STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma/Paraganglioma (PPGL)

To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.

开始日期2027-02-07

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+1]

NCT07753824

/ Not yet recruiting临床2期

A Phase II Study of Ivonescimab Combined With Intraperitoneal Paclitaxel in Patients With High-Grade Metastatic Appendiceal Adenocarcinoma (AA)

To evaluate the safety and effectiveness of Ivonescimab combined with intraperitoneal paclitaxel (IP PTX) in patients with unresectable metastatic high-grade Appendiceal Adenocarcinoma (AA).

开始日期2027-01-16

申办/合作机构

Summit Therapeutics, Inc.

[+1]

NCT07765433

/ Not yet recruiting临床2/3期IIT

A Phase II/III Randomized Study of Ivonescimab With Gemcitabine and Cisplatin Versus Standard of Care Chemoimmunotherapy in Advanced Biliary Tract Cancer

This phase II/III trial studies how well the addition of ivonescimab to standard chemotherapy (gemcitabine and cisplatin) works when compared to usual chemotherapy and immunotherapy (durvalumab or pembrolizumab) in treating patients with biliary tract cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as durvalumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivonescimab is a bispecific antibody that is directed against both the programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF) protein. By targeting PD-1, ivonescimab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. By targeting VEGF, ivonescimab may help stop the formation of blood vessels that bring oxygen and nutrients to tumor. Adding ivonescimab to standard chemotherapy may work better than usual chemotherapy and immunotherapy in lowering the chance of advanced biliary tract cancer growing or spreading.

开始日期2027-01-11

申办/合作机构

ECOG-ACRIN Medical Research Foundation, Inc.

[+1]

100 项与依沃西单抗相关的临床结果

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100 项与依沃西单抗相关的转化医学

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100 项与依沃西单抗相关的专利（医药）

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项与依沃西单抗相关的文献（医药）

2026-12-31·Human Vaccines & Immunotherapeutics

Ivonescimab combined with chemotherapy for the treatment of metastatic cervical cancer: A case report and literature review

Review

作者: Zhou, Jie ; Qiu, Shuo ; Xu, Motong ; Zhang, Yongchun

The prognosis for patients with recurrent or metastatic cervical cancer (r/mCC) remains challenging, with a 5-y survival rate of approximately 17%. Although first-line treatment has evolved from traditional single-agent chemotherapy to combination regimens that incorporate targeted therapy and immunotherapy-showing improved initial response rates - therapeutic options after disease progression remain limited and often yield suboptimal outcomes. Ivonescimab, the first tetravalent bispecific monoclonal antibody capable of simultaneously targeting programmed death receptor-1 (PD-1) and vascular endothelial growth factor A (VEGF-A), demonstrates robust anti-tumor activity and a manageable safety profile across various solid tumors through synergistic blockade of both immune checkpoint pathways and tumor angiogenesis. This case report describes a patient diagnosed with cervical squamous cell carcinoma accompanied by hepatic metastases who received first-line therapy with platinum-based chemotherapy in combination with cadonilimab and bevacizumab. According to RECIST 1.1 criteria, a partial response (PR) was achieved after four treatment cycles, with a PFS of 11 months. Subsequent to disease progression, second-line treatment was initiated with ivonescimab combined with single-agent albumin-bound paclitaxel. After two treatment cycles, PR was achieved, and the patient continues to derive clinical benefits. Throughout the treatment course, the patient experienced only low-grade adverse events (CTCAE grade 1 or below) and maintained a satisfactory quality of life. To our knowledge, this is the first reported case demonstrating a significant response to ivonescimab in recurrent or metastatic cervical cancer following failure of first-line immunotherapy combined with anti-angiogenic therapy. This case preliminarily validates its anti-tumor activity and safety characteristics, and presents a novel therapeutic strategy for later-line management.

2026-07-02·Journal of immunotherapy and precision oncology

Bispecific Antibodies in Solid Tumors: Mechanistic Insights, Clinical Advances, and Future Directions

Review

作者: Mendoza, Megan Macalalad ; Tang, Tin-Yun ; Stephen, Bettzy ; Almosa, Radiya

ABSTRACT:

