October 1, 2019 in Barcelona, Spain.
A key highlight will be the oral presentation of a Late-Breaking Abstract reporting efficacy and safety results from the positive Phase III trial in China of surufatinib in non-pancreatic neuroendocrine tumors (“NET”), known as SANET-ep. An interim analysis in June 2019 confirmed that the study met its primary endpoint of progression-free survival (“PFS”). As a result, the independent data monitoring committee (“IDMC”) recommended the study be stopped, a year ahead of schedule, and preparations are now underway for the submission of a New Drug Application (“NDA”) by the end of 2019 for this indication in China.
The Late-Breaking Abstract will be published on the ESMO website coincident with the its presentation; the details of which are as follows:
|
Title:
|
Efficacy and Safety of Surufatinib in Patients with Well-Differentiated Advanced Extrapancreatic Neuroendocrine Tumors: Results from the Randomized Phase III Study (SANET-ep) |
| Presenting Author: | Jianming Xu, Head of the Department of Gastrointestinal Oncology, The Fifth Medical Center, General Hospital of the PLA |
| Abstract #: | LBA76 |
| Date & Time: | Sunday, September 29, 2019, 16:30 CEST |
| Location: | Tarragona Auditorium (Hall 7), Fira de Barcelona Gran Via Conference Centre |
A conference call and webcast for analysts and investors will be held on Monday September 30, 1 p.m. U.K. time (2 p.m. Barcelona time; 8 a.m. New York time; 8 p.m. Hong Kong time) to review the SANET-ep trial data presented on Sunday, September 29. Safety and tolerability data presented from an ongoing U.S. Phase Ib study of surufatinib in pancreatic NET patients who have progressed on Sutent® or Afinitor® treatment will also be discussed.
Participating in the call will be Dr. James Yao, Chair of GI Oncology at MD Anderson Cancer Center and one of the lead investigators for our ongoing Phase I/Ib surufatinib study in NET, as well as members of the Chi-Med management team. Dial-in details for the conference call will be available prior to the event at www.chi-med.com/event-information, and a replay will also be available shortly after.
Details of the abstract for the U.S. Phase Ib trial of surufatinib in pancreatic NET patients are as follows:
| Title: | Safety and Tolerability of Surufatinib in Western Patients with Solid Tumors |
| Presenting Author: | Erika P. Hamilton, Director, Breast and Gynecologic Cancer Research at Sarah Cannon Research Institute |
| Abstract # & Link: | 1393P |
| Date & Time: | Sunday, September 29, 2019, 12:00 CEST |
| Location: | Hall 4, Fira de Barcelona Gran Via Conference Centre |
Fruquintinib in the U.S. and Europe: Safety and tolerability of fruquintinib in Western patients with solid tumors will be presented. Fruquintinib is currently in planning for a Phase III registration study in the U.S. and Europe in metastatic colorectal cancer (“CRC”) patients who are resistant to or intolerant of prior treatment with Stivarga® or Lonsurf®. In China, fruquintinib is currently sold under the brand name Elunate®, and is for the treatment of patients with metastatic CRC 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).
| Title: | Phase 1 Trial of Fruquintinib in Patients with Advanced Solid Tumors: Results of the Dose Escalation Phase |
| Presenting Author: | Andrea Wang-Gillam, Associate Professor of Medicine, Division of Oncology, Section of Medical Oncology, Washington University School of Medicine |
| Abstract #: | 467P |
| Date & Time: | Saturday, September 28, 2019, 12:00 CEST |
| Location: | Hall 4, Fira de Barcelona Gran Via Conference Centre |
Chi-Med retains all rights to surufatinib worldwide. It retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.
