不断演变的EGFR NSCLC市场：值得关注的8款后期新兴疗法 DelveInsight-动脉网

The Evolving EGFR NSCLC Market: 8 Emerging Late-stage Therapies to Watch

CISION 等信源发布 2026-06-01 20:31



可切换为仅中文







The EGFR-NSCLC pipeline possesses some drugs in late-stage development to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Zipalertinib (CLN-081) (Cullinan Oncology/Taiho Pharma), Firmonertinib (ArriVent BioPharma), Ivonescimab (SMT112) (Akeso Biopharma/Summit Therapeutics), PF-08046054 (Pfizer), Patritumab Deruxtecan (Daiichi Sankyo/AstraZeneca), Sacituzumab Tirumotecan (MK-2870) (Merck/Kelun-Biotech), SYS6010 (CSPC Pharmaceutical), and JMT101 (Shanghai JMT-Bio).

EGFR突变非小细胞肺癌（EGFR-NSCLC）研发管线中包含多款处于后期开发阶段、有望于近期获批的药物。这一新兴格局为治疗提供了多样化的替代方案，包括Zipalertinib（CLN-081）（Cullinan Oncology/大正制药）、Firmonertinib（ArriVent BioPharma）、Ivonescimab（SMT112）（康方生物/Summit Therapeutics）、PF-08046054（辉瑞）、Patritumab Deruxtecan（第一三共/阿斯利康）、Sacituzumab Tirumotecan（MK-2870）（默沙东/科伦博泰）、SYS6010（石药集团）以及JMT101（上海JMT-Bio）。

The expected launch of these therapies shall further create a positive impact on the market..

预计这些疗法的上市将进一步对市场产生积极影响。

LAS VEGAS

拉斯维加斯

，

June 1, 2026

2026年6月1日

/PRNewswire/ -- Non-small cell lung cancer is increasingly evolving into a biomarker-driven market, with EGFR-mutated disease emerging as one of the most commercially significant segments. The space is dominated by blockbuster EGFR-targeted therapies such as

/PRNewswire/ -- 非小细胞肺癌正日益演变为由生物标志物驱动的市场，其中EGFR突变型疾病已成为最具商业价值的细分领域之一。该领域主要由重磅EGFR靶向疗法主导，例如

TAGRISSO

泰瑞沙

, which now generates nearly

，目前其已创造近

USD 6 billion

60亿美元

annually, reinforcing the importance of precision medicine in NSCLC management.

每年，进一步强调了精准医学在非小细胞肺癌（NSCLC）管理中的重要性。

The treatment landscape has rapidly expanded beyond tyrosine kinase inhibitors (TKIs), particularly as resistance mutations continue to rise following the widespread first-line adoption of TAGRISSO. Consequently, the post-TAGRISSO setting has become one of the largest unmet needs in EGFR NSCLC, driving intense interest in next-generation therapeutic approaches capable of overcoming resistance and extending survival outcomes..

随着TAGRISSO在一线治疗中的广泛应用，耐药突变持续增加，治疗格局已迅速突破酪氨酸激酶抑制剂（TKIs）的范畴。因此，TAGRISSO治疗后的阶段已成为EGFR突变非小细胞肺癌领域最大的未满足临床需求之一，进而极大推动了业界对能够克服耐药并延长生存期的下一代治疗方案的高度关注。

Among these emerging modalities, antibody-drug conjugates (ADCs) are gaining considerable momentum. Following the approval of Datroway, several late-stage ADC candidates are advancing through pivotal studies, including

在这些新兴疗法中，抗体药物偶联物（ADC）正展现出强劲的发展势头。继Datroway获批后，数款处于后期阶段的ADC候选药物正在推进关键性研究，包括

izalontamab brengitecan

伊扎隆单抗布伦吉替康

from Bristol Myers Squibb,

来自百时美施贵宝，

telisotuzumab adizutecan

特立妥珠单抗阿迪佐替康偶联物

from AbbVie, and

来自艾伯维，以及

sacituzumab tirumotecan

沙妥珠单抗替鲁替康

from Merck. These programs highlight the growing industry focus on ADC innovation within EGFR-driven NSCLC.

