A Phase II Study of Induction/Window of Opportunity Toripalimab Followed by Definitive Chemoradiotherapy (CRT) and Adjuvant Toripalimab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC)

This is a phase 2/window of opportunity study to determine the efficacy, by clinical complete response, and safety of induction toripalimab (PD-1 inhibitor) followed by definitive chemoradiotherapy (dCRT) and adjuvant toripalimab (up to one year) in patients with stage II - IVA ESCC. Tumor biopsies (tumor tissue, adjacent normal tissue), blood including ctDNA, and saliva will be obtained before, during, and after the induction phase. These tissues will be assessed for clinical and research associated markers and processes that may provide information regarding the role of toripalimab in tumor related processes.

开始日期2026-12-31

申办/合作机构

The Vanderbilt-Ingram Cancer Center

[+1]

NCT07189793

/ Not yet recruiting临床2期IIT

Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive/-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study

This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with/without Ta/T1) and (2) non-CIS cohort (high-risk Ta/T1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (
month 3), monthly maintenance continues up to 24 months or until progression/unacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression/unacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression/unacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS/HG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.

开始日期2026-12-01

申办/合作机构

温州医科大学附属第一医院

NCT07819578

/ Not yet recruiting临床2期IIT

A Phase II Study of Toripalimab Combined With Sacituzumab Tirumotecan as Neoadjuvant Therapy for Resectable Non-Small Cell Lung Cancer

This is a prospective, multicenter, single-arm Phase II investigator-initiated trial evaluating neoadjuvant toripalimab plus sacituzumab tirumotecan (SKB264) in treatment-naive adults with resectable or potentially resectable, driver-negative non-small cell lung cancer (NSCLC). Eligible participants have stage II-IIIA or selected IIIB disease (T3N2 or T4N2) and will receive sacituzumab tirumotecan 5 mg/kg plus toripalimab 3 mg/kg intravenously on Day 1 every 2 weeks for up to 6 cycles. Participants deemed operable after multidisciplinary assessment will undergo definitive surgery. The primary endpoint is pathologic complete response. A Simon two-stage minimax design plans to enroll 30 participants.

开始日期2026-10-01

申办/合作机构

中山大学

[+2]

100 项与特瑞普利单抗相关的临床结果

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100 项与特瑞普利单抗相关的转化医学

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100 项与特瑞普利单抗相关的专利（医药）

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655

项与特瑞普利单抗相关的文献（医药）

2026-12-31·Human Vaccines & Immunotherapeutics

Cost‑effectiveness of first‑line immunotherapy-based combination regimens for advanced renal cell carcinoma in China and the United States

Article

作者: Yan, Chunyan ; Zhao, Quan ; Li, Jiayan ; Diao, Ruigang ; Gao, Yuan ; Li, Zhengxiong

Immunotherapy‑based combination regimens provide significant clinical benefits but impose substantial economic burdens on national healthcare systems. This study assessed the cost-effectiveness of immunotherapy‑based combination regimens as first-line treatments for advanced renal cell carcinoma (aRCC) in China and the United States (US). A partitioned survival model was developed to evaluate the cost-effectiveness of all approved regimens with a lifetime horizon. The primary outcomes were total costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). Sensitivity analyses were performed to evaluate model uncertainty. Compared to the sunitinib regimen, the ICERs for the toripalimab plus axitinib (T + A), nivolumab plus ipilimumab (N + I), lenvatinib plus pembrolizumab (L + P), pembrolizumab plus axitinib (P + A), nivolumab plus cabozantinib (N + C), avelumab plus axitinib (A + A) and atezolizumab plus bevacizumab (A + B) regimens in China were $64,536.98/QALY, $135,593.25/QALY, $174,956.58/QALY, $231,908.95/QALY, $728,876.75/QALY, $1,232,070.43/QALY, and $2,496,799.42/QALY, respectively. The ICERs for the N + I, T + A, N + C, P + A, L + P, A + A, and A + B regimens in the US were $160,243.50/QALY, $468,156.65/QALY, $804,963.69/QALY, $907,549.79/QALY, $2,170,769.66/QALY, $2,623,809.39/QALY, and $12,712,147.95/QALY, respectively. Probabilistic sensitivity analyses indicated that the probability of cost-effectiveness corresponding to N + I vs. sunitinib was 33.6% in the US. In China and the US, none of the seven first-line immunotherapy-based combination regimens was cost-effective compared with sunitinib for aRCC.

2026-09-02·Expert Review of Anticancer Therapy

Expert consensus on the role of immunotherapy in nasopharyngeal carcinoma: clinical and economic perspectives from the GCC region

Review

作者: Alanazi, Ahmed S. ; Khan, Fahmeeda ; Alfar, Mohammed ; Elazzazy, Shereen ; Abu Tabar, Osama ; Aljaber, Rana ; Hamad, Anas ; El-Sheashaey, Ahmed ; Khan, Mansoor Ahmed

INTRODUCTION:

Nasopharyngeal carcinoma (NPC) is a rare malignancy globally but poses a disproportionate clinical and economic burden in endemic regions, including parts of the Gulf Cooperation Council (GCC). Patients with recurrent or metastatic NPC (RM-NPC) often present with advanced disease and limited therapeutic options, historically relying on platinum-based chemotherapy with modest survival benefit and substantial toxicity. Recent advances in immunotherapy have begun to reshape the treatment landscape.

AREAS COVERED:

This position paper reviews the evolving role of immunotherapy in RM-NPC, with a particular focus on toripalimab. An advisory board meeting was convened to review disease burden, unmet needs, clinical outcomes associated with immune checkpoint inhibitors, and economic considerations relevant to formulary decision-making. A literature review was conducted from January 2015 to October 2025, focusing on clinical trials, guidelines, and economic evaluations related to immunotherapy in NPC.

