中国HER2靶向ADC药物曲妥珠单抗重组凝血酶获得NMPA批准用于HER2突变非小细胞肺癌-动脉网

China's HER2-Targeted ADC Trastuzumab Rezetecan Gains NMPA Approval for HER2-Mutant NSCLC

CISION 等信源发布 2025-05-29 17:27

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SHANGHAI

上海

，

May 29, 2025

2025年5月29日

/PRNewswire/ -- The National Medical Products Administration has recently granted approval for Trastuzumab rezetecan,

/PRNewswire/ -- 国家药品监督管理局近期批准了Trastuzumab rezetecan，

China's

中国的

first domestically developed antibody-drug conjugate (ADC), for treatment of adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating

首个国内自主研发的抗体药物偶联物（ADC），用于治疗携带激活型基因的不可切除的局部晚期或转移性非小细胞肺癌（NSCLC）成年患者。

HER2

(

ERBB2

) mutations who have previously received at least one systemic therapy.

) 之前至少接受过一种系统治疗的突变患者。

The approval of Trastuzumab rezetecan was based on the pivotal HORIZON-Lung study led by

Trastuzumab rezetecan 的批准基于由牵头的关键性 HORIZON-Lung 研究，

Professor Lu Shun at Shanghai Chest Hospital

上海胸科医院陆舜教授

, which demonstrated groundbreaking efficacy in

，这在以下方面显示出突破性的功效

HER2

-mutant locally advanced or metastatic NSCLC patients who have received prior systemic therapy. The trial achieved a median follow-up of 14.2 months, an IRC-confirmed objective response rate (ORR) of 74.5%, and a median progression-free survival (mPFS) of 11.5 months—thereby doubling the efficacy of conventional treatments.

-突变局部晚期或转移性非小细胞肺癌患者在接受过先前的系统治疗后。该试验达到了14.2个月的中位随访时间，独立评审委员会（IRC）确认的客观缓解率（ORR）为74.5%，中位无进展生存期（mPFS）为11.5个月，从而将传统治疗的效果提高了一倍。

In addition, Trastuzumab rezetecan significantly reduced the toxicity risks typically associated with conventional ADCs. These results have redefined global benchmarks for ADC research and garnered significant attention from the international scientific community..

此外，Trastuzumab rezetecan 显著降低了通常与传统 ADC 相关的毒性风险。这些结果重新定义了全球 ADC 研究的基准，并引起了国际科学界的广泛关注。

Trastuzumab rezetecan has achieved breakthroughs in both efficacy and safety through pioneering molecular design from the ground up, a milestone made possible by Hengrui Pharmaceuticals' decade-long development of its ADC R&D platform, the Hengrui Rapid Modular ADC Platform (HRMAP). HRMAP enables end-to-end capabilities spanning molecular design, preclinical optimization, and clinical translation.

通过从头开始的开创性分子设计，赫赛莱珠单抗在疗效和安全性上均取得了突破。这一里程碑得益于恒瑞医药长达十年的ADC研发平台——恒瑞快速模块化ADC平台（HRMAP）的发展。HRMAP实现了涵盖分子设计、临床前优化和临床转化的端到端能力。

To date, Hengrui has advanced over 10 differentiated ADC candidates into clinical development, including Trastuzumab rezetecan, its flagship .

截至目前，恒瑞已将十多个差异化ADC候选药物推进到临床开发阶段，包括其旗舰产品曲妥珠单抗。

HER2

-targeted ADC therapy.

-靶向ADC治疗。

Shun Lu

陆顺

, MD, PhD, Director of oncology department (Shanghai Lung Tumor Clinical Medical Center)，China, and principal investigator of Horizon-Lung, said, 'the HORIZON-Lung study validates Trastuzumab rezetecan as a transformative therapy for

医学博士、博士，上海肺部肿瘤临床医学中心肿瘤科主任，中国Horizon-Lung项目首席研究员表示：“HORIZON-Lung研究验证了Trastuzumab rezetecan作为一种变革性疗法用于

HER2

-mutant NSCLC, addressing a critical unmet need for advanced

-突变型非小细胞肺癌，满足了晚期患者的迫切未满足需求

HER2

-driven NSCLC patients in

驱动的非小细胞肺癌患者在

China

中国

. Grounded in epidemiological data that accurately reflect

. 基于准确反映的流行病学数据

China's

中国的

NSCLC epidemiological landscape, this therapeutic advance not only provides a novel treatment option for patients, but also heralds

非小细胞肺癌的流行病学领域，这一治疗进展不仅为患者提供了新的治疗选择，也预示着

China's

中国的

emergence as a pioneering force in shaping the global ADC landscape for precision oncology.

作为塑造全球ADC精准肿瘤学格局的先锋力量的崛起。

Beyond its established efficacy in lung cancer, Trastuzumab rezetecan has demonstrated significant clinical advances across multiple tumor types, with eight additional indications—including breast cancer, colorectal cancer, gastric cancer, biliary tract cancer, cervical cancer, ovarian cancer, fallopian tube cancer, and primary peritoneal cancer—receiving Breakthrough Therapy Designation (BTD) from .

除了在肺癌中已确立的疗效外，Trastuzumab rezetecan 还在多种肿瘤类型中展现了显著的临床进展，另有八个适应症（包括乳腺癌、结直肠癌、胃癌、胆道癌、宫颈癌、卵巢癌、输卵管癌和原发性腹膜癌）获得了突破性疗法认定（BTD）。

China's

中国的

National Medical Products Administration (NMPA).

国家药品监督管理局（NMPA）。

SOURCE Hengrui Pharma

来源：恒瑞医药

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