Hutchison China MediTech Limited (HCM.L)
| Previous close | 466.00 |
| Open | 462.00 |
| Bid | 478.00 x 0 |
| Ask | 482.00 x 0 |
| Day's range | 462.00 - 489.00 |
| 52-week range | 249.10 - 538.00 |
| Volume | 29,663 |
| Avg. volume | 74,946 |
| Market cap | 3.5B |
| Beta (5Y monthly) | 0.71 |
| PE ratio (TTM) | N/A |
| EPS (TTM) | -16.40 |
| Earnings date | 30 Jul 2020 |
| Forward dividend & yield | N/A (N/A) |
| Ex-dividend date | N/A |
| 1y target est | 65.02 |
- Globe Newswire
Chi-Med Highlights Savolitinib Clinical Data to be Presented at Virtual WCLC
HONG KONG, SHANGHAI and FLORHAM PARK, N.J., Jan. 14, 2021 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that the final analysis of savolitinib in Phase Ib TATTON study Parts B and D will be presented at the upcoming virtual 2020 World Conference on Lung Cancer (WCLC 2020), taking place on January 28-31, 2021, virtually. Further details of the featured poster presentation are as follows: Title:Osimertinib + savolitinib in patients with EGFRm MET-amplified/overexpressed NSCLC: Phase Ib TATTON Parts B and D final analysis Lead Author:Ji-Youn Han, Center for Lung Cancer, National Cancer Center, Goyang, Republic of KoreaSession:FP14 - Targeted Therapy - Clinically FocusedAbstract # / Link:#FP14.03 / LinkAvailability Date:Thursday, January 28, 2021 (from midnight Singapore time) About Savolitinib Savolitinib is an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase which has been shown to function abnormally in many types of solid tumors promoting tumor growth, angiogenesis, and metastasis. Savolitinib has been studied in over 1,000 patients to date. In clinical studies, it has shown promising clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile. In 2011, Chi-Med entered into a global licensing and joint development and commercialization agreement with AstraZeneca PLC (LSE/STO/NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes non-small cell lung cancer (“NSCLC”) and kidney cancer, and additional MET-driven tumors are being explored. Savolitinib development in NSCLC: Phase II in MET Exon 14 alteration NSCLC (NCT02897479) – In May 2020, data from an ongoing open-label, Phase II registration study was presented as part of the American Society of Clinical Oncology 2020 Virtual Scientific Program (“ASCO 2020”). In patients with MET Exon 14 skipping alteration NSCLC in the efficacy evaluable population, savolitinib demonstrated a 49.2% objective response rate (“ORR”), a 93.4% disease control rate (DCR) and a 9.6 months interim duration of response (“DoR”). 36% of patients in the study have pulmonary sarcomatoid carcinoma (PSC), an aggressive subtype of NSCLC. Data were not yet mature for DoR, progression-free survival (PFS) or overall survival (“OS”). Clinical data indicated an acceptable safety profile, with a low adverse event (AE) related discontinuations rate of 14.3%. This data supported the China new drug application (“NDA”) acceptance in May 2020. SAVANNAH Phase II study of savolitinib in combination with Tagrisso® in patients who have progressed following Tagrisso® due to MET amplification or overexpression (NCT03778229) – The SAVANNAH study is a single-arm, open-label study in epidermal growth factor receptor (“EGFR”) mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with Tagrisso®, an EGFR-tyrosine kinase inhibitor owned by AstraZeneca. Savolitinib development in kidney cancer: MET-driven papillary renal cell carcinoma (“RCC”) (NCT03091192) – In May 2020, data from 60 patients in the SAVOIR global study of savolitinib monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at ASCO 2020. Savolitinib demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no savolitinib responding patients with disease progression at data cut-off, and an encouraging OS hazard ratio of 0.51 (95% CI: 0.21–1.17; p=0.110) with median not reached at data cut-off. CALYPSO Phase II of savolitinib in combination with Imfinzi® PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of savolitinib in combination with Imfinzi®, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the savolitinib/Imfinzi® combination in patients with papillary RCC and clear cell RCC. Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to progress clinical work in papillary RCC for savolitinib. Savolitinib development in other cancer indications: Savolitinib opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including gastric cancer and colorectal cancer. About Chi-Med Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com. 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 regarding the therapeutic potential of savolitinib for the treatment of patients with NSCLC, the further clinical development of savolitinib in this and other indications, its expectations as to whether clinical studies of savolitinib 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 the sufficiency of its data to support NDA approval of savolitinib for the treatment of patients with NSCLC in China, its potential to gain expeditious approvals for savolitinib in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of savolitinib, the potential for savolitinib to become a new standard of care for NSCLC patients, its ability to implement and complete its further clinical development plans for savolitinib, its potential commercial launch of savolitinib in China and other jurisdictions, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of Tagrisso® and Imfinzi® as combination therapeutics with savolitinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of Tagrisso® and Imfinzi®. 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 Mark Lee, Senior Vice President+852 2121 8200Annie Cheng, Vice President+1 (973) 567 3786 Media Enquiries Americas – Brad Miles, Solebury Trout+1 (917) 570 7340 (Mobile) bmiles@troutgroup.comEurope – Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.comAsia – Joseph Chi Lo / Zhou Yi, Brunswick+852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 9783 6894 (Mobile), yzhou@brunswickgroup.com Nominated Advisor Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited+44 (20) 7886 2500