EXPERT OPINION:

Toripalimab in combination with chemotherapy should be adopted as the new standard of care for RM-NPC. Beyond efficacy, its potential value in the GCC extends to health system efficiency and resource allocation. Experts emphasized that value-based assessment frameworks, supported by local, real-world, and economic data, are essential to guide sustainable adoption and equitable patient access to immunotherapy in the region.

2026-09-01·JAMA Surgery

Surgical Outcomes of Perioperative Toripalimab in Stage III Resectable Non–Small Cell Lung Cancer

Article

作者: Yu, Dongliang ; Sun, Qian ; Shan, Jinlu ; Ye, Minhua ; Xu, Haipeng ; Zhong, Aihong ; Chen, Gang ; Zhu, Liangming ; Li, Shanqing ; Zou, Jianjun ; Wu, Nan ; Chen, Qixun ; Lin, Dongmei ; Liu, Lunxu ; Yao, Jian ; Sun, Longhua ; Tan, Lijie ; Sun, Xiaohong ; Zhang, Xiaochun ; Wu, Guowu ; Li, Yuan ; Hu, Xiaohua ; Hu, Jian ; Wang, Weihua ; Yang, Nong ; Hang, Xiaosheng ; Cao, Dezhen ; Wang, Yiyang ; Yu, Guohua ; Yang, Lin ; Jiang, Jie ; Liu, Yunpeng ; Kang, Mingqiang ; Lu, Shun ; Cao, Lejie ; Ma, Haitao ; Cai, Kaican ; Mei, Jiandong ; Wang, Wenxiang ; Xu, Shidong ; Huang, Yunchao ; Hu, Hong ; Zheng, Yan ; Chen, Keneng ; Zhang, Xun ; Tian, Hui ; Zhang, Peng ; Chen, Yuping ; Zhang, Zhiye ; Li, Xingya ; Xu, Jing ; Zhu, Lei ; Zhang, Wengang ; Fang, Haohui ; Wang, Changli ; Yang, Zhixiong ; Zhu, Kunshou ; Zhang, Jie ; Zhang, Yu ; Chen, Jun ; Wu, Lin ; Zhou, Ming ; Xing, Ligang ; Zhang, Liwei ; Fang, Wentao

Importance:

Perioperative immunotherapy has improved clinical outcomes for patients with early-stage non–small cell lung cancer (NSCLC). The influence of immune checkpoint inhibitor in combination with chemotherapy on surgical outcomes remains to be explored.

Objective:

To evaluate perioperative toripalimab in combination with chemotherapy on surgical outcomes.

Design, Setting, and Participants:

This multicenter, double-blind, placebo-controlled phase 3 randomized clinical trial (Neotorch study) enrolled patients with resectable stage III NSCLC and took place at 50 centers in China. Patients who had histologically confirmed resectable stage IIIA or IIIB NSCLC were eligible. These data were analyzed from July 2024 to March 2026.

Interventions:

Patients were randomized (1:1) to receive toripalimab (240 mg) plus platinum-based chemotherapy or placebo plus platinum-based chemotherapy for 3 cycles before surgery and 1 cycle after surgery, followed by maintenance with toripalimab or placebo alone for 13 cycles.

Main Outcomes and Measures:

Surgical outcomes, including perioperative complications, tumor downstaging, and lymph node downstaging, and their association with event-free survival (EFS), were studied in this post hoc analysis.

Results:

Among 404 patients enrolled, 314 patients (median [SD] age 60 [6.82] years; 90% of patients were male and 10% were female) underwent surgery (166 in toripalimab group and 148 in placebo group). Percentage of patients canceling surgery (17.8% vs 26.7%; P = .03) was significantly lower in the toripalimab group. Proportions of minimally invasive surgery, R0 resection, and lobectomy were slightly higher in the toripalimab group. Surgical complications were similar between the 2 groups. Rates of postsurgery tumor (80.7% vs 50.7%; P &lt; .001) and lymph node downstaging (67.5% vs 48.6%; P = .001) were both significantly higher with toripalimab than placebo. With a median follow-up of 18.3 months, a better EFS was noticed in the toripalimab group. Tumor and lymph node downstaging in the toripalimab group were both associated with better EFS than nondownstaging (median EFS, not estimable [NE] vs 17.5 months; P = .004 and NE vs 19.2 months; P = .001, respectively), and were also associated with even better EFS than tumor and lymph node downstaging in the placebo group (median EFS, NE vs 22.0 months; P = .002 and NE vs NE; P = .009, respectively).

Conclusions and Relevance:

In this study, perioperative toripalimab plus chemotherapy showed comparable perioperative outcomes, as with chemotherapy alone without new safety signals, and could help improve survival through effective tumor downstaging in patients with resectable stage III NSCLC.

