Hong Kong, Shanghai & Florham Park, NJ: Thursday, July 30, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM), an innovation-driven, commercial-stage biopharmaceutical company, today announces its unaudited financial results for the six months ended June 30, 2020 and provides updates on key clinical and commercial developments.
“During the first half of 2020, we continued to build our fully integrated business in China, from research and development to manufacturing and commercialization and sales, with a focus on oncology,” said Mr. Simon To, Chairman of Chi-Med. “NDAs for surufatinib and savolitinib are currently under review by the China NMPA6 and we are now preparing for multiple potential launches employing our newly-established commercial organization in oncology, covering all provinces in Mainland China.”
“We are also one of a few China-based biotech companies working to realize the global potential of our home-grown innovative drug candidates,” he added. “We currently have nine novel drug candidates in clinical trials, many with global potential, and an additional five drug candidates at the IND7-enabling stage.”
“Over the past three years, we have significantly expanded our international development footprint and, in the first half of 2020, locked in global registration strategies for surufatinib and fruquintinib, while our global partnership with AstraZeneca8 is approaching the same for savolitinib. A deep pipeline of unpartnered earlier-stage oncology assets follows, with most notably, global development of our Syk9 and PI3Kδ10 assets progressing well and our IDH 1/211 inhibitor expected to start Phase I in the United States this year.”
“We believe that the anticipated launches of multiple innovative oncology drugs over the next twelve to eighteen months will address a broad range of unmet medical needs and benefit a large number of patients globally, propelling Chi-Med into a new phase of growth.”
FIRST HALF 2020 OPERATING HIGHLIGHTS
Set out below are some of Chi-Med’s operating highlights so far this year. For more details, please refer to “Operations Review” below.
I. PREPARING TO LAUNCH MULTIPLE ONCOLOGY DRUGS IN CHINA
Savolitinib – NDA submitted for potential first-in-class selective MET TKI12 in China:
Surufatinib – Two NDAs with first China launch in NET planned for late 2020:
Fruquintinib – Commercial progress on Elunate® (fruquintinib capsules):
Established in-house oncology commercial organization – Team now in place for imminent launches:
II. REALIZING THE GLOBAL POTENTIAL OF OUR LATE STAGE ONCOLOGY ASSETS
Surufatinib – U.S. NDA under preparation:
Fruquintinib – global Phase III registration study in CRC28 underway:
Savolitinib – AstraZeneca collaboration making progress in lung and kidney cancer:
III. INVESTING IN THE FUTURE – EARLY PIPELINE
IV. UPDATE ON THE IMPACT OF COVID-19
KEY EVENTS PLANNED FOR BALANCE 2020 & EARLY 2021
| CHINA EVENTS: A FULLY INTEGRATED ONCOLOGY BUSINESS IN CHINA | ||
| Fruquintinib |
· Elunate® China commercialization – Chi-Med to assume medical detailing and marketing activities for Elunate® in all China on October 1, 2020; and · Enrollment completion of FRUTIGA Phase III – complete enrollment of China registration study in second-line gastric cancer. |
|
| Surufatinib |
· Presentation of SANET-p Phase III data – pancreatic NET patients study at ESMO37 2020 conference; · Acceptance of NDA in pancreatic NET – following recent NDA submission based on positive SANET-p Phase III interim analysis; · Phase II/III interim analysis – for futility in second-line BTC38 in China; and · Potential NDA approval and launch for non-pancreatic NET – first un-partnered oncology drug launch for Chi-Med in China. |
|
| Savolitinib | · Potential NDA approval and launch for NSCLC – monotherapy in MET Exon 14 skipping mutation NSCLC. If approved, this will be the first approval worldwide and the first selective c-MET TKI approval in China. Material milestone triggering event. | |
| Early-stage Assets |
· HMPL-689 (PI3Kδ) Phase I/Ib NHL data – potential presentation of China data at major scientific conference; · HMPL-689 (PI3Kδ) – Potential registration study start – in indolent NHL in China; · HMPL-523 (Syk) – Potential registration study start – in indolent NHL in China; and · HMPL-523 (Syk) – completion of dose escalation in ITP39. |
