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+ [9]

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+ [70]

非在研适应症

晚期胆道癌晚期癌症进展期胃腺癌+ [32]

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

德琪医药有限公司Ascentage Pharma Group, Inc.

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)

登录后查看时间轴

结构/序列

Sequence Code 453640391L

来源: *****

Sequence Code 524455911H

来源: *****

关联

821

项与特瑞普利单抗相关的临床试验

NCT07853053

/ Not yet recruiting临床1期IIT

Efficacy and Safety of Disitamab Vedotin Plus Toripalimab With Cetirizine and Mecobalamin Pretreatment in Patients With Locally Advanced Unresectable or Metastatic Bladder Cancer: A Single-Arm Clinical Study

This is a prospective, open-label, single-arm exploratory clinical study evaluating the efficacy and safety of disitamab vedotin (RC48) plus toripalimab with cetirizine and mecobalamin in patients with locally advanced unresectable or metastatic bladder cancer who have not received prior systemic therapy for advanced disease.
Disitamab vedotin is a HER2-targeted antibody-drug conjugate, and toripalimab is a PD-1 immune checkpoint inhibitor. Although antibody-drug conjugates have shown antitumor activity in urothelial cancer, treatment-related peripheral neuropathy may affect patients' quality of life and the ability to continue treatment. In this study, cetirizine and mecobalamin are incorporated as a supportive and preventive strategy to explore whether they may help reduce or delay treatment-related peripheral neuropathy while maintaining antitumor activity.
Approximately 10 to 20 participants will be enrolled. The primary outcomes are objective response rate according to RECIST v1.1 and the incidence of treatment-related Grade 2 or higher peripheral neuropathy. Secondary outcomes include overall safety, disease control rate, progression-free survival, and overall survival. Exploratory analyses will evaluate changes in the tumor immune microenvironment, including CD8-positive T-cell infiltration and activation, and their associations with treatment response and peripheral neuropathy.

开始日期2027-01-01

申办/合作机构

中山大学孙逸仙纪念医院

NCT07836049

/ Not yet recruiting临床2期IIT

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

100 项与特瑞普利单抗相关的临床结果

登录后查看更多信息

100 项与特瑞普利单抗相关的转化医学

登录后查看更多信息

100 项与特瑞普利单抗相关的专利（医药）

登录后查看更多信息

692

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.

2026-10-03·JOURNAL OF CHEMOTHERAPY

A case of ICIs-associated arthritis caused by Toripalimab initially presenting as oedema in both lower limbs

Article

作者: Hao Yang ; Jie-ling Zhang ; Jun-jun Shen ; Zhi-li Zhou

The use of immune checkpoint inhibitors (ICIs) has offered new hope for patients with malignant tumours; however, it is essential to acknowledge their potential toxic side effects. Among these, ICIs-associated arthritis (IA) is not uncommon but non-specific and lacks diagnostic criteria. In this case, a patient with advanced colon cancer developed IA following treatment with Toripalimab. Notably, the condition improved after the administration of steroids, and the tumour remains well-controlled. This case report significantly contributes to enhancing clinicians' understanding of IA.

2026-10-01·Journal for ImmunoTherapy of Cancer

Toripalimab consolidation after chemoradiotherapy in limited-stage small cell lung cancer: a phase II, randomized controlled study (GASTO-1052A)

Article

作者: Liu, Hui ; Huang, Yan ; Wang, MengRu ; Zhang, HongMei ; Dong, Yumei ; Zhang, Pengxin ; Wang, DaQuan ; Zhang, Yujiao ; He, Wenzhuo ; Wei, ShiHong ; Situ, Yu ; Qiu, Bo

Background:

Immune-checkpoint inhibitors (ICIs) plus chemotherapy have demonstrated survival benefits in extensive-stage small cell lung cancer (SCLC). The integration of immunotherapy with concurrent chemoradiotherapy (CCRT) may improve survival outcomes in limited-stage SCLC (LS-SCLC). This phase II randomized controlled study was designed to evaluate the efficacy and safety of toripalimab consolidation versus observation in patients with LS-SCLC after CCRT.

Methods:

We conducted this phase II, randomized controlled trial in patients with LS-SCLC who had completed CCRT. Eligible patients were randomized 1:1 to either toripalimab consolidation (240 mg every 3 weeks for up to 6 months) or observation. Randomization was stratified according to disease stage (I or II vs III) and the receipt of prophylactic cranial irradiation (PCI) (yes vs no). The primary endpoint was progression-free survival (PFS). The secondary endpoints included overall survival (OS), objective response rate and toxicities.