Trial Registration:

ClinicalTrials. gov Identifier: NCT04158440

4,922

项与特瑞普利单抗相关的新闻（医药）

2026-09-25

·证券之星

【每日科创】君实生物：PD-1红海中的逆袭

8月底，君实生物(688180)发布了半年度报告。数字本身并不复杂：营收16.96亿元，同比增长45.18%，归母净利润2166.3万元，而上年同期是亏损4.13亿元。但在这组数据背后，是一家创新药企从“烧钱研发”到“自我造血”的关键转折。当PD-1赛道从蓝海变成红海，当资本市场的耐心被不断消耗，君实生物用这份中报给出了自己的答案。 01. 四款产品打底，一款“王牌”撑起大半江山君实生物目前已有四款商业化药品推向市场：特瑞普利单抗(拓益®)、阿达木单抗(君迈康®)、氢溴酸氘瑞米德韦片(民得维®)和昂戈瑞西单抗(君适达®)。其中，特瑞普利单抗无疑是绝对的营收主力——上半年国内市场销售收入约12.99亿元，同比增长约36%，贡献了公司总营收的七成以上。这款PD-1单抗之所以能持续放量，靠的是扎实的适应症布局。截至目前，特瑞普利单抗已在中国内地获批13项适应症，其中12项纳入国家医保目录。更值得注意的是，它是医保目录中唯一用于肾癌、三阴性乳腺癌和黑色素瘤治疗的抗PD-1单抗药物。这种“人无我有”的差异化优势，让它在同类产品中保持了独特的竞争壁垒。 2026年5月，特瑞普利单抗联合维迪西妥单抗用于HER2表达的局部晚期或转移性尿路上皮癌一线治疗的新适应症再获NMPA批准；7月，联合化疗用于可切除非小细胞肺癌围手术期治疗的补充申请也已获受理。适应症的持续拓展，意味着这款核心产品的生命周期还有很大的延伸空间。 02. 研发投入占比下降，反而是个好信号科创属性是衡量一家科创板企业成色的核心标尺。君实生物上半年研发投入6.44亿元，同比略降；研发投入占营业收入的比例从上年同期的60.39%降至37.96%。乍看之下研发强度在下降，但这并不消极：一方面，营业收入45.18%的高速增长摊薄了研发强度；另一方面，公司主动将研发资源聚焦于JS207(PD-1/VEGF双抗)、JS212(EGFR/HER3 ADC)等核心管线，研发投入产出效率有望持续提升。规模效应与聚焦策略同步发力，是公司新阶段经营特征的重要体现。在专利层面，截至报告期末，公司累计获得授权专利202件，其中境内136件、境外66件。公司已形成丰富且有梯队的在研管线，拥有“源头创新”类靶点药物，是国内少数具备开发全球首创药物潜力的公司之一。从技术平台来看，君实生物已由传统单抗研发向小分子、ADC、双/多特异性抗体、融合蛋白及核酸药物等多技术平台拓展。这种多元化的技术储备，构成了公司长期竞争力的底层支撑。 03. 投资逻辑：从“故事”到“业绩”的切换对于投资者而言，君实生物最大的变化在于——公司正在从“讲管线故事”的阶段切换到“用业绩说话”的阶段。上半年扭亏为盈是一个标志性节点。在多位券商分析师看来，商业化能力是创新药企跨越“死亡谷”的关键跳板——管线成功获批只是“万里长征的第一步”；在医保谈判常态化的背景下，缺乏强大商业化能力的企业，即便手握重磅产品也难以将其转化为可观的现金流。君实生物上半年的表现，恰好验证了其商业化体系的成熟：销售费用5.07亿元仅同比微增，销售费用率降至29.90%，同比下降约11.8个百分点，销售效率显著提升。展望未来，多家券商给出了相对乐观的判断。开源证券预计公司2026至2028年营业收入分别为33.32亿元、43.66亿元、54.94亿元，维持“买入”评级。国金证券同样给出“买入”评级，认为公司充裕的现金储备(截至6月底约36.96亿元)为管线推进提供了坚实保障。在管线层面，接下来的催化节点也不少。Tifcemalimab联合特瑞普利单抗用于局限期小细胞肺癌的全球III期临床研究预计2026年完成患者入组；PD-1/VEGF双抗JS207已处于II期临床阶段，其联合JS212(EGFR/HER3 ADC)用于驱动基因阳性、TKI治疗失败肺癌的II期临床数据也有望在下半年读出。这些进展如果顺利，将为公司打开新的估值空间。 04. 风险从来不会缺席当然，硬币总有另一面。创新药企面临的风险从来不是“有没有”，而是“有多大”。首先是销售不及预期的风险——PD-1赛道竞争日趋激烈，特瑞普利单抗能否持续保持增速存在不确定性。其次是临床研发失败的风险，创新药研发本身具有高投入、长周期、高失败率的特点，任何一个管线在临床阶段的挫折都可能影响市场预期。此外，国内和海外市场竞争加剧、核心技术人员流失、政策波动等，都是需要持续关注的因素。值得一提的是，君实生物2025年全年仍处于亏损状态，扣非净利润上半年也仍为-2.03亿元。扭亏为盈只是第一步，能否持续盈利、能否在激烈的市场竞争中守住阵地，才是更大的考验。从2012年成立到2020年科创板上市，从多年亏损到今年上半年实现上市以来首次半年度盈利，君实生物走过了一条典型的创新药企发展路径。这份半年报的意义不在于盈利数字本身，而在于它证明了这家公司的商业化能力正在兑现研发投入的价值。对于科创板投资者来说，在众多仍处于亏损状态的创新药企中，君实生物率先实现了半年度盈利——这本身就是一个值得关注的变化。 - End -

