特瑞普利单抗(Toripalimab) - 药物靶点：PD-1_在研适应症：HER2阳性尿路上皮癌，转移性黑色素瘤，不可切除的黑色素瘤_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-PD1 monoclonal antibody、Terepril monoclonal antibody、Toripalimab-TPZI

+ [15]

靶点

PD-1

作用方式

抑制剂

作用机制

PD-1抑制剂(细胞程序性死亡-1抑制剂)

治疗领域

肿瘤消化系统疾病口颌疾病+ [10]

在研适应症

HER2阳性尿路上皮癌转移性黑色素瘤不可切除的黑色素瘤+ [72]

非在研适应症

晚期胆道癌晚期癌症进展期胃腺癌+ [28]

原研机构

上海君实生物医药科技股份有限公司

在研机构

上海君实生物医药科技股份有限公司

Coherus Oncology, Inc.Topalliance Biosciences, Inc.

+ [5]

非在研机构

泰州君实生物医药科技有限公司

Ascentage Pharma Group, Inc.

德琪医药有限公司

权益机构

Dr. Reddy's Laboratories Ltd.

亞盛醫藥集團Excellmab Pte. Ltd

+ [10]

最高研发阶段批准上市

首次获批日期

中国 (2018-12-17),

黑色素瘤

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (澳大利亚)、优先审评 (美国)、优先审评 (新加坡)、附条件批准 (中国)、优先审评 (中国)、突破性疗法 (美国)

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结构/序列

Sequence Code 453640391L

来源: *****

Sequence Code 524455911H

来源: *****

关联

805

项与特瑞普利单抗相关的临床试验

NCT07796126

/ Not yet recruiting临床2期IIT

A Phase 2 Pilot Study of the Role of Sequential Immune Checkpoint Inhibitor Toripalimab and Chemotherapy Paclitaxel in Patients With HNSCC and ECOG Performance Score of 2

The goal of this clinical trial is to learn if the drug Toripalimab can prime the tumor to optimize response to Paclitaxel in HNSCC patients with a decrease performance status in a way that make both drugs well tolerated and improve partial or complete response rate over each treatment. The main questions it aims to answer are:
* What is the response rate of the cancer to paclitaxel after priming with toripalimab
* What is the time to progression if we continue to cycle between toripalimab and paclitaxel
* What is the impact on the patient's quality of life and overall survival

开始日期2026-09-30

申办/合作机构

Barbara Ann Karmanos Cancer Institute

NCT05479045

/ Not yet recruiting临床2期IIT

A Combination Therapy Strategy to Prevent Anti-PD-1 Therapy Resistance in Metastatic Ovarian Cancer Patients

This is an open label, non-randomized, 2-stage phase II, single arm study to determine the efficacy of New York esophageal squamous cell carcinoma 1 (NY-ESO-1) peptide vaccine as a priming mechanism to prevent anti-PD1 resistance in patients with platinum-refractory stage III/IV ovarian cancer (OC).

开始日期2026-09-01

申办/合作机构

Georgetown University

[+1]

NCT07277322

/ Recruiting临床1/2期IIT

Master Protocol for A Phase 1b/2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases

This Phase 1b/2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.

开始日期2026-09-01

申办/合作机构

Icahn School of Medicine at Mount Sinai

[+1]

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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709

项与特瑞普利单抗相关的文献（医药）

2026-09-01·JOURNAL OF INORGANIC BIOCHEMISTRY

Copper (I) nicotinate complex potentiates chemotherapy-induced apoptosis in HCC-1806 triple negative breast cancer cells: An in vitro study

