Hong Kong, Shanghai & Florham Park, NJ: Tuesday, February 28, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today published the Form 20-F for the financial year ended December 31, 2022. This is available for viewing at http://www.rns-pdf.londonstockexchange.com/rns/3620R_1-2023-2-28.pdf and also on the website of the Company at www.hutch-med.com.
HUTCHMED (Nasdaq/AІM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. Іt is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Іt has more than 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception HUTCHMED has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
| Date: February 28, 2023 (Tuesday) |
| Announcement release: 3:30am EST / 8:30am GMT / 4:30pm HKT |
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Landmark licensing deal with Takeda for fruquintinib outside of China, bringing HUTCHMED up to US$1.13 billion, plus royalties, and demonstrating execution of the new global strategy
Record Full Year 2022 oncology/immunology revenues driven by significant increase in China in-market sales of ELUNATE®, SULANDA® and ORPATHYS® alongside clinical and strategic progress
Company to Host Annual Results Call & Webcast Today at 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, February 28, 2023: HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2022 and provides updates on key clinical and commercial developments.
All amounts are expressed in U.S. dollars unless otherwise stated.
“I am proud of the progress that we at HUTCHMED have made during 2022,” said Mr Simon To, Chairman of HUTCHMED. “This work is already bearing fruit, as indicated not only by the increase in revenues, but also the positive clinical and regulatory progress we have made with fruquintinib – culminating in the successful, post-period licensing agreement with Takeda, marking a significant delivery against the Company’s strategy. This out-licensing ensures we remain true to the overall goal of our business of safeguarding access to our innovative medicines to patients globally. Further, our partnerships provide significant financial momentum while we focus on revenue growth from increased product sales in China.”
“This strategy of revenue growth and strategic partnerships places us well on the path to a sustainable business. It is this path which will allow us to continue our expansion, as demonstrated by HUTCHMED’s continued delivery in China where our oncology commercial team has reached about 900 people to support greater access to our medicines; our ongoing development of savolitinib, which became our third product on the NRDL; and the continued ability of our business to develop medicines towards global markets. It is through this ability that we expect to see multiple New Drug Applications being made not only in China but with key regulators around the world as we look to extend our ability to bring potentially life changing medicines to patients around the world.”
“2022 has been a key turning point for HUTCHMED, but I believe it will enable us to truly reach our goal of becoming a global biopharmaceutical company.”
Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “2022 was a pivotal year for HUTCHMED. Challenged by difficult market conditions, the team worked incredibly hard to position HUTCHMED for success today as well as for a promising future. In November, we announced a new strategy that focuses on accelerating our path to a sustainable and profitable business, which involves a reprioritization of pipeline assets and a partnership approach for bringing our innovative medicines more efficiently to patients outside of China. We believe that this new strategy has unlocked greater value in the Company and we are already seeing a positive impact from this approach.”
“In early 2023 we announced a significant licensing deal with Takeda for the global development, commercialization and manufacturing of fruquintinib, outside of China. We are pleased to have attracted such a strong partner and to place fruquintinib in the hands of a company with the scale, expertise, resources and commitment to maximize its success globally, as we believe we are already doing in China. The expected proceeds from the deal notably extends our cash runway, and the additional bandwidth allows us to continue to pursue value-driving opportunities from our internal pipeline while supporting our commercial growth in China. The Takeda deal perfectly exemplifies our global partnership approach and showcases our commitment to fulfilling our promises, swiftly and effectively.”
“This approach goes hand in hand with the strategic prioritization of our pipeline. This includes focusing our development efforts on late-stage assets through clinical development and towards patients. Ultimately, this is how we will accelerate our path to a sustainable business over the long term. As part of our pipeline prioritization, we have reduced some funding to select international clinical programs and we look to further develop of some of these programs through partnerships. Specifically, these changes affect amdizalisib, HMPL-306 and HMPL-760 international clinical programs. We will continue the surufatinib clinical program in Japan where a bridging study is fully recruited. Going forward, HUTCHMED still intends to continue to run early phase development programs for select drug candidates in the U.S., EU and Japan including sovleplenib where we believe our compounds are differentiated from a global perspective. This does not impact our commitment to patients, which, if anything, has intensified as we sharpen our focus on a smaller set of programs that we believe have the most immediate patient impact.