| Title: | A Phase 1 Study of HMPL-523, a Selective Oral Anti-Spleen Tyrosine Kinase Inhibitor, in Patients with Relapsed or Refractory Lymphoma |
| Lead Author: | Nathan Fowler, Associate Professor, Department of Lymphoma/Myeloma, the University of Texas MD Anderson Cancer Center |
| Abstract #: | 1106TiP |
| Date & Time: | Saturday, September 28, 2019, 12:00 CEST |
| Location: | Hall 4, Fira de Barcelona Gran Via Conference Centre |
| Title: | A Phase 1 Study of HMPL-689, a Selective Oral Phosphoinositide 3-Kinase-Delta Inhibitor, in Patients with Relapsed or Refractory Lymphoma |
| Lead Author: | Jonathan B. Cohen, Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine |
| Abstract #: | 1107TiP |
| Date & Time: | Saturday, September 28, 2019, 12:00 CEST |
| Location: | Hall 4, Fira de Barcelona Gran Via Conference Centre |
SANET-ep is a randomized, double-blind, placebo-controlled, multi-center, Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. In June 2019, an interim analysis was conducted, leading to the IDMC determination that the study met the pre-defined primary endpoint of PFS and should be stopped early. Preparations for an NDA submission are now underway for this indication in China. In this study, patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors for whom there is no effective therapy are randomized at a 2:1 ratio to receive either 300 mg of surufatinib orally daily or placebo, on a 28-day treatment cycle. The primary endpoint of the study is to evaluate the PFS, with secondary endpoints including objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), overall survival (OS), safety, and tolerability. Additional details may be found at clinicaltrials.gov, using identifier NCT02588170.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. 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 surufatinib and fruquintinib, plans to initiate clinical studies for surufatinib and 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 candidates surufatinib and fruquintinib, including as a combination therapies, 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 surufatinib and fruquintinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
| Presentation Title : | Association Between Hand-Foot Skin Reaction and Survival Benefit of Fruquintinib in FRESCO Trial |
| Presenting Author: | Yuxian Bai, Harbin Medical University Cancer Hospital |
| Other Authors: | Jin Li, Shukui Qin, Yanhong Deng, Lei Yang, Rui-hua Xu, Zhendong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianming Xu, Lin Shen, Ning Wang, Chao Zhu, Songhua Fan, Wei Gong, Wei Wang |
| Abstract #: | 5517 |
| Session: | CSCO CRC Expert Committee, CRC standardized treatment and MDT |
| Date: | Saturday, September 21, 2019 |
| Time: | 11:17 AM |
Abstract 5517 is a subgroup analysis of the FRESCO results to explore whether patients in the fruquintinib group of the study experiencing hand-foot skin reaction (“HFSR”) saw a greater survival benefit. These reactions of any grade developed in 52% of patients who completed at least one cycle of fruquintinib treatment.
The analysis indicated that patients who reported HFSR had a greater survival benefit from fruquintinib, showing statistically significant benefit in both median OS (11.24 vs. 7.54 months; hazard ratio = 0.57, 95% CI: 0.42-0.78; p<0.001) and median PFS (5.49 vs 3.48 months; hazard ratio = 0.70, 95% CI: 0.54-0.91; p=0.008) compared to those that did not report HFSR.
Results of the FRESCO study were initially presented in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017 and published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
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-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. Fruquintinib has been designed to be a global best-in-class VEGFR inhibitor for many types of solid tumors. It was designed to improve kinase selectivity in comparison to other approved small molecule tyrosine kinase inhibitors, to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.
| Presentation Title : | Subgroup Analysis of Patients With Metastatic Colorectal Cancer Treated With Fruquintinib in the FRESCO Trial Who Had Liver Metastasis |
| Presenting Author: | Shukui Qin, Nanjing Chinese Medicine University Affiliated Bayi Hospital |
| Other Authors: | Jin Li, Rui-Hua Xu, Lin Shen, Jianming Xu, Yuxian Bai, Yanhong Deng, Lei Yang, Zhen-dong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu, Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang Yu, Peiguo Cao, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Xia Qin, Ning Wang, Bin Zhang, Songhua Fan, Xiaojun Guo, Mengye Peng |
| Abstract #: | 5278 |
| Session: | Plenary session |
| Date: | Thursday, September 19, 2019 |
| Time: | 10:45 AM |
The development of metastases is the main cause of death in patients with CRC, and about 70% of patients with CRC develop liver metastases during the course of their disease[i],[ii]. Abstract 5278 is a subgroup analysis to determine the benefit of fruquintinib to patients with liver metastases on study entry. Liver metastases were present in 69% of the patients recruited into the study.