Article

作者: Abdel-Mohsen, Mohamed A ; Helal, Marihan A ; Toson, Elshahat A

Triple negative breast cancer (TNBC) remains a clinically challenging subtype because it lacks established molecular targets and often depends on cytotoxic chemotherapy. Although doxorubicin (DOX) and mTOR inhibitors such as Torin1 (TOR) exhibit antitumor activity, their clinical use may be constrained by toxicity and resistance. Copper (I) Nicotinate Complex (CNC) has emerged as promising candidates due to their superoxide dismutase (SOD) -mimicking and cytoprotective properties. This study aimed to evaluate the potential effect of CNC combined with DOX or TOR to enhance cytotoxicity against HCC-1806 cells while reducing individual drug dosages. Cell viability was assessed via MTT assay. Drug interactions were analyzed by combination index methodology. Mechanistic responses were evaluated using Annexin V/PI flow cytometry, cell cycle analysis, Comet assay, and biochemical quantification of Caspase-3, Survivin, pCHK1^ser317, and SOD activity. CNC containing combinations enhanced cytotoxic responses relative to selected single-agent conditions, with ratio-dependent additive or synergistic interactions. Combination treatments increased apoptotic populations, altered cell cycle progression with enrichment of sub G0-G2/M fractions, and elevated DNA damage associated markers, including comet tail moment and pCHK1^ser317. CNC inclusive regimens also increased caspase-3 activity and reduced survivin expression. Increased SOD activity indicated modulation of oxidative stress related responses. Exploratory analysis showed treatment-associated changes in PD-1 expression. In conclusion, these findings provide preliminary in vitro evidence that CNC may potentiate selected anticancer responses of DOX or TOR in HCC-1806 cells through apoptosis-associated, cell cycle, and DNA damage-related mechanisms. Further validation in additional TNBC models and in vivo systems is required.

2026-08-01·LANCET ONCOLOGY

Neoadjuvant toripalimab plus celecoxib versus toripalimab monotherapy for mismatch repair-deficient or microsatellite instability-high, locally advanced colorectal cancer (PICC-2): an open-label, multicentre, randomised, phase 2 trial

Article

作者: Deng, Yanhong ; Kang, Liang ; Wang, Huaiming ; Zhai, Xiaohui ; Wang, Hui ; Cao, Wuteng ; Li, Shanshan ; Shen, Xutao ; Wu, Xiaojian ; Li, Jianxia ; Huang, Yan ; He, Xiaosheng ; Chen, Dianke ; Deng, Jiaye ; Yang, Zuli ; Huang, Meijin ; Shi, Lishuo ; Li, Yunfeng ; Hou, Yujie ; Hu, Huabin ; Li, Weiwei ; Zhou, Jiaming ; Luo, Shuangling ; Li, Fangqian ; He, Zhen ; Hu, Jiancong ; Ling, Li ; Zheng, Zhuoxin ; Huang, Liang ; Deng, Weihao ; Liu, Ping ; Xie, Xiaoyu ; Lan, Ping ; Zhang, Yan ; Yang, Tao ; Wang, Chao ; Zhang, Jianwei ; Wang, Xiaozhong

BACKGROUND:

Neoadjuvant immune checkpoint blockade has shown remarkable activity in mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H), locally advanced colorectal cancer. Preclinical studies suggest that COX-2 inhibition might modulate the inflammatory tumour microenvironment and augment the effect of PD-1 blockade. We aimed to investigate whether the addition of the COX-2 inhibitor celecoxib to neoadjuvant toripalimab would increase the pathological complete response in this population.

METHODS:

PICC-2 was a multicentre, open-label, randomised, controlled, phase 2 trial conducted at three academic hospitals in China. Eligible patients were aged 18-75 years; had histologically confirmed dMMR or MSI-H colorectal cancer, of clinical stage T3-T4 or any clinical T stage with lymph node positivity (N+); had an Eastern Cooperative Oncology Group performance status score of 0 or 1; and had adequate haematological, hepatic, and renal function. Participants were randomly assigned (1:1) via an interactive web response system, stratified by tumour location and clinical T stage, to receive neoadjuvant toripalimab plus celecoxib or toripalimab monotherapy every 14 days for 12 cycles, followed by surgery. Toripalimab 3 mg/kg was administered intravenously on day 1 in both groups; patients in the toripalimab plus celecoxib group also received celecoxib 200 mg orally twice daily on days 1-14. The primary endpoint was the proportion of patients with pathological complete response, defined as no presence of residual viable tumour in the primary tumour and all sampled lymph nodes at surgery, assessed by central blinded independent pathological review in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03926338, and is ongoing.