I am proud of what the team has achieved this year amidst very difficult times for the sector, and feel very positive about our outlook.”
| $’millions | In-market Sales* | Consolidated Revenues** | ||||
| 2022 | 2021 | % Change | 2022 | 2021 | % Change | |
| ELUNATE® | $93.5 | $71.0 | +32% | $69.9 | $53.5 | +31% |
| SULANDA® | $32.3 | $11.6 | +178% | $32.3 | $11.6 | +178% |
| ORPATHYS® | $41.2 | $15.9 | +159% | $22.3 | $11.3 | +97% |
| TAZVERIK® | $0.1 | – | – | $0.1 | – | – |
| Product Sales | $167.1 | $98.5 | +70% | $124.6 | $76.4 | +63% |
| Other R&D[13] services income | $24.2 | $18.2 | +33% | |||
| Milestone payment | $15.0 | $25.0 | -40% | |||
| Total Oncology/Immunology | $163.8 | $119.6 | +37% | |||
| * = For ELUNATE® and ORPATHYS®, represents total sales to third parties as provided by Lilly[14] and AstraZeneca, respectively; and ELUNATE® sales to other third parties as invoiced by HUTCHMED. ** = For ELUNATE®, represents manufacturing fees, commercial service fees and royalties paid by Lilly, to HUTCHMED, and sales to other third parties invoiced by HUTCHMED; for ORPATHYS® represents manufacturing fees and royalties paid by AstraZeneca; for SULANDA® and TAZVERIK®, represents the Company’s sales of the products to third parties. |
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China
Ex-China
Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET being developed broadly across MET-driven patient populations in lung, gastric and papillary renal cell carcinomas
Potential upcoming clinical and regulatory milestones for savolitinib:
Fruquintinib (ELUNATE® in China), a highly selective oral inhibitor of VEGFR[27] 1/2/3 designed to improve kinase selectivity to minimize off-target toxicity and thereby improve tolerability; approved and launched in China
Potential upcoming clinical and regulatory milestones for fruquintinib:
Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR[32] and CSF-1R[33] designed to inhibit tumor angiogenesis and promote the body’s immune response against tumor cells via tumor associated macrophage regulation; approved and launched in China
Potential upcoming clinical and regulatory milestones for surufatinib:
Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk[36], an important component of the Fc receptor and B-cell receptor signaling pathway
Potential upcoming clinical milestones for sovleplenib:
Amdizalisib (HMPL-689), an investigative and highly selective oral inhibitor of PI3Kδ[38] designed to address the gastrointestinal and hepatotoxicity associated with currently approved and clinical-stage PI3Kδ inhibitors
Potential upcoming clinical and regulatory milestones for amdizalisib:
Tazemetostat (TAZVERIK® in the U.S., Japan and the Hainan Pilot Zone), a first-in-class, oral inhibitor of EZH2 licensed from Ipsen[39] subsidiary Epizyme[40] in China
Earlier stage investigational drug candidates
In addition to the six drug candidates being developed in over 15 registration studies above, HUTCHMED is developing six further oncology candidates in early stage clinical trials. These are HMPL-306, a highly selective oral inhibitor of IDH1/2[41] designed to address resistance to currently marketed IDH inhibitors; HMPL-760, a highly selective, third-generation oral inhibitor of BTK[42] with improved potency versus first generation BTK inhibitors against both wild type & C481S mutant enzymes; HMPL-453, a highly selective oral inhibitor of FGFR 1/2/3; HMPL-295, a highly selective oral inhibitor of ERK[43] in the MAPK pathway [44] with the potential to address intrinsic or acquired resistance from upstream mechanisms such as RAS-RAF-MEK; HMPL-653, an oral, highly selective, and potent CSF-1R inhibitor designed to target CSF-1R driven tumors as a monotherapy or in combinations; and HMPL-A83, a differentiated, red blood cell sparing CD47 monoclonal antibody.
