和黄医药宣布国家药监局附条件批准TAZVERIK®（他泽司他）用于治疗复发或难治性滤泡性淋巴瘤-动脉网

HUTCHMED Announces NMPA Conditional Approval for TAZVERIK® (tazemetostat) for the Treatment of Relapsed or Refractory Follicular Lymphoma

GlobeNewswire 等信源发布 2025-03-21 06:00

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— First and only EZH2 inhibitor approved by the NMPA —

— 首个且唯一获得NMPA批准的EZH2抑制剂 —

— HUTCHMED’s fourth product, and its first approval in hematological malignancies —

— HUTCHMED的第四款产品，也是其在血液系统恶性肿瘤领域的首次获批 —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 21, 2025 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“

香港、上海和新泽西州弗洛勒姆帕克，2025年3月21日（环球新闻社）-- 和黄医药（中国）有限公司（“

HUTCHMED

和黄医药

”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the New Drug Application (“NDA”) for TAZVERIK

”) (纳斯达克/伦敦证交所：HCM；港交所：13) 今日宣布，TAZVERIK的新药申请（“NDA”）已提交。

(tazemetostat) has been granted conditional approval in China for the treatment of adult patients with relapsed or refractory (“R/R”) follicular lymphoma (“FL”) with EZH2 mutation who have received at least two prior systemic therapies. This approval follows the priority review status by the National Medical Products Administration (“NMPA”) and marks the first nationwide regulatory approval for TAZVERIK.

他泽司他（tazemetostat）已在中国获得有条件批准，用于治疗携带EZH2突变的复发或难治性（“R/R”）滤泡性淋巴瘤（“FL”）成年患者，这些患者至少接受过两种先前的系统治疗。此次批准是在国家药品监督管理局（“NMPA”）优先审评资格后授予的，也是TAZVERIK首次在全国范围内获得监管批准。

in China.

在中国。

The conditional approval by the NMPA was supported by results from a multicenter, open-label, Phase II bridging study in China, and clinical studies conducted by Epizyme, Inc. (“Epizyme”), an Ipsen company, outside China. The primary objective of the bridging study is to evaluate the objective response rate (“ORR”) of TAZVERIK.

中国国家药品监督管理局的附条件批准是基于一项多中心、开放标签的II期桥接研究的结果，以及益普生集团旗下Epizyme公司在中国境外进行的临床研究结果。桥接研究的主要目的是评估TAZVERIK的客观缓解率（“ORR”）。

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), and overall survival (OS) of TAZVERIK

用于治疗携带EZH2突变的R/R FL患者。次要目标包括TAZVERIK的缓解持续时间（“DoR”）、无进展生存期（PFS）和总生存期（OS）。

for the treatment of R/R FL patients, as well as to evaluate the safety and pharmacokinetics. Additional details can be found at clinicaltrials.gov, using identifier

用于治疗R/R FL患者，并评估其安全性和药代动力学。更多详情可访问clinicaltrials.gov，使用标识符查询。

NCT05467943

。

“This approval represents a significant advancement in the management of this challenging disease. The majority of FL patients experience multiple relapses over their lifetime, posing substantial treatment difficulties and often leading to poor outcomes,” said

“此次批准代表了在管理这一棘手疾病方面的重大进展。大多数FL患者在一生中会经历多次复发，这带来了巨大的治疗困难，并常常导致不良结果，”

Dr Junning Cao of Fudan University Cancer Center

复旦大学癌症中心曹军宁博士

and the lead principal investigator of the bridging study. “TAZVERIK

桥接研究的首席首席研究员。“TAZVERIK

has demonstrated promising efficacy in patients harboring EZH2 mutation in clinical trials. We are eager to provide this transformational epigenetic therapy to patients in China who have long sought new effective treatment options.”

在临床试验中，对携带EZH2突变的患者展现了良好的疗效。我们渴望将这种变革性的表观遗传疗法带给中国那些长期寻求新有效治疗选择的患者。”

“We are thrilled to be able to bring this innovative EZH2 inhibitor to patients in China. This approval highlights our dedication to addressing unmet medical needs not only through our internal pipeline, but also through partnering,” said

“我们非常高兴能够将这种创新的EZH2抑制剂带给中国的患者。这一批准彰显了我们不仅通过内部研发管线，还通过合作伙伴关系来满足未被满足的医疗需求的决心，”表示

Dr Michael Shi, Head of R&D and Chief Medical Officer of HUTCHMED.