|
| GLOBAL EVENTS: REALIZING THE GLOBAL POTENTIAL OF OUR ONCOLOGY ASSETS | ||
| Fruquintinib |
· Global Phase III study (FRESCO-2) – expansion of registration study in CRC in 10 countries including the U.S., Europe and Japan; and · Presentation of U.S. Phase Ib data – preliminary data from study of third and later line CRC patients at ESMO 2020 conference. |
|
| Surufatinib | · U.S. NDA submission for pancreatic- and non-pancreatic NET – U.S. NDA rolling submission beginning in late 2020 through early 2021. | |
| Savolitinib |
· Internal interim analyses on SAVANNAH – Complete the review of the first internal interim analysis and conduct further interim analysis to inform regulatory strategy; · Potential endorsement of global Phase III in kidney cancer – savolitinib monotherapy in MET-driven PRCC; · Potential endorsement of global Phase III in NSCLC – Tagrisso® combination in EGFRm40 positive, MET positive, NSCLC. Material milestone triggering event; · Potential endorsement of global registration study in NSCLC – savolitinib in MET Exon 14 skipping mutation NSCLC; and · Enrollment completion of SAVANNAH – AstraZeneca to complete enrollment of Phase II study, with registration potential, of savolitinib/Tagrisso® combination. |
|
| Early-stage Assets |
· HMPL-523 (Syk) – Global Phase Ib expansion – in indolent NHL in the U.S. and Europe; · HMPL-306 (IDH 1/2) – U.S. IND submission and initiation of Phase I; and · HMPL-689 (PI3Kδ) – Global Phase Ib expansion – in indolent NHL in the U.S. and Europe. |
|
FINANCIAL HIGHLIGHTS
The items below are selected financial data for the six months ended June 30, 2020. All dollars are expressed in U.S. dollar currency unless otherwise stated. For more details, please refer to “Financial Review”, “Operations Review” and “Interim Unaudited Condensed Consolidated Financial Statements” below.
FINANCIAL GUIDANCE
During the first half of 2020, we performed in-line with published guidance, with dividends from our Commercial Platform offsetting a material portion of our R&D expenses as expected.
Over the balance of 2020, cash investments will rise in a number of areas including: several major global clinical and regulatory activities such as the global FRESCO-2 Phase III for fruquintinib and the submission of the U.S. NDA for surufatinib; the first phase of construction of our new large-scale oncology manufacturing facility in Shanghai; and expansion of our commercial activities in oncology in China, specifically our new commercial role on Elunate® and preparation for the surufatinib launch.
We assume at this stage that the financial impact of the COVID-19 outbreak will not be material to the Group. Since we cannot predict how the situation will evolve, we will monitor and adjust if needed, as new material information emerges. We therefore provide unchanged Financial Guidance for 2020 below.
| H1 2020 Actual |
2020 Current Guidance |
Adjustments vs. Previous Guidance | |
| Adjusted (non-GAAP) Innovation Platform segment operating loss | $(81.2) million | $(180) – (210) million | nil |
| Adjusted (non-GAAP) Group net cash flows excluding financing activities | $(32.5) million | $(140) – (160) million | nil |
Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to adjusted Innovation Platform segment operating loss, adjusted Group net cash flows excluding financing activities and financial measures reported at CER are based on non-GAAP financial measures. Please see the “Use of Non-GAAP Financial Measures and Reconciliation” below for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.
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Conference Call and Audio Webcast Presentation Scheduled Today at 1 p.m. BST / 8 a.m. EDT / 8 p.m. HKT – Investors may participate in the call as follows: +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.) / +852 3027 6500 (Hong Kong), or access a live audio webcast of the call via Chi-Med’s website at www.chi-med.com/investors/event-information/.
Additional dial-in numbers are also available at Chi-Med’s website. Please use participant access code “54962123#.”