FINDINGS:

Between May 5, 2022, and Jan 20, 2025, 110 patients were randomly assigned to toripalimab plus celecoxib (n=55) or toripalimab monotherapy (n=55). Overall, 65 (59%) patients were male, all patients were Chinese, 76 (69%) had cT4 tumours, and 105 (95%) had clinically node-positive disease. At the data cutoff date (Oct 10, 2025), median follow-up was 18·1 months (IQR 11·5-25·3). 49 (89%) of 55 patients in each group completed all 12 planned cycles of neoadjuvant therapy. Surgery was done in 53 (96%) of 55 patients in the toripalimab plus celecoxib group and 51 (93%) of 55 in the monotherapy group. Pathological complete response was observed in 49 of 55 patients (89% [95% CI 78-96]) in the toripalimab plus celecoxib group versus 38 of 55 (69% [55-81]) in the monotherapy group (between-group difference 19 percentage points [95% CI 4-34]; p=0·014). Grade 3 treatment-related adverse events occurred in three (5%) patients and four (7%) patients, respectively; grade 3 treatment-related adverse events were tumour perforation (two [4%]) and bowel obstruction (one [2%]) in the toripalimab plus celecoxib group, and rash (one [2%]), tumour perforation (one [2%]), increased aminotransferase (one [2%]), and hypothyroidism (one [2%]) in the monotherapy group. No grade 4 or 5 treatment-related adverse events occurred.

INTERPRETATION:

In patients with dMMR or MSI-H locally advanced colorectal cancer, neoadjuvant toripalimab plus celecoxib significantly increased the proportion of patients attaining pathological complete response compared with toripalimab monotherapy, with a similar safety profile. These findings support further investigation of this combination strategy in larger phase 3 trials.

FUNDING:

The National Natural Science Foundation of China, Guangdong Basic and Applied Basic Research, the National Key Clinical Discipline of China, the Program of Guangdong Provincial Clinical Research Center for Digestive Diseases, and the Chinese Society of Clinical Oncology-Junshi Biosciences Oncology Immunity Research.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

2026-07-10·JOURNAL OF CLINICAL ONCOLOGY

Perioperative Toripalimab Plus Chemotherapy Versus Chemotherapy Alone in Locally Advanced Gastric or Gastroesophageal Junction Cancer: 3-Year Follow-Up of NEOSUMMIT-01 Trial

Article

作者: Guan, Yuan-Xiang ; Chi, Jun ; Liu, Zhi-Min ; Sun, Xiao-Wei ; Zhou, Zhi-Wei ; Li, Ji-Bin ; Wang, Wei ; Li, Yuan-Fang ; Nie, Run-Cong ; Ling, Yi-Hong ; Guan, Wen-Long ; Chen, Ying-Bo ; Zhang, Dong-Sheng ; Qiu, Hai-Bo ; Cai, Mu-Yan ; Liang, Cheng-Cai ; Wang, Zi-Xian ; Chen, Yong-Ming ; Yang, Qiu-Xia ; Xu, Rui-Hua ; Chen, Shi ; Jin, Ying ; Yuan, Shu-Qiang ; Peng, Jun-Sheng ; Xi, Shao-Yan ; Wang, Feng ; Tang, Xiong-Wen