石明博士，HUTCHMED研发负责人兼首席医学官。

“It also marks our first approval in hematological malignancies, unveiling a new chapter for HUTCHMED as we extend our footprint into this disease area. As we move forward, we are dedicated to making this product available to R/R FL patients as soon as possible and will continue striving to make a meaningful impact on the lives of more patients suffering from devastating diseases.”.

“它也标志着我们在血液恶性肿瘤方面的首次获批，开启了和黄医药将足迹扩展到这一疾病领域的新篇章。展望未来，我们致力于尽快将该产品提供给复发/难治性FL患者，并将继续努力对更多遭受严重疾病困扰的患者生活产生有意义的影响。”

TAZVERIK

他泽维克

is a first-in-class methyltransferase inhibitor of EZH2 developed by Epizyme. It is approved by the US 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.

是Epizyme公司开发的首创EZH2甲基转移酶抑制剂。它获得美国食品药品监督管理局（“FDA”）批准，用于治疗某些复发/难治性滤泡性淋巴瘤（R/R FL）患者和某些晚期上皮样肉瘤（“ES”）患者，属于FDA加速审批计划。同时，它还获得日本厚生劳动省（MHLW）批准，用于治疗某些复发/难治性滤泡性淋巴瘤（R/R FL）患者。

In 2021, HUTCHMED and Epizyme entered a strategic partnership. HUTCHMED is responsible for the research, development, manufacturing and commercialization of TAZVERIK.

2021年，和黄医药与Epizyme达成战略合作关系，和黄医药负责TAZVERIK的研究、开发、生产和商业化。

in China Mainland, Hong Kong, Macau and Taiwan. Epizyme will be the Marketing Authorization Holder of TAZVERIK

在中国大陆、香港、澳门和台湾。Epizyme将是TAZVERIK的上市许可持有人。

in China.

在中国。

TAZVERIK

他泽司他

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. TAZVERIK

2022年5月，TAZVERIK（他泽司他）获准通过临床急需进口药品批准在海南博鳌乐城国际医疗旅游先行区（海南先行区）使用，用于治疗某些符合FDA批准的标签中一致的ES和FL患者。

was approved in Macau in March 2023 and in Hong Kong in May 2024.

于2023年3月在澳门获批，2024年5月在香港获批。

The ongoing SYMPHONY-1 study will serve as the confirmatory trial to validate the clinical benefits of TAZVERIK

正在进行的SYMPHONY-1研究将作为确证性试验，以验证TAZVERIK的临床益处。

. SYMPHONY-1 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 TAZVERIK

SYMPHONY-1 是一项国际、多中心、随机、双盲、阳性对照、三阶段、生物标志物富集的确认性 Ib/III 期研究，旨在评估 TAZVERIK 的安全性和有效性。

in combination with rituximab and lenalidomide (R²) in patients with R/R FL after at least one prior line of therapy (

与利妥昔单抗和来那度胺（R²）联合使用，用于至少接受过一种先前治疗的 R/R FL 患者（

NCT04224493

). Epizyme is the sponsor of SYMPHONY-1 and HUTCHMED is leading the study in China.

). Epizyme是SYMPHONY-1的赞助商，而HUTCHMED正在中国主导这项研究。

About Follicular Lymphoma

关于滤泡性淋巴瘤

FL is the second most common subtype of non-Hodgkin’s lymphoma (“NHL”), making up 20-30% of all NHL. In 2022, there were an estimated 81,000 and 78,000 new cases of NHL in China and the US, respectively.

滤泡性淋巴瘤（FL）是最常见的非霍奇金淋巴瘤（“NHL”）亚型之一，占所有NHL的20-30%。2022年，中国和美国分别估计有81,000和78,000例新发NHL病例。

，

About Tazemetostat approval in the United States and Japan

关于Tazemetostat在美国和日本的批准

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

Tazemetostat是一种甲基转移酶抑制剂，在美国适用于治疗：

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced ES not eligible for complete resection.

年龄在16岁及以上的成人和儿科患者，患有转移性或局部晚期且无法完全切除的ES。

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.