A rapidly advancing class of engineered immunoglobulins, known as bispecific antibodies (bsAbs), that bind two distinct antigens offers new approaches for tumor targeting and immune modulation. BsAbs function as immune cell engagers, immune checkpoint modulators, or signaling pathway inhibitors. They differ in half-life, stability, and tissue penetration depending on whether they exist in crystallizable fragment (Fc)–based or fragment-based formats. Although bsAbs have shown strong efficacy in hematologic malignancies, their translation to solid tumors has been limited by antigen heterogeneity, off-tumor toxicity, and the immunosuppressive tumor microenvironment. Recent clinical advancements have led to eight approved bsAbs for solid tumors, including amivantamab for EGFR (epidermal growth factor receptor) exon 20 insertion–mutated non-small cell lung cancer (NSCLC), tebentafusp for uveal melanoma, cadonilimab for cervical cancer, tarlatamab for small cell lung cancer, ivonescimab for PD-L1 (programmed death–ligand 1)–positive NSCLC, zanidatamab for HER2 (human epidermal growth factor receptor 2)–amplified biliary tract cancer, zenocutuzumab for NRG1 (neuregulin 1) fusion–positive tumors, and catumaxomab for malignant ascites. These agents have demonstrated durable clinical benefit with manageable safety profiles. However, class-related toxicities such as cytokine release syndrome, immune effector cell–associated neurotoxicity syndrome, and on-target off-tumor effects remain important challenges. Advances in Fc silencing, affinity tuning, and tumor-restricted activation have improved therapeutic selectivity and tolerability. Ongoing innovations include bsAb-drug conjugates, proteolysis-targeting chimeras (PROTACs), and multispecific antibody platforms designed to reprogram the tumor microenvironment and enhance immune infiltration. Biomarker-driven patient selection and rational combination strategies are expected to further improve outcomes. As engineering technologies mature, bsAbs are expected to become integral to precision oncology, expanding safe and effective immunotherapy options for patients with solid tumors. This review aims to provide a comprehensive overview of the mechanisms, clinical applications, challenges, and future directions of bsAbs in solid tumors.

2026-07-01·Cancer Discovery

Ivonescimab Plus Chemo Extends Squamous NSCLC Survival

Abstract::

The anti–PD-1, anti-VEGF bispecific antibody ivonescimab plus chemotherapy significantly improves overall survival in advanced squamous non–small cell lung cancer versus an immunotherapy–chemotherapy combination, according to a trial conducted in China. However, questions remain over the trial’s applicability to patients in other countries.

