Hong Kong, Shanghai, & Florham Park, NJ — Friday, July 30, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) hereby notifies the market that as at July 30, 2021, the issued share capital of HUTCHMED consisted of 864,115,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury.
The above figure of 864,115,660 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, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules.
For illustrative purposes only, the 864,115,660 ordinary shares would be equivalent to 864,115,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,823,132 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
ELUNATE® in-market sales1 rose 186%, reflecting impact of in-house sales force
Received 1st approval in China for ORPATHYS® and 2nd approval in China for SULANDA®
U.S. and E.U. applications for surufatinib both accepted
Raised $615m2 gross proceeds from additional listing on HKEX3
Company to Host Interim Results Call & Webcast Today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, July 28, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2021 and provides updates on key clinical and commercial developments since the start of the year.
All amounts are expressed in U.S. dollar currency unless otherwise stated.
“HUTCHMED’s progress has been truly exceptional,” said Mr. Simon To, Chairman of HUTCHMED. “Our novel drug discovery and development engine keeps powering ahead. Not only have we secured our third and fourth oncology drug NDA4 approvals in China, but also our first U.S. FDA5 and EMA6 applications for market approval have been accepted.”
“Ten registrational studies are set to start this year on our five lead global assets. These are based on exciting data from proof-of-concept studies of both monotherapies and immunotherapy/TKI7 combinations. In addition, our early-stage portfolio is also progressing with our IDH1/28, ERK9 and third generation BTK10 inhibitors all starting development this year.”
“In parallel, our commercial oncology operations are rapidly progressing.”
“In China, our oncology team is now about 540 people on the ground marketing ELUNATE® and SULANDA®, recording in-market sales11 of $48.1 million in the first half of 2021. In the U.S., our oncology commercial team is building to support potential launches of surufatinib in 2022 and fruquintinib in 2023. On ORPATHYS®, our partner AstraZeneca12 will leverage its great commercial capabilities in lung cancer to market this important first-in-class drug.”
“On the corporate-level we took several important steps during the first half to support our global plans. We changed our name to HUTCHMED, consolidating several legacy group and operating names into a single ubiquitous global corporate identity. We also built a balance of about $1.2 billion in cash and resources through our homecoming IPO13 on HKEX as well as through divestment of our non-core OTC14 drug business.”
“Over the next three years, we will continue to rapidly build our global R&D15 and commercial organizations, supporting the anticipated global launches of our oncology drugs.”
Potential upcoming clinical and regulatory milestones for surufatinib:
Potential upcoming clinical and regulatory milestones for fruquintinib:
Potential upcoming clinical and regulatory milestones for savolitinib:
Potential upcoming clinical and regulatory milestones for HMPL-689:
Potential upcoming clinical and regulatory milestones for HMPL-523:
Potential upcoming clinical and regulatory milestones for HMPL-453:
Potential upcoming clinical and regulatory milestones for HMPL-306:
Potential upcoming clinical and regulatory milestones for HMPL-760:
Potential upcoming discovery milestones:
COVID-19 has not impacted our clinical studies in any material manner to date in 2021. We will continue to closely monitor the evolving situation.
ELUNATE® revenues increased 244% to $29.8 million (H1-20: $8.6m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 186% to $40.1 million (H1-20: $14.0m), as provided by Lilly58;
SULANDA® sales revenues of $8.0 million since mid-January launch, initially to treat patients with advanced extra-pancreatic (non-pancreatic) NET, then also to treat patients with pancreatic NET in June 2021; and
R&D service fee revenues of $5.1 million (H1-20: $7.8m) primarily from AstraZeneca and Lilly.
ORPATHYS® $25 million payment and fixed royalty of 30% on all China sales from AstraZeneca not included, as the milestone payment was recently triggered by its first sales in China in July 2021. AstraZeneca has launched ORPATHYS® across China through its extensive, market-leading oncology commercial organization.
Net Expenses for the six months ended June 30, 2021 were $259.8 million compared to $156.5 million in the six months ended June 30, 2020.
Net Loss attributable to HUTCHMED for the six months ended June 30, 2021 was $102.4 million compared to $49.7 million in the six months ended June 30, 2020.
Condensed Consolidated Balance Sheet Data
(in $’000)
| As of June 30, | As of December 31, | |||
| 2021 | 2020 | |||
| (Unaudited) | ||||
| Assets | ||||
| Cash and cash equivalents and short term investments | 950,448 | 435,176 | ||
| Accounts receivable | 58,878 | 47,870 | ||
| Other current assets | 81,848 | 47,694 | ||
| Property, plant and equipment | 29,168 | 24,170 | ||
| Investments in equity investees | 118,316 | 139,505 | ||
| Other non-current assets | 34,231 | 29,703 | ||
| Total assets | 1,272,889 | 724,118 | ||
| Liabilities and shareholders’ equity | ||||
| Accounts payable | 28,513 | 31,612 | ||
| Other payables, accruals and advance receipts | 181,610 | 120,882 | ||
| Bank borrowings | 26,883 | 26,861 | ||
| Other liabilities | 22,188 | 25,814 | ||
| Total liabilities | 259,194 | 205,169 | ||
| Total Company’s shareholders’ equity | 984,795 | 484,116 | ||
| Non-controlling interests | 28,900 | 34,833 | ||
| Total liabilities and shareholders’ equity | 1,272,889 | 724,118 |
Condensed Consolidated Statement of Operations Data
(Unaudited, in $’000, except share and per share data)
| Six Months Ended June 30, | |||
| 2021 | 2020 | ||
| Revenues: | |||
| Oncology/Immunology – Marketed Products | 37,795 | 8,645 | |
| Oncology/Immunology – R&D | 5,056 | 7,747 | |
| Oncology/Immunology consolidated revenues | 42,851 | 16,392 | |
| Other Ventures | 114,511 | 90,373 | |
| Total revenues | 157,362 | 106,765 | |
| Expenses: | |||
| Costs of revenues | (123,249) | (83,572) | |
| Research and development expenses | (123,050) | (73,974) | |
| Selling and general administrative expenses | (54,797) | (27,384) | |
| Total expenses | (301,096) | (184,930) | |
| Loss from Operations | (143,734) | (78,165) | |
| Other income | 3,287 | 1,585 | |
| Loss before income taxes and equity in earnings of equity investees | (140,447) | (76,580) | |
| Income tax expense | (1,859) | (2,032) | |
| Equity in earnings of equity investees, net of tax | 42,966 | 30,366 | |
| Net loss | (99,340) | (48,246) | |
| Less: Net income attributable to non-controlling interests | (3,057) | (1,448) | |
| Net loss attributable to HUTCHMED | (102,397) | (49,694) | |
| Losses per share attributable to HUTCHMED – basic and diluted | (0.14) | (0.07) | |
| Number of shares used in per share calculation – basic and diluted | 729,239,181 | 685,285,841 | |
| Losses per ADS attributable to HUTCHMED – basic and diluted | (0.70) | (0.35) | |
| Number of ADSs used in per share calculation – basic and diluted | 145,847,836 | 137,057,168 | |
All amounts are expressed in U.S. dollar currency unless otherwise stated.
