- Hutchmed
- | Announcements & Press Releases
London: Friday, June 30, 2017: For information purposes, Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) hereby notifies the market that as at June 30, 2017, the issued share capital of Chi-Med consisted of 60,737,204 ordinary shares of US$1.00 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 60,737,204 may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, Chi-Med under the Financial Conduct Authority’s Disclosure Rules and Transparency Rules.
For illustrative purposes only, the 60,737,204 ordinary shares would be equivalent to 60,737,204 CREST depositary interests (each equating to one ordinary share) which are traded on AIM or, if the CREST depositary interests were converted in their entirety, equivalent to 121,474,408 American depositary shares (each equating to one-half of one ordinary share) which are traded on Nasdaq.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
| AstraZeneca PLC (“AstraZeneca”) (LON/STO/NYSE: AZN) |
Hutchison China MediTech Limited (“Chi-Med”) |
London: Thursday, June 29, 2017: Chi-Med and AstraZeneca today announce that they have initiated a global pivotal Phase III, open-label, randomized multi-center registration study of the highly selective inhibitor of c-MET receptor tyrosine kinase, savolitinib, in c-MET-driven papillary renal cell carcinoma (“PRCC”). This is the first pivotal study ever conducted in c-MET-driven PRCC and the first molecularly selected trial in renal cell carcinoma (“RCC”).
“The launch of the SAVOIR trial, designed to support product registration in the U.S. and Europe, continues to advance our strategy to deliver innovative medicines to major markets worldwide,” said Christian Hogg, Chief Executive Officer of Chi-Med. “Based on the results of our Phase II study, we believe savolitinib has the potential to bring meaningful clinical benefit to patients with c-MET-driven PRCC. We also expect to further understand the correlations between c-MET alterations and patient outcomes through epidemiological analyses using our newly developed companion diagnostic assay.”
Susan Galbraith, SVP IMED Oncology, AstraZeneca commented that “It is exciting to achieve this milestone in savolitinib’s development. The data building across our early development studies are encouraging, that savolitinib has the potential to be an important treatment option for c-MET driven cancers including kidney, lung and gastric cancers.”
The initiation of this Phase III trial has triggered a US$5 million milestone payment to Hutchison MediPharma Limited (a 99.8% subsidiary of Chi-Med) from AstraZeneca under the terms of the license and collaboration agreement signed between them in 2011 (as amended).
In addition to SAVOIR, Chi-Med and AstraZeneca are conducting a number of Phase Ib and II studies of savolitinib in kidney cancer, lung cancer and gastric cancer. These studies involve savolitinib as a monotherapy or in combination with other targeted therapy, such as Tagrisso® (osimertinib) or Iressa® (gefitinib). Additional studies combining with Imfinzi® (durvalumab) and Taxotere® (docetaxel) are also in progress.
About SAVOIR
SAVOIR is a global Phase III, open-label, randomized, controlled trial evaluating the efficacy and safety of savolitinib, compared with sunitinib, in patients with c-MET-driven, unresectable, locally advanced or metastatic PRCC. Approximately 180 patients will be randomized at 50 to 75 sites across five to ten countries. c-MET status is confirmed by the novel targeted next-generation sequencing (NGS) assay developed for savolitinib. Patients will be randomized in a 1:1 ratio to receive either continuous treatment with savolitinib 600 mg (400 mg if <50 kg) orally, once daily, or intermittent treatment with sunitinib 50 mg orally once daily (4 weeks on/2 weeks off), on a 6-week cycle.
The primary objective is to evaluate the primary efficacy endpoint progression free survival (“PFS”) of savolitinib as compared with sunitinib. Secondary endpoints include overall survival, objective response rate (“ORR”), duration of response, best percentage change in tumor size, disease control rate, and safety and tolerability. The impact of savolitinib compared with sunitinib on disease symptoms and quality of life, along with the pharmacokinetics of savolitinib will also be assessed. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03091192.