6,342

项与依沃西单抗相关的新闻（医药）

5 小时之前

·ioncology

2026 WCLC｜LBA重磅揭晓：2 项中国研究强势入选主席研讨会，多项重磅成果蓄势首尔！

编者按 2026年9月12日至15日，由国际肺癌研究协会（IASLC）主办的2026世界肺癌大会（WCLC 2026）将在韩国首尔召开。作为全球胸科肿瘤学领域规模最大的学术会议，WCLC汇聚来自世界各地的研究者、临床医生、护士及患者倡导者，集中呈现肺癌诊疗领域的前沿进展。本届大会预计吸引超过7,000名参会者，设置150余场学术会议，展示2,200余篇摘要，内容覆盖肺癌筛查、精准治疗、免疫治疗、围术期管理及转化研究等多个领域。今日，大会官网公布了2026 WCLC全部入选摘要信息（含LBA）。更新内容涵盖主席研讨会（Presidential Symposium）、口头报告（Oral Abstract）及壁报导览（Poster Tour）等专场，涉及靶向治疗、免疫治疗、围术期管理、病理检测及多学科照护等多个方向。其中，主席研讨会作为WCLC学术日程的核心环节，其入选研究代表了当前领域内最具价值的重要成果。本次入选主席研讨会的8项研究中，2项来自中国，体现了国内肺癌研究在国际学术舞台上的持续活跃。《肿瘤瞭望》特将最新入选研究标题整理如下，以飨读者。主席研讨会 PL02. 主席研讨会1 日期：2026.9.13 摘要号：PL02.01 标题：SWOG S1827 MAVERICK: Phase III Trial of Brain MRI Surveillance +/- Prophylactic Cranial Irradiation for Small-Cell Lung Cancer 中文标题：SWOG S1827 MAVERICK：脑部MRI监测±预防性脑照射治疗小细胞肺癌的III期试验讲者：C.G. Rusthoven（美国）摘要号：PL02.03 标题：Tam-Peli, an Anti-B7-H3 Antibody-Drug Conjugate, Versus Topotecan in Relapsed SCLC: A Randomized, Open-Label, Phase 3 Study (TAISHAN-302) 中文标题：Tam-Peli（一种抗B7-H3抗体药物偶联物）对比Topotecan治疗复发小细胞肺癌：一项随机、开放标签、III期研究（TAISHAN-302）讲者：张力教授（中山大学肿瘤防治中心）摘要号：PL02.04 标题：Risvutatug Rezetecan (a B7-H3-Directed ADC) Versus Topotecan in Relapsed SCLC: Primary Results of Phase 3 ARTEMIS-008 中文标题：Risvutatug Rezeteccan（一种靶向B7-H3的ADC）对比Topotecan治疗复发小细胞肺癌：III期ARTEMIS-008研究的主要结果讲者：王洁教授（中国医学科学院肿瘤医院）摘要号：PL02.06 标题：Primary Results from Phase 3 EVOKE-03/KEYNOTE D46: Sacituzumab Govitecan + Pembrolizumab in PD-L1 TPS ≥50% Metastatic NSCLC 中文标题：III期EVOKE-03/KEYNOTE D46研究的主要结果：Sacituzumab Govitecan联合Pembrolizumab治疗PD-L1 TPS≥50%的转移性非小细胞肺癌讲者：Giannis Mountzios （希腊） PL03. 主席研讨会2 日期：2026.9.14 摘要号：PL03.01 标题：Adjuvant Osimertinib in Resected EGFR-Mutated Stage IB-IIIA NSCLC: ADAURA Exploratory 8-year Overall Survival Landmark Update 中文标题：辅助Osimertinib治疗切除后EGFR突变IB-IIIA期非小细胞肺癌：ADAURA探索性8年总生存里程碑更新讲者：R.S. Herbst（美国）摘要号：PL03.03 标题：First-line Amivantamab-chemotherapy vs Chemotherapy in NSCLC with EGFR Exon 20 Insertions: Overall Survival from PAPILLON 中文标题：一线Amivantamab联合化疗对比单纯化疗治疗EGFR外显子20插入突变非小细胞肺癌：PAPILLON研究的总生存结果讲者：Chul Kim（美国）摘要号：PL03.04 标题：Zipalertinib Plus Chemotherapy for 1st Line NSCLC with EGFR Exon 20 Insertions: Results From the Phase 3 Trial (REZILIENT 3) 中文标题：Zipalertinib联合化疗一线治疗EGFR外显子20插入突变非小细胞肺癌：III期REZILIENT 3研究结果讲者：D.S. Tan（新加坡）摘要号：PL03.06 标题：Zidesamtinib in TKI-naive Patients with Advanced/Metastatic ROS1+ NSCLC: ARROS-1 Efficacy and Safety Data 中文标题：Zidesamtinib治疗TKI初治的晚期/转移性ROS1阳性非小细胞肺癌：ARROS-1疗效和安全性数据讲者：Alexander Drilon（美国）口头报告 OA04. 重新定义可切除NSCLC的围术期治疗：整合免疫治疗和分子靶向策略以提高治愈率日期：2026.9.13专场主席：Pei-Jye Voon（马来西亚）、Vanessa Costa Menezes（巴西）摘要号：OA04.02 标题：Neoadjuvant Durvalumab+Chemotherapy for Resectable/Borderline Resectable Stage IIB-IIIB NSCLC: MDT-BRIDGE Primary Analysis 中文标题：新辅助Durvalumab联合化疗用于可切除/交界可切除 IIB-IIIB期非小细胞肺癌：MDT-BRIDGE主要分析讲者：Martin Reck（德国）摘要号：OA04.05 标题：14-Gene High-Risk Profile Predicts a Durable Overall Survival Benefit from Adjuvant Chemotherapy in Very Early-Stage NSCLC 中文标题：14基因高风险谱预测极早期非小细胞肺癌患者从辅助化疗中获得持久总生存获益讲者：J.R. Kratz（美国） OA05. 小细胞肺癌从发现到实践：重新定义治疗标准和下一代靶向治疗日期：2026.9.13专场主席：Sofia Baka（希腊）、Rosalyn Juergens（加拿大）摘要号：OA05.01 标题：Tarlatamab Extended-Interval Dosing Regimens in Patients With SCLC: The Randomized Phase 2 DeLLphi-309 Study 中文标题：Tarlatamab延长间隔给药方案在小细胞肺癌患者中的应用：随机II期DeLLphi-309研究讲者：Jonathan Goldman（美国） OA08. 