Subject to data and consultation with the CDE[45], several of these earlier stage drug candidates have potential to move into registration trials in 2023 and early 2024. We have recently agreed a registration enabling trial design for HMPL-453 for the treatment of IHCC[46] with the CDE and preparations are underway to start the study. Results supporting this decision will be submitted for scientific presentation in 2023.
Takeda Exclusive Worldwide License for Fruquintinib Outside China
Subject to customary closing conditions, including completion of antitrust regulatory reviews:
Inmagene candidates discovered by HUTCHMED
Two Phase I trials initiated in Australia and the U.S. on two HUTCHMED drug candidates being developed by Inmagene: IMG-007, an investigative OX40 antagonistic monoclonal antibody designed to selectively shut down OX40+ T cell function; and IMG-004, a reversible, non-covalent, highly selective oral BTK inhibitor designed to target immunological diseases.
Other Ventures include our profitable prescription drug marketing and distribution platforms
COVID-19 had some impact on our research, clinical studies and our commercial activities in 2022, particularly with respect to hospital lockdowns, travel restrictions, and shipping difficulties. Clinical sites in Shanghai were particularly impacted during April and May 2022. Measures were put in place to reduce the impact of such restrictions to the extent possible, including online patient follow-up and the retention of core research teams on-site to maintain critical activities, with business returning to normal in June. Restrictive measures related to the COVID-19 pandemic have gradually been lifted in China starting from December 2022, and we expect the travel, social and economic activities to normalize.
HUTCHMED has made continued progress in its commitment to the long-term sustainability of its businesses and communities in which it conducts business, including:
We believe all these efforts will guide us towards a more sustainable future. The 2022 Sustainability Report will be published alongside our 2022 Annual Report in due course and will include further information on HUTCHMED sustainability initiatives and their performance.
As had been expected, in 2022 the U.S. Securities and Exchange Commission (SEC) named over 170 China-based companies, including HUTCHMED, to its conclusive list of public companies identified as having retained a registered public accounting firm that the Public Company Accounting Oversight Board (“PCAOB”) is unable to inspect to investigate completely. However, on December 15, 2022, the PCAOB announced that it was able to inspect and investigate completely registered public accounting firms headquartered in mainland China and Hong Kong and vacated its prior determination that it was unable to inspect or investigate them completely. As a result, we do not expect to be identified as a Commission-Identified Issuer for the fiscal year ended December 31, 2022 after we file our annual report on Form 20-F for such fiscal year.
This has had no impact on the business operations of the Company.
Cash, Cash Equivalents and Short-Term Investments were $631.0 million as of December 31, 2022 compared to $1,011.7 million as of December 31, 2021.
Revenues for the year ended December 31, 2022 were $426.4 million compared to $356.1 million in 2021.
ELUNATE® revenues increased 31% to $69.9 million (2021: $53.5m) in manufacturing revenues, promotion and marketing service revenues and royalties, as our in-house sales team increased in-market sales 32% to $93.5 million (2021: $71.0m), as provided by Lilly;
SULANDA® revenues increased 178% to $32.3 million (2021: $11.6m), after inclusion on the NRDL starting in January 2022;
ORPATHYS® revenues increased 97% to $22.3 million (2021: $11.3m), in manufacturing revenues and royalties following its launch in the second half of 2021. AstraZeneca reported $41.2 million in-market sales (2021: $15.9m) of ORPATHYS® in 2022;
TAZVERIK® revenues of $0.1 million following its successful launch in Hainan province in June 2022;
Milestone payment of $15.0 million (2021: $25.0m milestone payment upon first sale of ORPATHYS® in China), to us by AstraZeneca, related to the initiation of SAFFRON; and
Other R&D services income of $24.2 million (2021: $18.2m), which were primarily fees from AstraZeneca and Lilly for the management of development activities in China.
