信达宣布与ASK制药合作的第三代EGFR TKI抑制剂林美替尼获NMPA批准，用于肺癌的一线治疗-动脉网

Innovent Announces NMPA Approval of Limertinib, a Third-generation EGFR TKI Collaborated with ASK Pharma, for the First-line Treatment of Lung Cancer

CISION 等信源发布 2025-04-26 08:00

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可切换为仅中文

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SAN FRANCISCO

旧金山

and SUZHOU,China

中国苏州

，

April 25, 2025

2025年4月25日

/PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that .

/PRNewswire/ -- 信达生物制药（Innovent Biologics, Inc.，简称“Innovent”）（港交所代码：01801），一家致力于开发、生产和销售用于治疗肿瘤、自身免疫、心血管和代谢、眼科及其他重大疾病的高质量药物的世界级生物制药公司，宣布。

China's

中国的

National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for limertinib as the first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 L858R mutations. Innovent and ASK Pharm entered into a commercial collaboration agreement for limertinib in Mainland China in 2024..

国家药品监督管理局（NMPA）已批准Limertinib的新药申请（NDA），用于一线治疗携带EGFR外显子19缺失或外显子21 L858R突变的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者。信达生物与ASK制药于2024年就Limertinib在中国大陆的商业化合作达成协议。

The approval of this new indication is supported by positive results from a randomized, double-blind, positive-controlled Phase 3 clinical trial. A total of 337 treatment-naïve patients with EGFR-sensitive mutation-positive locally advanced or metastatic NSCLC were enrolled and randomized 1:1 to receive either limertinib or gefitinib.

该新适应症的获批得到了一项随机、双盲、阳性对照的III期临床试验的积极结果的支持。研究共纳入337例EGFR敏感突变阳性的局部晚期或转移性非小细胞肺癌初治患者，并以1:1的比例随机分配接受利默替尼或吉非替尼治疗。

The primary endpoint was progression-free survival (PFS), as assed by an independent review committee (IRC)..

主要终点是由独立审查委员会（IRC）评估的无进展生存期（PFS）。

The data showed that limertinib significantly prolonged median PFS compared to gefitinib

数据显示，与吉非替尼相比，利默替尼显著延长了中位无进展生存期。

(20.7 months vs. 9.7 months)

（20.7个月 vs. 9.7个月）

, representing a

，代表一个

56%

risk reduction in disease progression or death (hazard ratio [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). In patients with central nervous system (CNS) lesions at baseline, median CNS PFS was also significantly longer with limertinib

疾病进展或死亡风险降低（风险比 [HR] 0.44；95% 置信区间：0.34–0.58；p < 0.0001）。在基线时有中枢神经系统 (CNS) 病变的患者中，使用利默替尼的中枢神经系统无进展生存期 (PFS) 中位数也显著更长。

(20.7 months vs. 7.1 months)

（20.7个月 vs. 7.1个月）

, corresponding to a

，对应于一个

72%

risk reduction for CNS progression or death (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), underscoring its robust intracranial activity and clinical utility in such population with high-unmet-needs.

中枢神经系统进展或死亡风险降低（HR 0.28；95% CI：0.10–0.82；p = 0.0136），凸显了其在高未满足需求的患者群体中强劲的颅内活性和临床效用。

The safety profile of limertinib was consistent with that of known EGFR-targeted therapies. Adverse events were predominantly mild to moderate and well-tolerated, with no new safety signals identified during the clinical trial. Full data and analysis from this pivotal Phase 3 study will be published in academic journals..

利默替尼的安全性特征与已知的EGFR靶向治疗一致。不良事件大多为轻度至中度，并且耐受性良好，在临床试验期间未发现新的安全性信号。这项关键的III期研究的全部数据和分析将发布在学术期刊上。

'Limertinib has demonstrated exceptional efficacy and safety as first-line therapy in patients with EGFR-muted locally advanced or metastatic NSCLC, including notable efficacy in those with brain metastases. The approval of this first-line indication introduces a new treatment option for Chinese patients, addressing a critical clinical need in this population.' said .