现代亚肺叶切除术：早期NSCLC的精准手术和非手术策略及STAS的挑战日期：2026.9.14专场主席：Paul E. Van Schil（比利时）、Stella Martinez-Jaramillo（哥伦比亚）摘要号：OA08.01 标题：Wedge Resection vs. Segmentectomy for GGO-Dominant cT1a-bN0M0 NSCLC: Initial Results of a Randomized Trial 中文标题：楔形切除对比肺段切除术治疗以磨玻璃影为主的cT1a-bN0M0非小细胞肺癌：一项随机试验的初步结果讲者：L. Liu（四川大学华西医院）摘要号：OA08.02 标题：Perioperative Outcomes of the GREAT Phase III Trial of Minimally-invasive Segmentectomy Versus Lobectomy for GGO-Containing Early Lung Cancer 中文标题：GREAT III 期试验中微创肺段切除术对比肺叶切除术治疗含磨玻璃影早期肺癌的围手术期结局讲者：Y. Chen（同济大学附属东方医院） OA14. 晚期NSCLC的突破性免疫治疗日期：2026.9.14专场主席：James Chih-Hsin Yang（國立台灣大學醫學院附設醫院）、Alona Zer （以色列）摘要号：OA14.01 标题：Pumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC) 中文标题：Pumitamig（PD-L1×VEGF-A双特异性抗体）联合Elfetabart Drozuotecan（Elfe-D，B7H3抗体药物偶联物）治疗晚期/转移性肺癌（非小细胞或小细胞肺癌）患者讲者：A.J. Schoenfeld（美国）摘要号：OA14.02 标题：Clinical Outcomes of the Phase III Lonestar Trial: Local Consolidation Therapy After Nivolumab Plus Ipilimumab in NSCLC 中文标题：III 期Lonestar试验的临床结局：Nivolumab联合Ipilimumab后局部巩固治疗在非小细胞肺癌中的应用讲者：M. Altan（美国）摘要号：OA14.04 标题：Ivonescimab-Chemo vs Placebo-Chemo in EGFR-TKI-Resistant, EGFR-Mutated NSCLC (HARMONi): Updated Overall Survival Analysis 中文标题：Ivonescimab联合化疗对比安慰剂联合化疗治疗EGFR-TKI耐药、EGFR突变非小细胞肺癌（HARMONi 研究）：更新总生存分析讲者：Antonio Passaro（意大利）壁报导览 PT1.04. 筛查与早期检测摘要号：PT1.04.03 标题：Ehrsmoker: Recovering Missed Lung Cancer Screening Eligibility via Longitudinal Smoothing of EHR Smoking Data 中文标题：Ehrsmoker：通过EHR吸烟数据的纵向平滑恢复漏判的肺癌筛查资格讲者：T.Y. Lee（美国）摘要号：PT1.04.04 标题：Comprehensive Characterization of the Blood Proteome Before Lung Cancer Diagnosis 中文标题：肺癌诊断前血液蛋白质组的全面特征描述讲者：A. Guenoun（法国）摘要号：PT1.04.05 标题：Precision LDCT Lung Cancer Screening Beyond Smoking to Occupational and Environmental Risk Groups in Taoyuan, Taiwan 中文标题：台湾桃园地区超越吸烟因素、面向职业与环境风险人群的精准LDCT肺癌筛查讲者：C-Y. YEH（中国台湾桃园市政府卫生局） PT1.05. 肺病学与分期：支气管镜及分期新策略摘要号：PT1.05.04 标题：EBUS-TBNA Washing NGS Improves Detection of Actionable Mutations Compared With Plasma ctDNA and Standard Tissue Testing in Advanced NSCLC 中文标题：晚期NSCLC中，EBUS-TBNA灌洗液NGS对比血浆ctDNA及标准组织检测可提高可靶向突变检出率讲者：W.C. Cheng（中国台湾中国医药大学附设医院）摘要号：PT1.05.05 标题：The Impact of Smoking Status on Lung Cancer Staging in EGFR-Mutant Tumors Within the Ninth Edition TNM Classification 中文标题：第九版TNM分期中吸烟状态对EGFR突变型肺癌分期的影响讲者：H. Abolfathi（加拿大） PT1.09. 转移性NSCLC——局部治疗摘要号：PT1.09.04 标题：Detection of Residual Cancer Cell Signals Through Deconvolution of Bulk RNA-Seq Data With Single-Cell Atlas in Advanced Lung Cancer 中文标题：基于单细胞图谱对晚期肺癌批量RNA-seq数据进行反卷积以检测残留癌细胞信号讲者：R. Fu（广东省人民医院）摘要号：PT1.09.05 标题：Efficacy and Spatial Microenvironment of ROS1-TKI Combined With Surgery in Advanced ROS1-Positive NSCLC 中文标题：ROS1-TKI联合手术在晚期ROS1阳性NSCLC中的疗效及空间微环境特征讲者：L. Jiang（广东省肺癌研究所） PT2.03. 转移性NSCLC——靶向治疗摘要号：PT2.03.06 标题：First-line Subcutaneous Amivantamab Plus Lazertinib in EGFR-mutated Advanced NSCLC: Updated Results From the PALOMA-2 Study 中文标题：皮下注射Amivantamab联合Lazertinib一线治疗EGFR突变晚期NSCLC：PALOMA-2研究最新结果讲者：M. Nagasaka（美国） PT2.06. 多学科照护：护理及联合健康专业人员摘要号：PT2.06.04 标题：Specialist Disease Manager and Outcomes in Multidisciplinary Lung Cancer Care: A Retrospective Cohort Study 中文标题：多学科肺癌诊疗中专科疾病管理师与患者结局：一项回顾性队列研究讲者：X. Chen（四川大学华西医院）摘要号：PT2.06.05 标题：The Hidden Burden of Lung Cancer. Psychosocial Distress and Functional Impairment Among Patients in Western Kenya. 中文标题：肺癌的隐性负担：肯尼亚西部患者的心理社会困扰与功能损害讲者：M. Wanja（肯尼亚） PT2.08. 全球健康、卫生服务与卫生经济学摘要号：PT2.08.05 标题：Advancing Practice With the Role of an Advanced Practice Lung Radiation Therapist in Motion Management Clinic for Lung SBRT Patients 中文标题：高级执业放疗师在肺癌SBRT患者运动管理门诊中的角色推动实践进步讲者：J.P.C. Ho（新加坡）内容来源：WCLC 官网 https://wclc.iaslc.org 排名不分先后按照摘要类别划分如有遗漏或任何问题请后台留言（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

