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Hong Kong, Shanghai & Florham Park, NJ — Wednesday, July 31, 2024: HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13) today reports its financial results for the six months ended June 30, 2024 and provides updates on key clinical and commercial developments.

 

HUTCHMED to host results webcasts today at 8:00 a.m. EDT / 1:00 p.m. BST / 8:00 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, August 1, 2024. After registration, investors may access the live webcast via HUTCHMED’s website at www.hutch-med.com/event.

 

All amounts are expressed in US dollars unless otherwise stated.

Continued revenue momentum with substantial cash balance to support growth

 

Globalization of fruquintinib continues, broader pipeline makes strong progress

 

Dr Dan Eldar, Non-executive Chairman of HUTCHMED, said, “HUTCHMED has delivered strong performance in the first half of this year. The team has made significant progress implementing our strategy in discovering and developing novel, effective medicines; conducting clinical trials in our home market and in the global markets; and rapidly advancing regulatory and commercial goals. I am very pleased with the ongoing success of our partnership with Takeda and with the growing ability of the Company to provide health benefits to patients overseas. We have grown our revenues from the US during this period and we expect to see revenue growth from many other countries in the coming months. We are also capitalizing on our proven track record of bringing new medicines and additional indications for our marketed medicines to China, with several potential NDA approvals for the next few years.”

“I would like to take this opportunity to express my appreciation to Mr Simon To, my predecessor, who has recently retired. Mr To has stood at the cradle of HUTCHMED and has made a very significant contribution to grow the Company and turn it into a global innovative player, discovering, developing and commercializing therapies for the treatment of cancer and immunological diseases, improving the quality of life of patients around the world. I look forward to guiding the Company along its next phase of growth, which is full of potential and promise.”

 

2024 Interim Results & Business Updates

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, said, “The HUTCHMED team has been working tirelessly to continue the outstanding clinical and regulatory momentum that we have had in recent years, whilst importantly driving the commercial success of our approved products. I would like to extend my thanks to everyone for their hard work and commitment. Our oncology product revenue has grown 59% compared to the first half of 2023 and we are progressing a more focused R&D pipeline that has considerable potential for value creation. This year we initiated three key late-stage studies across our pipeline and are excited to be running over a dozen such studies that could support future drug approvals.”

“The partnership strategy that we adopted for globalizing our medicines is allowing us to simultaneously fuel our in-house R&D engine, drive sales in our home market, and bring our medicines to patients in new geographies. Takeda’s impressive initial sales of FRUZAQLA® demonstrates both the quality of our medicines and their potential across the globe and our strategy of working with partners outside of our home market.”

“We expect to advance our registration trials in the second half of the year. Around year end, we anticipate the potential approval of sovleplenib in China and potential NDA filing of savolitinib in the US. We will continue to progress towards becoming a self-sustaining biopharma business.”

 

I. COMMERCIAL OPERATIONS

Oncology in-market sales were up 140% (145% at CER) to $243.3 million (H1-23: $101.3m), which led to strong growth in consolidated oncology product revenue of 59% (64% at CER) to $127.8 million (H1-23: $80.1m), and mainly comprised of the following:

 

Oncology/​Immunology consolidated revenue comprised of consolidated oncology product revenue, which included product revenue, commercial service fees and royalties, as well as R&D income from our collaboration partners, mainly as follows:

 

As a result, total Oncology/Immunology consolidated revenue was $168.7 million (H1-23: $359.2m). Including Other Ventures revenue, total revenue was $305.7 million (H1-23: $532.9m).

 

II. REGULATORY UPDATES

China

 

Ex-China

 

III. LATE-STAGE CLINICAL DEVELOPMENT ACTIVITIES

Savolitinib (ORPATHYS® in China), a highly selective oral inhibitor of MET[23]

Potential upcoming clinical and regulatory milestones for savolitinib:

 

Fruquintinib (ELUNATE® in China, FRUZAQLA® outside of China), a highly selective oral inhibitor of VEGFR[27] 1/2/3 designed to have enhanced selectivity that limits off-target kinase activity

Potential upcoming clinical and regulatory milestones for fruquintinib:

 

Sovleplenib (HMPL-523), an investigative and highly selective oral inhibitor of Syk, an important component of the Fc receptor and B-cell receptor signaling pathways

Potential upcoming clinical milestones for sovleplenib:

 

