Hong Kong, Shanghai, & Florham Park, NJ — Friday, September 29, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM; HKEX: 13) hereby notifies the market that as at September 29, 2023, the issued share capital of HUTCHMED consisted of 871,035,940 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 871,035,940 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 871,035,940 ordinary shares would be equivalent to 871,035,940 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 174,207,188 American depositary shares (each equating to five ordinary shares) which are traded on Nasdaq.
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 oncology drugs now approved and marketed in China. For more information, please visit: www.hutch‑med.com or follow us on LinkedIn.
Contacts
| Investor Enquiries | |
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 306 4490 |
| 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 / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
— Third major market authorization application based on data from the FRESCO-2 global Phase III trial —
Hong Kong, Shanghai & Florham Park, NJ — Friday, September 29, 2023: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that Takeda (TSE:4502/NYSE:TAK) has submitted a New Drug Application (“NDA”) to the Ministry of Health, Labour and Welfare (“MHLW”) in Japan for the approval of fruquintinib for the treatment of adult patients with previously treated metastatic colorectal cancer (“CRC”). Fruquintinib is a selective inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3, which play a pivotal role in blocking tumor angiogenesis. CRC has the highest incidence and second highest mortality rate among both men and women in Japan.[1]
The NDA for fruquintinib is based on results from FRESCO-2, a global Phase III multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia, as well as data from the Phase III FRESCO clinical trial conducted in China. The FRESCO-2 and FRESCO clinical trials compared fruquintinib plus best supportive care (“BSC”) with placebo plus BSC in patients with previously treated metastatic CRC. Both trials met their primary and key secondary endpoints, showing a statistically significant and clinically meaningful improvement in overall survival (“OS”) and progression-free survival (“PFS”). Fruquintinib has been generally well tolerated by patients.
“Alongside our partner Takeda, we are pleased to take this key step towards bringing fruquintinib to patients in Japan,” said Dr. Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED. “Supported by a strong clinical data set, and its success in China, we believe that fruquintinib is an important option for these patients and are optimistic about the impact it will have if approved in Japan. There is now real regulatory momentum behind fruquintinib, and we are excited to see this drug take to the global stage.”
This submission follows prior submissions for fruquintinib in the U.S. and Europe for the same indication. The U.S. Food and Drug Administration (“FDA”) granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. The FDA review is progressing and the inspection of HUTCHMED’s manufacturing facility in Suzhou, China has been completed. A Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) was validated and accepted for regulatory review in June 2023. Data from the global registrational FRESCO-2 clinical trial was published in The Lancet, also in June 2023 (NCT04322539).[2]
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of China. Fruquintinib is developed and marketed in China by HUTCHMED, under the brand name ELUNATE®. Approval in China was based on the results of the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, published in The Journal of the American Medical Association, JAMA (NCT02314819).[3]
Fruquintinib is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has been shown to be generally well tolerated in patients to date.
The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus BSC vs placebo plus BSC in patients with previously treated metastatic CRC. As previously disclosed, the 691-patient study met its primary endpoint of OS in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement in PFS, a key secondary endpoint, was observed. Fruquintinib has been generally well tolerated in patients to date. Results were presented at the European Society for Medical Oncology (ESMO) Congress in September 2022 and subsequently published in The Lancet.[4] Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539.
CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020.[5] In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023.[6] In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC was the most common cancer with an estimated 148,000 new cases and 60,000 deaths in 2020.5 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.[7],[8],[9],[10],[11]
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 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 approval of a NDA for fruquintinib for the treatment of CRC with the FDA, EMA and the MHLW and the timing of such approvals, the therapeutic potential of fruquintinib for the treatment of patients with CRC and the further clinical development of fruquintinib 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 fruquintinib for the treatment of patients with CRC or other indications in Japan or other jurisdictions such as the U.S. or the E.U., its potential to gain approvals from regulatory authorities on an expedited basis or at all; the efficacy and safety profile of fruquintinib; HUTCHMED and/or Takeda’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib; the timing of these events; each party’s ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; Takeda’s ability to successfully develop, manufacture and commercialize fruquintinib; and the impact of COVID-19 on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug products such as paclitaxel as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Such forward-looking statements include, without limitation, statements regarding the plan to develop, manufacture and commercialize fruquintinib under the license agreement; potential payments under the license agreement, including the upfront payment and any milestone or royalty payments; potential benefits of the license agreement; and HUTCHMED’s strategy, goals and anticipated milestones, business plans and focus. 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.