19 小时之前

·BioSpace

Merck’s Moderna-partnered vaccine success clears view of post-Keytruda future

iStock, lolo2013 Investors had been pessimistic about the probability of success for the personalized cancer vaccine intismeran autogene, so the Phase 3 win was a welcome surprise. The success of Merck’s Moderna-partnered melanoma vaccine didn’t just validate the idea of individualized cancer vaccines; it showed the world how the oncology juggernaut will likely thrive despite the upcoming loss of king Keytruda. Merck’s shares ended Wednesday trading up 12% to $152.20, reflecting strong investor enthusiasm after the Phase 3 INTerpath-001 study succeeded . Moderna also had a great day at the markets, closing with shares skyrocketing 176% to $174.38. Patients who received a combination of Keytruda and intismeran autogene, an mRNA-based cancer vaccine, lived longer without their cancer returning than did those who received Keytruda alone, achieving the trial’s primary endpoint of recurrence-free survival. The results show that Merck has a path to growth even without managing to expand the exclusivity period for Keytruda, analysts said on Wednesday afternoon. “Merck sentiment continues to improve as Keytruda solution becomes clearer,” BMO Capital Markets wrote. “While Merck may not be able to outright grow through the Keytruda [loss of exclusivity], updates like INTerpath-001 give us further confidence that the company has a meaningful revenue growth strategy for the business beyond just Keytruda.” China Summit, Merck must navigate new regulatory terrain in China-first cancer landscape Summit Therapeutics revealed positive Western data last week from a Phase 3 trial of lung cancer candidate ivonescimab. In a flipped geographical clinical trials landscape, what more will be required for Summit and China-based partner Akeso—and other transnational tandems—to secure FDA approval? July 27, 2026 · 10 min read · Heather McKenzie Read more Keytruda, the immuno-oncology mega-blockbuster, has been approved in dozens of oncology indications. It has reached the top of pharma’s sales charts, only to recently be eclipsed by Eli Lilly’s GLP-1 franchise. The drug will begin sliding off its patent in 2028, despite Merck’s efforts to get a new formulation approved. To offset the expected decline, Merck has been working on new antibody-drug conjugates such as the TROP2-directed candidate sac-TMT and other emerging cancer modalities to bulk up its pipeline. And last September, the FDA greenlit a subcutaneous version of Keytruda, which could help to buttress sales. But investors remain concerned about the loss of Keytruda. They had not thrown a lot of weight behind the Moderna cancer program, meaning the successful trial result was a happy surprise. BMO said investors had viewed neoantigen trials like INTerpath-001 as risky, given mixed data to date and the novelty of the idea. “With most expecting trial failure, positive results position Merck and Moderna to move forward with intismeran in cutaneous melanoma,” BMO said. That means the companies could now have a program worth $2 billion in unadjusted peak revenue in melanoma alone, BMO predicted—with potential across other solid tumors. Merck will, of course, split the profits with Moderna 50/50, but this revenue stream is brand new to investor expectations since they had been so skeptical. With multiple indications, Merck and Moderna could see $5.6B in unadjusted peak revenue, according to the analysts. Intismeran is being tested in other solid tumors, including renal cell carcinoma, lung cancer and other advanced types of melanoma. The Phase 2 renal cell trial will read out first in April 2027, according to BMO. “While translation in efficacy from melanoma to other solid tumors is not certain, we do see reason to be more optimistic about the opportunity in these indications given today’s results,” the firm said. Merck and Moderna will reveal more detailed data from the INTerpath-001 program at an upcoming medical meeting, Guggenheim noted. “While we wait to see the full data, if they are as encouraging as they now appear, INT could represent an important part of MRK’s growth story as it works to navigate through biosimilar and pricing pressure for Keytruda starting later this decade,” the firm wrote Wednesday.