来自默克。这些项目凸显了业界在EGFR驱动型非小细胞肺癌领域对ADC创新日益增长的关注。

Sadaf Javed, an oncology expert, said that the market is witnessing a convergence of multiple advanced therapeutic platforms, including TKIs, ADCs, bispecific antibodies, CDACs, and gene therapy-based combinations. This expanding competitive landscape suggests that future market leadership will depend heavily on differentiation across efficacy, resistance mutation coverage, administration convenience, safety, and combination potential..

肿瘤学专家萨达夫·贾维德表示，市场正迎来多种先进治疗平台的融合，包括TKIs、ADCs、双特异性抗体、CDACs以及基于基因疗法的联合方案。这一不断扩大的竞争格局表明，未来的市场主导地位将很大程度上取决于在疗效、耐药突变覆盖范围、给药便捷性、安全性以及联合用药潜力等方面的差异化表现。

While exon 20 insertion mutations have attracted substantial attention in recent years and transformed into a highly competitive segment, uncommon and atypical EGFR mutations, including

尽管近年来20号外显子插入突变备受关注，并已发展成为竞争激烈的领域，但罕见和非典型EGFR突变，包括

G719X, S768I, and PACC mutations

G719X、S768I和PACC突变

, are emerging as the next frontier in EGFR NSCLC research and drug development, creating additional opportunities for targeted innovation.

，正成为EGFR非小细胞肺癌研究与药物开发的下一个前沿，为靶向创新创造了更多机遇。

Discover who will dominate EGFR NSCLC after osimertinib @

了解奥希替尼之后谁将主导EGFR非小细胞肺癌领域 @

https://www.delveinsight.com/sample-request/epidermal-growth-factor-receptor-non-small-cell-lung-cancer-market

表皮生长因子受体非小细胞肺癌市场

Reflecting the strong commercial and clinical momentum in this space, DelveInsight estimates that the EGFR NSCLC market across the 7MM, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately

反映了该领域强劲的商业与临床发展势头，DelveInsight估计，涵盖美国、EU4（德国、法国、意大利和西班牙）、英国和日本的7MM（七大主要市场）EGFR非小细胞肺癌（NSCLC）市场规模约为

USD 6.6 billion

66亿美元

in 2025.

在2025年。

Below, we highlight 8 late-stage EGFR NSCLC therapies poised to reshape the future of EGFR NSCLC management.

以下，我们重点介绍8种有望重塑EGFR非小细胞肺癌未来治疗格局的后期临床疗法。

Akeso Bio and Summit Therapeutics' Ivonescimab

康方生物与Summit Therapeutics的依沃西单抗

Bispecific antibody

双特异性抗体

Akeso's ivonescimab (AK112, SMT112) is a first-in-class PD-1/VEGF bispecific antibody and the first candidate in this category to advance into Phase III clinical trials. Developed using the company's proprietary Tetrabody platform, the therapy is designed to simultaneously inhibit PD-1 interactions with PD-L1 and PD-L2 while also preventing VEGF from binding to its receptors..

康方生物的依沃西单抗（AK112，SMT112）是一款同类首创的PD-1/VEGF双特异性抗体，也是该类别中首个进入III期临床试验的候选药物。该疗法基于公司专有的Tetrabody平台开发，旨在同时抑制PD-1与PD-L1及PD-L2的相互作用，并阻止VEGF与其受体结合。

The combination of PD-1 inhibition and VEGF blockade has already demonstrated strong clinical benefit across several tumor types, including NSCLC, renal cell carcinoma, and hepatocellular carcinoma. By integrating both mechanisms into a single molecule, ivonescimab may provide more efficient dual-pathway suppression and potentially deliver stronger antitumor activity than conventional combination regimens..