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.
Investor Enquiries |
+852 2121 8200 / +1 973 306 4490 / 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 / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
[1] Cancer Statistics. Cancer Information Service, National Cancer Center, Japan (Vital Statistics of Japan, Ministry of Health, Labour and Welfare). https://ganjoho.jp/public/qa_links/report/statistics/2023_jp.html.
[2] Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study [published online ahead of print, 2023 Jun 15]. Lancet. 2023. DOI: 10.1016/S0140-6736(23)00772-9.
[3] Li J, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.
[4] Dasari NA, et al. LBA25 – FRESCO-2: A global phase III multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. doi:10.1016/annonc/annonc1089.
[5] Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.
[6] Siegel RL, et al. Colorectal cancer statistics, 2023 [published online ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023; 73(3):233-254. doi:10.3322/caac.21772.
[7] Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol. 2023;20(5):306-322. doi:10.1038/s41575-022-00736-1.
[8] D’Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.
[9] Venderbosch, et al. Mismatch repair status and braf mutation status in metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2, coin, and Focus Studies. Clinical Cancer Res. 2014;20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.
[10] Koopman, M., et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 2009;100(2):266–273. doi:10.1038/sj.bjc.6604867.
[11] Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.
Hong Kong, Shanghai & Florham Park, NJ — Thursday, September 14, 2023: HUTCHMED (China) Limited (“HUTCHMED” or the “Company”) (Nasdaq/AIM: HCM; SEHK:13) has received notifications that the spouse of Mr Graeme Jack, Independent Non-executive Director, sold a total of 3,000 American Depositary Shares of the Company (“ADSs”, each representing five Ordinary Shares of US$0.10 each of the Company) at a price of US$14.70 per ADS on September 12, 2023.
Following the above sale of 3,000 ADSs, the holding of Mr Jack is 17,339 ADSs Note, representing approximately 0.01% of the current issued share capital of the Company.
Note: 17,339 ADSs included (i) 9,128 ADSs currently held by Mr Jack and (ii) 8,211 ADSs as beneficiary of a trust under long term incentive plan.
Please download the full announcement for the notification as provided in accordance with the requirements of the EU Market Abuse Regulation.
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 12, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM: HCM, HKEX: 13) today announces that results from the confirmatory Phase IIIb clinical trial of savolitinib in patients with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration non-small cell lung cancer (“NSCLC”), were presented during the IASLC 2023 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (“WCLC”), which took place from September 9 to 12, 2023 in Singapore.
| Title: | A Phase 3b Study of 1L Savolitinib in Patients with Locally Advanced or Metastatic NSCLC Harboring MET Exon 14 Mutation |
| Lead Author: | Shun Lu, MD, head of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong University |
| Type: | Oral presentation |
| Abstract Number: | OA21.03 |
| Session: | OA21. MET Matters in NSCLC |
| Date & Time: | Tuesday, September 12, 2023, 2:32-2:42 pm Singapore time |
| Location: | Room 406, Suntec Singapore Convention & Exhibition Centre |
| Abstract Link: | https://cattendee.abstractsonline.com/meeting/10925/presentation/995 |
Here we reported initial efficacy and safety data from the first-line cohort of a confirmatory Phase IIIb trial conducted in China of savolitinib as a monotherapy in patients with NSCLC MET exon 14 skipping alterations (NCT04923945). At data cut-off date of April 30, 2023, among the 84 patients in the tumor response evaluable set (TRES), objective response rate (ORR) was 60.7% (95% Confidence Interval (“CI”): 49.5% to 71.2%) and disease control rate (DCR) was 95.2% (95% CI: 88.3% to 98.7%), as assessed by an independent review committee. At median follow-up of 11.1 months, median progression free survival (mPFS) was 13.8 months (95% CI: 9.7 months to not reached). Median duration of response (DoR) and overall survival (OS) have not been reached. No new safety signals were observed.