Fruquintinib demonstrated a statistically significant increase in overall survival (“OS”; 8.61 vs. 5.98 months; hazard ratio = 0.59, 95% CI: 0.45-0.77, p<0.001) and progression-free survival (“PFS”; 3.71 vs 1.84 months; hazard ratio = 0.22, 95% CI: 0.17-0.30, p<0.001) as compared with placebo in CRC patients with liver metastasis, while the hepatotoxicity of fruquintinib was comparable with placebo in CRC patients with liver metastasis.
[i] van de Velde CJH. Treatment of liver metastases of colorectal cancer. Annals of Oncology, Volume 16 (Supplement 2): ii144 – ii149, June 2005. doi:10.1093/annonc/mdi702.
[ii] Welch JP & Donaldson GA. The clinical correlation of an autopsy study of recurrent colorectal cancer. Annals of Surgery, 189(4), 496–502, 1979. doi:10.1097/00000658-197904000-00027.
London: Wednesday, September 18, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) shares additional analyses from three completed and ongoing clinical studies of fruquintinib and savolitinib at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (“CSCO”) on September 18 to 22, 2019 in Xiamen, China.
Fruquintinib (Elunate®): Two subgroup analyses will be presented from the FRESCO study, a randomized, double-blind, placebo-controlled, multi-center, Phase III study of fruquintinib efficacy and safety in third-line or above colorectal cancer (“CRC”) patients.
| Presentation Title 1: | Subgroup Analysis of Patients With Metastatic Colorectal Cancer Treated With Fruquintinib in the FRESCO Trial Who Had Liver Metastasis |
| Presenting Author: | Shukui Qin, Nanjing Chinese Medicine University Affiliated Bayi Hospital |
| Other Authors: | Jin Li, Rui-Hua Xu, Lin Shen, Jianming Xu, Yuxian Bai, Yanhong Deng, Lei Yang, Zhen-dong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu, Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang Yu, Peiguo Cao, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Xia Qin, Ning Wang, Bin Zhang, Songhua Fan, Xiaojun Guo, Mengye Peng |
| Abstract #: | 5278 |
| Session: | Plenary session |
| Date: | Thursday, September 19, 2019 |
| Time: | 10:45 AM |
The development of metastases is the main cause of death in patients with CRC, and about 70% of patients with CRC develop liver metastases during the course of their disease[i],[ii]. Abstract 5278 is a subgroup analysis to determine the benefit of fruquintinib to patients with liver metastases on study entry. Liver metastases were present in 69% of the patients recruited into the study.
Fruquintinib demonstrated a statistically significant increase in overall survival (“OS”; 8.61 vs. 5.98 months; hazard ratio = 0.59, 95% CI: 0.45-0.77, p<0.001) and progression-free survival (“PFS”; 3.71 vs 1.84 months; hazard ratio = 0.22, 95% CI: 0.17-0.30, p<0.001) as compared with placebo in CRC patients with liver metastasis, while the hepatotoxicity of fruquintinib was comparable with placebo in CRC patients with liver metastasis.