PD-1抑制与VEGF阻断的联合已在包括非小细胞肺癌、肾细胞癌和肝细胞癌在内的多种肿瘤类型中展现出显著的临床获益。通过将这两种机制整合至单一分子中，依沃西单抗有望实现更高效的双通路抑制，并可能比传统联合方案产生更强的抗肿瘤活性。

The FDA has accepted for filing Summit Therapeutics' Biologics License Application based on results from the

FDA已受理Summit Therapeutics的生物制品许可申请，该申请基于……的结果。

Phase III HARMONi trial

III期HARMONi试验

, with a PDUFA target action date set for

，PDUFA目标行动日期定于

November 14, 2026

2026年11月14日

。

As per Javed, ivonescimab has already made notable regulatory progress in China, reinforcing confidence in the therapy and supporting its broader international expansion strategy. Furthermore, ongoing regulatory reviews and submissions across major markets suggest the drug could establish a presence in the global immunotherapy landscape in the near future.

据贾维德表示，依沃西单抗在中国已取得显著的监管进展，这增强了对该疗法的信心，并支持其更广泛的国际扩张战略。此外，主要市场正在进行的监管审查与申报表明，该药物有望在不久的将来在全球免疫治疗格局中占据一席之地。

Partnerships with pharmaceutical companies exploring combination approaches involving targeted therapies and antibody-drug conjugates may also broaden its therapeutic applications and commercial potential..

与制药公司合作探索涉及靶向治疗和抗体药物偶联物的联合疗法，也可能拓宽其治疗应用范围和商业潜力。

ArriVent BioPharma and Shanghai Allist Pharmaceuticals' Firmonertinib

阿瑞万特生物制药公司与上海艾力斯医药的伏美替尼

Small molecule

小分子

Firmonertinib (previously known as furmonertinib) is an orally administered, mutation-selective EGFR inhibitor characterized by strong brain penetration and broad activity against both common and uncommon EGFR alterations, including PACC and Exon 20 insertion mutations. The therapy is currently under evaluation in a global .

伏美替尼（曾用名：furmonertinib）是一种口服的突变选择性EGFR抑制剂，具有强效的脑渗透性，并对常见及罕见EGFR突变（包括PACC及20号外显子插入突变）均具有广泛活性。该疗法目前正在一项全球性试验中进行评估。

Phase III study, FURVENT

III期研究，FURVENT

(NCT05607550), for first-line NSCLC patients harboring EGFR Exon 20 insertion mutations, as well as in the global Phase Ib FURTHER trial (NCT05364043), which is assessing its efficacy in patients with EGFR PACC mutations. Additionally, firmonertinib is being investigated in combination regimens for advanced or metastatic NSCLC patients with classical EGFR mutations through a collaboration with InnoCare Pharma..

（NCT05607550），针对携带EGFR 20号外显子插入突变的一线非小细胞肺癌患者，以及在全球Ib期FURTHER试验（NCT05364043）中，该试验正在评估其对EGFR PACC突变患者的疗效。此外，通过与诺诚健华（InnoCare Pharma）的合作，伏美替尼（firmonertinib）也正在探索用于携带经典EGFR突变的晚期或转移性非小细胞肺癌患者的联合治疗方案。

Firmonertinib is emerging as a promising targeted therapy with the potential to enhance the treatment landscape for EGFR-mutant NSCLC, especially in patients with rare EGFR alterations and CNS involvement, according to Aparna Thakur, Assistant Project Manager, Forecasting at DelveInsight. Should ongoing global studies continue to deliver encouraging efficacy and safety data, the drug may establish itself as a strong contender within the EGFR TKI market while broadening therapeutic options for patients with uncommon EGFR mutations..