2026-09-25

·肿瘤界

2026 ESMO | LBA名单出炉！28项中国研究亮相，4项登上主席研讨会

点击蓝字关注我们前言 2026年10月23日至27日，全球肿瘤领域顶级学术盛会——欧洲肿瘤内科学会（ESMO）年会将在西班牙马德里隆重召开。本届大会将全面汇聚全球肿瘤基础研究、转化医学及临床前沿研究成果，为全球临床诊疗革新、多学科学术交流搭建平台，助力全球肿瘤诊疗水平持续进阶。日前，ESMO官网公布了本届大会LBA类摘要标题，共有28项中国学者主导的研究成功入选，其中4项研究成果亮相主席研讨会，充分印证了中国肿瘤科研实力的飞速成长，医脉通特此整理如下。 Session 1 肺癌摘要号：LBA6 研究名称（英文）：Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results 研究名称（中文）：奥希替尼联合赛沃替尼对比铂类 + 培美曲塞用于奥希替尼进展后、伴 EGFR 突变且 MET 过表达和 / 或 MET 扩增的晚期非小细胞肺癌：SAFFRON III 期研究主要结果讲者：陆舜 | 上海市胸科医院报告类型：Presidential Symposium（主席研讨会）摘要号：LBA64 研究名称（英文）：Toripalimab plus chemotherapy as perioperative treatment for resectable stage II or III non-small cell lung cancer (NSCLC): Final analysis of the Phase 3 Neotorch study 研究名称（中文）：特瑞普利单抗联合化疗围手术期治疗可切除 II/III 期非小细胞肺癌：III 期 Neotorch 研究最终分析讲者：陆舜 | 上海市胸科医院报告类型：Proffered Paper session 摘要号：LBA65 研究名称（英文）：Surgical Conversion and Survival Outcomes After Induction Chemoimmunotherapy in Potentially Resectable or Unresectable Stage III NSCLC: Preliminary Results from the Prospective Phase II Study (CTONG 1804 Part 3) 研究名称（中文）：III 期潜在可切除或不可切除非小细胞肺癌诱导化疗免疫治疗后的手术转化及生存结局：前瞻性 II 期 CTONG 1804 研究第 3 部分初步结果讲者：潘燚 | 广东省人民医院报告类型：Rapid Oral session 摘要号：LBA66 研究名称（英文）：Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: randomized phase 3 OptiTROP-Lung06 study 研究名称（中文）：芦康沙妥珠单抗（sac-TMT）联合帕博利珠单抗对比化疗联合帕博利珠单抗一线治疗 PD-L1 阴性晚期非鳞非小细胞肺癌：随机 III 期 OptiTROP-Lung06 研究讲者：周彩存 | 上海市东方医院报告类型：Proffered Paper session 摘要号：LBA67 研究名称（英文）：Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: phase III OptiTROP-Lung04 study 研究名称（中文）：芦康沙妥珠单抗（sac-TMT）对比含铂化疗用于 EGFR-TKI 进展后 EGFR 突变非小细胞肺癌的最终总生存期（OS）分析：III 期 OptiTROP-Lung04 研究讲者：张力 | 中山大学肿瘤防治中心报告类型：Proffered Paper session 摘要号：LBA69 研究名称（英文）：Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study 研究名称（中文）：赛沃替尼或安慰剂联合奥希替尼用于初治、伴 EGFR 突变及 MET 过表达的晚期非小细胞肺癌：III 期 SANOVO 研究结果讲者：吴一龙 | 广东省人民医院报告类型：Proffered Paper session 摘要号：LBA71 研究名称（英文）：PANKU-Lung01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in EGFR-Mutant Non-squamous Non‑Small Cell Lung Cancer (NSCLC) After Progression on a Third Generation EGFR TKI 研究名称（中文）：PANKU-Lung01：Izalontamab Brengitecan（iza-bren）用于三代 EGFR-TKI 进展后 EGFR 突变非鳞非小细胞肺癌的随机 III 期研究讲者：张力 | 中山大学肿瘤防治中心报告类型：Proffered Paper session 摘要号：LBA72 研究名称（英文）：Ruzaltatug rezetecan, a HER3-directed ADC, vs platinum-based chemotherapy (PBC) in EGFR-mutated advanced NSCLC progressing after EGFR-TKI: interim analyses (IA) from the phase 3 HERON-Lung01 trial 研究名称（中文）：靶向 HER3 的 ADC 药物 Ruzaltatug rezetecan 对比含铂化疗（PBC）治疗 EGFR-TKI 进展后 EGFR 突变晚期非小细胞肺癌：III 期 HERON-Lung01 研究期中分析（IA）讲者：吴一龙 | 广东省人民医院报告类型：Proffered Paper session 摘要号：LBA75 研究名称（英文）：Deulorlatinib (TGRX‑326) vs crizotinib in TKI-naive advanced ALK+ NSCLC: a phase 3 study 研究名称（中文）：Deulorlatinib（TGRX‑326）对比克唑替尼治疗未经 TKI 治疗的晚期 ALK 阳性非小细胞肺癌：一项 III 期研究讲者：张力 | 中山大学肿瘤防治中心报告类型：Rapid Oral session Session2 乳腺癌摘要号：LBA13 研究名称（英文）：Trastuzumab rezetecan (SHR-A1811) in