| Presentation Title 2: | Association Between Hand-Foot Skin Reaction and Survival Benefit of Fruquintinib in FRESCO Trial |
| Presenting Author: | Yuxian Bai, Harbin Medical University Cancer Hospital |
| Other Authors: | Jin Li, Shukui Qin, Yanhong Deng, Lei Yang, Rui-hua Xu, Zhendong Chen, Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianming Xu, Lin Shen, Ning Wang, Chao Zhu, Songhua Fan, Wei Gong, Wei Wang |
| Abstract #: | 5517 |
| Session: | CSCO CRC Expert Committee, CRC standardized treatment and MDT |
| Date: | Saturday, September 21, 2019 |
| Time: | 11:17 AM |
Abstract 5517 is a subgroup analysis of the FRESCO results to explore whether patients in the fruquintinib group of the study experiencing hand-foot skin reaction (“HFSR”) saw a greater survival benefit. These reactions of any grade developed in 52% of patients who completed at least one cycle of fruquintinib treatment.
The analysis indicated that patients who reported HFSR had a greater survival benefit from fruquintinib, showing statistically significant benefit in both median OS (11.24 vs. 7.54 months; hazard ratio = 0.57, 95% CI: 0.42-0.78; p<0.001) and median PFS (5.49 vs 3.48 months; hazard ratio = 0.70, 95% CI: 0.54-0.91; p=0.008) compared to those that did not report HFSR.
Results of the FRESCO study were initially presented in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017 and published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
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-related angiogenesis, cutting off the blood supply that a tumor needs to grow rapidly. Fruquintinib has been designed to be a global best-in-class VEGFR inhibitor for many types of solid tumors. It was designed to improve kinase selectivity in comparison to other approved small molecule tyrosine kinase inhibitors, to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. Chi-Med retains all rights to fruquintinib outside of China and is partnered with Eli Lilly and Company in China.
Savolitinib:
| Presentation Title: | Phase II Study of Savolitinib in Patients with NSCLC Harboring MET Exon 14 Skipping Mutations: Preliminary Efficacy and Safety Results |
| Presenting Author: | Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University |
| Other Authors: | Jian Fang, Xingya Li, Jianying Zhou, Lejie Cao, Ying Cheng, Liyan Jiang, Qisen Guo, Zongan Liang, Yuan Chen, Helong Zhang, Nong Yang, Hua Xu, Xin Zhang, Biao Wu, Jianhua Shi, Zhigang Han, Jianjin Huang, Zhixiong Yang, Xiaodong Zhang, Gongyan Chen, Yanping Hu, Jingxun Wu, Shan Zeng, Sanyuan Sun, Longzhen Zhang, Rui Ma, Xiaorong Dong, Di Zhang, Jing Li, Linfang Wang, Yongxin Ren, Weiguo Su |
| Abstract #: | 5707 |
| Session: | CSCO NSCLC Expert Committee, SCLC Expert Committee, MDT for liver cancer with ALK and other rare mutations |
| Date: | Friday, September 20, 2019 |
| Time: | 4:40 PM |
Abstract 5707 highlights updated preliminary efficacy and safety results from the ongoing China Phase II study of savolitinib monotherapy in NSCLC patients with mesenchymal epithelial transition receptor (“MET”) Exon 14 skipping mutations who have failed prior systemic therapy or are unable to receive chemotherapy.
Savolitinib showed promising antitumor activity in this population with rapid and durable tumor response and disease control, anti-tumor activity in brain metastasis, and a generally tolerable safety profile with mostly grade 1 or 2 related treatment emergent adverse events. The study continues to enroll patients. Earlier results of this study were first presented on March 31, 2019 at the American Association of Cancer Research (AACR) Annual Meeting 2019 (clinicaltrials.gov identifier: NCT02897479).
Savolitinib is a potent and selective inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. In clinical studies to date in over 1,000 patients globally, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in lung cancer, kidney cancer, and gastric cancer with an acceptable safety profile. Chi-Med is currently testing savolitinib in global partnership with AstraZeneca, both as a monotherapy and in combinations.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. 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 and savolitinib, plans to initiate clinical studies for fruquintinib and savolitinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidates fruquintinib and savolitinib, including as a combination therapies, 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 and savolitinib for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
—
[i] van de Velde CJH. Treatment of liver metastases of colorectal cancer. Annals of Oncology, Volume 16 (Supplement 2): ii144 – ii149, June 2005. doi:10.1093/annonc/mdi702.