During the first half of 2021, we performed as expected with commercial progress on ELUNATE®, SULANDA® and now ORPATHYS®. While results are encouraging, we leave guidance unchanged.
| H1 2021 Actual |
2021 Current Guidance |
Adjustments vs. Previous Guidance |
|
| Oncology/Immunology consolidated revenues | $42.9 million | $110 – 130 million | nil |
Use of Non-GAAP Financial Measures and Reconciliation – References in this announcement to 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.
—–
Conference Call and Audio Webcast Presentation scheduled today at 8 p.m. HKT / 1 p.m. BST / 8 a.m. EDT – Investors may participate in the call as follows: +852 3027 6500 (Hong Kong) / +44 20 3194 0569 (U.K.) / +1 646 722 4977 (U.S.), or access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/.
Additional dial-in numbers are also available at HUTCHMED’s website. Please use participant access code “45675713#.”
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development & commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel. has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and launched. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
Unless the context requires otherwise, references in this announcement to the “Group,” the “Company,” “HUTCHMED,” “HUTCHMED Group,” “we,” “us,” and “our,” mean HUTCHMED (China) 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 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, uncertainties regarding future global exchange rates and uncertainties regarding the impact of the COVID-19 pandemic. For further discussion of these and other risks, see HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on HKEX. HUTCHMED 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 HUTCHMED obtained from industry publications and reports generated by third-party market research firms. Although HUTCHMED believes that the publications, reports and surveys are reliable, HUTCHMED 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 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018).
REFERENCES AND ABBREVIATIONS
| Announcement released: Wednesday, July 28, 2021 |
| Time: 7pm HKT / 7am EDT / 12 noon BST |
| >> View Announcement << |
| Presentation webcast & call: |
| Time: 8pm HKT / 8am EDT / 1pm BST |
To participate by phone, please use one of the following numbers.
Participant Access Code is : “45675713#“
| United Kingdom (Toll-Free) | 0800 026 1542 |
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— Follows multiple Phase II studies of ORPATHYS® in Asia including VIKTORY, which reported an 50% objective response rate (ORR) in gastric cancer patients whose tumors harbor MET amplification —
Hong Kong, Shanghai & Florham Park, NJ — Wednesday, July 28, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) and AstraZeneca PLC (“AstraZeneca”) (LSE/STO/Nasdaq: AZN) have initiated a Phase II study of ORPATHYS® (savolitinib), an oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, in patients with advanced or metastatic MET amplified gastric cancer (“GC”) or adenocarcinoma of the gastroesophageal junction (“GEJ”). The first patient was dosed on July 27, 2021.
The Phase II trial is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (“PK”) of ORPATHYS® in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy. The primary endpoint is objective response rate (“ORR”) as assessed by an independent review committee. Other endpoints include 12-week and 6-month progression-free survival (“PFS”) rates, median PFS, duration of response (“DoR”), disease control rate (“DCR”), median overall survival (“OS”), safety, PK and quality of life.
The Beijing Cancer Hospital is the lead institution of this study. The lead investigator is Dr Shen Lin. For more information, please see clinicaltrials.gov identifier: NCT04923932.
MET-driven gastric cancer has a very poor prognosis.[i] This trial follows multiple Phase II studies that have been conducted in Asia to study ORPATHYS® in MET-driven gastric cancer patients, including VIKTORY.2 VIKTORY is an investigator initiated Phase II umbrella study in gastric cancer in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified gastric cancer. Patients whose tumors harbor MET amplification were treated with ORPATHYS® monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
It is estimated that MET amplification accounts for approximately 4-6% of GC patients.[ii],[iii] The annual incidence of MET amplification GC is estimated to be approximately 24,000 in China.[iv]
ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.
ORPATHYS® is marketed in China for the treatment of patients with non-small cell lung cancer (“NSCLC”) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.
In 2011, following its discovery and initial development by HUTCHMED, AstraZeneca and HUTCHMED entered a global licensing agreement to jointly develop and commercialize ORPATHYS®. Joint development in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of ORPATHYS® in China. AstraZeneca is responsible for the commercialization of ORPATHYS® in China and worldwide. Sales of ORPATHYS® will be recognized by AstraZeneca.
Phase II study of ORPATHYS® monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021, ORPATHYS® was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were presented during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program in May 2020, and updated results were published in The Lancet Respiratory Medicine[v] in June 2021. At a median follow up of 17.6 months, ORPATHYS® demonstrated an objective response rate (“ORR”) of 42.9% (95% confidence interval [CI] 31.1-55.3) and median progression-free survival (“PFS”) of 6.8 months (95% CI 4.2-9.6) in the overall trial population. PFS was clinically meaningful across subgroups, and ORR results were consistent regardless of prior treatment or tumor histology, including in patients with the pulmonary sarcomatoid carcinoma (PSC) subtype (40.0%, 95% CI 21.1-61.3) and patients with other NSCLC subtypes (44.4%, 95% CI 29.6-60.0). Disease control rate (“DCR”) in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of ORPATHYS® was consistent with previous trials, and no new safety signals were identified. Continued approval is contingent upon the successful completion of a confirmatory trial in this patient population (NCT04923945).
SAVANNAH Phase II study of ORPATHYS® in combination with TAGRISSO® in patients who have progressed following TAGRISSO® due to MET amplification or overexpression (NCT03778229) – This is a single-arm, open-label, global study in epidermal growth factor receptor (“EGFR”) mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO®, an EGFR TKI owned by AstraZeneca.
Phase III study of ORPATHYS® in combination with TAGRISSO® in patients who have progressed following EGFR TKI treatment due to MET amplification (in planning) – This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.
Phase III study of ORPATHYS® in combination with TAGRISSO® in treatment naïve patients with EGFR mutant positive NSCLC with MET overexpression (in planning) – This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.