The NEOSUMMIT-01 trial previously showed that adding the PD-1 antibody toripalimab to perioperative chemotherapy improved the pathologic response in patients with locally advanced gastric or gastroesophageal junction cancer. Here, we present the event-free survival (EFS) and overall survival (OS) after extended follow-up. A total of 108 patients were enrolled (toripalimab plus chemotherapy, n = 54; chemotherapy alone, n = 54). At the data cutoff date (August 29, 2025), the median follow-up was 43.2 months (interquartile range: 36.6-53.7). The 3-year EFS was 74.7% (95% CI, 63.6% to 87.7%) in the toripalimab plus chemotherapy group and 56.2% (95% CI, 43.3% to 73.0%) in the chemotherapy group, with a hazard ratio (HR) of 0.51 (95% CI, 0.27 to 0.98; P = .044). The 3-year OS was 81.3% (95% CI, 71.4% to 92.4%) versus 72.2% (95% CI, 61.2% to 85.2%), respectively, with an HR of 0.45 (95% CI, 0.21 to 0.95; P = .036). The survival benefits were consistent across most predefined subgroups and were maintained in the analysis excluding patients with dMMR. In conclusion, perioperative toripalimab plus chemotherapy significantly improved 3-year EFS and OS compared with chemotherapy alone, suggesting it as a promising treatment option for patients with locally advanced gastric or gastroesophageal junction cancer.

4,709

项与特瑞普利单抗相关的新闻（医药）

2026-09-04

·搜狐新闻

君实生物跌0.77%，成交额2.91亿元，后市是否有机会？

来源：新浪证券-红岸工作室 9月4日，君实生物跌0.77%，成交额2.91亿元，换手率1.13%，总市值343.84亿元。异动分析创新药+生物疫苗+猴痘概念+AIGC概念 1、2026年3月14日公告：2025年，公司核心产品特瑞普利单抗新增2项获批适应症，12项获批适应症已全部纳入国家医保目录，公司多款产品已进入三期临床研究或上市申报阶段，并于报告期内快速推进了PD-1/VEGF双抗（JS207）、EGFR/HER3 ADC（JS212）、PD-1/IL-2融合蛋白（JS213）等多款具有国际市场竞争力的创新药物的临床试验，开启全球探索征程。全年超135项研究成果亮相国际学术舞台，200余篇研究报告发表于国际顶刊，彰显中国创新药的全球竞争力。公司以“创新驱动”为引擎，积极推进优势管线布局，正快速推进PD-1/VEGF双抗（JS207）、EGFR/ HER3 ADC（JS212）、PD-1/IL-2融合蛋白（JS213）等多款具有国际市场竞争力的创新药物的临床试验，并积极探索多种联用方案，以最大程度发挥管线协同作用。JS207和JS212的临床试验申请也相继于2025年10月和2025年12月获得FDA批准，让中国创新方案在前沿领域开启全球探索。 2、2024年3月12日互动易：公司控股子公司君拓生物通过与科研院所和高校合作开发等形式持有疫苗相关产品管线，如猴痘疫苗、寨卡疫苗等，目前均处于临床前开发阶段。 3、公司公众号：2023年10月27日，君实生物宣布，公司与北京大学、中国科学院微生物研究所（中科院微生物所）、山西高等创新研究院、北京航空航天大学达成合作，共同开发猴痘重组蛋白疫苗。 4、2025年3月10日互动易：公司训练部署了基于大模型技术的AI翻译平台，已替换80%以上科学文献、临床试验、质量管理、知识产权等各领域的文档翻译的外部服务。公司上线了基于AI大模型和知识库的数字员工“i小君”为一线销售提供医学信息问答，为员工提供IT系统支持，HR和财务政策解答，文献内容总结，内部知识库查询等服务。 (免责声明：分析内容来源于互联网，不构成投资建议，请投资者根据不同行情独立判断) 资金分析今日主力净流入-246.22万，占比0.01%，行业排名26/55，连续2日被主力资金减仓；所属行业主力净流入-5.89亿，连续2日被主力资金减仓。区间今日近3日近5日近10日近20日主力净流入 -246.22万 633.19万 -6010.26万 -7607.45万 -4.04亿主力持仓主力没有控盘，筹码分布非常分散，主力成交额1.20亿，占总成交额的7.16%。技术面：筹码平均交易成本为36.78元该股筹码平均交易成本为36.78元，近期筹码减仓，但减仓程度减缓；目前股价在压力位34.45和支撑位31.29之间，可以做区间波段。公司简介资料显示，上海君实生物医药科技股份有限公司位于上海市浦东新区平家桥路100弄6号7幢16层,香港铜锣湾希慎道33号利园1期19楼1918室，成立日期2012年12月27日，上市日期2020年7月15日，公司主营业务涉及单克隆抗体药物和其他治疗型蛋白药物的研发与产业化,单克隆抗体药物研发的技术服务与技术转让等。主营业务收入构成为：药品销售82.97%，技术许可及特许权使用收入14.98%，技术服务及其他2.05%。君实生物所属申万行业为：医药生物-生物制品-其他生物制品。所属概念板块包括：肿瘤治疗、抗癌治癌、抗癌药物、单抗概念、抗癌等。截至6月30日，君实生物股东户数3.77万，较上期减少1.22%；人均流通股20324股，较上期增加1.23%。2026年1月-6月，君实生物实现营业收入16.96亿元，同比增长45.18%；归母净利润2166.30万元，同比增长105.25%。机构持仓方面，截止2026年6月30日，君实生物十大流通股东中，中欧医疗健康混合A（003095）位居第七大流通股东，持股1481.14万股，为新进股东。创新药（159992）位居第九大流通股东，持股888.69万股，相比上期增加58.40万股。返回搜狐，查看更多