据DelveInsight预测部助理项目经理Aparna Thakur表示，Firmonertinib正逐渐成为一种颇具前景的靶向疗法，有望进一步优化EGFR突变非小细胞肺癌（NSCLC）的治疗格局，尤其适用于伴有罕见EGFR变异及中枢神经系统（CNS）受累的患者。若正在进行的全球研究能持续展现出令人鼓舞的有效性和安全性数据，该药物有望在EGFR TKI市场中确立强有力的竞争地位，同时为携带非常见EGFR突变的患者拓宽治疗选择。

Explore best emerging therapies post-TAGRISSO @

探索泰瑞沙（TAGRISSO）治疗后的最佳新兴疗法 @

Emerging Therapies in EGFR NSCLC Market

EGFR NSCLC市场的新兴疗法

Merck and Kelun-Biotech's Sacituzumab tirumotecan

默克与科伦博泰的沙妥昔单抗-替鲁替康

ADC

模数转换器

Sacituzumab tirumotecan is an investigational antibody-drug conjugate (ADC) composed of three key elements: sacituzumab, a monoclonal antibody directed against TROP2; a cytotoxic payload belonging to the topoisomerase I inhibitor class; and an innovative irreversible yet hydrolyzable linker that connects the antibody to the payload using proprietary conjugation technology..

戈沙妥珠单抗替鲁替康是一种在研抗体药物偶联物（ADC），由三个关键部分组成：靶向TROP2的单克隆抗体戈沙妥珠单抗；属于拓扑异构酶I抑制剂类的细胞毒性载荷；以及一种采用专有偶联技术将抗体与载荷相连的创新型不可逆但可水解连接子。

The therapy was developed by Kelun-Biotech, a holding subsidiary of Kelun Pharmaceutical, which specializes in the research, development, manufacturing, commercialization, and global partnering of innovative biologics and small-molecule therapies. Through a collaboration agreement, Kelun-Biotech granted Merck exclusive rights to develop, manufacture, and commercialize sacituzumab tirumotecan outside Greater China..

该疗法由科伦药业控股子公司科伦博泰开发，该公司专注于创新生物药与小分子疗法的研发、生产、商业化及全球授权合作。根据合作协议，科伦博泰授予默沙东在大中华区以外地区开发、生产和商业化萨西妥珠单抗替美替康的独家权利。

Pfizer's PF-08046054

辉瑞的PF-08046054

ADC

模数转换器

Pfizer's PF-08046054 (PDL1V) is an experimental antibody-drug conjugate designed to target PD-L1–expressing cells by delivering the potent cytotoxic payload monomethyl auristatin E (MMAE). Beyond its direct cell-killing mechanism, PDL1V also demonstrates antitumor effects through bystander activity and the induction of immunogenic cell death..

辉瑞的PF-08046054（PDL1V）是一款实验性抗体药物偶联物，旨在通过递送强效细胞毒性载荷单甲基澳瑞他汀E（MMAE）来靶向表达PD-L1的细胞。除直接的细胞杀伤机制外，PDL1V还通过旁观者效应及诱导免疫原性细胞死亡展现出抗肿瘤作用。

To know more about best ADCs in EGFR NSCLC, visit @

欲了解更多关于EGFR非小细胞肺癌最佳ADC药物的信息，请访问 @

EGFR NSCLC Medication

EGFR非小细胞肺癌治疗药物

Cullinan Therapeutics and Taiho Pharma's Zipalertinib

Cullinan Therapeutics与泰和制药的齐帕替尼

Small molecule

小分子

Zipalertinib is a next-generation, orally available, irreversible EGFR inhibitor designed to selectively and strongly inhibit tumor cells harboring EGFR Exon 20 insertion mutations. Preclinical studies suggest that it largely spares wild-type EGFR-expressing cells, potentially reducing the toxicities commonly linked to wild-type EGFR inhibition..

Zipalertinib是一种新一代口服不可逆EGFR抑制剂，旨在选择性且强效地抑制携带EGFR 20号外显子插入突变的肿瘤细胞。临床前研究表明，该药物对表达野生型EGFR的细胞影响甚微，从而可能降低与野生型EGFR抑制相关的常见毒性。

Thakur anticipated that zipalertinib will play a notable role in the EGFR Exon 20ins segment as a next-gen, mutant-selective TKI, especially given its oral dosing, CNS activity, and breakthrough therapy designation by the FDA. Future performance will be shaped by outcomes from ongoing Phase III (REZILIENT3) studies assessing zipalertinib plus platinum-pemetrexed chemotherapy versus standard care..