- Globe Newswire
Chi-Med and Inmagene Announce Strategic Partnership to Develop and Commercialize Portfolio of Drug Candidates for Immunological Diseases
HONG KONG, SHANGHAI, China, SAN DIEGO & FLORHAM PARK, N.J., Jan. 10, 2021 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) and Inmagene Biopharmaceuticals (“Inmagene”) today announce a strategic partnership to further develop four novel preclinical drug candidates discovered by Chi-Med for the potential treatment of multiple immunological diseases. Funded by Inmagene, the companies will work together to move the drug candidates towards investigational new drug (“IND”) submission. If successful, Inmagene will then move the drug candidates through global clinical development. Under the terms of the agreement, Chi-Med grants Inmagene exclusive options to four drug candidates solely for the treatment of immunological diseases. Should Inmagene exercise the option, it will have the right to further develop, manufacture and commercialize that specific drug candidate worldwide, with Chi-Med retaining first right to co-commercialization in mainland China. For each of the drug candidates, Chi-Med will be entitled to development milestones of up to US$95 million and up to US$135 million in commercial milestones, as well as up to double-digit royalties upon commercialization. Christian Hogg, Chief Executive Officer of Chi-Med, said, “This partnership will enable Inmagene to investigate the immunological disease applications of these four drug candidates, discovered by our in-house discovery organization. We believe that these four candidates have scope in multiple immunological diseases and we are pleased to see these opportunities investigated further by Inmagene.” Jonathan Wang, Chairman and Chief Executive Officer of Inmagene, added, “We are delighted to partner with Chi-Med, one of China’s flagship biopharmaceutical companies with a proven track record and excellent reputation for innovation. Focused on immunology-related therapeutic areas, Inmagene is ideally positioned to unlock the global potential of these important Chi-Med immunology innovations.” About Chi-Med Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com. About Inmagene Biopharmaceuticals Inmagene, with wholly owned subsidiaries in Shanghai, San Diego, and Hangzhou, is one of the leading companies in immunology drug development in China. It is building a strong pipeline of over ten compounds, among which IMG-020 is about to enter global clinical trials in multiple indications for registration. For additional information about Inmagene Biopharmaceuticals, please visit www.inmagenebio.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 further preclinical and clinical development of certain drug candidates in partnership with Inmagene, Chi-Med’s and Inmagene’s roles and responsibilities in the partnership, and the potential benefits of such drug candidates for the treatment of autoimmune diseases. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, the ability of Chi-Med and Inmagene to develop and receive regulatory approvals for their partnered drug candidates; the risk that the potential benefits of such drug candidates do not materialize or do not outweigh the costs; the preclinical and clinical results for such drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Inmagene’s ability to obtain funding to complete the development and commercialization as planned; and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. CONTACTS Chi-Med Investor Enquiries Mark Lee, Senior Vice President+852 2121 8200Annie Cheng, Vice President+1 (973) 567 3786 Chi-Med Media Enquiries Americas – Brad Miles, Solebury Trout+1 (917) 570 7340 (Mobile) bmiles@troutgroup.comEurope – Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.comAsia – Joseph Chi Lo / Zhou Yi, Brunswick+852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 9783 6894 (Mobile), yzhou@brunswickgroup.com Chi-Med Nominated Advisor Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited+44 (20) 7886 2500 Inmagene Enquiries Jimmy Wei, Chief Business OfficerPR@inmagenebio.com
- Globe Newswire
Chi-Med Announces the NMPA Approval of Surufatinib (Sulanda® in China) for Non-Pancreatic Neuroendocrine Tumors
– Sulanda® is Chi-Med’s first oncology drug brought to market without a partnership and the company’s second oncology drug approved in China – – The pivotal Phase III SANET-ep trial demonstrated surufatinib reduced risk of progression or death by 67%, extending PFS in all subgroups of non-pancreatic NET patients with an acceptable risk/benefit ratio – – ~400-strong oncology commercial team in place to bring Sulanda® to patients in China – HONG KONG and FLORHAM PARK, N.J., Dec. 30, 2020 (GLOBE NEWSWIRE) -- Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that surufatinib has been granted approval for drug registration by the National Medical Products Administration of China (“NMPA”) for the treatment of non-pancreatic neuroendocrine tumors (“NETs”). Surufatinib will be marketed in China under the brand name Sulanda®. Surufatinib is Chi-Med’s first self-discovered oncology drug to be approved in China without the support of a development partner, and follows the approval of Chi-Med’s first oncology drug, Elunate® (fruquintinib capsules), in 2018. Christian Hogg, Chief Executive Officer of Chi-Med commented, “We are very pleased to have achieved this major milestone for Chi-Med. The approval of surufatinib, our first un-partnered oncology drug, is a strong testament to our in-house research and development capability.” “Today’s approval also marks an important development for NET patients, for whom there are currently limited treatment options. Compared with other NET therapies available in the market, surufatinib has a unique mode of action by both inhibiting angiogenesis and promoting the body’s immune response against tumor cells. If our second new drug application (“NDA”) in pancreatic NET is successful, this therapy would be approved in China to address all NET