SAVOIR randomized, controlled study of ORPATHYS® monotherapy in MET-driven papillary renal cell carcinoma (“RCC”) (NCT03091192) – In May 2020, data from 60 patients in this global study of ORPATHYS® monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO 2020 Program and published simultaneously in JAMA Oncology[vi]. ORPATHYS® demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no ORPATHYS® responding patients experiencing disease progression at data cut-off, and an encouraging overall survival (“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 I/II study of ORPATHYS® in combination with IMFINZI® PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of ORPATHYS® in combination with IMFINZI®, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the ORPATHYS®/IMFINZI® combination in patients with papillary RCC and clear cell RCC. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO Annual Meeting[vii], showing a confirmed response rate in 14 MET-driven patients of 57%, with a median duration of response (“DoR”) of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.
Phase III study in combination with IMFINZI® PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (in planning) – Based on the encouraging results of the SAVOIR and CALYPSO studies, we intend to initiate a global Phase III, open-label, randomized, controlled study of ORPATHYS® plus IMFINZI® versus sunitinib monotherapy versus IMFINZI® monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC.
ORPATHYS® opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including non-small cell lung cancer, gastric cancer and colorectal cancer.
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of ORPATHYS® for the treatment of patients with gastric cancer, the further clinical development of ORPATHYS® in this and other indications, its expectations as to whether clinical studies of ORPATHYS® 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 New Drug Application approval of ORPATHYS® for the treatment of patients with gastric cancer in China, its potential to gain expeditious approvals for ORPATHYS® in other jurisdictions such as the U.S., E.U. or Japan, the safety profile of ORPATHYS®, the potential for ORPATHYS® to become a new standard of care for gastric cancer patients, its ability to implement and complete its further clinical development plans for ORPATHYS®, its potential commercial launch of ORPATHYS® 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 ORPATHYS®, 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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and with The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
[i] Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase receptor expression and amplification as prognostic biomarkers of survival in gastroesophageal adenocarcinoma. Cancer. 2017;123(6):1061-1070. doi:10.1002/cncr.30437
[ii] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-044
[iii] Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter Phase II Study of AMG 337 in Patients with MET-Amplified Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and Other MET-Amplified Solid Tumors. Clin Cancer Res. 2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337
[iv] Global Cancer Observatory. China Fact Sheet. gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[v] Lu S, et al. Once-daily savolitinib in Chinese patients with pulmonary sarcomatoid carcinomas and other non-small-cell lung cancers harbouring MET exon 14 skipping alterations: a multicentre, single-arm, open-label, phase 2 study. Lancet Respir Med. 2021 Jun 21:S2213-2600(21)00084-9. doi: 10.1016/S2213-2600(21)00084-9.
[vi] Choueiri TK, et al. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. doi: 10.1001/jamaoncol.2020.2218.
[vii] Powles T, et al. A phase II study investigating the safety and efficacy of savolitinib and durvalumab in metastatic papillary renal cancer (CALYPSO). J Clin Oncol 37, 2019 (suppl 7S; abstr 545). doi: 10.1200/JCO.2019.37.7_suppl.545.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Friday, July 23, 2021: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; HKEX: 13) announces that the stabilization period in connection with the Global Offering ended on July 23, 2021, being the 30th day after the last day for the lodging of applications under the Hong Kong Public Offering on June 23, 2021. The stabilizing actions undertaken by Morgan Stanley Asia Limited, as the Stabilizing Manager (or any person acting for it) during the stabilization period were:
(1) over-allocations of an aggregate of 15,600,000 Offer Shares in the International Offering, representing approximately 15% of the total number of the Offer Shares initially available under the Global Offering before any exercise of the Over-allotment Option;
(2) borrowing of an aggregate of 15,600,000 Shares by Morgan Stanley & Co. International plc (an affiliate of Morgan Stanley Asia Limited) from Hutchison Healthcare Holdings Limited (an indirect wholly-owned subsidiary of CK Hutchison Holdings Limited) pursuant to the Stock Borrowing Agreement dated June 23, 2021, to cover over-allocations in the International Offering; and
(3) the full exercise of the Over-allotment Option by the Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, in respect of an aggregate of 15,600,000 Offer Shares, representing approximately 15% of the total number of the Offer Shares initially available under the Global Offering before any exercise of the Over-allotment Option, at the Offer Price, to facilitate the return to Hutchison Healthcare Holdings Limited of all the borrowed Shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering.
There has been no purchase or sale of any Shares on the market for the purpose of price stabilization by the Stabilizing Manager during the stabilization period.
For further details of the full exercise of the Over-allotment Option, please refer to the HUTCHMED announcement dated July 12, 2021.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced eleven cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
Unless otherwise defined herein, capitalized terms used in this announcement shall have the same meanings as those defined in the prospectus dated Friday, June 18, 2021 (the “Prospectus”) of HUTCHMED.
This announcement is for information purposes only and does not constitute an offer or an invitation to induce an offer by any person to acquire, purchase or subscribe for any securities. Potential investors should read the Prospectus for detailed information about the Company and the Global Offering before deciding whether or not to invest in the Offer Shares.
This announcement is not for release, publication, distribution, directly or indirectly, in or into the United States (including its territories and possessions, any state of the United States and the District of Columbia) or to any U.S. person (as defined in Regulation S under the U.S. Securities Act of 1933, as amended from time to time, (the “U.S. Securities Act”) or any other jurisdiction where such distribution is prohibited by law. This announcement does not constitute or form a part of any offer to sell or solicitation to purchase or subscribe for securities in Hong Kong, the United States or elsewhere. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the U.S. Securities Act. Any public offering of the Company’s securities outside of the public offering in Hong Kong will be made (i) pursuant to the shelf registration statement on Form F-3ASR that was filed with the U.S. Securities and Commission and became effective on April 6, 2020 and (ii) in respect of securities to be sold to certain cornerstone investors, in reliance on Rule 901 of Regulation S under the U.S. Securities Act or pursuant to another exemption from the registration requirements of the U.S. Securities Act, as described in the section headed “Structure of the Global Offering – The International Offering” in the Prospectus.
No prospectus required for the purposes of Regulation (EU) 2017/1129 (“EU Prospectus Regulation”) or Regulation (EU) 2017/1129 (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018) (“UK Prospectus Regulation”) or admission document (as defined in the AIM Rules for Companies published by the London Stock Exchange plc) will be made available in connection with the matters contained in this announcement. In any member state of the European Economic Area, this announcement is only addressed to and directed at qualified investors in that member state as defined in article 2(e) of the EU Prospectus Regulation.