Net Expenses for the year ended December 31, 2022 were $787.2 million compared to $550.7 million in 2021.
Net Loss attributable to HUTCHMED for the year ended December 31, 2022 was $360.8 million compared to $194.6 million in 2021.
Condensed Consolidated Balance Sheets Data
(in $’000)
| As of December 31, | ||||
| 2022 | 2021 | |||
| Assets | ||||
| Cash and cash equivalents and short-term investments | 630,996 | 1,011,700 | ||
| Accounts receivable | 97,988 | 83,580 | ||
| Other current assets | 110,904 | 116,796 | ||
| Property, plant and equipment | 75,947 | 41,275 | ||
| Investments in equity investees | 73,777 | 76,479 | ||
| Other non-current assets | 39,833 | 42,831 | ||
| Total assets | 1,029,445 | 1,372,661 | ||
| Liabilities and shareholders’ equity | ||||
| Accounts payable | 71,115 | 41,177 | ||
| Other payables, accruals and advance receipts | 264,621 | 210,839 | ||
| Bank borrowings | 18,104 | 26,905 | ||
| Other liabilities | 38,735 | 54,226 | ||
| Total liabilities | 392,575 | 333,147 | ||
| Company’s shareholders’ equity | 610,367 | 986,893 | ||
| Non-controlling interests | 26,503 | 52,621 | ||
| Total liabilities and shareholders’ equity | 1,029,445 | 1,372,661 | ||
Condensed Consolidated Statements of Operations Data
(in $’000, except share and per share data)
| Year Ended December 31, | |||
| 2022 | 2021 | ||
| Revenues: | |||
| Oncology/Immunology – Marketed Products | 124,642 | 76,429 | |
| Oncology/Immunology – R&D | 39,202 | 43,181 | |
| Oncology/Immunology consolidated revenues | 163,844 | 119,610 | |
| Other Ventures | 262,565 | 236,518 | |
| Total revenues | 426,409 | 356,128 | |
| Operating expenses: | |||
| Costs of revenues | (311,103) | (258,234) | |
| Research and development expenses | (386,893) | (299,086) | |
| Selling and general administrative expenses | (136,106) | (127,125) | |
| Total operating expenses | (834,102) | (684,445) | |
| (407,693) | (328,317) | ||
| Gain on divestment of an equity investee | – | 121,310 | |
| Other expense, net | (2,729) | (8,733) | |
| Loss before income taxes and equity in earnings of equity investees | (410,422) | (215,740) | |
| Income tax benefit/(expense) | 283 | (11,918) | |
| Equity in earnings of equity investees, net of tax | 49,753 | 60,617 | |
| Net loss | (360,386) | (167,041) | |
| Less: Net income attributable to non-controlling interests | (449) | (27,607) | |
| Net loss attributable to HUTCHMED | (360,835) | (194,648) | |
| Losses per share attributable to HUTCHMED – basic and diluted (US$ per share) | (0.43) | (0.25) | |
| Number of shares used in per share calculation – basic and diluted | 847,143,540 | 792,684,524 | |
| Losses per ADS attributable to HUTCHMED – basic and diluted (US$ per ADS) | (2.13) | (1.23) | |
| Number of ADSs used in per share calculation – basic and diluted | 169,428,708 | 158,536,905 | |
We provide financial guidance for 2023 below reflecting expected revenue growth of ELUNATE®, SULANDA® and ORPATHYS® in China and out-licensing revenue. While we are not providing net cash flow guidance for 2023, we will extend our cash runway through partnering and strategic shifting to focus on the most advanced assets from our internal development pipeline.
| 2022 Actual |
2023 Guidance |
|
| Oncology/Immunology consolidated revenues | $163.8 million | $450 – $550 million |
Shareholders and investors should note that:
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 9 p.m. HKT / 1 p.m. GMT / 8 a.m. EST – After registering, investors may access a live audio webcast of the call via HUTCHMED’s website at www.hutch-med.com/event/.
Participants who wish to join the call and ask a question must register here. Upon registration, each participant will be provided with dial-in numbers and a unique PIN.