Surufatinib (SULANDA® in China), an oral inhibitor of VEGFR, FGFR[40] and CSF-1R[41] designed to inhibit tumor angiogenesis and promote immune response against tumor cells via tumor associated macrophage regulation

 

Tazemetostat (TAZVERIK® in Hainan, Macau and Hong Kong), a first-in-class, oral inhibitor of EZH2

 

HMPL-453, a novel, highly selective and potent inhibitor targeting FGFR 1, 2 and 3

 

HMPL-306, an investigative and highly selective oral dual-inhibitor of IDH1 and IDH2 enzymes, which have been implicated as drivers of certain hematological malignancies, gliomas and solid tumors

 

Other early-stage investigational drug candidates

 

IV. COLLABORATION UPDATES

Further clinical progress by Inmagene[46] with two candidates discovered by HUTCHMED

 

V. OTHER VENTURES

 

VI. SUSTAINABILITY

HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders. In April 2024, we published our 2023 Sustainability Report, which highlighted progress made in our 11 goals and targets; our enhanced climate actions including Scope 3 emissions screening and measurement and engaging with suppliers; our enhanced data quality; our strengthened alignment of our five most relevant and material sustainability pillars; and our enhanced disclosure and sector specific disclosure standards ahead of requirement.

Wider recognition of HUTCHMED’s efforts have been reflected in steady improvements in major local and international sustainability ratings including from Hang Seng, ISS, MSCI, S&P Global, Sustainalytics and Wind. Recently, HUTCHMED scored 49 for S&P Global ESG[48] Ratings, significantly higher than the industry average of 31. HUTCHMED also received the Best ESG(E) at the Hong Kong Investor Relations Association’s 10th Investor Relations Awards, two awards at Bloomberg Businessweek’s ESG Leading Enterprises event, five awards from Metro Finance’s GBA ESG Achievement Awards, and was listed amongst the Top 20 Chinese Pharmaceutical Listed Companies in ESG Competitiveness by Healthcare Executive.

In 2024, we continue our efforts on the above areas and further strengthening our climate action by conducting a more comprehensive climate risk assessment to quantify the impact of climate risks in our major operations; incorporate sustainability into our corporate culture; and considering future goals and targets.

 

Financial Highlights

Foreign exchange impact: The RMB depreciated against the US dollar on average by approximately 4% during the first half of 2024, which has impacted our consolidated financial results as highlighted below.

 

Cash, Cash Equivalents and Short-Term Investments were $802.5 million as of June 30, 2024 compared to $886.3 million as of December 31, 2023.

 

Revenue for the six months ended June 30, 2024 was $305.7 million compared to $532.9 million in the six months ended June 30, 2023.

 

Net Expenses for the six months ended June 30, 2024 were $279.9 million compared to $364.3 million in the six months ended June 30, 2023, reflecting our strong efforts on cost control.

 

Net Income attributable to HUTCHMED for the six months ended June 30, 2024 was $25.8 million compared to $168.6 million for the six months ended June 30, 2023.

 

FINANCIAL GUIDANCE

We reiterate full year 2024 guidance for Oncology/Immunology consolidated revenue is $300 million to $400 million, driven by 30% to 50% growth target in oncology marketed product revenue. HUTCHMED’s work in 2024 and beyond will be supported by its strong balance sheet. The Company is thus well placed to deliver against its target to become a self-sustaining business and its goal to bring its innovative medicines to patients globally through its own sales network in China markets and through partners worldwide.

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” for further information relevant to the interpretation of these financial measures and reconciliations of these financial measures to the most comparable GAAP measures, respectively.

———

 

Financial Summary

Condensed Consolidated Balance Sheets Data

 

Condensed Consolidated Statements of Operations Data

 

About HUTCHMED

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 approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three oncology medicines marketed in China, the first of which is also marketed in the US. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

Contacts

Investor Enquiries
 +852 2121 8200 / ir@hutch-med.com
Media Enquiries
 
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
 
 
Nominated Advisor
 
Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum +44 (20) 7886 2500

 

References

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 subsidiaries unless otherwise stated or indicated by context.

 

Past Performance and Forward-Looking Statements

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 US 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 have been obtained will continue to remain valid and effective in the future, 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; discovery, development and/or commercialization of 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 pandemics and disease outbreaks. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on HKEX[53]. 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.

 

Inside Information

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).

 

Medical Information

This announcement contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

 

[1] CER = Constant exchange rate. We also report changes in performance at 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.