patients regardless of the tumor origin.” “We look forward to making this unique therapy available to patients as quickly and broadly as possible through our own expanded oncology commercial team.” Chi-Med has established an oncology commercial team that today covers more than 2,000 hospitals across China. The team is led by a leadership team highly experienced in oncology products commercialization in China with deep knowhow in the field of NETs. The NMPA approval of Sulanda® was based on results from the SANET-ep1 study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced non-pancreatic NETs conducted in China. The study met the pre-defined primary endpoint of progression-free survival (“PFS”) at a preplanned interim analysis. The positive results of this trial were highlighted in an oral presentation at the 2019 ESMO Congress) and published in The Lancet Oncology in September 2020.2 Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment-related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%). In China, there were an estimated 67,600 newly diagnosed NET patients in 2018. Considering the current incidence to prevalence ratio, there may be as many as 300,000 patients living with the disease.3 About NETs NETs 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. NETs are typically classified as pancreatic NET (“pNET”) or non-pancreatic NET (“epNET”). Approved targeted therapies include Sutent® (for pNET only) and Afinitor® for pNET and well-differentiated, non-functional gastrointestinal or lung NET. According to Frost and Sullivan, there were 19,000 newly diagnosed cases of NETs in the U.S. in 2018. Importantly, NETs 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 NETs in the U.S. in 2018. About Surufatinib (Sulanda® in China) Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptor (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects. Chi-Med currently retains all rights to surufatinib worldwide. About Surufatinib Development NETs in the U.S. and Europe: In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019. A U.S. FDA NDA rolling submission was initiated in December 2020, to be followed by a marketing authorization application (MAA) submission to the European Medicines Agency (EMA) in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p4 studies, along with existing data from surufatinib in U.S. non-pancreatic and pancreatic NET patients (clinicaltrials.gov identifier: NCT02549937). Pancreatic NETs in China: The SANET-p study is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pNET in China. It was terminated early as the pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at an preplanned interim analysis, leading to a second NDA accepted by the China NMPA in September 2020. The results of this study were presented at the ESMO Virtual Congress 2020 and published simultaneously in The Lancet Oncology. 5 Biliary tract cancer in China: A Phase IIb/III study was initiated in March 2019, comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier NCT03873532). Immunotherapy combinations: Chi-Med has entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317, developed by BeiGene, Ltd.), Tuoyi® (toripalimab, developed by Shanghai Junshi Biosciences Co. Ltd.) and Tyvyt® (sintilimab, developed by Innovent Biologics, Inc.), which are approved as monotherapies in China. About Chi-Med Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage, biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of nine cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com. 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 regarding the commercial launch of surufatinib in China, the ability of its in-house oncology sales team to distribute surufatinib quickly and broadly, the potential market for surufatinib in non-pancreatic NET patients China, the potential approval of surufatinib in pancreatic NET, and the further clinical development for surufatinib in these and other indications in China, the United States and other jurisdictions. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding Chi-Med’s ability to commercialize surufatinib, the benefits obtained from surufatinib during clinical trials being the same for all patients who are prescribed surufatinib, no unidentified side effects occurring which could result in the NMPA pulling surufatinib from the market, Chi-Med’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib, the timing of these events, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of capecitabine, tislelizumab, Tuoyi®, and Tyvyt® as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this 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 Mark Lee, Senior Vice President+852 2121 8200Annie Cheng, Vice President+1 (973) 567 3786 Media Enquiries Americas – Brad Miles, Solebury Trout+1 (917) 570 7340 (Mobile) bmiles@troutgroup.comEurope – Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.comAsia – Joseph Chi Lo / Zhou Yi, Brunswick+852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 9783 6894 (Mobile), yzhou@brunswickgroup.com Nominated Advisor Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited+44 (20) 7886 2500 ______________________ 1 Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).2 Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced extrapancreatic neuroendocrine tumours (SANET-ep): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30496-4. DOI: 10.1016/S1470-2045(20)30496-4.3 According to Frost & Sullivan. In 2018, there were 19,000 newly diagnosed cases of NETs in the U.S and an estimated 141,000 patients living with NETs. The current incidence to prevalence ratio in China is estimated at 4.4, lower than the 7.4 ratio in the U.S. due to lower access to treatment options.4 Surufatinib in advanced neuroendocrine tumors – pancreatic.5 Xu J, Shen L, Bai C, et al. Surufatinib in advanced pancreatic neuroendocrine tumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3 study [published online ahead of print, 2020 Sep 20]. Lancet Oncol. 2020; S1470-2045(20)30493-9. DOI: 10.1016/S1470-2045(20)30493-9.