“Limertinib作为一线疗法在EGFR突变的局部晚期或转移性NSCLC患者中表现出卓越的疗效和安全性，包括对脑转移患者也有显著的疗效。该一线适应症的批准为中国患者提供了一种新的治疗选择，满足了这一人群的关键临床需求。”

Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 3 Clinical Study.

中国医学科学院肿瘤内科石远凯教授，医学博士，III期临床研究的主要研究者。

Dr.

博士

Hui Zhou

惠州市

, Senior Vice President of Innovent,

，信达生物高级副总裁，

stated：'We are delighted that both the first-line and second-line indications for limertinib have been successively approved. As a next-generation EGFR TKI, limertinib is poised to significantly improve survival outcomes for mutation-positive patients. Innovent has built a rich portfolio of precision therapies for lung cancer—including limertinib, Retsevmo®(selpercatinib), Dupert®(fulzerasib) and DOVBLERON® (taletrectinib)—with ongoing efforts to enhance their synergistic value.

表示：“我们很高兴利美替尼的一线和二线适应症相继获得批准。作为下一代EGFR TKI，利美替尼将显著改善突变阳性患者的生存结果。信达生物已经建立了针对肺癌的丰富精准治疗产品组合——包括利美替尼、Retsevmo®（塞尔帕替尼）、Dupert®（福泽拉西布）和DOVBLERON®（塔莱曲妥昔单抗），并正在努力提升它们的协同价值。

We will continue to work closely with Ask Pharm to ensure that limertinib brings a new hope to the broad population of patients with EGFR-mutated NSCLC.'.

我们将继续与Ask Pharm密切合作，确保limertinib为EGFR突变的非小细胞肺癌患者群体带来新的希望。

Mr.

先生

Jingfei Ma

马静飞

, CEO of ASK Pharm,

，ASK制药公司首席执行官，

stated: 'Within a few months, limertinib has obtained approvals for both second-line and first-line indications. The approval of the first-line indication further expands its clinical applicability. Meanwhile, ASK Pharm is advancing a clinical trial of limertinib in combination with the cMET inhibitor ASKC202 for patients with NSCLC resistant to third-generation EGFR-TKIs.

表示：“在短短几个月内，Limertinib就获得了二线和一线适应症的批准。一线适应症的批准进一步扩大了其临床应用范围。同时，ASK制药公司正在推进Limertinib与cMET抑制剂ASKC202联合用于对第三代EGFR-TKIs耐药的非小细胞肺癌（NSCLC）患者的临床试验。

We look forward to working with our partner Innovent to accelerate the accessibility of limertinib for more patients in need.'.

我们期待与我们的合作伙伴信达生物携手，加快Limertinib对于更多有需要的患者的可及性。

About EGFR mutation-positive non-small-cell lung cancer (NSCLC)

关于EGFR突变阳性的非小细胞肺癌（NSCLC）

Lung cancer remains one of the deadliest and most common cancers globally

肺癌仍然是全球最致命和最常见的癌症之一。

[1]

, with NSCLC accounting for approximately 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic stages that are not amenable to surgical resection. EGFR mutations are particularly prevalent among Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended standard of care in the first-line setting, with third-generation EGFR-TKIs offering the broadest treatment applicability..

，其中非小细胞肺癌（NSCLC）约占85%的病例。约70%的NSCLC患者在局部晚期或转移阶段被诊断出，这些阶段不适合手术切除。EGFR突变在亚洲NSCLC患者中尤为常见，影响30%到50%的病例。EGFR-TKIs是推荐的一线治疗标准，其中第三代EGFR-TKIs提供了最广泛的治疗适用性。

About Limertinib

关于Limertinib

Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights. It has been approved by the

利默替尼是一种口服的、具有自主知识产权的第三代EGFR TKI。它已经获得批准。

China's

中国的

NMPA for: 1) the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC), who have previously experienced disease progression during or after treatment with EGFR TKI; and 2) the first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations..

国家药监局批准用于：1）治疗既往接受表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKI）治疗后出现疾病进展的局部晚期或转移性 EGFR T790M 突变阳性的非小细胞肺癌（NSCLC）成人患者；2）一线治疗携带 EGFR 第 19 外显子缺失或第 21 外显子 L858R 突变的局部晚期或转移性 NSCLC 成人患者。

在

October 2024

2024年10月

, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China.