HER2-low advanced breast cancer (BC): a randomized, phase 3 study (HORIZON-Breast06) 研究名称（中文）：瑞康曲妥珠单抗（SHR‑A1811）用于 HER2 低表达晚期乳腺癌：一项随机 Ⅲ 期研究（HORIZON‑Breast06）讲者：樊英 | 中国医学科学院肿瘤医院报告类型：Proffered Paper session 摘要号：LBA15 研究名称（英文）：Anbenitamab plus albumin-bound docetaxel in patients (pts) with HER2-positive advanced breast cancer (BC): A randomized phase III study 研究名称（中文）：安尼妥单抗联合白蛋白结合型多西他赛用于 HER2 阳性晚期乳腺癌患者：一项随机 Ⅲ 期研究讲者：徐兵河 | 中国医学科学院肿瘤医院报告类型：Proffered Paper session 摘要号：LBA17 研究名称（英文）：HER2-PET imaging to predict trastuzumab deruxtecan (T-DXd) efficacy in advanced breast cancer: The phase II PREDICT-HER trial 研究名称（中文）：HER2-PET 显像预测晚期乳腺癌患者德曲妥珠单抗（T-DXd）疗效：Ⅱ 期 PREDICT-HER 研究讲者：金娟 | 复旦大学附属肿瘤医院报告类型：Rapid Oral session 摘要号：LBA27 研究名称（英文）：APEX-Breast01: TQB2102 versus chemotherapy in HER2-low recurrent or metastatic breast cancer (r/m BC) : Results from a randomized phase 3 study 研究名称（中文）：APEX-Breast01：TQB2102 对比化疗用于 HER2 低表达复发或转移性乳腺癌（r/m BC）：一项随机 Ⅲ 期研究结果讲者：王树森 | 中山大学肿瘤防治中心报告类型：Rapid Oral session 摘要号：LBA50 研究名称（英文）：PANKU-Breast01: Randomized Phase III Study of Izalontamab Brengitecan (iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic (LA/M) Hormone Receptor-Positive/HER2-negative (HR+/HER2-) Breast Cancer (BC) 研究名称（中文）：PANKU-Breast01：伦康依隆妥单抗（iza-bren）用于经治不可切除局部晚期或转移性（LA/M）HR+/HER2-乳腺癌的随机 Ⅲ 期研究讲者：兰波 | 中国医学科学院肿瘤医院报告类型：Proffered Paper session Session3 消化系统肿瘤摘要号：LBA7 研究名称（英文）：CLARITY-Gastric 01 (CG-01): a Phase 3 study of sonesimatug vedotin (Sone-Ve) in second or later-line (2L+) advanced or metastatic Claudin 18.2 (CLDN18.2) positive gastroesophageal carcinoma (GEC) 研究名称（中文）：CLARITY-Gastric 01（CG-01）：Sonesimatug vedotin（Sone-Ve）用于二线及以上（2L+）晚期或转移性 Claudin 18.2（CLDN18.2）阳性胃食管结合部癌的 III 期研究讲者：徐瑞华 | 中山大学肿瘤防治中心报告类型：Presidential Symposium（主席研讨会）摘要号：LBA8 研究名称（英文）：Ivonescimab plus chemotherapy versus durvalumab plus chemotherapy as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) 研究名称（中文）：依沃西单抗联合化疗对比度伐利尤单抗联合化疗一线治疗晚期胆道癌：一项随机、对照、双盲 III 期试验（HARMONi-GI1）讲者：周俭 | 复旦大学附属中山医院报告类型：Presidential Symposium（主席研讨会）摘要号：LBA80 研究名称（英文）：Anbenitamab plus chemotherapy for previously treated HER2-positive gastric or gastroesophageal carcinomas (GC/GEJC): Updated overall survival (OS) analysis of KC-WISE 研究名称（中文）：安尼妥单抗联合化疗用于经治 HER2 阳性胃或胃食管结合部癌：KC-WISE 研究更新的总生存期（OS）分析讲者：徐建明 | 中国人民解放军总医院报告类型：Rapid Oral session 摘要号：LBA81 研究名称（英文）：Four Months of Adjuvant XELOX versus Six Months in Stage II–IIIB Gastric Cancer — The LOMAC Randomized Trial 研究名称（中文）：II–IIIB 期胃癌辅助 XELOX 治疗 4 个月对比 6 个月：LOMAC 随机试验讲者：徐大志 | 复旦大学附属肿瘤医院报告类型：Rapid Oral session 摘要号：LBA85 研究名称（英文）：HRS-4642 Plus Chemotherapy ± Adebrelimab as Perioperative Therapy in KRAS G12D-Mutant Pancreatic Cancer: Preliminary Results of a Phase 2 Study 研究名称（中文）：HRS-4642 联合化疗 ± 阿得贝利单抗用于 KRAS G12D 突变胰腺癌的围手术期治疗：一项 II 期研究的初步结果讲者：沈柏用 | 上海交通大学医学院附属瑞金医院报告类型：Rapid Oral session Session4 黑色素瘤及皮肤肿瘤摘要号：LBA55 研究名称（英文）：Autologous Tumor-Infiltrating Lymphocytes (GC101 TIL) in Advanced Melanoma: Extended Follow‑up of a Randomized, Open-Label, Pivotal Phase II Trial 研究名称（中文）：自体肿瘤浸润淋巴细胞（GC101 TIL）治疗晚期黑色素瘤：一项随机、开放标签、关键性 II 期试验的延长随访讲者：斯璐 | 北京大学肿瘤医院报告类型：Proffered Paper session 摘要号：LBA61 研究名称（英文）：Disitamab Vedotin in locally advanced or metastatic extramammary Paget's disease with HER2 high expression: a prospective, single-arm phase II trials (Formula-10) 研究名称（中文）：维迪西妥单抗用于 HER2 高表达的局部晚期或转移性乳房外 Paget 病：一项前瞻性、单臂 II 期研究（Formula-10）讲者：谭星亮 | 中山大学肿瘤防治中心报告类型：Rapid Oral session Session5 头颈肿瘤摘要号：LBA43 研究名称（英文）：Tam-Peli versus chemotherapy in heavily pretreated recurrent/metastatic nasopharyngeal carcinoma (R/M NPC): a multicenter, randomized, open-label, phase 3 study (TAISHAN-301) 研究名称（中文）：Tam-Peli 对比化疗用于重度经治的复发性/转移性鼻咽癌（R/M NPC）：一项多中心、随机、开放标签 III 期研究（TAISHAN-301）讲者：洪少东 | 中山大学肿瘤防治中心报告类型：Proffered Paper session 摘要号：LBA47 研究名称（英文）：A Prospective, Randomized, Phase II Study of Perioperative Tislelizumab with Chemotherapy in Patients with Locally Advanced Resectable Oral Squamous Cell Carcinoma(OPTIMAL study) 研究名称（中文）：替雷利珠单抗联合化疗用于局部晚期可切除口腔鳞状细胞癌围手术期治疗的前瞻性、随机 II 期研究（OPTIMAL 研究）讲者：何悦 | 上海交通大学医学院附属第九人民医院报告类型：Rapid Oral session Session6 神经内分泌肿瘤摘要号：LBA57 研究名称（英文）：Opamtistomig (LBL-024) monotherapy in advanced extra-pulmonary neuroendocrine carcinoma (EP-NEC) after ≥2 prior lines of therapies: results from a pivotal, registrational phase IIb study of a novel PD-L1×4-1BB bispecific antibody 研究名称（中文）：Opamtistomig（LBL-024）单药用于经 ≥2 线治疗后的晚期肺外神经内分泌癌（EP-NEC）：一种新型 PD-L1×4-1BB 双特异性抗体的关键性、注册 IIb 期研究结果讲者：陆明 | 北京大学肿瘤医院报告类型：Proffered Paper session Session7 肉瘤 / 骨肿瘤摘要号：LBA9 研究名称（英文）：Risvutatug Rezetecan (Ris-Rez) versus Gemcitabine and Docetaxel (GD) in Heavily Pretreated Patients (pts) with Relapsed or Refractory (R/R) Osteosarcoma: Primary Results from the Phase 3 ARTEMIS-011 Study 研究名称（中文）：Risvutatug Rezetecan（Ris-Rez）对比吉西他滨联合多西他赛（GD）用于重度经治的复发或难治性（R/R）骨肉瘤患者：III 期 ARTEMIS-011 研究主要结果讲者：谢璐 | 北京大学人民医院报告类型：Presidential Symposium（主席研讨会） Session8 泛实体瘤及其他摘要号：LBA33 研究名称（英文）：Safety and efficacy of GFH276 monotherapy in previously treated RAS-mutated advanced solid tumors 研究名称（中文）：GFH276 单药用于经治 RAS 突变晚期实体瘤的安全性和疗效讲者：马宇翔 | 中山大学肿瘤防治中心报告类型：Rapid Oral session 摘要号：LBA34 研究名称（英文）：First-in-human study of MRG007 (ARR-217), a CDH17-directed exatecan ADC, in patients with locally advanced or metastatic solid tumors 研究名称（中文）：靶向 CDH17 的 Exatecan ADC 药物 MRG007（ARR-217）用于局部晚期或转移性实体瘤的首次人体研究讲者：李健 | 北京大学肿瘤医院报告类型：Rapid Oral session 摘要号：LBA52 研究名称（英文）：Personalized Neoantigen Vaccine Combined with Precision Critical Lesion Radiotherapy (CLERT) in Advanced Solid Tumors: Updated Results from the iNATURE Phase II Trial 研究名称（中文）：个性化新抗原疫苗联合精准关键病灶放疗（CLERT）用于晚期实体瘤：iNATURE II 期试验更新结果讲者：孔凤鸣 | 香港大学深圳医院报告类型：Rapid Oral session 备注：排名不分先后，按照摘要号进行排序如有遗漏或任何问题，请给我们留言~ 推荐阅读 2026 ESMO | 中国力量集结：47项口头报告入选，奏响学术强音声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通肿瘤科编辑：Lagertha 审核：阿希雅