2026-09-04

·腾讯网

每日科创｜君实生物：PD-1红海中的逆袭

026年8月26日，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。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。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。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。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。来源：大湾区经济网证券之星频道

抗体药物偶联物财报申请上市

2026-09-03

·新浪财经

生物医药行业2026年创新药中报总结(二)：大药企创新收入占比持续提升双抗与ADC前沿探索拓宽成长边界

传统药企稳步创新转型，创新药商业销售与授权收入带动业绩增长。2026年上半年，传统大型制药企业创新转型成效凸显：恒瑞医药创新药收入达88.09亿元（yoy +16.38%），占药品销售比重跨越至63.16%，非肿瘤创新药同比增长73.97%；中国生物制药创新药及对外授权收入达87.9亿元（yoy+44.3%）；石药集团在成药稳健增长（yoy +10.8%，剔除授权费收入贡献）与AZ战略合作大额授权费驱动下，实现归母净利60.94亿元（yoy +139.2%）。　　传统药企有望逐步摆脱仿制药集采阵痛，凭借高壁垒自研平台、全球BD交易与战略并购，确立高质量成长中枢。　　前沿疗法迈入“IO 2.0 + ADC 2.0”时代，前移一线/围手术期与多维联合有望重塑治疗格局。从2026年9月WCLC全球顶级学术会议看，国内企业在前沿靶点与创新构型上布局。（1）双抗多靶点加速前移：荣昌、君实、维立志博推进PD-1/VEGF、PD-L1/4-1BB双抗进入一线晚期及围手术期新辅助治疗；康方生物依沃西在国内外布局多项注册3期、卡度尼利全线出击术后及一线适应症。（2）ADC多靶点与联合创新百花齐放：科伦博泰sac-TMT（TROP2ADC）迎来国内首批放量与全球多项3期顶线数据；宜联、翰森在2L SCLC进入B7-H3 ADC临床3期数据读出阶段；映恩生物、石药集团积极推进B7-H3ADC、EGFR ADC联合双抗或PD-1的创新组合，拓宽实体瘤天花板。　　专精特新与差异化矩阵进入密集收获期，多元商业化变现路径更加清晰。具备特色管线矩阵的Biopharma/Biotech迎来商业化快速放量与管线收获双重共振：诺诚健华奥布替尼自免/血液双线发力；云顶新耀耐赋康放量破局并叠加引进/自研多款重磅商业化产品；君实生物通过特瑞普利单抗持续造血并启动下一代双抗/双抗ADC联合布局。自主研发、海外出海许可（如映恩与罗氏合作、恒瑞与BMS 152亿美元合作）与境内资产并购引进多元模式齐头并进，未来有望迎来国内新药获批与重磅注册临床读出的密集期。　　投资建议：结合2026年中报表现与下半年学术会议催化，在业绩上多数创新药企实现扭亏为盈，此外传统药企创新收入占比提升并积极布局前沿IO/ADC创新升级。建议关注以下三条主线：（1）创新药收入占比不断提升且深度绑定跨国MNC的转型药企（建议关注恒瑞医药、中国生物制药、石药集团等）；（2）双抗/ADC/双抗+ADC联合前沿布局，技术平台成长型标的（建议关注康方生物、科伦博泰、君实生物、映恩生物等）；（3）血液瘤/自免/肾病等高壁垒单品加速放量且实现业绩拐点的细分标的（建议关注诺诚健华、云顶新耀等）。　　风险提示：行业政策变动风险；研发进展不及预期风险；竞争加剧风险；产品上市后商业化表现不及预期等