This announcement, insofar as it constitutes an invitation or inducement to enter into investment activity (within the meaning of section 21 of the U.K. Financial Services and Markets Act 2000, as amended) in connection with the securities which are the subject of the Global Offering, is being directed only at (i) persons who are outside the United Kingdom or (ii) if in the United Kingdom, persons who are qualified investors as defined in article 2(e) of the UK Prospectus Regulation who also (a) have professional experience in matters relating to investments who fall within Article 19(5) (investment professionals) of the U.K. Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “Order”) or (b) fall within Article 49(2)(a) to (d) (high net worth companies, unincorporated associations etc.) of the Order; or (iii) any other person to whom it may lawfully be communicated (all such persons in (i) to (iii) together being referred to as “specified persons”). This announcement is directed only at specified persons and must not be acted on or relied on in the United Kingdom by persons who are not specified persons. Any investment or investment activity to which this announcement relates is available only to specified persons and will be engaged in only with specified persons.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: | HUTCHMED (China) 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 | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify) iii: | ||||||
| 3. Details of person subject to the notification obligation iv | ||||||
| Name | Canada Pension Plan Investment Board | |||||
| City and country of registered office (if applicable) | Toronto, Canada | |||||
| 4. Full name of shareholder(s) (if different from 3.) v | ||||||
| Name | N/A | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 5. Date on which the threshold was crossed or reached vi: | 30 June 2021 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 16 July 2021 | |||||
| 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 instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | 3.17% | 0.00 | 3.17% | 26,883,270 | ||
| Position of previous notification (if applicable) | N/A | N/A | N/A | |||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of shares ISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
| Direct (DTR5.1) | Indirect (DTR5.2.1) | Direct (DTR5.1) | Indirect (DTR5.2.1) | ||||||
| Ordinary Shares KYG4672N1198 | 26,883,270 | 0 | 3.17% | 0.00 | |||||
| SUBTOTAL 8. A | 26,883,270 | 3.17% | |||||||
| B 1: Financial Instruments according to DTR5.3.1R (1) (a) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Number of voting rights that may be acquired if the instrument is exercised/converted. | % of voting rights | |||
| N/A | N/A | N/A | N/A | N/A | |||
| SUBTOTAL 8. B 1 | N/A | N/A | |||||
| B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Physical or cash Settlement xii | Number of voting rights | % of voting rights | ||
| N/A | N/A | N/A | N/A | N/A | N/A | ||
| SUBTOTAL 8.B.2 | N/A | N/A | |||||
| 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) issuer xiii | 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 entity (please add additional rows as necessary) xiv |
||||
| Name | % 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 | |
| N/A | N/A | N/A | N/A | |
| 10. In case of proxy voting, please identify: | ||||
| Name of the proxy holder | N/A | |||
| The number and % of voting rights held | N/A | |||
| The date until which the voting rights will be held | N/A | |||
| 11. Additional information xvi | ||||
| N/A | ||||
| Place of completion | Hong Kong |
| Date of completion | 16 July 2021 |
– EMA commences review of surufatinib for the treatment of advanced neuroendocrine tumors –
– Expands potential global reach of surufatinib, in addition to China where it is already launched, and in the U.S. where it is under review for marketing approval –
Hong Kong, Shanghai & Florham Park, NJ — Friday, July 16, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the European Medicines Agency (“EMA”) has validated and accepted its marketing authorization application (“MAA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”). The EMA’s validation confirms that the submission is sufficiently complete and that it is ready to commence the formal review process.
The submission follows scientific advice from the EMA’s Committee for Medicinal Products for Human Use (“CHMP”), from which it was concluded that the two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET‑p[i] and SANET‑ep[ii], both previously reported in The Lancet Oncology), along with existing data from surufatinib in U.S. extra-pancreatic and pancreatic NET patients, could form the basis to support a MAA. The submission follows the acceptance of a new drug application (“NDA”) with the U.S. Food and Drug Administration (“FDA”), as announced on July 1, 2021.
Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said, “HUTCHMED’s novel oncology pipeline is making important progress globally and the EMA’s validation of surufatinib’s MAA, which we believe recognizes the scientific value of this submission package, follows the recent acceptance of the U.S. NDA by the FDA. With its launch earlier this year in China, surufatinib has given NET patients an important new therapeutic option and we now hope to soon be able to bring this important treatment to patients across the U.S. and Europe.”
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 extra-pancreatic (non-pancreatic) NET (“epNET”).
According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Rates across the European Union (E.U.) appear largely similar to the U.S.. This is supported by an analysis of global epidemiologic trends, which also show growth in the incidence of NETs worldwide.[iii] Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 140,000 estimated patients living with NET in France, Germany, Italy, Spain, and the United Kingdom in 2020.[iv]
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (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.
HUTCHMED currently retains all rights to surufatinib worldwide.
NETs in the U.S. and Europe: A U.S. FDA NDA submission was accepted in June 2021, followed by a MAA submission to the EMA in Europe validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). 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.
epNETs in China: On December 30, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name Sulanda®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs 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.[v] 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%).
pNETs in China: On June 18, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology[vi], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.
Biliary tract cancer in China: In March 2019, HUTCHMED initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).
Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi® (toripalimab) and Tyvyt® (sintilimab), which are approved as monotherapies in China.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and marketed. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the review of an MAA for surufatinib for the treatment of NET with the EMA and the timing of such review, the therapeutic potential of surufatinib for the treatment of patients with NET and the further clinical development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S., China and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, HUTCHMED’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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
[i] Surufatinib in advanced neuroendocrine tumors – pancreatic.
[ii] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
[iii] Fraenkel M, Kim M, Faggiano A, de Herder WW, Valk GD; Knowledge NETwork. Incidence of gastroenteropancreatic neuroendocrine tumours: a systematic review of the literature. Endocr Relat Cancer. 2014;21(3):R153-R163. Published 2014 May 6. doi:10.1530/ERC-13-0125.
[iv] According to Frost & Sullivan, in 2020, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 143,000 patients living with NETs.
[v] 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.