—–
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.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
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| Americas – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.com |
| Asia – Joseph Chi Lo / 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 |
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “Chi-Med,” “Chi-Med Group,” “we,” “us,” and “our,” mean Hutchison China MediTech Limited and its consolidated subsidiaries and joint ventures unless otherwise stated or indicated by context.
The performance and results of operations of the Group contained within this announcement are historical in nature, and past performance is no guarantee of future results of the Group. This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by words like “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “pipeline,” “could,” “potential,” “first-in-class,” “designed to,” “objective,” “guidance,” “pursue,” or similar terms, or by express or implied discussions regarding potential drug candidates, potential indications for drug candidates or by discussions of strategy, plans, expectations or intentions. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that any of our drug candidates will be approved for sale in any market, or that any approvals which are obtained will be obtained at any particular time, or that any such drug candidates will achieve any particular revenue or net income levels. In particular, management’s expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the uncertainties inherent in research and development, including the inability to meet our key study assumptions regarding enrollment rates, timing and availability of subjects meeting a study’s inclusion and exclusion criteria and funding requirements, changes to clinical protocols, unexpected adverse events or safety, quality or manufacturing issues; the inability of a drug candidate to meet the primary or secondary endpoint of a study; the impact of the COVID-19 pandemic or other health crises in China or globally; the inability of a drug candidate to obtain regulatory approval in different jurisdictions or gain commercial acceptance after obtaining regulatory approval; global trends toward health care cost containment, including ongoing pricing pressures; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, intellectual property disputes, and government investigations generally; and general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries and uncertainties regarding future global exchange rates. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med is providing the information in this announcement as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.
In addition, this announcement contains statistical data and estimates that Chi-Med obtained from industry publications and reports generated by third-party market research firms. Although Chi-Med believes that the publications, reports and surveys are reliable, Chi-Med has not independently verified the data and cannot guarantee the accuracy or completeness of such data. You are cautioned not to give undue weight to this data. Such data involves risks and uncertainties and are subject to change based on various factors, including those discussed above.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Ends
REFERENCES AND ABBREVIATIONS
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London: Thursday, July 30, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces an application has been made to the London Stock Exchange plc for a block admission of 30,221,458 ordinary shares, par value of US$0.10 each (“Ordinary Shares”) to be admitted to trading on AIM. It is expected that such admission will become effective on August 4, 2020.
These Ordinary Shares will be issued from time to time pursuant to the exercise of share options under the Share Option Scheme conditionally adopted by Chi-Med in 2015 (“2015 Share Option Scheme”). When issued, these Ordinary Shares will be credited as fully paid and will rank pari passu with the existing Ordinary Shares in issue. Chi-Med is seeking this block admission due to the recent refreshment of the limits of the 2015 Share Option Scheme, as approved at Chi-Med’s annual general meeting held on April 27, 2020 (“AGM”), whereby Chi-Med was empowered to grant further options under that scheme in respect of a maximum of 34,528,738 Ordinary Shares. Under the existing block admission facility for the 2015 Share Option Scheme, the unutilised balance covers 23,130,970 Ordinary Shares. Of this remaining balance, 18,823,690 Ordinary Shares are reserved for the exercise of options already granted under the 2015 Share Option Scheme. Therefore, only 4,307,280 Ordinary Shares of the remaining balance under the existing block admission facility could be utilised with respect to share options to be granted under the 2015 Share Option Scheme as refreshed at the AGM. Following admission, the Company’s total issued share capital remains unchanged at 710,574,765 Ordinary Shares, with each share carrying one right to vote and with no shares held in treasury. The Company will make six-monthly announcements of the utilisation of the block admission, in line with its obligations under AIM Rule 29 and monthly announcements as to any changes to its total voting rights.
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.
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.com |
| Asia – Joseph Chi Lo / 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 |
Hong Kong, Shanghai, & Florham Park, NJ: Tuesday, July 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) and Eli Lilly and Company (“Lilly”) today announce an amendment to the 2013 License and Collaboration Agreement on Fruquintinib with Lilly Shanghai, an affiliate of Lilly. The 2020 Amendment covers the expansion of Chi-Med’s role in the commercialization of Elunate® (fruquintinib capsules) in China.