[ii] Welch JP & Donaldson GA. The clinical correlation of an autopsy study of recurrent colorectal cancer. Annals of Surgery, 189(4), 496–502, 1979. doi:10.1097/00000658-197904000-00027.
Morgan Stanley Office, Hong Kong
Macquarie Office, Hong Kong
Venue: IASLC 2019 World Conference on Lung Cancer in Barcelona, Spain
Session:MA14 – The Adequate MTarget Is Still the Issue
Date: Monday, September 09, 2019
Time: 15:45-17:15
Presenter: Shun Lu
Authors: Gongyan Chen, Yuping Sun, Sanyuan Sun, Jianhua Chang, Yu Yao, Zhendong Chen, Feng Ye, Junguo Lu, Jianhua Shi, Jianxing He, Xiaoqing Liu, Yiping Zhang, Zhihua Liu, Jian Fang, Ying Cheng, Chunhong Hu, Weidong Mao, Yanping Hu, Youling Gong, Li Shan, Zhixiong Yang, Yong Song, Wei Li, Chong Bai, buhai Wang, Rui Ma, Zhendong Zheng, Mingfang Liu, Zhijun Jie, Lejie Cao, Wangjun Liao, Hongming Pan, Dongning Huang, Yuan Chen, Jinji Yang, Shukui Qin, Shenglin Ma, Li Liang, Zhe Liu, Jianying Zhou, Min Tao, Yijiang Huang, Feng Qiu, Yunchao Huang, Ye Hua, Yiping Chen, Weiguo Su
Background
Fruquintinib, an orally active kinase inhibitor that selectively targets vascular endothelial growth factor (VEGF) receptor, demonstrated significant benefit in progression-free survival and disease control in a randomized Phase II study in patients with non-small-cell lung cancer (NSCLC) who had failed two lines of chemotherapy. This Phase III FALUCA trial is a randomized, double-blind, placebo-controlled, multicenter trial designed to confirm the efficacy in the same patient population (NCT02691299).
Method
From December 2015 to February 2018, 45 clinical centers across China participated in the trial. A total of 730 patients aged 18-75 with advanced NSCLC who had failed two lines of chemotherapy were screened and 527 who met the eligibility criteria were enrolled into the study. Patients were stratified based on epidermal growth factor receptor mutation status and prior use of VEGF inhibitor therapy, and were randomized in a 2:1 ratio to receive fruquintinib (n=354) or placebo (n=173) once daily in a 3 weeks on/1 week off 4-week cycle. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), duration of response. The final data cutoff was on September 21, 2018.
Result
Median OS was 8.94 months for fruquintinib and 10.38 months for placebo (hazard ratio, 1.02; 95% CI, 0.816 to 1.283; p=0.841). Median PFS was 3.68 months for fruquintinib comparing to 0.99 months for placebo, respectively (hazard ratio, 0.34; 95%CI, 0.279 to 0.425; p<0.001). The ORR and DCR were 13.8% and 66.7% for fruquintinib, compared with 0.6% and 24.9% for placebo (both p<0.001), respectively. The most frequent treatment-emergent adverse events with fruquintinib (≥grade 3) were hypertension (20.7%), hand-foot syndrome (11.0%), and proteinuria (1.4%). A sensitivity analysis revealed that median OS was significantly prolonged with fruquintinib compared with placebo in patients who received no subsequent systemic anti-tumor therapies (7.00 months versus 5.06 months ; hazard ratio, 0.64; 95%CI, 0.453 to 0.903; p=0.010).
Conclusion
The FALUCA trial failed to meet the primary end point of OS while confirming significant benefit in secondary end points including PFS, ORR and DCR. The safety profile of fruquintinib in this patient population was acceptable and consistent with that identified in the Phase II study. A post-hoc sensitivity analysis revealed that the anti-tumor therapies that patients received post disease progression probably contributed to the failure of this study on the primary end point.