About Savolitinib
Savolitinib (AZD6094/HMPL-504) is a potential first-in-class selective inhibitor of c-MET (also known as mesenchymal epithelial transition factor) receptor tyrosine kinase, an enzyme which has been shown to function abnormally in many types of solid tumors. It was developed as a potent and highly selective oral inhibitor specifically designed to address issues observed in the clinic with other selective c-MET inhibitors, such as renal toxicity.
Savolitinib was discovered by Chi-Med and is being developed in collaboration with AstraZeneca. Savolitinib is currently being studied in multiple tumor types worldwide including kidney, lung and gastric cancers, both as a monotherapy or in combination with other targeted and immunotherapy agents.
About c-MET-Driven PRCC
Worldwide, about 366,000 new patients are diagnosed with kidney cancer annually. RCC accounts for approximately 80-85% of kidney cancer and has several histological sub-types with different genetic and biochemical characteristics. PRCC is the most common of the non-clear cell renal carcinomas accounting for 10-15% of RCC. However, the biology and molecular characteristics of PRCC are different from those of clear cell RCC (“ccRCC”). Multiple studies indicate that PRCC is c-MET-driven in 40-70% of patients.
There are no therapies approved for patients with PRCC, who currently receive treatments approved for RCC such as sunitinib. These RCC agents were mostly approved on the basis of studies where the majority of subjects were ccRCC patients and where the benefits to the PRCC minority were more modest. Currently the National Comprehensive Cancer Network Guidelines advise PRCC patients to enter clinical trials.
About Savolitinib in PRCC
In February 2017, the results of a global Phase II multicenter study in advanced PRCC was presented at the 2017 American Society of Clinical Oncology Genitourinary Cancers Symposium, which indicated a clear efficacy signal with savolitinib monotherapy in c-MET-driven patients. Median PFS of 6.2 months in c-MET-driven patients as compared with 1.4 months (p<0.0001) in c-MET-independent patients. ORR was 18.2% in c-MET-driven patients vs. 0% (p=0.002) in c-MET independent patients. An encouraging durable response and safety profile were reported in savolitinib treated patients. Further details are available at www.chi-med.com/asco-gu-2017-savolitinib-ph2-in-prcc-pres/.
Studies of c-MET-driven disease in gastric cancer and lung cancer suggest that c-MET amplification and/or overexpression can be a negative prognostic for disease progression. Over the course of 2017, Chi-Med and AstraZeneca are also conducting a comprehensive molecular epidemiology study of approximately 300 PRCC patient samples to further understand the correlations between c-MET alterations and patient outcomes, including any predictive biomarkers.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least 6 new medicines to be launched between 2014 and 2020 and a broad pipeline of small molecules and biologics in development, we are committed to advance new oncology as one of AstraZeneca’s six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by our investment in Acerta Pharma in hematology.
By harnessing the power of four scientific platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage response and antibody drug conjugates – and by championing the development of personalized combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three main therapy areas – oncology, cardiovascular & metabolic diseases and respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.
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 expectations for the clinical development of savolitinib, plans to initiate clinical studies for 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 candidate savolitinib 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 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 announcement, whether as a result of new information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Thursday, June 29, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announces the following blocklisting six monthly return:
| 1. | Name of applicant: | Hutchison China MediTech Limited |
| 2. | Name of scheme: | Hutchison China MediTech Limited Share Option Schemes |
| 3. | Period of return: | From December 29, 2016 to June 28, 2017 |
| 4. | Balance under scheme from previous return: | 1,361,308 ordinary shares of US$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: | Nil |
| 6. | Number of securities issued/allotted under scheme during period: | 31,381 ordinary shares of US$1 each |
| 7. | Balance under scheme not yet issued/allotted at end of the period: | 1,329,927 ordinary shares of US$1 each |
| 8. | Number and class of securities originally listed and the date of admission: | 2,560,606 ordinary shares of US$1 each admitted on June 26, 2007 |
| 9. | Total number of securities in issue at the end of the period: | 60,737,204 ordinary shares of US$1 each |
| Name of contact: | Christian Hogg | |
| Address of contact: | 21/F., Hutchison House, 10 Harcourt Road, Hong Kong | |
| Telephone number of contact: | +852 2121 8200 |
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
London: Thursday, June 29, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) will be announcing its interim results for the six months ended June 30, 2017 on Monday, July 31, 2017 at 7:00 am British Summer Time (BST).