[vi] 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.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie /Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: | HUTCHMED (China) 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 | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify) iii: | ||||||
| 3. Details of person subject to the notification obligation iv | ||||||
| Name | Jean Eric Salata | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 4. Full name of shareholder(s) (if different from 3.) v | ||||||
| Name | N/A | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 5. Date on which the threshold was crossed or reached vi: | 30 June 2021 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | 13 July 2021 | |||||
| 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 instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | 3.06% | 25,993,445 | ||||
| Position of previous notification (if applicable) | ||||||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of shares ISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
| Direct (DTR5.1) | Indirect (DTR5.2.1) | Direct (DTR5.1) | Indirect (DTR5.2.1) | ||||||
| Ordinary Shares KYG4672N1198 | 25,993,445 | 3.06% | |||||||
| SUBTOTAL 8. A | 25,993,445 | 3.06% | |||||||
| B 1: Financial Instruments according to DTR5.3.1R (1) (a) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
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 DTR5.3.1R (1) (b) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Physical or cash Settlement xii | 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) issuer xiii | ||||
| 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 entity (please add additional rows as necessary) xiv |
X | |||
| Name | % 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 | |
| Chain 1: Jean Eric Salata | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII Limited | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII, L.P. | 3.06% | 3.06% | ||
| The Baring Asia Private Equity Fund VII, L.P. | 3.06% | 3.06% | ||
| Baring Private Equity Asia Fund VII Limited | 3.06% | 3.06% | ||
| Rhapso Holding Limited | Less than 3% | Less than 3% | ||
| Rhapso Limited | Less than 3% | Less than 3% | ||
| Chain 2: Jean Eric Salata | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII Limited | 3.06% | 3.06% | ||
| Baring Private Equity Asia GP VII, L.P. | 3.06% | 3.06% | ||
| The Baring Asia Private Equity Fund VII, L.P. | 3.06% | 3.06% | ||
| Baring Private Equity Asia Fund VII Limited | 3.06% | 3.06% | ||
| Pachytene Holding Limited | Less than 3% | Less than 3% | ||
| Pachytene Limited | Less than 3% | Less than 3% | ||
| 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 information xvi | ||||
| Place of completion | Hong Kong |
| Date of completion | 14 July 2021 |
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, July 13, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) announces the first commercial sale in China of ORPATHYS® (savolitinib), HUTCHMED’s oral, potent, and highly selective small molecule inhibitor of MET, a receptor tyrosine kinase, which occurred on July 12, 2021.
This follows less than three weeks after the June 22, 2021 approval of ORPATHYS® in China for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
Under the terms of the license and collaboration agreement between HUTCHMED and AstraZeneca (“AstraZeneca”) (LSE/STO/Nasdaq: AZN), a US$25 million non-creditable and non-refundable milestone payment is triggered by the first commercial sales of ORPATHYS® in China. HUTCHMED is responsible for the clinical development, marketing authorization, manufacturing and supply of ORPATHYS® in China, while AstraZeneca is responsible for its commercialization for which it will pay HUTCHMED fixed royalties of 30% based on all China sales.
More than a third of the world’s lung cancer patients are in China and, among those with NSCLC, approximately 2-3% have tumors with MET exon 14 skipping alterations, a targetable mutation in the MET gene.[i],[ii],[iii] This mutation is more common (13-22%) among patients with pulmonary sarcomatoid carcinoma (PSC), a rare and aggressive subtype of NSCLC usually resistant to chemotherapy.[i],[iv]
ORPATHYS® is an oral, potent, and highly selective MET tyrosine kinase inhibitor (“TKI”) that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations) or gene amplification.
ORPATHYS® is marketed in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines.
Phase II study of ORPATHYS® monotherapy in MET Exon 14 skipping alteration NSCLC (NCT02897479) – In June 2021, ORPATHYS® was granted drug registration conditional approval by the National Medical Products Administration of China (NMPA) for MET Exon 14 skipping alteration NSCLC. The approval was based on the results of a Phase II study in China; results of this study were presented during the American Society of Clinical Oncology ASCO20 Virtual Scientific Program in May 2020, and updated results were published in The Lancet Respiratory Medicine in June 2021. At a median follow up of 17.6 months, ORPATHYS® demonstrated an objective response rate (“ORR”) of 42.9% (95% confidence interval [CI] 31.1-55.3) and median progression-free survival (“PFS”) of 6.8 months (95% CI 4.2-9.6) in the overall trial population. PFS was clinically meaningful across subgroups, and ORR results were consistent regardless of prior treatment or tumor histology, including in patients with the PSC subtype (40.0%, 95% CI 21.1-61.3) and patients with other NSCLC subtypes (44.4%, 95% CI 29.6-60.0). Disease control rate (“DCR”) in the overall trial population was 82.9% (95% CI 72.0-90.8). The safety and tolerability profile of ORPATHYS® was consistent with previous trials, and no new safety signals were identified.
SAVANNAH Phase II study of ORPATHYS® in combination with TAGRISSO® in patients who have progressed following TAGRISSO® due to MET amplification or overexpression (NCT03778229) – This is a single-arm, open-label, global study in epidermal growth factor receptor (“EGFR”) mutation positive NSCLC patients with MET amplified/overexpressed tumors following progression after treatment with TAGRISSO®, an EGFR TKI owned by AstraZeneca.
Phase III study of ORPATHYS® in combination with TAGRISSO® in patients who have progressed following EGFR TKI treatment due to MET amplification (in planning) – This is a randomized, open-label study in China in EGFR mutation positive NSCLC patients with MET amplified tumors following progression after treatment with any EGFR TKI.
Phase III study of ORPATHYS® in combination with TAGRISSO® in treatment naïve patients with EGFR mutant positive NSCLC with MET overexpression (in planning) – This is a randomized, blinded study in China in untreated, unresectable or metastatic patients with EGFR mutation positive NSCLC with MET positive tumors.
SAVOIR randomized, controlled study of ORPATHYS® monotherapy in MET-driven papillary renal cell carcinoma (“RCC”) (NCT03091192) – In May 2020, data from 60 patients in this global study of ORPATHYS® monotherapy compared with sunitinib monotherapy in MET-driven papillary RCC was presented at the ASCO 2020 Program and published simultaneously in JAMA Oncology. ORPATHYS® demonstrated encouraging activity, including an ORR of 27% versus 7% for sunitinib, with no ORPATHYS® responding patients experiencing disease progression at data cut-off, and an encouraging overall survival (“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 I/II study of ORPATHYS® in combination with IMFINZI® PD-L1 inhibitor in RCC (NCT02819596) – The CALYPSO study is an investigator initiated open-label Phase I/II study of ORPATHYS® in combination with IMFINZI®, a PD-L1 antibody owned by AstraZeneca. The study is evaluating the safety and efficacy of the ORPATHYS®/IMFINZI® combination in patients with papillary RCC and clear cell RCC. An analysis of 41 patients enrolled in the PRCC cohort of in this study was presented at the 2021 ASCO Annual Meeting, showing a confirmed response rate in 14 MET-driven patients of 57%, with a median duration of response (“DoR”) of 9.4 months, median PFS of 10.5 months and median OS of 27.4 months. No new safety signals were seen.