上市批准临床3期疫苗临床结果抗体药物偶联物

2026-08-19

·精准把控核心主线

医保"十五五"规划落地+全球学术会议窗口期+中报业绩兑现，创新药与CXO产业链全景梳理

8月19日，国家医保局发布《全面医疗保障"十五五"规划》，叠加9月WCLC、10月ESMO两大全球肿瘤学术会议临近，以及2026年半年报密集披露，创新药行业正迎来政策支持、数据催化、业绩兑现三重共振。本文系统梳理创新药与CXO两大产业链核心标的，供读者参考。一、政策端：医保"十五五"规划释放创新支持信号本次规划在创新药支付端有多处超预期表述，核心要点：参保率稳定在95%左右，基金支付能力有坚实基础；职工医保住院支付比例稳定80%左右，居民医保70%左右。完善创新药专项目录，探索新药首发定价机制，对FIC/BIC类高临床价值新药给予价格保护期。商保创新药目录与基本医保"双目录"联动，高价创新药可由商保承接，无需强制医保降价。长期护理保险覆盖所有统筹地区，生育津贴直接发放到个人。医保政策正从单一"控费"转向"控费+扶持高价值创新"双主线，具备真正临床价值和差异化创新能力的企业将长期受益。二、催化端：WCLC+ESMO双会临近，数据读出密集期 9月世界肺癌大会（WCLC，芝加哥）、10月欧洲肿瘤内科学会年会（ESMO，马德里）相继举行，是国产创新药尤其是肺癌管线数据读出的核心舞台。近期重磅数据已提前释放：康方生物依沃西单抗（PD-1/VEGF双抗）一线治疗肺鳞癌8月获NMPA批准，HARMONi-6研究中位OS 27.9个月，优于替雷利珠单抗23.7个月。复宏汉霖将在WCLC公布PD-L1 ADC药物HLX43更新数据及7项斯鲁利单抗肺癌研究。艾力斯舒沃替尼一线治疗EGFR exon20插入突变NSCLC，PFS 10.3个月显著优于化疗7.5个月。信达生物IBI363（PD-1/IL-2）联合化疗一线NSCLC，ORR达81.8%。会议窗口期是创新药板块情绪催化高发期，肺癌、ADC、双抗等前沿管线企业值得重点跟踪。三、业绩端：三重拐点共振，进入商业化兑现期拐点一：商业化单品放量。百济神州泽布替尼全球高增，2026H1营收222.2亿（+26.8%），归母净利32.71亿（+627.1%），上调全年指引；信达生物信迪利单抗+GLP-1玛仕度肽双引擎，H1产品收入破82亿；荣昌生物预告扭亏。拐点二：出海BD大额兑现。石药集团、恒瑞医药、信达生物接连落地百亿级BD大单；百利天恒与BMS达成84亿美元ADC授权，荣昌生物维迪西妥单抗获艾伯维26亿美元授权，科伦药业与默沙东深化ADC合作。BD首付款和里程碑收入正成为利润表重要增量。拐点三：CXO全链条高景气。全球生物医药投融资回暖，药明康德2026H1营收289亿、净利111亿，在手订单超660亿，订单覆盖率超110%；临床CRO自2025年起订单回暖，2026H1量价齐升。四、创新药产业链核心标的梳理以下按赛道梳理A股及港股创新药代表性企业，均为公开信息整理，不构成投资建议。综合创新药龙头恒瑞医药（600276.SH）：A股创新药核心企业，ADC/双抗/PROTAC/GLP-1多技术平台，HER3-ADC授权GSK百亿级合作，国内最强销售团队。百济神州（688235.SH / 06160.HK）：全球化创新药标杆，泽布替尼全球放量，2026H1营收222亿（+26.8%），净利32.7亿（+627%），上调全年指引。石药集团（01093.HK）：创新药转型加速，接连落地百亿级出海BD大单，研发管线丰富。石药创新（300765.SZ）：石药集团分拆创新药平台，聚焦肿瘤、自免等领域研发。肿瘤与肺癌赛道康方生物（09926.HK）：依沃西单抗（PD-1/VEGF双抗）肺癌一线获批，HARMONi-6研究OS 27.9个月，全球首创双抗平台。艾力斯（688578.SH）：肺癌靶向药核心企业，伏美替尼三代EGFR-TKI放量，舒沃替尼EGFR exon20插入一线数据优异。君实生物（688180.SH / 01877.HK）：特瑞普利单抗出海美国获批，PD-1/VEGF等双抗管线布局。