An analyst presentation will be held at 9:00 am BST (4:00 pm Hong Kong Time) on the same day at Panmure Gordon & Co, One New Change, London EC4M 9AF, UK, which will be webcast via the company website at www.chi-med.com/investors/event-information/. The presentation will be available to download before the analyst presentation begins.
For North America based analysts and investors, Chi-Med will also host a conference call with Q&A at 9:00 am Eastern Daylight Time (2:00 pm BST).
Details of the analyst presentation and conference call dial-in will be provided in the financial results announcement. A replay will also be available on the website shortly after each event.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
Toni K. Choueiri, Elizabeth Plimack, Hendrik-Tobias Arkenau, Eric Jonasch, Daniel Y.C. Heng, Thomas Powles, Melanie M. Frigault, Edwin A. Clark, Amir A. Handzel, Humphrey Gardner, Shethah Morgan, Laurence Albiges, and Sumanta Kumar Pal
Abstract
Purpose
Patients with advanced papillary renal cell carcinoma (PRCC) have limited therapeutic options. PRCC may involve activation of the MET pathway, for example, through gene amplification or mutations. Savolitinib (AZD6094, HMPL-504, volitinib) is a highly selective MET tyrosine kinase inhibitor. We report results of a single-arm, multicenter, phase II study evaluating the safety and efficacy of savolitinib in patients with PRCC according to MET status.
Patients and Methods
Patients with histologically confirmed locally advanced or metastatic PRCC were enrolled and received savolitinib 600 mg orally once daily. MET-driven PRCC was defined as any of the following: chromosome 7 copy gain, focal MET or HGF gene amplification, or MET kinase domain mutations. Efficacy was assessed according to MET status. Safety, toxicity, and patient-reported health-related quality-of-life outcomes were assessed in all patients.
Results
Of 109 patients treated, PRCC was MET driven in 44 (40%) and MET independent in 46 (42%); MET status was unknown in 19 (17%). MET-driven PRCC was strongly associated with response; there were eight confirmed partial responders with MET-driven disease (18%), but none with MET-independent disease (P = .002). Median progression-free survival for patients with MET-driven and MET-independent PRCC was 6.2 months (95% CI, 4.1 to 7.0 months) and 1.4 months (95% CI, 1.4 to 2.7 months), respectively (hazard ratio, 0.33; 95% CI, 0.20 to 0.52; log-rank P < .001). The most frequent adverse events associated with savolitinib were nausea, fatigue, vomiting, and peripheral edema.
Conclusion
These data show activity and tolerability of savolitinib in the subgroup of patients with MET-driven PRCC. Furthermore, molecular characterization of MET status was more predictive of response to savolitinib than a classification based on pathology. These findings justify investigating savolitinib in MET-driven PRCC.
Citations and Links
Please follow the DOI link to access the publication:
J Clin Oncol. 2017 Jun 23:JCO2017722967
DOI link: 10.1200/JCO.2017.72.2967
Intercontinental, Boston, MA, USA
Press Release
London: Thursday, June 22, 2017: Hutchison China MediTech Limited (“Chi‑Med”) (AIM/Nasdaq: HCM) has just initiated a Phase I/II clinical trial of HMPL‑453 in China. HMPL‑453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptor (“FGFR”). The first drug dose was administered on June 19, 2017. This study complements the first-in-human Phase I clinical trial in Australia that was initiated earlier this year.
This Phase I/II study is a multi‑center, single‑arm, open‑label, two‑stage study to evaluate safety, tolerability, pharmacokinetics (“PK”) and preliminary efficacy of HMPL‑453 monotherapy in patients with solid tumors harboring FGFR genetic alterations. The dose-escalation stage will enroll patients with locally advanced or metastatic solid tumors, for whom standard therapy either does not exist or has proven to be ineffective or intolerable, regardless genetic status, to determine the maximum tolerated dose (MTD) and recommended Phase II dose (“RP2D”).