Phase III in combination with IMFINZI® PD-L1 inhibitor in MET-driven, unresectable and locally advanced or metastatic PRCC (in planning) – Based on the encouraging results of the SAVOIR and CALYPSO studies, we intend to initiate a global Phase III, open-label, randomized, controlled study of ORPATHYS® plus IMFINZI® versus sunitinib monotherapy versus IMFINZI® monotherapy in patients with MET-driven, unresectable and locally advanced or metastatic PRCC.
Phase II study of ORPATHYS® monotherapy in advanced or metastatic MET amplified gastric cancer (“GC”) or adenocarcinoma of the gastroesophageal junction (“GEJ”) (NCT04923932) – This Phase II trial is an open-label, two-cohort, multi-center study to evaluate the efficacy, safety and pharmacokinetics (“PK”) of ORPATHYS® in locally advanced or metastatic GC or GEJ patients whose disease progressed after at least one line of standard therapy. The primary endpoint is ORR as assessed by an independent review committee. Other endpoints include 12-week and 6-month PFS rates, median PFS, DoR, DCR, median OS, safety, PK and quality of life.
This trial follows multiple Phase II studies that have been conducted in Asia to study ORPATHYS® in MET-driven gastric cancer patients, including VIKTORY.[v] VIKTORY is an investigator initiated Phase II umbrella study in gastric cancer in South Korea in which a total of 715 patients were successfully sequenced into molecular-driven patient groups, including those with MET amplified gastric cancer. Patients whose tumors harbor MET amplification were treated with ORPATHYS® monotherapy, reporting an ORR of 50% (10/20, 95% CI: 28.0, 71.9).
ORPATHYS® opportunities are also continuing to be explored in multiple other MET-driven tumor settings via investigator-initiated studies including non-small cell lung cancer, gastric cancer and colorectal cancer.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved and launched. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the commercial launch of ORPATHYS® in China, our ability to manufacture and supply ORPATHYS®, the ability of its partner AstraZeneca to distribute ORPATHYS® quickly and broadly, the potential market for ORPATHYS® in non-small cell lung cancer patients China, and the further clinical development for ORPATHYS® in these and other indications and in combination with other medicines 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 AstraZeneca’s ability to effectively commercialize ORPATHYS®, the benefits obtained from ORPATHYS® during clinical trials being the same for all patients who are prescribed ORPATHYS®, no unidentified side effects occurring which could result in the NMPA pulling ORPATHYS® from the market, AstraZeneca and HUTCHMED’s ability to fund, implement and complete further clinical development and commercialization plans for ORPATHYS®, 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 ORPATHYS®, 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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
[i] Vuong HG, et al. Clinicopathological implications of MET exon 14 mutations in non-small cell lung cancer – A systematic review and meta-analysis. Lung Cancer 2018; 123: 76-82. doi: 10.1016/j.lungcan.2018.07.006.
[ii] World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed June 2021.
[iii] World Health Organization. International Agency for Research on Cancer. Globocan China Fact Sheet 2020. Available at http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf. Accessed June 2021.
[iv] Liu X, et al. Next-generation sequencing of pulmonary sarcomatoid carcinoma reveals high frequency of actionable MET gene mutations. J Clin Oncol 2016; 34: 794-802. doi: 10.1200/JCO.2015.62.0674.
[v] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides Patients with Metastatic Gastric Cancer to Targeted Treatment: The VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405. doi:10.1158/2159-8290.CD-19-0442.
Hong Kong, Shanghai, & Florham Park, NJ — Monday, July 12, 2021: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM, HKEX:13) today announces the full exercise of the over-allotment option of the Global Offering. The Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, fully exercised the Over-allotment Option, in respect of an aggregate of 15,600,000 offer shares (the “Over-allotment Shares”), representing approximately 15% of the total number of offer shares initially available under the Global Offering before any exercise of the Over-allotment Option to (among other things) facilitate the return to Hutchison Healthcare Holdings Limited (an indirect wholly owned subsidiary of CK Hutchison Holdings Limited) the borrowed shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering. The Company has been notified that following the return of such shares, the shareholding of CK Hutchison Holdings Limited in the Company will be 332,502,740 shares, representing 38.48% of the total number of voting rights of the Company as enlarged by the issuance of the Over-allotment Shares.
The Over-allotment Shares will be allotted and issued by the Company at HK$40.10 per offer share (exclusive of brokerage of 1%, Securities and Futures Commission transaction levy of 0.0027% and Hong Kong Stock Exchange trading fee of 0.005%), being the offer price per offer share under the Global Offering.
Approval for the listing of and permission to deal in the Over-allotment Shares has already been granted by the Listing Committee of the Hong Kong Stock Exchange. Listing of and dealings in the Over-allotment Shares are expected to commence on the Main Board of the Hong Kong Stock Exchange at 9:00 a.m. on Thursday, July 15, 2021.
The Company’s total number of issued shares as of the date of this announcement and immediately after the completion of the full exercise of the Over-allotment Option (assuming there are no other changes to the total number of issued shares since the date of this announcement) is 848,515,660 shares and 864,115,660 shares, respectively.
Application will be made to the London Stock Exchange for the 15,600,000 Over-allotment Shares to be admitted to the AIM market operated by the London Stock Exchange (“Admission”). It is expected that Admission will become effective at 8:00 a.m. UK time on July 16, 2021.
Following the above, the issued share capital of HUTCHMED will consist of 864,115,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. This figure 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, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules. For illustrative purposes only, 864,115,660 shares would be equivalent to 864,115,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,823,132 ADSs (each equating to five ordinary shares) which are traded on Nasdaq.
The gross proceeds to the Company from the Over-allotment Option, before deducting underwriting fees and the offering expenses, are expected to be approximately HK$625 million. The Company intends to apply the additional net proceeds towards the same purposes as set out in the section headed “Use of Proceeds” in the prospectus.
The Company will make a further announcement after the end of the stabilization period in connection with the Global Offering pursuant to Section 9(2) of the Securities and Futures (Price Stabilizing) Rules (Chapter 571W of the Laws of Hong Kong).