Under the terms of the 2020 Amendment, Lilly will maintain the exclusive commercialization rights, and as a consequence, will continue to consolidate the sales of Elunate® in China. Chi-Med will collaborate with Lilly in commercializing Elunate® across China.
In a joint statement, Mr. Christian Hogg, CEO of Chi-Med and Mr. Julio Gay-Ger, President & General Manager, Lilly China, said “After many years of constructive and successful collaboration, Lilly and Chi-Med believe that this agreement now establishes the optimal structure that will allow us to leverage the full resources of both companies to maximize the potential of Elunate® in China.”
Starting October 1, 2020, Chi-Med will be responsible, through its commercial team in oncology of over 320 staff, for the development and execution of all on-the-ground medical detailing, promotion and local and regional marketing activities in China for Elunate®. Lilly and Chi-Med will continue to collaborate, as before, in the formulation and execution of national marketing strategy and events in China for Elunate®.
Chi-Med and Lilly will share gross profits linked to sales target performance. Subject to meeting pre-agreed sales targets, Lilly will pay Chi-Med an estimated total of 70% to 80% of Elunate® sales in the form of royalties, manufacturing costs and service payments. There is no upfront payment by Lilly or Chi-Med relating to this amendment.
Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor (“VEGFR”) 1/2/3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed to improve kinase selectivity to minimize off-target toxicities, improve tolerability and provide more consistent target coverage. The generally good tolerability in patients to date, along with fruquintinib’s low potential for drug-drug interaction based on preclinical assessment, suggests that it may also be highly suitable for combinations with other anti-cancer therapies.
Chi-Med retains all rights to fruquintinib outside of China and is partnered with Lilly in China.
Fruquintinib was approved for marketing by the China National Medical Products Administration (“NMPA”) in September 2018 and commercially launched by Lilly in late November 2018 under the brand name Elunate®. Elunate® is for the treatment of patients with mCRC that have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan, including those who have previously received anti-VEGF therapy and/or anti-epidermal growth factor receptor (“EGFR”) therapy (RAS wild type). Results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with mCRC in China demonstrating improvement in overall survival, were published in The Journal of the American Medical Association, JAMA, in June 2018 (clinicaltrials.gov identifier: NCT02314819).
In December 2017, Chi-Med initiated a Phase Ib clinical study to evaluate fruquintinib in U.S. patients with advanced solid tumors. Proof-of-concept cohorts in patients with mCRC and metastatic breast cancer were added in 2019 (clinicaltrials.gov identifier: NCT03251378).
Chi-Med is initiating FRESCO-2, a randomized, double-blind, placebo-controlled, multicenter Phase III registration trial in refractory mCRC in the U.S., Europe and Japan. The primary endpoint of the study is overall survival. Over 500 patients will be enrolled from approximately 130 sites in 10 countries. The U.S. Food and Drug Administration (FDA) granted Fast Track Designation for development for mCRC patients in June 2020. The FRESCO-2 study design was also reviewed and endorsed by the European Medicines Agency (EMA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) (clinicaltrials.gov identifier: NCT04322539).
Gastric Cancer in China: In October 2017, Chi-Med initiated the FRUTIGA study, a randomized, double-blind, Phase III trial evaluating the efficacy and safety of fruquintinib combined with paclitaxel for second-line treatment of advanced gastric or GEJ adenocarcinoma. The trial is designed to enroll patients who did not respond to first-line standard chemotherapy. Subjects will receive either fruquintinib combined with paclitaxel or placebo combined with paclitaxel. The primary efficacy endpoint is overall survival. In June 2020, Chi-Med completed a planned interim data review. Based on the preset criteria, the Independent Data Monitoring Committee (IDMC) recommended that the trial continue (clinicaltrials.gov identifier: NCT03223376).
Immunotherapy combinations: Chi-Med has entered into three collaboration agreements to evaluate the safety, tolerability and efficacy of fruquintinib in combination with programmed death-1 (PD-1) monoclonal antibodies, including with tislelizumab (BGB-A317), Tyvyt® (sintilimab, IBI308) and geptanolimab (GB226, genolimzumab).