HUTCHMED will today file with the U.S. Securities and Exchange Commission its Annual Report on Form 20-F.
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. It has more than 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. 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) 306 4490 |
Media Enquiries |
|
| Americas – Brad Miles, Solebury Trout |
+1 (917) 570 7340 (Mobile) bmiles@soleburystrat.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,” “best-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, that any approvals which are obtained will be obtained at any particular time, or that the sales of products marketed or otherwise commercialized by HUTCHMED and/or its collaboration partners (collectively, “HUTCHMED’s Products”) 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, including, among others, the risk that HUTCHMED’s ADSs could be barred from trading in the United States as a result of the Holding Foreign Companies Accountable Act and the rules promulgated thereunder; 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 the utilization, market acceptance and commercial success of HUTCHMED’s Products after obtaining regulatory approval; competing products and drug candidates that may be superior to, or more cost effective than, HUTCHMED’s Products and drug candidates; the impact of studies (whether conducted by HUTCHMED or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of HUTCHMED’s Products and drug candidates in development; the ability of HUTCHMED to manufacture and manage supply chains for multiple products and drug candidates; the availability and extent of reimbursement of HUTCHMED’s Products from third-party payers, including private payer healthcare and insurance programs and government insurance programs; the costs of developing, producing and selling HUTCHMED’s Products; the ability of HUTCHMED to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; 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).
Ends
[1] Takeda = Takeda Pharmaceuticals International AG.
[2] CRC = Colorectal cancer.
[3] ESMO = European Society for Medical Oncology.
[4] NDA = New Drug Application.
[5] FDA = Food and Drug Administration.
[6] PFS = Progression-free survival.
[7] MET = Mesenchymal epithelial transition factor.
[8] NSCLC = Non-small cell lung cancer.
[9] NRDL = National Reimbursement Drug List.
[10] We also report changes in performance at constant exchange rate (“CER”) which is a non-GAAP measure. Please refer to “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.
[11] In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), AstraZeneca (ORPATHYS®) and HUTCHMED (ELUNATE®, SULANDA® and TAZVERIK®).
[12] AstraZeneca = AstraZeneca AB (publ), a wholly-owned subsidiary of AstraZeneca PLC.
[13] R&D = Research and development.
[14] Lilly = Eli Lilly and Company.
[15] ITP = Immune thrombocytopenia purpura.
[16] NMPA = National Medical Products Administration.
[17] EMA = European Medicines Agency.
[18] PMDA = Pharmaceuticals and Medical Devices Agency.
[19] MAA = Marketing Authorization Application.
[20] EGFR = Epidermal growth factor receptor.
[21] WCLC = World Conference on Lung Cancer.
[22] ORR = Objective response rate.
[23] DoR = Duration of response.
[24] OS = Overall survival.
[25] ELCC = European Lung Cancer Congress.
[26] PRCC = Papillary renal cell carcinoma.
[27] VEGFR = Vascular endothelial growth factor receptor.
[28] ASCO GI = ASCO (American Society of Clinical Oncology) Gastrointestinal Cancers Symposium.
[29] DCR = Disease control rate.
[30] PD-1 = Programmed cell death protein-1.
[31] RCC = Renal cell carcinoma.
[32] FGFR = Fibroblast growth factor receptor.
[33] CSF-1R = Colony-stimulating factor 1 receptor.
[34] ASCO = American Society of Clinical Oncology.
[35] NANETS = North American Neuroendocrine Tumor Society Medical Symposium.
[36] Syk = Spleen tyrosine kinase.
[37] AIHA = autoimmune hemolytic anemia.
[38] PI3Kδ = Phosphoinositide 3-kinase delta.
[39] Ipsen = Ipsen SA, parent of Epizyme Inc.
[40] Epizyme = Epizyme Inc., a wholly owned subsidiary of Ipsen SA.
[41] IDH = Isocitrate dehydrogenase.
[42] BTK = Bruton’s tyrosine kinase.