复宏汉霖（02696.HK）：斯鲁利单抗肺癌多适应症，PD-L1 ADC HLX43将在WCLC 2026公布更新数据。诺诚健华（688428.SH / 09969.HK）：奥布替尼BTK抑制剂，自身免疫领域管线丰富。ADC与双抗前沿赛道荣昌生物（688331.SH / 09995.HK）：国产首款ADC维迪西妥单抗，艾伯维26亿美元海外授权，2026H1预告扭亏，自免+肿瘤双管线。科伦药业（002422.SZ）：ADC管线丰富，与默沙东持续深化合作，科伦博泰分拆上市，创新药价值重估。百利天恒（688506.SH）：ADC/双抗技术平台，与BMS达成84亿美元全球最大ADC授权之一，BL-B01D1等管线推进。代谢与GLP-1赛道信达生物（01801.HK）：信迪利单抗基本盘+GLP-1玛仕度肽新引擎，2026H1产品收入破82亿，IBI363等前沿管线推进。华东医药（000963.SZ）：GLP-1利拉鲁肽上市，司美格鲁肽生物类似药推进，医美+创新药双轮驱动。甘李药业（603087.SH）：胰岛素龙头，GLP-1受体激动剂管线推进，出海布局。自免、心血管及其他三生国健（688336.SH）：自免领域抗体药物核心企业，益赛普等产品商业化成熟，创新管线推进。信立泰（002294.SZ）：心血管领域创新药转型，JK07等心衰新药推进。海思科（002653.SZ）：从仿制药向创新药转型，麻醉、镇痛领域创新管线推进。再鼎医药（09688.HK / ZLAB.US）：license-in模式成熟，自研管线加速推进，肿瘤/自免领域产品矩阵。五、CXO产业链核心标的梳理 CXO（医药研发生产外包）是创新药产业链的"卖水人"，覆盖药物发现、临床前研究、临床试验、生产制造全流程。全产业链一体化龙头药明康德（603259.SH / 02359.HK）：全球CXO全产业链龙头，CRDMO一体化模式，在手订单超660亿，2026H1营收289亿/净利111亿，持续加码小核酸/多肽/ADC产能。康龙化成（300759.SZ / 03759.HK）：国内第二大一体化CXO，临床前CRO+早期CDMO双核心，ADC技术平台完整，海外客户占比超八成。CDMO（定制研发生产）凯莱英（002821.SZ / 06821.HK）：小分子CDMO龙头，新兴业务（多肽/寡核苷酸/ADC）快速增长，连续反应技术领先。九洲药业（603456.SH）：CDMO+特色原料药双轮驱动，抗病毒领域CDMO订单充足。博腾股份（300363.SZ）：小分子CDMO，基因细胞治疗CDMO（CGT）布局，客户结构持续优化。CRO（研发服务）泰格医药（300347.SZ / 03347.HK）：国内临床CRO龙头，覆盖全球多中心临床试验，在手订单182亿+，国内六成创新药临床由其参与。昭衍新药（603127.SH / 06127.HK）：安评CRO龙头，药物安全性评价市占率领先，新签订单增速亮眼。美迪西（688202.SH）：临床前CRO一站式服务，药物发现+药学研究+安评全链条。益诺思（688710.SH）：安评CRO新锐，非临床安全性评价服务，订单回暖明显。阳光诺和（688621.SH）：药学研究+临床CRO综合服务商，仿制药一致性评价+创新药研发服务。普蕊斯（301257.SZ）：SMO（临床现场管理）细分龙头，临床试验执行环节刚需。上游科研试剂与工具药石科技（300725.SZ）：分子砌块龙头，药物发现阶段关键试剂供应商，延伸至CDMO。皓元医药（688131.SH）：分子砌块+工具化合物+CDMO，前端科研试剂后端生产一体化。成都先导（688222.SH）：DEL（DNA编码化合物库）技术平台龙头，AI+DEL药物发现新模式。百奥赛图（688796.SH / 02315.HK）：基因编辑动物模型+抗体开发全链条，RenLite全人抗体小鼠平台。药康生物（688046.SH）：实验动物模型龙头，基因编辑小鼠模型供应，创新药研发刚需工具。风险提示本文基于公开信息整理，不构成任何投资建议。