The dose-escalation will be followed by a dose-expansion stage, which will further evaluate safety, tolerability and PK as well as preliminary anti-tumor efficacy at the RP2D. This stage will enroll primarily cancer patients harboring FGFR dysregulated tumors, including those with advanced bladder cancer, advanced cholangiocarcinoma and other solid tumors. For this second stage, the primary endpoint is objective response rate (ORR), with secondary endpoints including duration of response (DoR), disease control rate (DCR), progression free survival (PFS), overall survival (OS) and safety. Additional details about this study can be found at clinicaltrials.gov, using identifier NCT03160833.
About bladder cancer and cholangiocarcinoma
Bladder cancer makes up approximately 90% of urothelial carcinomas. Bladder cancer is the sixth most common cancer in the U.S., and the ninth most common cancer in China, with about 80,000 new cases annually in both countries.[1],[2] In the U.S. the five-year survival rate for those whose disease has metastasized is approximately 5%.[1] Despite advances in the treatment of locally advanced or metastatic urothelial carcinoma, the prognosis for patients remains poor and more treatment options are needed.
A highly unmet medical need around the world, cholangiocarcinoma (bile duct cancer, “CCA”) accounts for approximately 3% of all gastrointestinal cancers and is the most common malignancy of the biliary tract (the combined system of the liver, gall bladder and bile ducts).[3] CCA is classified as intrahepatic or extrahepatic based on anatomical location, with studies suggesting that the incidence of intrahepatic CCA in particular is increasing.[4] Currently CCA has a bleak prognosis, with a 5-year survival rate of less than 5%.[5]
About FGFR
FGFRs are a sub‑family of receptor tyrosine kinases. Activation of FGFR signaling pathways is central to several biological processes. In normal physiology, FGF/FGFR signaling is involved in embryonic development (organogenesis and morphogenesis), tissue repair, angiogenesis, neuroendocrine and metabolism homeostasis. Given its complexity and critical role in a number of important physiological processes, aberrant FGFR signaling has been found to be a driving force in tumor growth, promotion of angiogenesis, as well as conferring resistance to anti‑tumor therapies. To date, there are no approved therapies specifically targeting the FGFR signaling pathway.
About HMPL‑453
HMPL‑453 is a novel, highly selective and potent small molecule inhibitor targeting fibroblast growth factor receptors 1, 2 and 3. In pre‑clinical studies, HMPL‑453 demonstrated superior potency and better kinase selectivity as compared to other drugs in the same class, as well as a favorable safety profile. Chi‑Med is also conducting a Phase I study of HMPL‑453 in Australia, for which additional details can be found at clinicaltrials.gov, using identifier NCT02966171.
About Chi‑Med
Chi‑Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi‑Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi‑med.com.
Forward‑Looking Statements
This 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‑453, plans to initiate clinical studies for HMPL‑453, 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 HMPL‑453 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‑453 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.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
[1] National Cancer Institute. The Surveillance, Epidemiology, and End Results (SEER): Cancer Stat Facts: Bladder Cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Accessed May 23, 2017.
[2] R. Zheng et al, National estimates of cancer prevalence in China 2011, Cancer Letters 2016 370(1) 33-38.
[3] A. Bergquist et al, Epidemiology of cholangiocarcinoma, Best Pract Res Clin Gastroenterol 2015 29(2) 221–32.
[4] T. Patel, Cholangiocarcinoma, Nat Clin Pract Gastroenterol Hepatol 2006 3(1) 33-42.
[5] J. Byrling et al, Cholangiocarcinoma-current classification and challenges towards personalised medicine, Scand J Gastroenterol 2016 51(6) 641-3.