Chi-Med (Nasdaq/AIM: HCM) is an innovative, 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.
Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com.
This announcement contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect Chi-Med’s current expectations regarding future events, including its expectations regarding its collaboration with Lilly and their ability to maximize the commercial potential of Elunate® in China under the terms of the above mentioned amendment. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding Chi-Med’s ability to successfully assume the medical detailing, promotion and local and regional marketing activities for Elunate® in China, that no unidentified side effects will occur which could result in the NMPA pulling fruquintinib from the market, the sufficiency of funding to support the commercialization and further clinical development of fruquintinib in CRC and other indications, and the impact of the COVID-19 pandemic on general economic, regulatory and political conditions. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see Chi-Med’s filings with the U.S. Securities and Exchange Commission and on AIM. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) No 596/2014.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.com |
| Asia – Joseph Chi Lo / 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 |
Hong Kong, Shanghai & Florham Park, NJ: Tuesday, July 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announced that the China National Medical Products Administration (“NMPA”) has granted Priority Review status to the New Drug Application (“NDA”) for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations. This is the first NDA filing for savolitinib globally and first for a selective MET inhibitor in China.
With over 774,000 new cases every year, China accounted for 37% of the world’s annual incidence of lung cancer in 2018.[1] Approximately 80-85% of lung cancer cases are NSCLC.[2] It is estimated that 2-3% of NSCLC patients have MET Exon 14 skipping mutations; these mutations lead to poor prognosis.[3] The annual incidence of MET Exon 14 skipping mutation NSCLC is estimated to be 12,000 to 20,000 in China.
The NMPA’s Priority Review procedure encourages research and development of potential new medicines with clear clinical value, medicines or vaccines that address urgent clinical needs, as well as medicines that address serious infectious diseases, certain rare diseases, and select pediatric conditions or formulations. A potential new medicine may have clear clinical value if it is being developed for serious conditions that are life threatening, debilitating, or impact quality of life. NDAs undergoing Priority Review would receive preferential allocation of NMPA resources during the review process.[4]
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 (LSE, STO, NYSE: AZN) for savolitinib. Savolitinib’s global development plan includes NSCLC and kidney cancer, and additional MET-driven tumors are being explored.
Phase II in MET Exon 14 mutation 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 mutation 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 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 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.
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. Based on these data, AstraZeneca and Chi-Med are actively evaluating the opportunity to progress clinical work in papillary RCC for monotherapy savolitinib.
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.
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.
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.
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. 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.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.com |
| Asia – Joseph Chi Lo / 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] Global Cancer Observatory. China Fact Sheet. gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[2] American Cancer Society. www.cancer.org/cancer/lung-cancer/about/what-is.html.
[3] Awad M et al. “MET Exon 14 Mutations in Non–Small-Cell Lung Cancer Are Associated With Advanced Age and Stage-Dependent MET Genomic Amplification and c-Met Overexpression.” Journal of Clinical Oncology 2016;34(7):721-730. doi:10.1200/JCO.2015.63.4600.
[4] National Medical Products Administration, “Drug Marketing Authorization Priority Review Process.” http://www.nmpa.gov.cn/WS04/CL2138/378606.html.
— HMPL-306 is the ninth innovative oncology drug candidate discovered in house by Chi-Med —
Hong Kong, Shanghai & Florham Park, NJ: Friday, July 24, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) has initiated a Phase I study of HMPL-306, its novel selective small molecule dual inhibitor of isocitrate dehydrogenase (“IDH”) 1 and 2 mutations, in patients with hematological malignancies in China. The first patient was dosed today.
This is a multi-center study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL‑306 in patients of relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation. The first stage of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of HMPL‑306 to determine the maximum tolerated dose and/or the recommended Phase II dose (“RP2D”). The second stage of the study is a dose expansion phase where three cohorts of patients will receive HMPL‑306 to further evaluate the safety, tolerability, and clinical activity at the RP2D. Additional details may be found at clinicaltrials.gov, using identifier NCT04272957.