*****
HUTCHMED (Nasdaq/AIM: HCM, HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations regarding future events, including statements about the Global Offering and listing, the use of proceeds and the Company’s plans and objectives. Forward-looking statements involve risks and uncertainties. More information about the risks and uncertainties faced by HUTCHMED will be contained or incorporated by reference in the prospectus registered with The Stock Exchange of Hong Kong Limited (“SEHK”), prospectus and prospectus supplement that have been filed with the SEC and the international offering circular, in each case related to the Global Offering. 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 HUTCHMED’s filings with the SEHK, U.S. Securities and Exchange Commission and on AIM. HUTCHMED 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.
In connection with the Global Offering, Morgan Stanley Asia Limited as stabilizing manager (the “Stabilizing Manager”) (or any person acting for it), on behalf of the underwriters, may effect transactions on the SEHK with a view to stabilizing or supporting the market price of the shares at a level higher than that which might otherwise prevail for a limited period after the listing date. However, there is no obligation on the Stabilizing Manager (or any person acting for it) to conduct any such stabilizing action, which, if taken, will be done at the absolute discretion of the Stabilizing Manager (or any person acting for it) and in what the Stabilizing Manager reasonably regards as the best interest of the Company and may be discontinued at any time. Any such stabilizing action is required to be brought to an end on the 30th day after the last day for lodging applications under the Hong Kong Public Offering.
Such stabilization action, if commenced, may be effected in all jurisdictions where it is permissible to do so, in each case in compliance with all applicable laws, rules and regulatory requirements, including the Securities and Futures (Price Stabilizing) Rules (Cap. 571W of the Laws of Hong Kong), as amended, made under the Securities and Futures Ordinance (Cap. 571 of the Laws of Hong Kong), Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (as it forms part of retained EU law as defined in the European Union (Withdrawal) Act 2018) and Regulation M under the U.S. Securities Exchange Act of 1934, as amended.
Potential investors should be aware that no stabilizing action can be taken on the SEHK to support the price of the shares for longer than the stabilization period which began on the listing date and is expected to expire on Friday, July 23, 2021, being the 30th day after the last day for lodging applications under the Hong Kong Public Offering. After this date, when no further stabilizing action may be taken, demand for the shares, and therefore the price of the shares, could fall.
Hong Kong, Shanghai and Florham Park, NJ — Tuesday, July 6, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) has initiated a Phase I study of HMPL‑295, its investigative and highly selective oral inhibitor of ERK, which is a downstream component of the RAS-MAPK[1] pathway signaling cascade. HMPL-295 has the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS, RAF and MEK. This is our first of multiple candidates in discovery addressing the RAS-MAPK pathway. The first patient was dosed on July 2, 2021.
The clinical trial is a multi-center, open-label study to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-295, and to determine the maximum tolerated dose and recommended Phase II dose (“RP2D”) in patients with advanced malignant solid tumors. Following the initial dose escalation stage, another 10 to 15 patients will be enrolled at the RP2D to further evaluate its safety and the preliminary efficacy of HMPL-295. An exploratory study on the pharmacokinetic biomarkers of HMPL-295 is also planned. Additional details may be found at clinicaltrials.gov, using identifier NCT04908046.
We currently retain all rights to HMPL-295 worldwide.
The RAS-MAPK pathway is dysregulated in human diseases, particularly cancer, in which mutations or nongenetic events hyperactivate the pathway in more than 50% of cancers. Activating mutations in RAS genes occur in more than 30% of cancers. RAS and RAF predict worse clinical prognosis in a wide variety of tumor types, mediate resistance to targeted therapies, and decrease the response to the approved standards of care, namely, targeted therapy and immunotherapy. On the RAS-MAPK pathway, KRAS inhibitors are under clinical evaluation, and acquired resistance develops for RAF/MEK targeted therapies. ERK inhibition has the potential to overcome or avoid the intrinsic or acquired resistance from upstream mechanisms such as these.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) (formerly Hutchison China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of HMPL-295, the further clinical development for HMPL-295, 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 HMPL-295, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions, to gain commercial acceptance after obtaining regulatory approval, the potential market of HMPL-295 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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and The Stock Exchange of Hong Kong Limited. HUTCHMED 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.
[1] Mitogen‑activated protein kinase, MAPK.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Atholl Tweedie / Freddy Crossley, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
| NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible) i | ||||||
| 1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached ii: | HUTCHMED (China) 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 | ||||||
| An event changing the breakdown of voting rights | ||||||
| Other (please specify) iii: | ||||||
| 3. Details of person subject to the notification obligation iv | ||||||
| Name | CA Fern Parent | |||||
| City and country of registered office (if applicable) | Mauritius | |||||
| 4. Full name of shareholder(s) (if different from 3.) v | ||||||
| Name | N/A | |||||
| City and country of registered office (if applicable) | N/A | |||||
| 5. Date on which the threshold was crossed or reached vi: | June 30, 2021 | |||||
| 6. Date on which issuer notified (DD/MM/YYYY): | July 2, 2021 | |||||
| 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 instruments (total of 8.B 1 + 8.B 2) |
Total of both in % (8.A + 8.B) | Total number of voting rights held in issuer (8.A + 8.B) vii | |||
| Resulting situation on the date on which threshold was crossed or reached | 4.81% | 40,847,500 | ||||
| Position of previous notification (if applicable) | N/A | N/A | N/A | |||
| 8. Notified details of the resulting situation on the date on which the threshold was crossed or reached viii | |||||||||
| A: Voting rights attached to shares | |||||||||
| Class/type of shares ISIN code (if possible) |
Number of voting rights | % of voting rights | |||||||
| Direct (DTR5.1) | Indirect (DTR5.2.1) | Direct (DTR5.1) | Indirect (DTR5.2.1) | ||||||
| Ordinary Shares KYG4672N1198 | 40,847,500 | N/A | 4.81% | N/A | |||||
| SUBTOTAL 8. A | 40,847,500 | 4.81% | |||||||
| B 1: Financial Instruments according to DTR5.3.1R (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 | |||
| N/A | N/A | N/A | N/A | N/A | |||
| SUBTOTAL 8. B 1 | N/A | N/A | |||||
| B 2: Financial Instruments with similar economic effect according to DTR5.3.1R (1) (b) | |||||||
| Type of financial instrument | Expiration date x |
Exercise/ Conversion Period xi |
Physical or cash Settlement xii | Number of voting rights | % of voting rights | ||
| N/A | N/A | N/A | N/A | N/A | N/A | ||
| SUBTOTAL 8.B.2 | N/A | N/A | |||||
| 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) issuer xiii | ||||
| 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 entity (please add additional rows as necessary) xiv |
X | |||
| Name | % 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 | |
| CAP V Mauritius Limited | 4.37% | N/A | 4.37% | |
| CAP V Coinvest Mauritius Limited | Less than 3% | N/A | Less than 3% | |
| Carlyle Asia PE Alternative Opportunities Mauritius Limited | Less than 3% | N/A | Less than 3% | |
| Carlyle Asia PE Alternative Opportunities II Mauritius Limited | Less than 3% | N/A | Less than 3% | |
| The Carlyle Group Inc. | 4.81% | N/A | 4.81% | |
| 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 information xvi | ||||
| CA Fern Parent is wholly owned by CAP V Mauritius Limited, CAP V Coinvest Mauritius Limited, Carlyle Asia PE Alternative Opportunities Mauritius Limited and Carlyle Asia PE Alternative Opportunities II Mauritius Limited, which are, by and through their control affiliates (including their respective general partners), ultimately controlled (directly or indirectly) by The Carlyle Group Inc., but The Carlyle Group Inc. has no beneficial interest in the underlying securities of HUTCHMED (China) Limited. | ||||
| Place of completion | Hong Kong |
| Date of completion | July 2, 2021 |
Hong Kong, Shanghai & Florham Park, NJ — Friday, July 2, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX:13) will be announcing its interim results for the six months ended June 30, 2021 on Wednesday, July 28, 2021 at 12:00 noon British Summer Time (BST) (7:00 pm Hong Kong Time (HKT); 7:00 am Eastern Daylight Time (EDT)).