礼来制药与信达生物和问制药就利默替尼在大陆中国达成战略合作伙伴关系和许可协议。

About Innovent

关于信达

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.

信达生物是一家领先的生物制药公司，成立于2011年，使命是为全球患者提供负担得起的高质量生物制药。公司致力于发现、开发、生产和商业化针对一些最棘手疾病的创新药物。其开创性疗法治疗癌症、心血管和代谢、自身免疫和眼科疾病。

Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center..

信达生物已上市15款产品，有3个新药上市申请在审评中，4项资产处于III期或关键性临床试验阶段，还有15个分子处于早期临床阶段。信达生物与超过30家全球医药公司建立了合作关系，包括礼来、赛诺菲、Incyte、Adimab、LG化学以及MD安德森癌症中心。

Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit

信达恪守“始于信，达于行”的理念，致力于维护业界最规范的行业实践，并且通力合作以推动生物医药行业的发展，从而使一流的医药产品能够得到广泛使用。欲了解更多信息，请访问

www.innoventbio.com

, or follow Innovent on Facebook and LinkedIn.

，或者在Facebook和LinkedIn上关注信达。

Statement:

声明：

（

）

Innovent does not recommend the use of any unapproved drug (s)/indication (s).

信达不建议使用任何未经批准的药物/适应症。

（

）

Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company.

雷莫芦单抗（Cyramza®）、塞尔帕替尼（Retsevmo®）和皮托布替尼（Jaypirca®）由礼来公司开发。

About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm)

关于江苏奥赛康药业有限公司（ASK制药）

Founded in

成立于

January 2003

2003年1月

, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas..

江苏奥赛康药业有限公司（ASK Pharm）是一家基于研究的制药企业，集创新研发、生产、市场推广及销售专利药品、精细化学品和保健品于一体。奥赛康专注于消化系统疾病、多重耐药感染、肿瘤学和慢性病领域。

ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials.

ASK Pharm专注于小分子靶向创新药物和免疫肿瘤生物药物的研发。目前拥有48个主要研究项目，其中包括11个已披露的关键项目，专注于创新化学药物和生物药物。其中，ASKC109（麦芽酚铁胶囊）和ASKB589（Claudin18.2单克隆抗体）处于III期临床试验阶段。

ASK Pharm has Ranked among the top 20 best industrial enterprises in .

ASK制药公司已跻身前20名最佳工业企业之列。

China's

中国的

pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as 'Top Ten National R&D Innovators', 'Best National Enterprise for Investment', and 'National Torch Program High-Tech Enterprises'.

连续14年入选制药研发管道，并获得“全国十大研发创新者”、“最佳国家级投资企业”和“国家火炬计划高新技术企业”等诸多荣誉。

For more information, visit

欲了解更多信息，请访问

www.ask-pharm.com

。

Innovent's Forward-Looking Statements

信达前瞻性声明

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words 'anticipate', 'believe', 'estimate', 'expect', 'intend' and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。与信达相关的“预期”、“相信”、“估计”、“预计”、“意图”等词语及类似表达旨在识别某些此类前瞻性陈述。

Innovent does not intend to update these forward-looking statements regularly..

信达不打算定期更新这些前瞻性声明。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict.

这些前瞻性声明是基于信达生物管理层在作出这些声明时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并非对未来发展的保证，并受风险、不确定性及其他因素影响，其中部分因素超出信达生物的控制范围且难以预测。

Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions..

因此，由于我们业务、信达的竞争环境以及政治、经济、法律和社会状况的未来变化或发展，实际结果可能与前瞻性陈述中包含的信息有重大差异。

Reference

参考文献

[1] Bray F, et al. Global cancer statistics 2022. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024

[1] Bray F, 等。全球癌症统计2022。《CA：临床肿瘤学杂志》。2024年5月-6月；74(3):229-263。doi: 10.3322/caac.21834。电子版发布于2024年。

Apr 4

4月4日

. PMID: 38572751.

PMID: 38572751。

SOURCE Innovent Biologics

来源：信达生物

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