Mandarin Oriental, Hong Kong
London: Friday, June 16, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has received notifications that:-
- Dynamic Drive Limited, a person closely associated (“PCA”) with Mr Simon To, Executive Director and Chairman, purchased a total of 11,158 American Depositary Shares of the Company (“ADSs”, each representing one half of one ordinary share of US$1.00 each in the capital of Chi-Med (“Ordinary Share”)) between June 13 and 15, 2017 at an average price of US$21.18 per ADS. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust (the “DDT”) which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor;
- Wencheng Capital Limited (“WCL”), a PCA with Mr To, purchased a total of 25,669 ADSs between June 13 and 15, 2017 at an average price of US$21.15 per ADS. WCL is controlled by the trustee of Wencheng Trust (“WT”) which has been established for the benefit of Mr To’s family member, of which Mr To is the settlor;
- Mr To transferred a total of 70,000 ADSs from an account in his own name to WCL on June 14, 2017; and
- Ms Edith Shih, Non-executive Director and Company Secretary, purchased a total of 25,403 ADSs on June 14 and 15, 2017 at an average price of US$21.17 per ADS.
Following the above purchase of a total of 36,827 ADSs and transfer of 70,000 ADSs, Mr To is interested in 106,827 ADSs (in DDT and WT of which his family members are the beneficiaries) and 180,000 Ordinary Shares (including the holding of 78,000 Ordinary Shares in DDT of which his family members are the beneficiaries), representing in aggregate approximately 0.38% of the current issued share capital of Chi-Med.
Following the above purchase, Ms Shih is interested in 76,144 ADSs and 60,000 Ordinary Shares, representing approximately 0.16% of the current issued share capital of Chi-Med.
The notification set out below is provided in accordance with the requirements of the EU Market Abuse Regulation.
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Dynamic Drive Limited | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Dynamic Drive Limited is controlled by the trustee of Dynamic Drive Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||
| a) | Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 11,158 ADSs in the name of Dynamic Drive Limited which holds the ADSs for a family trust (Dynamic Drive Trust) of which Mr To is the settlor between June 13 and 15, 2017 at an average price of US$21.18 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 11,158 Price information: US$21.18 |
||||||||
| e) | Date of the transaction | 2017-06-13 – acquisition of 6,780 ADSs 2017-06-14 – acquisition of 500 ADSs 2017-06-15 – acquisition of 3,878 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Wencheng Capital Limited | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Wencheng Capital Limited is controlled by the trustee of Wencheng Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||
| a) | Description of the financial instrument, type of instrument Identification code |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 25,669 ADSs in the name of Wencheng Capital Limited which holds the ADSs for a family trust (Wencheng Trust) of which Mr To is the settlor between June 13 and 15, 2017 at an average price of US$21.15 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 25,669 Price information: US$21.15 |
||||||||
| e) | Date of the transaction | 2017-06-13 – acquisition of 16,958 ADSs 2017-06-14 – acquisition of 1,300 ADSs 2017-06-15 – acquisition of 7,411 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | ||||||||
| a) | Name | Mr Simon To | |||||||
| 2 | Reason for the notification | ||||||||
| a) | Position/status | Executive Director and Chairman | |||||||
| b) | Initial notification/Amendment | Initial notification | |||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | ||||||||
| a) | Name | Hutchison China MediTech Limited | |||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | |||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | ||||||||
| a) | Description of the financial instrument, type of instrument Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
|||||||
| b) | Nature of the transaction | Disposal of 70,000 ADSs from Mr Simon To to Wencheng Capital Limited which holds the ADSs for a trust (Wencheng Trust), established for the benefit of Mr To’s family members, of which Mr To is the settlor on June 14, 2017 | |||||||
| c) | Price(s) and volume(s) |
|
|||||||
| d) | Aggregated information
|
N/A | |||||||
| e) | Date of the transaction | 2017-06-14 | |||||||
| f) | Place of the transaction | Outside a trading venue | |||||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||
| a) | Name | Wencheng Capital Limited | ||||
| 2 | Reason for the notification | |||||
| a) | Position/status | Person closely associated with Mr Simon To, Executive Director and Chairman. Wencheng Capital Limited is controlled by the trustee of Wencheng Trust which has been established for the benefit of Mr To’s family members, of which Mr To is the settlor. | ||||
| b) | Initial notification/Amendment | Initial notification | ||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||