HMPL-306 is Chi-Med’s ninth innovative oncology asset discovered in house. Cytoplasmic mutant IDH1 and mitochondrial mutant IDH2 have been known to switch to the other form when targeted by an inhibitor of IDH1 mutant alone or IDH2 mutant alone. By targeting both IDH1 and IDH2 mutations, this drug candidate may provide therapeutic benefits in cancer patients harboring IDH mutations, and may address acquired resistance to IDH inhibition through isoform switching.
IDHs are critical metabolic enzymes that help to break down nutrients and generate energy for cells. When mutated, IDH creates a molecule that alters the cell’s genetic programming and prevents cells from maturing. IDH1 or IDH2 mutations are common genetic alterations in various types of blood and solid tumors, including acute myeloid leukemia (“AML”) with approximately 20% of patients having mutant IDH genes, myelodysplastic syndrome (MDS), myeloproliferative neoplasms (MPNs), low-grade glioma and intrahepatic cholangiocarcinoma. Mutant IDH isoform switching, either from cytoplasmic mutant IDH1 to mitochondrial mutant IDH2, or vice versa, is a mechanism of acquired resistance to IDH inhibition in AML and cholangiocarcinoma.[1],[2],[3]
According to the National Cancer Institute (NCI), there will be approximately 20,000 new cases of AML in the U.S. in 2020 and the five-year relative survival rate is 28.7%[4]. Currently, the U.S. Food and Drug Administration (FDA) has approved one drug for IDH1 mutation and one drug for IDH2 mutation, but no dual inhibitor targeting both IDH1 and IDH2 mutants has been approved. There were an estimated 19,700 new cases of AML in China in 2018 and is estimated to reach 24,200 in China in 2030.[5] In China no IDH inhibitor has been approved.
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.
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 initiation of clinical development of HMPL-306 and the potential benefits of HMPL-306 in patients harboring IDH mutations. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding clinical trial 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-306 as a monotherapy or in combinations to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-306 for a targeted indication, the sufficiency of funding, 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.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Trout | +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com |
| Europe – Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) Chi-Med@fticonsulting.com |
| Asia – Joseph Chi Lo / 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] S Choe S et al. Blood 2019;134(Supplement_1):545. doi:10.1182/blood-2019-122671.
[2] Harding JJ et al. Isoform Switching as a Mechanism of Acquired Resistance to Mutant Isocitrate Dehydrogenase Inhibition. Cancer Discov. 2018;8(12):1540-1547. doi:10.1158/2159-8290.CD-18-0877.
[3] Delahousse J et al. Circulating oncometabolite D-2-hydroxyglutarate enantiomer is a surrogate marker of isocitrate dehydrogenase-mutated intrahepatic cholangiocarcinomas. Eur J Cancer. 2018;90:83-91. doi:10.1016/j.ejca.2017.11.024.
[4] Source: National Cancer Institute – seer.cancer.gov/statfacts/html/amyl.html.
[5] Lin J et al. IDH1 and IDH2 mutation analysis in Chinese patients with acute myeloid leukemia and myelodysplastic syndrome. Ann Hematol. 2012;91(4):519-525. doi:10.1007/s00277-011-1352-7.