100 项与特瑞普利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XC	DB15043

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
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

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
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

评价

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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	淵窪願選鬱憲鏇獵積襯(淵糧艱鹹衊繭膚選糧壓) = 繭製醖顧齋繭獵鬱窪網獵鬱積網淵鹹蓋衊繭簾 (齋選鑰鹹簾築鹽網築網 ) 更多	积极	2026-09-12
WCLC2026	N/A	非小细胞肺癌一线	50	Toripalimab in combination with chemotherapy	獵觸範顧衊顧選製餘膚(衊築鹹網範餘觸襯選艱) = 觸遞獵艱蓋顧遞壓憲糧糧選壓艱簾獵醖選鬱簾 (築壓遞衊蓋選淵廠衊網 ) 更多	积极	2026-09-12
				Toripalimab in combination with chemotherapy (PD-L1 ≥50%)	窪淵窪蓋獵齋網顧網廠(獵艱襯淵蓋膚簾鹽製壓) = 鬱淵醖醖願願夢鏇構夢鑰顧鹽遞膚鏇構夢艱蓋 (餘獵夢構鹹憲顧網獵窪 ) 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	觸窪衊願憲選憲築糧餘(鹹衊醖選範遞遞夢鑰觸) = 鹹糧夢繭範襯鏇觸遞餘夢醖窪築壓壓鑰齋窪繭 (鏇夢鬱窪繭遞鹹餘範艱, 78 ~ 96) 更多	积极	2026-08-01
				Toripalimab monotherapy	觸窪衊願憲選憲築糧餘(鹹衊醖選範遞遞夢鑰觸) = 築廠膚構願齋壓網觸鹹夢醖窪築壓壓鑰齋窪繭 (鏇夢鬱窪繭遞鹹餘範艱, 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	築網壓範襯獵選觸鑰獵(淵築築鹹網願窪衊積醖) = 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). 獵憲憲廠遞繭憲繭糧廠 (遞餘衊鑰憲鹹築積選網 ) 更多	积极	2026-07-15
				Placebo plus platinum-based chemotherapy
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	積衊築鑰鏇憲選鏇膚築(範齋夢鏇憲夢衊窪鏇觸) = 積簾遞選網夢齋憲顧範簾壓顧糧範糧膚襯築鹽 (夢鏇獵餘鬱鹹艱衊製憲 ) 更多	积极	2026-06-25
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)	簾築顧憲鬱鬱鏇築醖鹹(積鏇膚壓遞衊蓋範獵構) = 廠顧築範範襯鹽襯憲窪衊繭膚糧糧壓鹹構鏇鏇 (觸簾顧醖齋壓積襯餘鹽, 54.1 ~ 88.2) 更多	积极	2026-06-25
				Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen) (non-pCR group)	餘蓋繭鬱憲顧蓋襯鑰願(廠艱鹹觸壓鏇夢膚廠膚) = 鬱願範膚鏇鏇範築築廠齋餘糧網範艱糧醖淵願 (壓糧獵齋蓋鹹範鬱構襯, 12 ~ NR) 更多
ASCO_Breakthrough2026	N/A	晚期食管鳞状细胞癌	30	Toripalimab (PD-L1 ≥1%)	範衊夢構膚憲膚淵觸鏇(觸齋糧膚膚糧醖醖顧鬱) = 膚鹽衊壓糧鑰鏇憲夢壓選醖膚鬱襯簾獵鹹築鬱 (遞衊顧鹽淵膚網鹽膚構 ) 更多	积极	2026-06-25
				Toripalimab (PD-L1 <1%/not done/unknown)	範衊夢構膚憲膚淵觸鏇(觸齋糧膚膚糧醖醖顧鬱) = 糧廠願繭選鹽艱觸顧願選醖膚鬱襯簾獵鹹築鬱 (遞衊顧鹽淵膚網鹽膚構 ) 更多
ASCO_Breakthrough2026	N/A	食管鳞状细胞癌新辅助	916	Toripalimab-based regimens	壓願淵觸齋範顧願廠衊(繭艱醖積鬱遞築衊製製) = 淵顧鬱顧齋願鬱餘繭獵觸觸鹹醖襯鑰積醖網襯 (觸顧製製鹽製簾鬱憲憲 )	积极	2026-06-25
				Camrelizumab-based regimens	壓願淵觸齋範顧願廠衊(繭艱醖積鬱遞築衊製製) = 遞糧鏇鑰製簾餘醖窪糧觸觸鹹醖襯鑰積醖網襯 (觸顧製製鹽製簾鬱憲憲 )
NCT04856631 (Pubmed \| Signal Transduct Target Ther)	临床1/2期	转移性头颈部鳞状细胞癌 PD-L1-positive	88	Toripalimab 240 mg IV every 3 weeks + Cetuximab (400 mg/m2 loading, then 250 mg/m2 weekly maintenance)	遞淵襯餘糧積鬱繭鑰積(製膚鏇廠蓋壓鏇蓋齋醖) = 衊窪襯夢築鹹鹽衊淵鑰繭壓築構齋顧衊範鏇窪 (鏇網遞鬱築窪選觸廠衊, 44.3 ~ 74.3) 更多	积极	2026-06-09
				Toripalimab 240 mg IV every 3 weeks + Cetuximab (400 mg/m2 loading, then 250 mg/m2 weekly maintenance)	遞淵襯餘糧積鬱繭鑰積(製膚鏇廠蓋壓鏇蓋齋醖) = 鏇範壓壓築鹽獵構艱廠繭壓築構齋顧衊範鏇窪 (鏇網遞鬱築窪選觸廠衊, 29.1 ~ 60.1) 更多
NCT04135690 (ASCO2026)	临床2期	局部晚期肝细胞癌一线	72	FOLFOX-HAIC plus Toripalimab	鏇醖廠夢觸遞餘積鹽齋(鬱鑰繭膚糧鏇鹹憲鹹夢) = 獵鏇製膚窪艱願艱夢廠襯願淵齋鬱淵遞網願齋 (窪鏇艱遞願鹹餘構簾觸 ) 更多	积极	2026-05-29
				FOLFOX-HAIC plus Sorafenib	鏇醖廠夢觸遞餘積鹽齋(鬱鑰繭膚糧鏇鹹憲鹹夢) = 製襯鏇願齋選觸壓憲繭襯願淵齋鬱淵遞網願齋 (窪鏇艱遞願鹹餘構簾觸 ) 更多