Analysts and investors are invited to join a conference call and audio webcast presentation with Q&A, conducted by HUTCHMED management.
The conference call and audio webcast will take place at 1:00 pm BST / 8:00 pm HKT / 8:00 am EDT on Wednesday, July 28, 2021 and will be webcast live via the company website at www.hutch-med.com/investors/event-information/. The presentation will be available for downloading before the conference call begins. Details of the conference call dial-in will be provided in the financial results announcement and on the company website. A replay will also be available on the website shortly after the event.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) (formerly Hutchison China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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) HUTCHMED@fticonsulting.com |
| Asia | |
| Joseph Chi Lo, Brunswick | +852 9850 5033 (Mobile) |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) HUTCHMED@brunswickgroup.com |
Nominated Advisor |
|
| Freddy Crossley /Atholl Tweedie, Panmure Gordon (UK) Limited |
+44 (20) 7886 2500 |
– U.S. FDA has assigned a target action date of April 30, 2022 –
– If approved, surufatinib would be HUTCHMED’s first novel oncology drug marketed outside of China –
Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 1, 2021: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its filing of the New Drug Application (“NDA”) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (“NETs”). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this NDA is April 30, 2022.
Surufatinib received fast track designation in April 2020 for the treatment of pancreatic and extra-pancreatic NET. Orphan Drug Designation for pancreatic NET was also granted in November 2019.
Dr. Marek Kania, Managing Director and Chief Medical Officer of HUTCHMED International Corporation, said: “This NDA filing acceptance of surufatinib in the U.S. is a significant achievement for HUTCHMED as we expand our global operations and work to bring our innovative oncology drugs to cancer patients worldwide. The FDA’s acceptance of the NDA highlights the clinical value of this submission package and the importance of bringing more treatment options to US NET patients.”
The NDA is supported by data from two positive Phase III studies of surufatinib in patients with pancreatic and extra-pancreatic NET in China (SANET‑p[i] and SANET‑ep[ii] both previously reported in The Lancet Oncology), and a surufatinib study conducted in the U.S.[iii] The data package will also be used to file a Marketing Authorization Application (“MAA”) to the European Medicines Agency (“EMA”) imminently, based on scientific advice from the EMA’s Committee for Medicinal Products for Human Use.
HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).
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 extra-pancreatic NET (“epNET”).
According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 143,000 estimated patients living with NET in the U.S. in 2020.[iv]
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (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.
HUTCHMED currently retains all rights to surufatinib worldwide.
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 completed in April 2021, to be followed by a MAA submission to the EMA in Europe. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937).
epNETs in China: On December 30, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China (“NMPA”) for the treatment of epNET. Surufatinib is marketed in China under the brand name Sulanda®. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs 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.[v] 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%).
pNETs in China: On June 18, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNETs conducted in China. The pre-defined primary endpoint of PFS was met (clinicaltrials.gov identifier: NCT02589821) at a preplanned interim analysis, leading to a second NDA accepted by the NMPA in September 2020. The positive results of this study were presented at the 2020 ESMO Virtual Congress and published simultaneously in The Lancet Oncology[vi], demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.
Biliary tract cancer in China: In March 2019, HUTCHMED initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is overall survival (OS) (clinicaltrials.gov identifier: NCT03873532).
Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), Tuoyi® (toripalimab) and Tyvyt® (sintilimab), which are approved as monotherapies in China.
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) (formerly Hutchison China MediTech) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. A dedicated organization of over 1,300 personnel has advanced ten cancer drug candidates from in-house discovery into clinical studies around the world, with its first three oncology drugs now approved. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.
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 HUTCHMED’s current expectations regarding future events, including its expectations regarding the submission of an NDA for surufatinib for the treatment of NET with the FDA and the timing of such submission, the therapeutic potential of surufatinib for the treatment of patients with NET, the further clinical development of surufatinib in this and other indications and HUTCHMED’s expansion of its global operations. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of surufatinib for the treatment of patients with NET in the U.S., China and other jurisdictions such as the E.U., its potential to gain expeditious approvals from regulatory authorities, the safety profile of surufatinib, HUTCHMED’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 HUTCHMED’s filings with the U.S. Securities and Exchange Commission, on AIM and the Stock Exchange of Hong Kong. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
[i] Surufatinib in advanced neuroendocrine tumors – pancreatic.
[ii] Surufatinib in advanced neuroendocrine tumors – extra-pancreatic (non-pancreatic).
[iii] ASCO 2021 J Clin Oncol 39, 2021 (suppl 15; abstr 4114)
[iv] According to Frost & Sullivan, in 2020, there were 19,000 newly diagnosed cases of NETs in the U.S. and an estimated 143,000 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.
[v] 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.
[vi] 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.
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