| a) | Name | Hutchison China MediTech Limited | ||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||
| a) | Description of the financial instrument, type of instrument Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||
| b) | Nature of the transaction | Acquisition of 70,000 ADSs in the name of Wencheng Capital Limited which holds the ADSs for a family trust (Wencheng Trust) of which Mr To is the settlor on June 14, 2017 | ||||
| c) | Price(s) and volume(s) |
|
||||
| d) | Aggregated information
|
N/A | ||||
| e) | Date of the transaction | 2017-06-14 | ||||
| f) | Place of the transaction | Outside a trading venue | ||||
| 1 | Details of the person discharging managerial responsibilities/person closely associated | |||||||||
| a) | Name | Ms Edith Shih | ||||||||
| 2 | Reason for the notification | |||||||||
| a) | Position/status | Non-executive Director and Company Secretary | ||||||||
| b) | Initial notification/Amendment | Initial notification | ||||||||
| 3 | Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor | |||||||||
| a) | Name | Hutchison China MediTech Limited | ||||||||
| b) | LEI | 2138006X34YDQ6OBYE79 | ||||||||
| 4 | Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted | |||||||||
| a) | Description of the financial instrument, type of instrument Identificationcode |
ADS each representing one half of one Ordinary Share of US$1.00 ADS ISIN: US44842L1035 |
||||||||
| b) | Nature of the transaction | Acquisition of 25,403 ADSs on June 14 and 15, 2017 at an average price of US$21.17 per ADS | ||||||||
| c) | Price(s) and volume(s) |
|
||||||||
| d) | Aggregated information
|
Aggregated volume: 25,403 Price information: US$21.17 |
||||||||
| e) | Date of the transaction | 2017-06-14 – Acquisition of 24,445 ADSs 2017-06-15 – Acquisition of 958 ADSs |
||||||||
| f) | Place of the transaction | Nasdaq Stock Market | ||||||||
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
– Application accepted by CFDA for technical review by the Center for Drug Evaluation –
– Triggers RMB30.8 million milestone payment from Eli Lilly and Company (“Lilly”) –
London: Monday, June 12, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today announces that the China Food and Drug Administration (“CFDA”) has acknowledged acceptance of the New Drug Application (“NDA”) for fruquintinib for the treatment of patients with advanced colorectal cancer, which triggers a milestone payment of RMB30.8 million (US$4.5 million) from Lilly to Chi-Med. The NDA is supported by data from the successful FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with locally advanced or metastatic colorectal cancer (“CRC”) in China, which was highlighted in an oral presentation at the American Society of Clinical Oncology Annual Meeting on June 5, 2017.
About CRC
CRC is the second most common cancer type in China, with about 380,000 new cases per year, according to National Central Cancer Registry of China. There were approximately 1.5 million new CRC cases globally in 2015 which are expected to increase to approximately 1.7 million new cases per year by 2020, according to Frost & Sullivan.
About Fruquintinib
Fruquintinib is a highly selective small molecule drug candidate that has been shown to inhibit vascular endothelial growth factor receptor (“VEGFR”) 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy.
At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
Fruquintinib is currently under joint development in China by Chi-Med and its partner Lilly. Chi-Med and Lilly jointly announced top-line results from the FRESCO CRC trial on March 3, 2017. In addition, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer (“NSCLC”), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the United States, and certain exploratory studies in combination with other oncology agents.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
Forward-Looking Statements
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations for the clinical development of fruquintinib, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding. 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.
Inside Information
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
CONTACTS
Investor Enquiries
Christian Hogg, CEO
+852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
+44 (20) 7886 2500
Press Release
Chicago: Monday, June 5, 2017: Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) announced that results from its pivotal Phase III trial with fruquintinib, its novel vascular endothelial growth factor receptor (“VEGFR”) kinase inhibitor, were highlighted in an oral presentation today during the American Society of Clinical Oncology Annual Meeting (“ASCO”), held in Chicago. Results showed that FRESCO, a randomized, double-blind, placebo-controlled, multi-centered Phase III trial assessing fruquintinib in patients with locally advanced or metastatic colorectal cancer (“CRC”) in China, met all primary and secondary endpoints including significant improvements in overall and progression-free survival with a manageable safety profile and lower off-target toxicities compared to other targeted therapies.