[2]  In-market sales = total sales to third parties provided by Eli Lilly (ELUNATE®), Takeda (FRUZAQLA®), AstraZeneca (ORPATHYS®) and

HUTCHMED (ELUNATE®, SULANDA®, ORPATHYS® and TAZVERIK®).

[3]  R&D = Research and development.

[4] Takeda = Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited.

[5] ITP = immune thrombocytopenia purpura.

[6] NDA = New Drug Application.

[7] NSCLC = Non-small cell lung cancer.

[8] METex14 = MET exon 14 skipping alterations.

[9] AIHA = Autoimmune hemolytic anemia.

[10] AML = Acute myeloid leukemia.

[11] PDAC = Pancreatic ductal adenocarcinoma.

[12] Syk = Spleen tyrosine kinase.

[13] EZH2 = Enhancer of zeste homolog 2.

[14] IDH = Isocitrate dehydrogenase.

[15] BTK = Bruton’s tyrosine kinase.

[16] CRC = Colorectal cancer.

[17] NRDL = China National Reimbursement Drug List.

[18] Lilly = Eli Lilly and Company.

[19] sNDA = Supplemental New Drug Application.

[20] NMPA = China National Medical Products Administration.

[21] R/R = Relapsed and/or refractory.

[22] EMA = European Medicines Agency.

[23] MET = Mesenchymal epithelial transition factor.

[24] AACR = American Association for Cancer Research Annual Meeting.

[25] EGFR = Epidermal growth factor receptor.

[26] FDA = Food and Drug Administration.

[27] VEGFR = Vascular endothelial growth factor receptor.

[28] pMMR = Proficient mismatch repair.

[29] ASCO = American Society of Clinical Oncology Annual Meeting.

[30] ASCO GI = ASCO Gastrointestinal Cancers Symposium.

[31] CEA = Carcinoembryonic antigen.

[32] PFS = Progression free survival.

[33] ORR = Objective response rate.

[34] DCR = Disease control rate.

[35] OS = Overall survival.

[36] PMDA = Pharmaceuticals and Medical Devices Agency.

[37] RCC = Renal cell carcinoma.

[38] EHA = European Hematology Association.

[39] TPO/TPO-RA = Thrombopoietin and/or thrombopoietin receptor agonists.

[40] FGFR = Fibroblast growth factor receptor.

[41] CSF-1R = Colony-stimulating factor 1 receptor.

[42] PD-1 = Programmed cell death protein-1.

[43] IHCC = Intrahepatic cholangiocarcinoma.

[44] ERK = Extracellular signal-regulated kinase.

[45] ADC = Antibody-drug conjugate.

[46] Inmagene = Inmagene Biopharmaceuticals.

[47] SHPL = Shanghai Hutchison Pharmaceuticals Limited.

[48] ESG = Environmental, Social and Governance.

[49] GAAP = Generally Accepted Accounting Principles.

[50] Hainan Pilot Zone = Hainan Boao Lecheng International Medical Tourism Pilot Zone.

[51] S&A= Selling and administrative expenses.

[52] ADS = American depositary share.

[53] HKEX = The Main Board of The Stock Exchange of Hong Kong Limited.

 

Announcement release:   July 31, 2024 (Wed)
7am EDT / 12 noon BST / 7pm HKT
 >> View announcement here <<
Presentation webcast & call
➤  English Session: July 31, 2024 (Wed)
8am EDT / 1pm BST / 8pm HKT

Watch Webcast Replay (English Session)

➤  Chinese (Putonghua) Session: Aug 1, 2024 (Thu)
8:30am HKT / 1:30am BST / (8:30pm EDT on July 31)

Watch Webcast Replay (Chinese Session)

 

Job Title: Senior Manager, Financial Planning & Analysis
Location: Hong Kong/Shanghai

 

Key Responsibilities

  • Collaborate with the local finance team to prepare and review annual budgets, forecasts, monthly bookings, and long-range strategic plans;
  • Monitor financial performance by measuring and analyzing results. Conduct analytical reviews on management reports to explain business performance;
  • Provide operational support to local business units, including contract review, financial modeling for special transactions, accounting treatment review, and business performance improvement processes;
  • Develop and implement procedures to streamline operations, enhance business processes, and ensure proper control and compliance;
  • Participate in ad-hoc projects such as M&A valuation and analysis, financial modeling, and financial due diligence etc.