临床3期临床结果免疫疗法临床2期

2026-09-24

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创新药概念，关联公司梳理（附名单）

创新药产业正在从过去的“单一品种研发”向多技术平台、全球临床和License-out国际授权升级。当前最值得关注的方向主要包括ADC、双抗/多抗、小分子靶向药、代谢类创新药、蛋白降解以及核酸药物等。观察一家创新药企业，核心不仅看管线数量，还要看临床阶段、差异化疗效、商业化能力以及能否获得跨国药企授权认可。石药创新主营业务：公司业务覆盖创新生物药、功能性原料和保健食品，依托巨石生物重点发展ADC、抗体药物及mRNA疫苗。概念关联：ADC+抗体药+mRNA疫苗+创新药BD。公司亮点：核心EGFR ADC SYS6010已有多个适应症进入Ⅲ期临床，并于2026年9月披露最新肺癌临床数据；公司同时与阿斯利康开展多项创新药全球合作。百洋医药主营业务：公司主营医药品牌商业化运营，同时通过投资、产品引进和产业合作向创新药研发成果转化延伸。概念关联：创新药商业化+小核酸+肿瘤创新药产业孵化。公司亮点：公司已投资华昊中天、思合基因、济坤医药等创新药企业，并锁定部分创新管线商业化或权益，定位更偏“创新药成果转化平台”而非传统自研药企。君实生物主营业务：公司专注创新生物药研发和商业化，管线覆盖肿瘤、自身免疫、代谢和感染等领域。概念关联：PD-1+ADC+双抗+肿瘤免疫。公司亮点：核心产品特瑞普利单抗已形成全球化商业基础，公司继续推进PD-1×VEGF、PD-1×IL-2、Claudin18.2 ADC等新一代肿瘤管线。恒瑞医药主营业务：公司是国内大型创新药研发平台，布局肿瘤、代谢、心血管、免疫、呼吸和神经等多个治疗领域。概念关联：ADC+双抗+小分子+代谢创新药+全球BD。公司亮点：截至2026年7月底，公司已有27款1类创新药上市、100余款自主创新产品处于临床开发；2026年上半年创新药销售收入88.09亿元，同比增长16.38%。百普赛斯主营业务：公司主营重组蛋白、抗体、试剂盒和分析检测服务，为全球创新药企业提供药物研发和生产所需的核心生物试剂。概念关联：创新药研发试剂+ADC/双抗/CGT上游“卖铲人”。公司亮点：公司服务全球超过1.3万家客户，产品覆盖药物发现、临床前、CMC及商业化生产环节，本质上是创新药研发景气度提升的上游受益企业。百利天恒主营业务：公司重点发展ADC、ARC和多特异性T细胞衔接器等创新肿瘤药物，拥有中美两地研发体系。概念关联：双抗ADC+ADC平台+全球创新药。公司亮点：核心EGFR×HER3双抗ADC宜泽康已于2026年6月获批上市，公司目前拥有15款临床阶段创新药，并正在全球推进100余项临床试验。信诺维主营业务：公司专注肿瘤精准治疗、耐药菌感染及自身免疫等创新药研发，技术路线覆盖小分子、ADC和抗体药物。概念关联：肿瘤小分子+ADC+创新药License-out。公司亮点：2026年9月，EZH2抑制剂XNW5004上市申请获受理并纳入优先审评；公司已有多款产品进入Ⅲ期或NDA阶段。甘李药业主营业务：公司传统优势为胰岛素及糖尿病治疗，目前向GLP-1、周制剂胰岛素及代谢创新药全面升级。概念关联：GLP-1+周制剂胰岛素+肥胖/糖尿病创新药。公司亮点：双周GLP-1博凡格鲁肽GZR18和周制剂胰岛素GZR4均已推进至全球Ⅲ期临床，是公司由传统胰岛素向代谢创新药转型的核心管线。百济神州主营业务：公司专注全球肿瘤创新药研发和商业化，布局血液瘤、实体瘤、小分子、双抗、ADC及蛋白降解等技术路线。概念关联：BTK+PD-1+ADC+蛋白降解+全球肿瘤创新药。公司亮点：泽布替尼、替雷利珠单抗已形成全球商业化基础，公司目前拥有40余款临床及商业化阶段产品，并自主开展190余项全球临床试验。海思科主营业务：公司重点布局麻醉镇痛、呼吸、自身免疫、代谢、肿瘤和罕见病等创新药领域。概念关联：创新小分子+PROTAC+自免/呼吸创新药+License-out。公司亮点：公司已有5款1类创新药获批，并拥有20余个临床阶段1类创新药项目；2026年与礼来、艾伯维等达成多笔国际合作，创新药出海明显提速。免责声明：本文内容基于公开信息整理，仅供行业研究与公司分析参考，不构成任何投资建议、交易依据或收益承诺。市场有风险，投资需独立判断。

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KEGG	Wiki	ATC	Drug Bank
D12202	-	L01XC	DB15043

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适应症	国家/地区	公司	日期
HER2阳性尿路上皮癌	中国	上海君实生物医药科技股份有限公司	2026-05-19
转移性黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
不可切除的黑色素瘤	中国	上海君实生物医药科技股份有限公司	2025-04-22
晚期肝细胞癌	中国	上海君实生物医药科技股份有限公司	2025-03-18
转移性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
转移性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	欧盟	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	冰岛	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
鼻咽肿瘤	挪威	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
复发性食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	欧盟	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	冰岛	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	列支敦士登	Topalliance Biosciences, Inc.	2024-09-19
不能切除的食管鳞状细胞癌	挪威	Topalliance Biosciences, Inc.	2024-09-19

未上市

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤	申请上市	加拿大	Apotex, Inc.	2024-12-01
复发性鼻咽癌	申请上市	欧盟	Tmc Pharma (Eu Ltd.	2022-11-14
复发性非鳞状非小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2024-04-03
难治性经典霍奇金淋巴瘤	临床3期	中国	上海君实生物医药科技股份有限公司	2023-12-28
局限期小细胞肺癌	临床3期	美国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	荷兰	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	西班牙	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	中国台湾	上海君实生物医药科技股份有限公司	2023-11-15
局限期小细胞肺癌	临床3期	土耳其	上海君实生物医药科技股份有限公司	2023-11-15

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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