Grand Hyatt, Hong Kong
| Location: New York, NY, United States |
| Time: 09:55 AM EDT |
London: Tuesday, September 3, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that Christian Hogg, Chief Executive Officer, will participate in a fireside chat at Morgan Stanley 17th Annual Global Healthcare Conference on Wednesday, September 11, 2019 at 9:55 am (EDT) in New York, NY.
The presentation will be webcast live and can be accessed at www.chi-med.com in the Shareholder Information section under “Events, Circulars & Forms.” Investors interested in listening to the live webcast should log on before the start time to download any software required. A replay of the event will be available shortly thereafter, for 90 days.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. 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.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
+1 (973) 567 3786
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout
+1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
Hong Kong & Asia ex-China – Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China – Sam Shen, Edelman
+86 1367 179 1029 (Mobile)
sam.shen@edelman.com
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500
London: Tuesday, September 3, 2019: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated an international Phase I/Ib study of HMPL-689, its novel, highly selective and potent small molecule phosphoinositide-3 kinase delta isoform (“PI3Kδ”) inhibitor, in patients with relapsed or refractory lymphoma. The first patient was dosed on August 26, 2019 in the U.S.
The international clinical study, with sites in the U.S. and Europe, is a multi-center, open-label, two-stage study, including dose escalation and expansion, investigating the effects of HMPL-689 administered orally to patients with relapsed or refractory lymphoma. The primary outcome measures are safety and tolerability. Secondary outcomes include pharmacokinetic (“PK”) measurements and preliminary efficacy such as objective response rate (ORR). The co-lead investigators of the study are Dr. Nilanjan Ghosh (Lymphoma Program Director, Levine Cancer Institute-Morehead, Charlotte, NC), and Dr. Jonathan B. Cohen (Associate Professor, Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA). Additional details may be found at clinicaltrials.gov, using identifier NCT03786926.
This study complements the ongoing Phase I/Ib dose escalation and expansion study of HMPL-689 in China (clinicaltrials.gov identifier: NCT03128164) addressing a broad range of hematological cancers. A Phase I dose escalation study in Australia in healthy adult volunteers to evaluate HMPL-689’s PK and safety profile following single oral dosing was completed in 2016 (clinicaltrials.gov identifier: NCT02631642).
HMPL-689 is a novel, potential best-in-class, highly selective and potent small molecule inhibitor targeting the isoform PI3Kδ. In preclinical PK studies, HMPL-689’s PK properties have been found to be favorable with expected good oral absorption, moderate tissue distribution and low clearance. HMPL-689 is also expected to have low risk of drug accumulation and drug-to-drug interaction and is highly potent, particularly at the whole blood level.
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical company which researches, develops, manufactures and markets pharmaceutical products. Its Innovation Platform, Hutchison MediPharma, has about 440 scientists and staff focusing on discovering, developing and commercializing targeted therapies and immunotherapies in oncology and autoimmune diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world. Chi-Med’s Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products, covering an extensive network of hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the AIM market of the London Stock Exchange and the Nasdaq Global Select Market. 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 HMPL‑689, plans to initiate further clinical studies for HMPL‑689, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward‑looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate HMPL‑689 to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL‑689 for a targeted indication and the sufficiency of funding. Existing and prospective investors are cautioned not to place undue reliance on these forward‑looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi‑Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi‑Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Mark Lee, Senior Vice President, Corporate Finance & Development
+852 2121 8200
Annie Cheng, Vice President, Corporate Finance & Development
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David Dible, Citigate Dewe Rogerson
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Xuan Yang, Solebury Trout
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UK & Europe – Anthony Carlisle, Citigate Dewe Rogerson
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Hong Kong & Asia ex-China – Joseph Chi Lo, Brunswick
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Hong Kong & Asia ex-China – Zhou Yi, Brunswick
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Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited
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