HUTCHMED Announces NDA Acceptance in China for Tazemetostat for the Treatment of Relapsed or Refractory Follicular Lymphoma with Priority Review Status
HUTCHMED (Nasdaq/AIM: HCM) has announced that its New Drug Application (NDA) for tazemetostat, aimed at treating adult patients with relapsed or refractory follicular lymphoma (R/R FL), has been accepted for review by the China National Medical Products Administration (NMPA) with Priority Review status. Tazemetostat, developed by Epizyme (an Ipsen company), is a first-in-class EZH2 methyltransferase inhibitor already approved by the FDA for specific patients with R/R FL and advanced epithelioid sarcoma (ES). The NDA acceptance in China is backed by a multicenter, open-label Phase II bridging study in China and global clinical studies by Epizyme. This drug was previously approved in the Hainan Pilot Zone, Macau, and Hong Kong. HUTCHMED has a strategic collaboration to develop, manufacture, and commercialize tazemetostat in Greater China.
- NDA for tazemetostat accepted by China's NMPA with Priority Review status.
- Tazemetostat is already approved for similar uses by the FDA, Japan MHLW, and in Hong Kong and Macau.
- Supported by positive data from a multicenter Phase II study in China and global studies.
- None.
The acceptance of the NDA for tazemetostat by the China NMPA for the treatment of relapsed or refractory follicular lymphoma is a significant step in addressing an unmet medical need in this patient population. Follicular lymphoma is a type of non-Hodgkin lymphoma that can be challenging to treat, especially when patients relapse or do not respond to conventional therapies. Tazemetostat’s mechanism as a first-in-class methyltransferase inhibitor targeting EZH2 offers a novel approach, potentially providing a treatment option where few exist.
This move can accelerate the availability of innovative therapies in China, which can be particularly impactful given the larger patient population compared to other regions where the drug is already approved. The priority review status further underscores the urgency and potential benefit of this treatment, suggesting that the NMPA recognizes its potential to address a significant gap in current treatment options.
From a clinical perspective, the results from the Phase II bridging study in China, along with data from Epizyme's studies, will be critical in determining the drug's efficacy and safety profile in the Chinese population. If these results align with those seen in other regions, tazemetostat could not only provide a new standard of care but also stimulate further research in targeted therapies for lymphoma.
For investors, the acceptance of the NDA with priority review status marks a pivotal moment for HUTCHMED. The priority review indicates that the NMPA considers tazemetostat to have the potential for significant improvements in treatment outcomes, which could translate into faster market entry and potentially higher initial market penetration. This is important for HUTCHMED’s growth trajectory, particularly within the highly competitive oncology market.
Given that tazemetostat is already approved in major markets like the U.S. and Japan, its acceptance in China expands its commercial footprint significantly. China is one of the largest pharmaceutical markets in the world and gaining early access through priority review can provide a competitive edge. This can lead to an increase in revenue streams not only from direct sales but also from potential partnerships and further development opportunities within the region.
Analysts will likely monitor the sales performance of tazemetostat closely following its launch in China. Positive performance could bolster HUTCHMED's financial health, supporting share price appreciation and investor confidence. However, it is also important to consider potential challenges, such as pricing pressures and competition from other emerging therapies. Strategic execution and market adoption will be critical to realizing the drug’s full commercial potential.
The entry of tazemetostat into the Chinese market under priority review status is not just a win for HUTCHMED but also for the broader pharmaceutical landscape in the region. The Chinese regulatory environment has been evolving, increasingly aligning with global standards to expedite the availability of innovative treatments. This development could signal a trend towards quicker access to breakthrough therapies for patients in China.
From a market perspective, the acceptance highlights the growing importance of China as a key player in the global pharmaceutical industry. HUTCHMED's strategic collaboration with Epizyme and Ipsen underscores a successful model of cross-border partnerships in drug development and commercialization. This collaboration can serve as a case study for other companies looking to enter or expand within the Chinese market.
For retail investors, it’s important to consider the long-term implications. The successful commercialization of tazemetostat in China can pave the way for HUTCHMED to introduce more innovative therapies, leveraging its established regulatory and market framework. This move can enhance HUTCHMED's reputation and positioning, potentially attracting further investments and collaborations.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 04, 2024 (GLOBE NEWSWIRE) -- 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
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:
- Adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection.
- Adult patients with R/R FL whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
- Adult patients with R/R FL who have no satisfactory alternative treatment options.
- 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 (≥
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
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REFERENCES
| 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/ |
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