The other cohort of this confirmatory trial was fully enrolled in H1 2023 and included patients who received prior treatments. The trial follows the June 2021 approval of savolitinib as a monotherapy in this indication from China’s National Medical Products Administration (NMPA), which was based on positive results from a Phase II trial (NCT02897479). This confirmatory trial enrolled a more representative proportion of the different NSCLC subtypes, which may confer different prognostic outcomes.
More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations. Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
| Title: | Computational Pathology-Based Assessment of cMET IHC Expression for Patient Selection in the Treatment of MET Overexpressing NSCLC |
| Lead Author: | Simon Christ, AstraZeneca |
| Type: | E-Poster |
| Abstract Number: | EP06.05-09 |
| Session: | EP06.05 Pathology and Biomarkers – Pathology |
| Abstract Link: | https://cattendee.abstractsonline.com/meeting/10925/presentation/1348 |
A Quantitative Continuous Scoring (QCS) algorithm is being developed as an automated methodology to identify patients who are most likely to respond to treatment. This e-poster showcased the application of this method based on information collected in the Phase II SAVANNAH study. The global Phase III study SAFFRON will serve as an additional independent validation cohort.
Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor 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), gene amplification or protein overexpression.
Savolitinib is marketed in China under the brand name ORPATHYS® for the treatment of patients with non-small cell lung cancer 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. Starting on March 1, 2023, ORPATHYS® was included in the National Reimbursement Drug List (NRDL) for the treatment of locally advanced or metastatic NSCLC adult patients with MET exon 14-skipping alterations who have progressed after or unable to tolerate platinum-based chemotherapy.
In 2011, AstraZeneca and HUTCHMED entered a global licensing and collaboration agreement to jointly develop and commercialize savolitinib. Joint development of savolitinib in China is led by HUTCHMED, while AstraZeneca leads development outside of China. HUTCHMED is responsible for the marketing authorization, manufacturing and supply of savolitinib in China. AstraZeneca is responsible for the commercialization of savolitinib in China and worldwide. Sales of savolitinib are recognized by AstraZeneca.
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 it 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 savolitinib, surufatinib, HMPL-760, HMPL-306 and HMPL-453, the further clinical development for savolitinib, surufatinib, HMPL-760, HMPL-306 and HMPL-453, its expectations as to whether any studies on savolitinib and HMPL-453 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 and the 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 savolitinib, surufatinib, HMPL-760, HMPL-306 and HMPL-453, including as a combination therapy, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential market of savolitinib, surufatinib, HMPL-760, HMPL-306 and HMPL-453 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, 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.
Contacts
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 306 4490 |
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 / Daphne Zhang, Panmure Gordon |
+44 (20) 7886 2500 |
Hong Kong, Shanghai & Florham Park, NJ — Tuesday, September 12, 2023: HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has completed patient enrollment of a bridging study of tazemetostat in China.
The bridging study is a multicenter, open-label, Phase II study to evaluate the efficacy, safety and pharmacokinetics of tazemetostat for the treatment of patients with relapsed/refractory follicular lymphoma (“R/R FL”). The primary objective is to evaluate the objective response rate (“ORR”) of tazemetostat for the treatment of patients with R/R FL whose disease harbor EZH21 mutations (Cohort 1). The secondary objectives included duration of response (“DoR”), progression-free survival (PFS), and overall survival (OS) of tazemetostat for the treatment of R/R FL patients whose disease do or do not harbor EZH2 mutations (Cohort 2), as well as to evaluate the safety and pharmacokinetics. The lead principal investigator is Dr Junning Cao of Shanghai Fudan University Cancer Center. A total of 42 patients were enrolled. Additional details may be found at clinicaltrials.gov, using identifier NCT05467943.
Tazemetostat is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme, Inc. (“Epizyme”), an Ipsen company. It is approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of certain patients with advanced epithelioid sarcoma (“ES”) and certain patients with R/R FL under the FDA accelerated approval granted in January and June 2020, respectively. HUTCHMED entered into a strategic collaboration to research, develop, manufacture and commercialize tazemetostat in China, Hong Kong, Macau and Taiwan.
In May 2022, tazemetostat was approved by the Health Commission and Medical Products Administration of Hainan Province of China to be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (“Hainan Pilot Zone”), 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.
In March 2023, tazemetostat was approved and launched in Macau. A market authorization application has been under review in Hong Kong since December 2022.