 

Qualifications

  • Degree holder in Accounting or Finance or related disciplines;
  • Member of HKICPA / ACCA / AICPA;
  • Ideally around 7-10 years of relevant working experience with Pharmaceutical industry experience and exposure to working in China are a must;
  • Big 4 working experience is preferred but not a must;
  • Frequent traveling requirement between Hong Kong (Corporate office) and Shanghai;
  • Good capability in both English and Mandarin.

 

If interested, please forward your resume to recruit@hutch-med.com.

Job Title: Associate Director/Director, Translational Research
Location: Hong Kong

 

The individual is expected to play a leadership role for oncology and translational research in Hong Kong R&D.  He/She will lead the team to develop assays and platforms for evaluation of oncology drug candidates and exploring new biomarkers and indications of oncology drugs. In this role, the candidate will collaborate broadly with colleagues in Shanghai to deliver results.

 

Key Responsibilities

  • Develop and implement research strategy, identify new areas for research and development, ensuring the activities alignment with the company’s overall goals and objectives.
  • Design and lead research and development programs and projects, ensuring that work is delivered to time and quality expectations. Present project and research achievements.
  • Manage the resources, including R&D budget, personnel, and equipment.
  • Collaborate with internal and external teams, including R&D team in Shanghai, academic institutions and hospitals in Hong Kong, as well as other CRO partners, to ensure staying up-to-date with the latest research and technology development.

 

Qualifications

  • PhD in biology, biochemistry or related field, with at least 8 years of industry working experience in epigenetics research is a plus
  • A track record to lead a team to complete projects
  • Broad knowledge and working experience, including but not limited to cellular and in vivo assays. Knowledge of NGS, bioinformatics, experience with in vivo studies or pathology experimental skills is a plus
  • Strong communication skills and ability to work effectively across multidisciplinary teams and across sites
  • Good interpersonal skill and oral and written communication skills, fluent in English and Mandarin Chinese

 

If interested, please forward your resume to recruit@hutch-med.com.

Job Title: Senior technician for Oncology Research
Location: Hong Kong

 

Key Responsibilities

  • Daily operation and maintenance of laboratory instruments and equipment
  • Order and storage of experiment expendable, reagents and materials
  • Cell bank maintenance, including cell thawing, culturing, freezing procedures and documents
  • Perform or support a variety of biology experiments
  • Ensure strict adherence to relevant safety procedures

 

Qualifications

  • Bachelor’s degree in chemistry, biology or related field, with working history in industry preferred
  • Technical expertise in the following: cell culture, cell viability assay, kinase assay, etc.
  • Data recording, analysis and troubleshooting capabilities
  • Strong sense of responsibility and teamwork, well communicate with the team

 

If interested, please forward your resume to recruit@hutch-med.com.

Job Title: Scientist/Senior Scientist for Oncology Research
Location: Hong Kong

 

Key Responsibilities

  • Design and perform molecular and cell biology experiments, analyze data and draft study report
  • Summary and presentation of study findings at internal or external meetings
  • Research of tumor biomarkers, mechanism of action of new anti-cancer products and exploration of new indications or drug combinations
  • Literature review and raise the proposal of potential new targets for cancer therapy
  • Coordinate internal resource or outsourcing services to ensure timely delivery of study results

 

Qualifications

  • PhD in biology, biochemistry or related field, or a master’s degree for at least 3 years of industry working experience
  • A track record experience in cancer research
  • Expertise of molecular biology and cell biology experiments, including cell culture, western blot, RT-PCR and flow cytometry
  • Knowledge of NGS, bioinformatics, experience with in vivo animal studies or pathology experiment is a plus
  • A self-motivated scientist, attention to detail, and ability to think independently
  • Ability to work under pressure and deliver on time
  • Good interpersonal skill, good oral and written communication skills, fluent in English and Mandarin Chinese

 

If interested, please forward your resume to recruit@hutch-med.com.

Job Title: Senior/Marketing Executive
Location: Hong Kong

 

Tasks and Responsibilities

  • Provide support in branding operations & key marketing initiatives;
  • Assist in defining, monitoring and achieving key performance metrics to inform strategy and support execution;
  • Work closely with internal & external parties to ensure excellent execution in aligning marketing strategies with overall business goals;
  • Create the content of marketing collateral and promotional materials product to tie with business needs;
  • Assist in ad hoc marketing, event and projects assigned;
  • Maintain strong compliance with all relevant internal policies, compliance and legal requirements.