肿瘤经FDA批准的检测方法检测为EZH2突变阳性的复发/难治性滤泡性淋巴瘤（R/R FL）成年患者，且既往至少接受过两种系统治疗。

Adult patients with R/R FL who have no satisfactory alternative treatment options.

没有满意替代治疗方案的复发/难治性滤泡性淋巴瘤（R/R FL）成人患者。

These indications are approved under accelerated approval by the US FDA based on ORR and DoR. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

这些适应症是基于客观缓解率（ORR）和缓解持续时间（DoR）通过美国FDA的加速审批程序批准的。这些适应症的持续批准可能取决于在确证性试验中对临床获益的验证和描述。

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.

ES患者最常见的（≥20%）不良反应包括疼痛、疲劳、恶心、食欲减退、呕吐和便秘。FL患者最常见的（≥20%）不良反应包括疲劳、上呼吸道感染、肌肉骨骼疼痛、恶心和腹痛。

Please see the

请参见

US Full Prescribing Information

美国完整处方信息

for TAZVERIK

用于TAZVERIK

(tazemetostat).

(tazemetostat)。

TAZVERIK

他泽维克

is approved in Japan with the indication of relapsed or refractory

在日本获批用于复发或难治性适应症

EZH2

gene mutation-positive FL (only when standard treatment is not applicable).

基因突变阳性的FL（仅在标准治疗不适用时）。

TAZVERIK

is commercialized by Epizyme in the US and by Eisai in Japan.

在美国由Epizyme公司商业化，在日本由Eisai公司商业化。

TAZVERIK

他泽维克

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

是Epizyme Inc.（一家Ipsen公司）的注册商标。

About HUTCHMED

关于和黄医药

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. Since inception it has focused on bringing 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 approved around the world including in the US, Europe and Japan.

和黄医药（纳斯达克/伦敦证交所：HCM；香港交易所：13）是一家创新型的商业化阶段生物医药公司。公司致力于发现与全球开发及商业化用于治疗癌症和免疫性疾病的小分子靶向疗法和免疫疗法。自成立以来，公司一直专注于将自主发现的候选药物推向全球患者，其前三种药物已在中国上市，其中首个药物也在包括美国、欧洲和日本在内的全球多个国家获批。

For more information, please visit: .

如需更多信息，请访问：。

www.hutch-med.com

or follow us on

或关注我们

领英

。

Forward-Looking Statements

前瞻性声明

This press release 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 reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of tazemetostat for the treatment of patients with relapsed or refractory follicular lymphoma and the further clinical development of tazemetostat in this and other indications.

本新闻稿包含1995年《美国私人证券诉讼改革法案》“安全港”条款意义上的前瞻性陈述。这些前瞻性陈述反映了和黄医药对未来事件的当前预期，包括其对tazemetostat治疗复发或难治性滤泡性淋巴瘤患者的治疗潜力的预期，以及tazemetostat在此适应症及其他适应症中的进一步临床开发。

Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support NDA approval of tazemetostat for the treatment of patients with follicular lymphoma in China and other jurisdictions, 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.

前瞻性声明涉及风险和不确定性。这些风险和不确定性包括（但不限于）以下假设：临床数据是否足以支持他泽司他用于治疗中国及其他司法管辖区滤泡性淋巴瘤患者的NDA批准、他泽司他的安全性、和黄医药为他泽司他提供资金、实施并完成其进一步的临床开发和商业化计划的能力，以及这些事件的时间安排。

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 US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM.

现有投资者及潜在投资者谨请注意，切勿过分依赖该等前瞻性陈述，该等陈述仅截至本日期有效。有关该等风险及其他风险的进一步讨论，请参阅HUTCHMED向美国证券交易委员会、香港联合交易所有限公司及AIM提交的文件。

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..

和黄医药不对更新或修改本新闻稿中包含的信息承担任何义务，无论是否由于新信息、未来事件或其他情况等原因。

Medical Information

医学信息

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..

本新闻稿包含的信息涉及可能并非在所有国家都可用的产品，或者可能在不同的商标、适应症、剂量或强度下可用。此处所含的任何内容均不应被视为对包括正在开发中的处方药在内的任何处方药的招揽、推广或广告。

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联系人

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投资者查询

+852 2121 8200 /

ir@hutch-med.com

投资者关系@和黄医药.com

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