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached: | Hutchison China MediTech Limited; Legal Entity Identifier: 2138006X34YDQ6OBYE79 |
|||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | X | |||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | X | |||||
| An acquisition or disposal of financial instruments | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify)iii: | ||||||
| 3. Details of person subject to the notification obligation | ||||||
| Name | Mitsui & Co., Ltd. | |||||
| City and country of registered office (if applicable) | Tokyo, Japan | |||||
| 4. Full name of shareholder(s) (if different from 3.)v | ||||||
| Name | ||||||
| City and country of registered office (if applicable) | ||||||
| 5. Date on which the threshold was crossed or reached: | 06/07/2020 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 08/07/2020 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instr-uments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
| Resulting situation on the date on which threshold was crossed or reached | 2.92% | 2.92% | 710,574,765 | |||
| Position of previous notification (if applicable) | 3.96% (dated 12 December 2018) | – | 3.96% | |||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
|
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
||||||
| Ordinary Shares (KYG4672N1016) and American Depositary Shares (US44842L1035) | 20,742,325 | – | 2.92% | – | |||||
| SUBTOTAL 8. A | 20,742,325 | 2.92% | |||||||
| B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||
| SUBTOTAL 8. B 1 | |||||||
| B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Physical or cash settlementxii |
Number of voting rights | % of voting rights | ||
| SUBTOTAL 8.B.2 | |||||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | X | |||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
||||
| Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional informationxvi | ||||
|
The warrants in Box B 2 have not been exercised, in part or whole, as of the below “Date of completion.” Accordingly, the “Total number of voting rights of issuer” in Box 7 do not account for any issuance of the new voting shares, in part or whole, from the exercise of the warrants. Once the warrants are exercised in full, assuming no other changes in the interests or the voting shares in the meantime, the “Total number of voting rights of issuer” in Box 7 will become 727,241,435. On that basis, the ownership ordinary shares would represent 2.75%, the ownership of warrants would represent 2.29%, and the combined ownership of the ordinary shares and warrants would represent 5.04%. |
||||
| Place of completion | Tokyo, Japan |
| Date of completion | 08 July 2020 |
| Date: August 12, 2020 (Wednesday) |
| Time: 08:30 am EDT (01:30 pm BST/08:30 pm HKT) |
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached: | Hutchison China MediTech Limited | |||||
| 1b. Please indicate if the issuer is a non-UK issuer (please mark with an “X” if appropriate) | ||||||
| Non-UK issuer | X | |||||
| 2. Reason for the notification (please mark the appropriate box or boxes with an “X”) | ||||||
| An acquisition or disposal of voting rights | X | |||||
| An acquisition or disposal of financial instruments | X | |||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify)iii: | ||||||
| 3. Details of person subject to the notification obligation | ||||||
| Name | General Atlantic Singapore HCM Pte. Ltd. | |||||
| City and country of registered office (if applicable) | Singapore | |||||
| 4. Full name of shareholder(s) (if different from 3.)v | ||||||
| Name | ||||||
| City and country of registered office (if applicable) | ||||||
| 5. Date on which the threshold was crossed or reached: | 06/07/2020 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 06/07/2020 | |||||
| 7. Total positions of person(s) subject to the notification obligation | ||||||
| % of voting rights attached to shares (total of 8. A) | % of voting rights through financial instr-uments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights of issuervii | |||
| Resulting situation on the date on which threshold was crossed or reached | 2.81% | 2.35% | 5.16% | 710,574,765 | ||
| Position of previous notification (if applicable) | ||||||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of sharesISIN code (if possible) |
Number of voting rightsix | % of voting rights | |||||||
|
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
Direct (Art 9 of Directive 2004/ 109/ EC) (DTR5.1) |
Indirect (Art 10 of Directive 2004/ 109/ EC) (DTR5.2.1) |
||||||
| Ordinary Shares (KYG4672N1198) |
20,000,000 | 2.81% | |||||||
| SUBTOTAL 8. A | 20,000,000 | 2.81% | |||||||
| B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a)) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Number of voting rights that may be acquired if the instrument is exercised/converted. |