“Data from this 416-patient trial showed that treatment with fruquintinib resulted in statistically significant and clinically meaningful survival benefits in colorectal cancer patients who failed two previous lines of systemic therapy,” said Dr. Jin Li, Director of the Department of Oncology, Tongji University affiliated Shanghai East Hospital. “Importantly, adverse events associated with fruquintinib therapy were manageable and controllable. Particularly encouraging was that fruquintinib showed relatively low frequency and less severe liver function abnormalities as compared with other targeted therapies used in this disease setting.”
“The totality of safety and efficacy data suggest fruquintinib can be an important new treatment option for patients whose colorectal cancer continues to progress,” he concluded.
Efficacy Results
The FRESCO trial is a randomized, double-blind, placebo-controlled, multicenter, Phase III pivotal trial in patients with locally advanced or metastatic CRC who have failed at least two prior systemic antineoplastic therapies, including fluoropyrimidine, oxaliplatin and irinotecan. No drugs have been approved in third-line CRC in China, with best supportive care (“BSC”) being the general standard of care. Enrollment was completed in May 2016. 519 patients were screened. The intention-to-treat (ITT) population of 416 patients was randomized at a 2:1 ratio to receive either: 5mg of fruquintinib orally once per day, on a three-weeks-on / one-week-off cycle, plus BSC (278 patients); or placebo plus BSC (138 patients). Randomization was stratified for prior anti-VEGF therapy and K-Ras gene status. The trial was concluded on January 17, 2017.
The primary endpoint of median overall survival (OS) was 9.30 months [95% CI 8.18–10.45] in the fruquintinib group vs. 6.57 months [95% CI 5.88–8.11] in the placebo group, with a hazard ratio of 0.65 [95% CI: 0.51–0.83; two-sided p<0.001].
The secondary endpoint of median progression-free survival (PFS) was 3.71 months [95% CI 3.65–4.63] in the fruquintinib group vs. 1.84 months [95% CI 1.81–1.84] in the placebo group, with a hazard ratio of 0.26 [95% CI: 0.21–0.34; two-sided p<0.001].
Significant benefits were also seen in other secondary endpoints. The fruquintinib group disease control rate (DCR) was 62.2% vs. 12.3% for placebo (p<0.001), while the overall response rate (ORR) was 4.7% vs. 0% for placebo (p=0.012).
Safety and Tolerability Results
Results showed that fruquintinib had a manageable safety profile with lower off-target toxicities compared to other targeted therapies, and did not demonstrate the sometimes severe and fatal hepatotoxicity (liver toxicity) observed with other therapies in this disease setting. The most frequently reported fruquintinib-related grade ≥3 adverse events included hypertension (21.2%), hand-foot skin reaction (10.8%), proteinuria (3.2%) and diarrhea (2.9%), all associated with VEGFR inhibition. No other grade ≥3 adverse events exceeded 1.4% in the fruquintinib population, including hepatic function adverse events such as elevations in bilirubin (1.4%), alanine aminotransferase (ALT) (0.7%) or aspartate aminotransferase (AST) (0.4%).
Dose interruptions or reductions occurred in only 35.3% and 24.1% of patients in the fruquintinib arm, respectively, and only 15.1% of patients discontinued treatment vs. 5.8% for placebo.
The FRESCO study may be found at clinicaltrials.gov using identifier NCT02314819. The presentation will be available at chi-med.com/wp-content/uploads/2017/06/pre170605-013asco.pdf.
Chi-Med expects to complete the New Drug Application (NDA) submission for fruquintinib to the China Food and Drug Administration imminently. The Company also expects to initiate U.S. clinical studies in 2017.