[43] ERK = Extracellular signal-regulated kinase.
[44] MAPK pathway = RAS-RAF-MEK-ERK signaling cascade.
[45] CDE = Center for Drug Evaluation
[46] IHCC = Intrahepatic cholangiocarcinoma.
[47] SHPL = Shanghai Hutchison Pharmaceuticals Limited.
[48] HBYS = Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited.
[49] GAAP = Generally Accepted Accounting Principles.
[50] HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.
[51] ADS = American depositary share.
[52] SG&A Expenses = selling, general and administrative expenses.
Hong Kong, Shanghai & Florham Park, NJ — Monday, February 27, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that it has completed patient enrollment of Phase II registration trial of amdizalisib in patients with relapsed or refractory follicular lymphoma (“FL”), a subtype of non-Hodgkin’s lymphoma (“NHL”). The last patient was enrolled on February 24, 2023.
The clinical trial is a multi-center, single-arm, open-label clinical study to evaluate the efficacy and safety of amdizalisib once a day oral monotherapy in patients with relapsed/refractory FL or marginal zone lymphoma (“MZL”). The primary endpoint is objective response rate (“ORR”), with secondary endpoints including complete response rate (CRR), progression-free survival (PFS), time to response (TTR) and duration of response (DoR). A total of 108 relapsed/refractory FL patients were enrolled. The trial is being conducted in over 35 sites in China. Additional details may be found at clinicaltrials.gov, using identifier NCT04849351.
Topline results on the FL patients in this trial are expected to be reported in the second half of 2023, followed by submission of results for presentation at an appropriate medical conference. If positive, HUTCHMED would initiate plans to apply for marketing authorization of amdizalisib for relapsed/refractory FL from the China National Medical Products Administration (NMPA).
PI3Kδ (phosphoinositide 3-kinase delta) is a lipid kinase that controls the activation of several important signaling proteins. Upon an antigen binding to B-cell receptors, PI3Kδ can be activated through the Lyn and Syk signaling cascade. The abnormal activation of B-cell receptor signaling is closely related to the development of B-cell type hematological cancers, which represent approximately 85% of all NHL cases. Therefore, PI3Kδ is a target for drugs that aim to prevent or treat hematologic cancer.
FL accounts for approximately 17% of NHL and MZL accounts for approximately 8% of NHL. In the U.S., there were estimated 13,000 and 6,000 new cases of FL and MZL in 2020, respectively. In China, there were estimated 16,000 and 7,000 new cases of FL and MZL in 2020, respectively.[1],[2],[3]
Amdizalisib (HMPL-689) is a novel, selective and potent oral inhibitor targeting the isoform PI3Kδ. Amdizalisib’s pharmacokinetic (“PK”) properties are favorable with good oral absorption, moderate tissue distribution and low clearance in preclinical PK studies, suggesting a low risk of drug accumulation and drug-to-drug interaction. Because of its high target selectivity and optimal PK profile, amdizalisib has the potential to demonstrate an optimal benefit-risk profile in this class.
In addition to the current Phase II trial and the supportive Phase I trial in China, amdizalisib is also being evaluated in combination with tazemetostat (a methyltransferase inhibitor of EZH2) in patients with relapsed or refractory lymphoma in a Phase II study in China.
HUTCHMED currently retains all rights to amdizalisib worldwide.
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. It has more than 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology drugs now approved and marketed in China. 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 amdizalisib for patients with NHL, the further clinical development for amdizalisib, 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 amdizalisib, 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 amdizalisib 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 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.
[1] Source: NCCN® – https://www.nccn.org
[2] Source: SEER – https://seer.cancer.gov/statfacts/html/follicular.html
[3] Source: GLOBOCAN – https://gco.iarc.fr/
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 567 3786 |
Media Enquiries |
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| Americas – Brad Miles, Solebury |
+1 (917) 570 7340 (Mobile) bmiles@soleburystrat.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 |
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| Atholl Tweedie / Freddy Crossley, Panmure Gordon |
+44 (20) 7886 2500 |