% of voting rights | |||
| SUBTOTAL 8. B 1 | |||||||
| B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b)) | |||||||
| Type of financial instrument | Expiration datex |
Exercise/ Conversion Periodxi |
Physical or cash settlementxii |
Number of voting rights | % of voting rights | ||
| Warrants over Ordinary Shares | January 3, 2022 | At any time after July 2, 2020 | Physical | 16,666,670 | 2.35% | ||
| SUBTOTAL 8.B.2 | 16,666,670 | 2.35% | |||||
| 9. Information in relation to the person subject to the notification obligation (please mark the applicable box with an “X”) | ||||
| Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii | ||||
| Full chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary) |
X | |||
| Namexv | % of voting rights if it equals or is higher than the notifiable threshold | % of voting rights through financial instruments if it equals or is higher than the notifiable threshold | Total of both if it equals or is higher than the notifiable threshold | |
| GAP (Bermuda) Limited | 5.16% | |||
| General Atlantic LLC | 5.16% | |||
| General Atlantic GenPar (Bermuda), L.P. | 5.16% | |||
| General Atlantic (Lux) S.à r.l. | 5.16% | |||
| General Atlantic GenPar (Lux) SCSp, L.P. | 5.16% | |||
| General Atlantic Part- ners (Bermuda) IV, L.P. | 5.16% | |||
| General Atlantic Part- ners (Bermuda) EU, L.P. | 5.16% | |||
| General Atlantic Part- ners (Lux) SCSp, L.P. | 5.16% | |||
| GAP Coinvestments III, LLC | 5.16% | |||
| GAP Coinvestments IV, LLC | 5.16% | |||
| GAP Coinvestments V, LLC | 5.16% | |||
| GAP Coinvestments CDA, L.P. | 5.16% | |||
| General Atlantic Singa- pore Interholdco Ltd. | 5.16% | |||
| General Atlantic Singa- pore Fund Pte. Ltd. | 5.16% | |||
| General Atlantic Singa- pore HCM Pte. Ltd. | 5.16% | |||
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | ||||
| The number and % of voting rights held | ||||
| The date until which the voting rights will be held | ||||
| 11. Additional informationxvi | ||||
|
The warrants in Box B 2 have not been exercised, in part or whole, as of the below “Date of completion.” Accordingly, the “Total number of voting rights of issuer” in Box 7 do not account for any issuance of the new voting shares, in part or whole, from the exercise of the warrants. Once the warrants are exercised in full, assuming no other changes in the interests or the voting shares in the meantime, the “Total number of voting rights of issuer” in Box 7 will become 727,241,435. On that basis, the ownership ordinary shares would represent 2.75%, the ownership of warrants would represent 2.29%, and the combined ownership of the ordinary shares and warrants would represent 5.04%. |
||||
| Place of completion | Hong Kong, China |
| Date of completion | July 6, 2020 |
London: Tuesday, July 7, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) was notified that CK Hutchison Holdings Limited (“CK Hutchison”) shareholding1 in Chi-Med remains unchanged, at 332,478,770 ordinary shares of par value US$0.10 each in the capital of Chi-Med (“Shares”).
Each American Depositary Share (“ADS”) represents five Shares. As announced on June 25, 2020, Chi-Med issued a total of 20,000,000 Shares (equivalent to 4,000,000 ADSs) to General Atlantic. Chi-Med was notified on July 6, 2020 that this issuance diluted CK Hutchison’s holding1 to 46.79 per cent of the total number of voting rights of Chi-Med. The date on which the notification threshold was crossed was July 3, 2020.
About CK Hutchison
Listed on The Stock Exchange of Hong Kong Limited, CK Hutchison is a renowned multinational conglomerate committed to innovation and technology with businesses spanning the globe. With operations in about 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 HK$440 billion (US$56 billion) for the year ended 31 December 2019.
For more information, please visit www.ckh.com.hk.
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical company committed, over the past twenty years, to the discovery and global development of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has a portfolio of eight cancer drug candidates currently in clinical studies around the world and extensive commercial infrastructure in its home market of China. For more information, please visit: www.chi-med.com.
[1] Held through CK Hutchison’s indirect wholly-owned subsidiary Hutchison Healthcare Holdings Limited.
Mark Lee, Senior Vice President
+852 2121 8200
Annie Cheng, Vice President
+1 (973) 567 3786
Americas – Brad Miles, Solebury Trout
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
UK & Europe –Ben Atwell / Alex Shaw, FTI Consulting
+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia – Joseph Chi Lo, Brunswick
+852 9850 5033 (Mobile)
jlo@brunswickgroup.com
– Zhou Yi, Brunswick
+852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited
+44 (20) 7886 2500