About Fruquintinib
Fruquintinib is a highly selective small molecule drug candidate that has been shown to inhibit VEGFR 24 hours a day via an oral dose, with lower off-target toxicities compared to other targeted therapies. Its tolerability, along with its clean drug-drug interaction profile demonstrated to date, may enable rational combination with other cancer therapies such as in our ongoing clinical trials of fruquintinib in combination with chemotherapy and targeted therapy.
At an advanced stage, tumors secrete large amounts of VEGF, a protein ligand, to stimulate formation of excessive vasculature (angiogenesis) around the tumor to provide greater blood flow, oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal roles in tumor-related angiogenesis, and fruquintinib inhibits the VEGF/VEGFR pathway. This represents an important therapeutic strategy in blocking the development of new blood vessels essential for tumors to grow and invade.
Fruquintinib is currently under joint development in China by Chi-Med and its partner Eli Lilly and Company (“Lilly”). Chi-Med and Lilly jointly announced top-line results from the FRESCO CRC trial on March 3, 2017. In addition, fruquintinib is being studied in China in a Phase III pivotal trial in non-small cell lung cancer (“NSCLC”), known as FALUCA; and a Phase II study using fruquintinib combined with Iressa® (gefitinib) in the first-line setting for patients with advanced or metastatic NSCLC. Other studies currently being planned, and soon to be initiated, include a Phase III study in gastric cancer in combination with paclitaxel in China, new studies in the United States, and certain exploratory studies in combination with other oncology agents.
About Chi-Med
Chi-Med is an innovative biopharmaceutical company which researches, develops, manufactures and sells pharmaceuticals and healthcare products. Its Innovation Platform, Hutchison MediPharma Limited, focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases for the global market. Its Commercial Platform manufactures, markets, and distributes prescription drugs and consumer health products in China.
Chi-Med is majority owned by the multinational conglomerate CK Hutchison Holdings Limited (SEHK: 0001). For more information, please visit: www.chi-med.com.
Forward-Looking Statements
This 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, plans to initiate clinical studies for fruquintinib, its expectations as to whether such studies would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria, changes to clinical protocols or regulatory requirements, unexpected adverse events or safety issues, the ability of the drug candidate fruquintinib to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of fruquintinib for a targeted indication and the sufficiency of funding. In addition, as certain studies rely on the use of Iressa® (gefitinib) and Taxol® (paclitaxel) as a combination therapeutic with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Iressa® and Taxol®. 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.
CONTACTS
Investor Enquiries
Christian Hogg, CEO +852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson
+44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications
+1 (917) 570 7340 (Mobile)
bmiles@bmccommunications.com
Susan Duffy, BMC Communications
+1 (917) 499 8887 (Mobile)
sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group
+1 (917) 415 1750 (Mobile)
mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson
+44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
A randomized, double-blind, placebo-controlled, multi-centered phase III trial comparing fruquintinib versus placebo plus best supportive care in Chinese patients with metastatic colorectal cancer (FRESCO)
Venue: American Society of Clinical Oncology Annual Meeting in Chicago, IL
Abstract #: 3508
Presenter: Dr. Jin Li, Oncologist and Director of the Tumor Department, Shanghai East Hospital, Tongji University School of Medicine
Authors: J Li, S Qin, RH Xu, J Xu, L Shen, Y Bai, Y Deng, L Yang, ZD Chen, H Zhong, H Pan, W Guo, Y Shu, Y Yuan, J Zhou
Session: Gastrointestinal (Colorectal) Cancer – Oral Abstract Session
Date & Time: Monday, June 5, 2017, 5:24 PM CDT
Location: Hall D2
A phase II multicenter trial of the multitargeted kinase inhibitor sulfatinib in advanced medullary thyroid cancer (MTC) and radioiodine (RAI)-refractory differentiated thyroid cancer (DTC)
Venue: American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, USA
Abstract #: 6037
Authors: J Chen, Q Ji, J Cao, D Ji, C Bai, Y Lin, B Pan, G Sun, J Li, C Qi, Y Hua
Session: Head and Neck Cancer
Date & Time: Monday, June 5, 2017, 1:15 PM CDT
Location: Hall A