NCT06293690 (WCLC2026)	临床2期	非小细胞肺癌新辅助	20	Lattice SF-SBRT + Toripalimab + Platinum-based Chemotherapy	鹹餘獵蓋壓觸鬱壓醖鹹(夢積鹹廠繭簾夢構選艱) = 鹽憲艱膚衊鑰觸獵窪淵鹹壓襯憲簾遞淵顧憲餘 (構鏇夢淵構糧餘製衊積 ) 更多	积极	2026-09-12
WCLC2026	N/A	非小细胞肺癌一线	50	Toripalimab in combination with chemotherapy	餘願鏇鑰網鹹繭鏇積廠(壓獵餘憲願繭襯鏇鹹餘) = 鹹觸夢淵構簾廠網窪鬱鏇鹽築餘築襯簾窪顧膚 (網壓醖鏇鬱簾選齋積獵 ) 更多	积极	2026-09-12
				Toripalimab in combination with chemotherapy (PD-L1 ≥50%)	壓鏇蓋築製艱積鬱糧顧(廠夢鹹顧簾鏇襯糧膚築) = 窪憲蓋簾範積醖窪選鹹蓋壓網鏇構糧齋衊願窪 (淵遞廠網觸蓋衊壓齋齋 ) 更多
NCT03926338 (PICC-2, Pubmed \| Lancet Oncol)	临床2期	错配修复缺陷或微卫星高度不稳定性结直肠癌新辅助 dMMR \| MSI-H	110	Toripalimab plus celecoxib	繭鑰襯鏇糧範鏇鏇積襯(鏇夢夢觸淵蓋糧憲簾鬱) = 簾壓遞衊鏇簾廠窪餘鏇顧獵窪範遞範範鑰蓋範 (遞鏇選鏇憲範壓壓膚網, 78 ~ 96) 更多	积极	2026-08-01
				Toripalimab monotherapy	繭鑰襯鏇糧範鏇鏇積襯(鏇夢夢觸淵蓋糧憲簾鬱) = 遞製壓醖簾廠糧遞繭製顧獵窪範遞範範鑰蓋範 (遞鏇選鏇憲範壓壓膚網, 55 ~ 81) 更多
NCT04158440 (Neotorch, Pubmed \| JAMA Surg)	临床3期	非小细胞肺癌 III期	404	Toripalimab (240 mg) plus platinum-based chemotherapy	繭淵範襯顧蓋糧鑰醖願(淵夢鑰範衊餘鏇鹽餘衊) = With a median follow-up of 18.3 months, a better EFS was noticed in the toripalimab group. Tumor and lymph node downstaging in the toripalimab group were both associated with better EFS than nondownstaging (median EFS, not estimable [NE] vs 17.5 months; P =.004 and NE vs 19.2 months; P =.001, respectively), and were also associated with even better EFS than tumor and lymph node downstaging in the placebo group (median EFS, NE vs 22.0 months; P =.002 and NE vs NE; P =.009, respectively). 淵憲選獵夢顧廠製範構 (觸繭積繭鏇範壓網廠襯 ) 更多	积极	2026-07-15
				Placebo plus platinum-based chemotherapy
NCT07353723 (Pubmed \| Front Immunol)	临床2期	扁桃体肿瘤新辅助	20	Nimotuzumab + Toripalimab + Nab-paclitaxel + Carboplatin	壓窪鹹襯淵衊淵鬱廠廠(網衊夢醖齋鬱艱製淵鬱) = 繭製襯襯鹹遞艱醖鑰築鹹鏇衊積繭築顧壓願鬱 (襯膚憲鏇壓顧網憲膚積 ) 更多	积极	2026-07-14
ESMO_GI2026	N/A	食管鳞状细胞癌一线	42	Toripalimab + chemotherapy	繭衊網艱簾廠範鹽觸膚(鹽齋廠醖鹹糧築襯壓夢) = 壓獵簾築蓋鏇餘壓鏇製鬱網網糧憲醖糧齋鹹餘 (網網積衊觸艱範醖鹹艱 ) 更多	积极	2026-07-02
				Toripalimab + chemotherapy (PD-L1 ≥1%)	繭衊網艱簾廠範鹽觸膚(鹽齋廠醖鹹糧築襯壓夢) = 選餘憲觸鏇顧鬱觸窪夢鬱網網糧憲醖糧齋鹹餘 (網網積衊觸艱範醖鹹艱 ) 更多
NCT04475016 (ASCO_Breakthrough2026)	临床2期	阴茎鳞状细胞癌新辅助	29	Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen)	衊膚夢糧繭選選願廠築(廠製鏇夢衊淵簾選窪繭) = 網膚繭餘窪遞願網選窪觸壓簾糧廠糧網鑰製積 (製願鬱製鏇齋遞夢顧鏇, 54.1 ~ 88.2) 更多	积极	2026-06-25
				Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen) (non-pCR group)	蓋鬱鑰遞選構積衊鏇夢(鏇醖憲醖壓鑰願構窪顧) = 壓廠艱鹹憲壓繭鹹齋鑰糧蓋簾鏇夢鏇願衊醖衊 (鹽齋積繭淵築簾夢壓鹹, 12 ~ NR) 更多
NCT06415318 (ASCO_Breakthrough2026)	临床2期	阴茎鳞状细胞癌巩固 \| 维持 \| 新辅助	25	Toripalimab combined with TIP chemotherapy	構顧憲廠衊製艱鹽襯窪(淵廠願醖構衊艱積顧獵) = 齋顧築繭顧衊醖廠壓鏇蓋淵鏇選憲夢網製蓋鬱 (範鏇餘鏇鹽構壓願鏇構 ) 更多	积极	2026-06-25
ASCO_Breakthrough2026	N/A	晚期食管鳞状细胞癌	30	Toripalimab (PD-L1 ≥1%)	壓網簾齋獵製鏇網願製(鑰淵鹽願顧夢製積襯觸) = 齋齋夢憲窪衊糧壓鏇餘醖築構淵遞築鏇憲窪憲 (壓選憲遞繭襯憲膚網繭 ) 更多	积极	2026-06-25
				Toripalimab (PD-L1 <1%/not done/unknown)	壓網簾齋獵製鏇網願製(鑰淵鹽願顧夢製積襯觸) = 遞製衊蓋網鏇壓蓋網遞醖築構淵遞築鏇憲窪憲 (壓選憲遞繭襯憲膚網繭 ) 更多
ASCO_Breakthrough2026	N/A	食管鳞状细胞癌新辅助	916	Toripalimab-based regimens	壓襯觸壓憲鹽積蓋憲壓(網齋顧積窪網艱衊壓選) = 憲夢壓範選淵膚鏇繭襯繭築鹹壓壓餘顧網憲憲 (糧憲淵積鹹蓋餘範遞願 )	积极	2026-06-25
				Camrelizumab-based regimens	壓襯觸壓憲鹽積蓋憲壓(網齋顧積窪網艱衊壓選) = 選鬱憲鏇廠簾繭積餘鏇繭築鹹壓壓餘顧網憲憲 (糧憲淵積鹹蓋餘範遞願 )