Tazemetostat was included in the Chinese Society of Clinical Oncology (CSCO) guidelines for ES in 2022 and for FL in 2023.
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. 2, 3, 4
ES is a rare, slow-growing type of soft tissue cancer. Radical tumor resection is the primary treatment for patients with ES. However, ES is known for its high propensity for locoregional recurrence and distant metastases. The survival of patients with ES is often unsatisfactory with very limited treatment options. 5
TAZVERIK® is a methyltransferase inhibitor indicated in the United States for the treatment of:
These indications are approved under accelerated approval by the U.S. FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.
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.
View the U.S. Full Prescribing Information here:
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.
HUTCHMED and Ipsen are developing tazemetostat in various hematological and solid tumors in Greater China. We are participating in Ipsen’s SYMPHONY-1 (EZH-302) study, leading it in China. We also initiated a Phase ІІ study in combination with our phosphoinositide 3-kinase delta (PІ3Kδ) inhibitor amdizalisib in patients with R/R FL in February 2023. We are generally responsible for funding all clinical trials of tazemetostat in China, including the portion of global trials conducted there.
SYMPHONY-1 (EZH-302) is an international, multicenter, randomized, double-blind, active-controlled, 3-stage, biomarker-enriched, confirmatory Phase 1b/3 study, which is designed to evaluate the safety and efficacy of tazemetostat in combination with rituximab + lenalidomide (R2) in patients with R/R FL after at least one prior line of therapy (clinicaltrials.gov identifier: NCT04224493).
China combination study in R/R FL is an open-label, Phase ІІ study in approximately 140 patients to evaluate the safety, tolerability and preliminary anti-tumor efficacy of tazemetostat in combination with amdizalisib in patients with R/R lymphoma. The first patient was dosed in February 2023 (clinicaltrials.gov identifier: NCT05713110).
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 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 TAZVERIK® for the treatment of patients with ES or FL, the further clinical development of TAZVERIK® in this and other indications, risks associated with the use of TAZVERIK® in the Hainan Pilot Zone and Macau, including that it could be discontinued in the future for a variety of reasons, the risk that ongoing or future clinical trials conducted by HUTCHMED for TAZVERIK® may not meet their primary or secondary endpoints or will warrant meetings with regulatory authorities, submissions for regulatory approval or review by governmental authorities under the accelerated approval process and 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 regulatory approvals, including accelerated approval, to conduct trials or to market products (including to continue offering TAZVERIK® in the Hainan Pilot Zone, Macau or elsewhere in China, Hong Kong and Taiwan), its expectations that preclinical studies or earlier clinical studies are predictive of the results of future trials, such as the ongoing confirmatory trials, the safety profile of TAZVERIK®, the potential for TAZVERIK® to become a new standard of care for ES or FL patients, HUTCHMED’s and Epizyme’s ability to implement and complete its further clinical development plans for TAZVERIK®, the potential commercial launch of TAZVERIK® in China and other jurisdictions in the approved indications, the sufficiency of each company’s cash resources to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the timing of these events, and the impact of COVID-19 on HUTCHMED’s business, results of operations and financial condition and on general economic, regulatory and political conditions. In addition, as certain studies rely on the use of other drug candidates as combination therapeutics with TAZVERIK®, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and regulatory approval of such drug candidates. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. HUTCHMED anticipates that subsequent events and developments may cause its views to change; however, HUTCHMED does not undertake any 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. For a 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.
Investor Enquiries |
|
| Mark Lee, Senior Vice President | +852 2121 8200 |
| Annie Cheng, Vice President | +1 (973) 306 4490 |
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 / Daphne Zhang, Panmure Gordon |
+44 (20) 7886 2500 |
1 EZH2 = Enhancer of Zeste Homolog 2
2 Source: NCCN® – https://www.nccn.org
3 Source: SEER – https://seer.cancer.gov/statfacts/html/follicular.html
4 Source: GLOBOCAN https://gco.iarc.fr/
5 Sobanko JF, Meijer L, Nigra TP. Epithelioid sarcoma: a review and update. J Clin Aesthet Dermatol. 2009;2(5):49-54.
| Date: Thursday, November 16, 2023 |
| Time: 2:30pm GMT (10:30pm HKT/ 9:30am EST) |