Thakur预计，泽来替尼（zipalertinib）作为一款新一代突变选择性TKI，将在EGFR 20号外显子插入突变细分市场发挥重要作用，这尤其得益于其口服给药方式、中枢神经系统活性以及已获FDA突破性疗法认定。其未来表现将取决于正在进行的III期（REZILIENT3）研究结果，该研究正评估泽来替尼联合铂类-培美曲塞化疗与标准治疗的疗效对比。

CSPC Pharmaceutical's SYS6010

石药集团的SYS6010

ADC

模数转换器

SYS6010 is a novel antibody-drug conjugate (ADC) that combines a humanized anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody with the topoisomerase I inhibitor JS-1 through a cleavable glycine-glycine-phenylalanine-glycine tetrapeptide linker. As per company's Q2 presentation, SYS6010 is currently under evaluation in a Phase III study for first- and second-line EGFR-mutated NSCLC.

SYS6010是一款新型抗体药物偶联物（ADC），通过可裂解的甘氨酸-甘氨酸-苯丙氨酸-甘氨酸四肽连接子，将人源化抗表皮生长因子受体（EGFR）IgG1单克隆抗体与拓扑异构酶I抑制剂JS-1偶联而成。根据公司第二季度的演示资料，SYS6010目前正在进行针对一线及二线EGFR突变型非小细胞肺癌（NSCLC）的III期临床评估。

The presentation also noted that, in third-line and later EGFR-mutant NSCLC, the company is preparing a trial that will compare SYS6010 against chemotherapy. In 2L+ EGFR-wildtype NSCLC, a separate comparative trial against chemotherapy is also in the preparation phase..

报告还指出，在三线及以上的EGFR突变型非小细胞肺癌（NSCLC）治疗中，该公司正在筹备一项将SYS6010与化疗进行对比的试验。在二线及以上（2L+）的EGFR野生型NSCLC领域，另一项与化疗对比的试验也正处于筹备阶段。

Find out more about top EGFR NSCLC ADC pipeline assets @

了解更多关于重点EGFR NSCLC ADC研发管线资产的信息 @

EGFR NSCLC Clinical Trials

EGFR非小细胞肺癌临床试验

Source:

请提供需要翻译的具体文本。

EGFR NSCLC Market Report

EGFR非小细胞肺癌市场报告

EGFR NSCLC Market Insights, Epidemiology, and Market Forecast – 2036

EGFR非小细胞肺癌市场洞察、流行病学及市场预测——至2036年

report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key EGFR NSCLC companies, including

本报告深入解析了该疾病，提供历史与预测的流行病学数据，以及市场趋势、市场驱动因素、市场壁垒和关键的EGFR NSCLC相关企业，包括

AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hansoh Pharmaceutical, Johnson & Johnson Innovative Medicine, Pfizer, Cullinan Oncology, Taiho Pharmaceutical, ArriVent Biopharma, Black Diamond Therapeutics, Daiichi Sankyo, Akeso Biopharma, Summit Therapeutics

阿斯利康, 勃林格殷格翰, 礼来, 翰森制药, 强生创新制药, 辉瑞, 卡利南肿瘤, 大鹏制药, 艾福医药, 黑钻制药, 第一三共, 康方生物, 萨米特制药

, and others.

，等人。

About

关于

DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

DelveInsight 是一家领先的商业咨询与市场研究公司，专注于生命科学领域。公司通过提供全面的端到端解决方案，助力制药企业提升业绩。通过我们的订阅制平台 PharmDelve，您可便捷获取所有医疗保健与制药市场的研究报告。

。

联系我们

Shruti Thakur

什鲁蒂·塔库尔

[email protected]

support@tencent.com

+14699457679

www.delveinsight.com

Logo:

标志：

https://mma.prnewswire.com/media/1082265/3528414/DelveInsight_Logo.jpg