 

Qualifications

  • Bachelor Degree in Science, Marketing, Business Administration or related disciplines;
  • Related working experience in pharmaceutical industry is preferable;
  • Proactive with excellent interpersonal skills;
  • Detail minded with good organizational & analytical skills;
  • Think out-of-the-box with a can-do attitude;
  • Proficiency in both spoken and written English, Cantonese and Mandarin;
  • Proficient in Microsoft Office (Word, Excel, PowerPoint);
  • Job title is subjected to the candidate’s qualification and experience.

 

If interested, please forward your resume to recruit@hutch-med.com.

➤  Chinese (Putonghua) Session: July 9, 2024 (Tue)
3pm HKT / 8am BST / 3am EST

Listen to webcast replay (Chinese Session)

➤  English Session: July 9, 2024 (Tue)
8:30pm HKT / 1:30pm BST / 8:30am EST

Listen to webcast replay (English Session)

 

Hong Kong, Shanghai & Florham Park, NJ — Thursday, July 4, 2024: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the New Drug Application (“NDA”) for tazemetostat for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) has been accepted for review and granted Priority Review by the China National Medical Products Administration (“NMPA”).

Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. (“Epizyme”), an Ipsen company. Tazemetostat is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of certain patients with R/R FL and certain patients with advanced epithelioid sarcoma (“ES”) under the FDA accelerated approval program. It is also approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for certain patients with R/R FL. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

This China NDA is supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme outside China.

Tazemetostat was approved for use in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (Hainan Pilot Zone) in May 2022, under the Clinically Urgently Needed Imported Drugs scheme, for the treatment of certain patients with ES and FL consistent with the label as approved by the FDA. Tazemetostat was approved in the Macau Special Administrative Region (“SAR”) in March 2023 and in the Hong Kong SAR in May 2024.

 

About Follicular Lymphoma

FL is a subtype of non-Hodgkin’s lymphoma (“NHL”). FL accounts for approximately 17% of NHL. In 2020, there were an estimated 16,000 and 13,000 new cases of FL in China and the U.S., respectively.[1],[2],[3]

 

About Tazemetostat Clinical Development in China

Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, an Ipsen company. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.

42 patients were enrolled in the Phase II bridging study in China. The primary objective was to evaluate the objective response rate (“ORR”) of tazemetostat for the treatment of patients with R/R FL whose disease harbor EZH2 mutations. The secondary objectives included duration of response (“DoR”), progression-free survival (PFS), overall survival (OS), safety and pharmacokinetics of tazemetostat for the treatment of R/R FL patients whose disease do or do not harbor EZH2 mutations. Results of the study will be submitted for presentation at an upcoming medical conference (NCT05467943).

HUTCHMED is participating in Ipsen’s SYMPHONY-1 study, leading it in China. This is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase Ib/III study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (NCT04224493).

 

About Tazemetostat approval in the United States

Tazemetostat is a methyltransferase inhibitor indicated in the United States for the treatment of:

The most common (≥20%) adverse reactions in patients with ES are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with FL are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

Please see the U.S. Full Prescribing Information for TAZVERIK® (tazemetostat).

TAZVERIK® is approved in Japan with the indication of relapsed or refractory EZH2 gene mutation-positive FL (only when standard treatment is not applicable).

TAZVERIK® is a registered trademark of Epizyme Inc., an Ipsen company.

 

About HUTCHMED

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 approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/​immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also marketed in the U.S. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.

 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the review of a NDA for tazemetostat for the treatment of FL with the NMPA and the timing of such review, therapeutic potential of tazemetostat for the treatment of patients with FL and the further development of tazemetostat in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support NDA approval of tazemetostat for the treatment of patients with FL or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the safety profile of tazemetostat, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for tazemetostat and the timing of these events. 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, The Stock Exchange of Hong Kong Limited and on AIM. 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.

 

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

 

CONTACTS

Investor Enquiries
 +852 2121 8200 / ir@hutch-med.com
Media Enquiries
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
Zhou Yi, Brunswick +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley/ Rupert Dearden, Panmure Liberum* +44 (20) 7886 2500

*Name changed from “Panmure Gordon (UK) Limited” to “Panmure Liberum Limited” following completion of its own corporate merger

 

Reference:

[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/