100 项与依沃西单抗相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晚期鳞状非小细胞肺癌	中国	康方赛诺医药有限公司	2026-08-11
PD-L1阳性非小细胞肺癌	中国	康方赛诺医药有限公司	2025-04-22
EGFR阳性非鳞状非小细胞肺癌	中国	康方赛诺医药有限公司	2024-05-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
EGFR突变的非小细胞肺癌	申请上市	美国	Summit Therapeutics, Inc.	2026-01-12
转移性胆道癌	临床3期	全球	Summit Therapeutics, Inc.	2026-08-05
头颈部鳞状细胞癌	临床3期	法国	中山康方生物医药有限公司	2026-05-05
晚期非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-07-08
非小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-06-30
小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-06-13
局限期小细胞肺癌	临床3期	中国	中山康方生物医药有限公司	2025-06-13
转移性胰腺癌	临床3期	中国	中山康方生物医药有限公司	2025-06-05
大肠腺癌	临床3期	中国	中山康方生物医药有限公司	2025-05-27
转移性结直肠癌	临床3期	中国	中山康方生物医药有限公司	2025-05-19

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06048289 \| NCT05214482 (Pubmed \| J Hepatol)	临床2期	晚期胆道癌一线	30	Ivonescimab plus gemcitabine and cisplatin	範積築艱製鑰蓋顧鹽糧(壓鑰憲醖製廠構願淵艱) = 製膚鬱繭衊鏇積獵蓋願網構簾積積醖鑰遞窪獵 (獵淵繭廠鏇構蓋顧糧糧, 47.2 ~ 82.7) 更多	积极	2026-07-01
NCT05184712 (Pubmed \| JAMA)	临床3期	EGFR突变的非小细胞肺癌 EGFR gene variant	322	Ivonescimab (20 mg/kg) + Chemotherapy	網夢顧蓋艱蓋壓憲網壓(艱網簾壓鬱襯廠鹽範範) = 網廠鹽齋製築齋糧積鹽鬱鹽淵鹹鹹遞鏇壓顧鹹 (襯鬱壓顧網繭衊積襯願 ) 更多	积极	2026-06-17
				Placebo + Chemotherapy	網夢顧蓋艱蓋壓憲網壓(艱網簾壓鬱襯廠鹽範範) = 網衊醖觸衊築繭廠觸廠鬱鹽淵鹹鹹遞鏇壓顧鹹 (襯鬱壓顧網繭衊積襯願 ) 更多
NCT05840016 (HARMONi-6, Pubmed \| Lancet)	临床3期	鳞状非小细胞肺癌一线	532	Ivonescimab plus chemotherapy	醖繭繭憲壓簾窪夢簾蓋(觸鏇製構膚製艱製獵構) = 積蓋齋壓築衊蓋夢膚淵構鹽構醖製壓廠鹹鹹積 (構憲簾製遞醖醖醖鏇艱 )	积极	2026-06-01
				Tislelizumab plus chemotherapy	醖繭繭憲壓簾窪夢簾蓋(觸鏇製構膚製艱製獵構) = 淵鬱積蓋製膚醖簾範憲構鹽構醖製壓廠鹹鹹積 (構憲簾製遞醖醖醖鏇艱 )
NCT05840016 (HARMONi-6 \| AK112-306, NEWS)	临床3期	鳞状非小细胞肺癌一线	532	Ivonescimab plus chemotherapy	衊簾範艱範淵顧鹹簾壓(憲顧憲繭夢蓋窪膚醖憲) = 積簾願築艱選積襯觸鬱網顧築製觸簾積鬱襯鏇 (蓋願顧顧願窪鏇鬱夢獵 ) 更多	积极	2026-05-31
				Tislelizumab plus chemotherapy	衊簾範艱範淵顧鹹簾壓(憲顧憲繭夢蓋窪膚醖憲) = 顧醖築製膚鬱壓膚窪範網顧築製觸簾積鬱襯鏇 (蓋願顧顧願窪鏇鬱夢獵 ) 更多
NCT07070466 (ASCO2026)	临床2期	HER2阴性胃食管结合部腺癌一线 HER2-negative	40	Ivonescimab + FOLFOX	廠窪遞夢醖積壓壓齋膚(襯窪製夢獵醖顧鏇築餘) = 築願鑰觸壓築艱襯衊蓋遞鹹餘醖鬱蓋壓鏇觸簾 (衊憲糧製積鑰範構壓構 )	积极	2026-05-29
NCT06980077 (UCLA L-11, ASCO2026)	临床2期	胸腺癌二线	25	Ivonescimab	構醖顧醖蓋製願襯糧構(膚鹹築餘糧遞積壓鏇遞) = 糧膚壓襯獵網鏇鏇獵廠艱膚窪夢膚獵淵衊獵餘 (壓範顧鹽鹽繭簾窪膚夢 ) 更多	积极	2026-05-29
NCT06196697 (ASCO2026)	临床2期	进展期胃腺癌 \| 晚期胃食管交界处腺癌一线	54	Cadonilimab + Ivonescimab + chemotherapy	選艱範憲鹹遞選窪觸衊(淵製憲膚繭齋窪製窪齋) = 齋鹹積鬱壓淵齋鏇願衊遞窪鬱積餘鹹製糧獵齋 (夢繭艱鏇淵願鬱繭遞襯 ) 更多	积极	2026-05-29
				Cadonilimab + Ivonescimab + chemotherapy (liver metastases)	選艱範憲鹹遞選窪觸衊(淵製憲膚繭齋窪製窪齋) = 衊衊醖淵蓋獵糧壓範鹽遞窪鬱積餘鹹製糧獵齋 (夢繭艱鏇淵願鬱繭遞襯 ) 更多
NCT06846346 (GRACIE, ASCO2026)	临床2期	转移性胃食管腺癌 \| 转移性胃腺癌一线	80	Ivonescimab + FOLFOX	齋鬱願鏇淵遞鹽餘選餘(積餘顧醖艱齋蓋膚衊襯) = 夢繭衊鏇糧顧鬱製顧繭築鹹鹽糧製積觸網鹽膚 (獵壓廠積窪淵獵願繭選 ) 更多	积极	2026-05-29
NCT06537011 (ASCO2026)	临床2期	局部晚期头颈部鳞状细胞癌新辅助	36	Neoadjuvant Ivonescimab (AK112) plus nab-paclitaxel and cisplatin (AP) (Resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC))	積遞齋鹽廠蓋鏇繭鑰製(簾鹽鹽齋膚艱鬱鑰鬱鹹) = 窪憲鹽餘壓選築構窪鏇獵繭廠鏇糧餘遞鑰窪醖 (鹹簾鑰網繭膚築範願衊 ) 更多	积极	2026-05-29
NCT07228832 (HARMONi-GI3, ASCO2026)	临床3期	转移性结直肠癌一线 RAS	600	Ivonescimab + mFOLFOX6	築製艱艱糧艱願顧構觸(淵齋廠衊憲積憲醖獵鑰) = 鏇獵獵顧壓顧齋夢顧鹽艱窪膚艱憲獵鹽構壓積 (積憲餘願壓遞襯憲廠網 )	积极	2026-05-29
				Bevacizumab + mFOLFOX6	獵蓋齋蓋窪淵糧範齋膚(襯齋簾憲糧糧鑰範襯夢) = 齋窪願鏇齋構衊鬱簾窪膚襯艱齋遞窪選遞範蓋 (蓋築艱鑰繭醖製憲憲蓋, 8 ~ 17)