Results:

Between June 30, 2020, and May 31, 2024, a total of 98 patients were randomized to receive either toripalimab consolidation (n=49) or observation (n=49) after CCRT. The trial was prematurely terminated on May 31, 2024. Objective responses were observed in 14 of 23 patients (60.9%) in the toripalimab group and in 9 of 24 patients (37.5%) in the observation group. The median PFS was not reached in the toripalimab group, compared with 14.1 months (95% CI 2.8 to 25.4) in the observation group (HR, 0.55; 95% CI 0.31 to 0.96). The median OS was not reached with toripalimab, compared with 30.3 months (95% CI 20.4 to 40.2) with observation (HR, 0.39; 95% CI 0.19 to 0.80). Treatment-related toxicities were generally mild. Adverse events led to discontinuation of study drug in 6 of 48 patients (12.5%) in the toripalimab group. Grade 3 pneumonitis or radiation pneumonitis occurred in two patient (4.2%) in the toripalimab group and one patient (2.0%) in the observation group. No grade 4 or 5 adverse events occurred in either group. Subgroup analyses of PFS and OS favored toripalimab over observation across all predefined subgroups, including age, sex, Eastern Cooperative Oncology Group performance status, smoking status, disease stage, response to CCRT and the receipt of PCI.

Conclusion:

Consolidative toripalimab showed promising signals of improved PFS and OS with a manageable safety profile in patients with LS-SCLC. These findings warrant confirmation in larger, adequately powered randomized trials.

5,096

项与特瑞普利单抗相关的新闻（医药）

18 小时之前

·药时空

2026 ESMO LBA | 延长随访持续展现PFS获益，两大难治亚组显著获益

2026年10月23日（西班牙当地时间），全球肿瘤学界高规格盛会欧洲肿瘤内科学会（ESMO）年会盛大召开，君赛生物以最新突破摘要(Late-Breaking Abstract, LBA) (LBA55) 口头报告形式公布全球首款无需高强度清淋化疗、无需IL-2给药的肿瘤浸润淋巴细胞(TIL)疗法诺吉仑赛(Nolgileucel，GC101)治疗晚期黑色素瘤的关键II期临床研究的延长随访结果[1]。图1. 斯璐教授，北京大学肿瘤医院主任医师、博导，ESMO 2026现场作口头报告该研究结果于今年6月在ASCO年会上以LBA (LBA 9509) 口头报告形式首次公布[2]，本次2026 ESMO年会则发布了延长随访结果，并公布黑色素瘤黏膜型及肢端型相关亚组数据，进一步巩固了诺吉仑赛的疗效证据，显示稳健的持续获益。 01 立足中国疾病谱黏膜型和肢端型亚组显著获益与欧美人群的皮肤型黑色素瘤不同，中国的黑色素瘤以黏膜型与肢端型为主，基于其生物特性与皮肤型黑色素瘤存在差异，既往治疗的获益比例与获益程度，均明显劣于皮肤型，治疗难度高。有文章报道，PD-1单抗治疗黏膜型黑色素瘤的客观缓解率（ORR）为0%，肢端型黑色素瘤的ORR为14%[3]。 MIZAR-003（NCT06703398）是一项开放标签、随机对照、多中心的关键性II期研究，旨在研究诺吉仑赛用于PD-1抗体治疗失败的晚期黑色素瘤患者的疗效与安全性。入组人群均经过两种以上系统性治疗（必包含PD-1抗体治疗）失败，黏膜和肢端型占绝大多数，89.9%患者发生远处转移，一半以上患者发生≥3个器官转移，其中肝、肺、骨等重要脏器转移者占比66.7%。本次延长随访结果显示，与化疗对照组相比，GC101延长了所有亚型的PFS，黏膜型、肢端型和皮肤型亚组的中位PFS分别为4.81、4.37和4.14个月。 GC101组在黏膜型及肢端型亚组获益显著，黏膜型亚组HR（风险比）为0.23，即试验组患者疾病进展或死亡的风险降低77%；在肢端型亚组中，HR为0.41，即试验组患者疾病进展或死亡的风险降低59%。两亚组均显示与总体人群一致的显著获益，进一步支持诺吉仑赛在我国更常见的黏膜型和肢端型患者中的疗效优势。图2. GC101 黏膜型和肢端型PFS数据 02 延长随访，数据更稳键诺吉仑赛有望重塑治疗格局本次延长随访时间增加1.5个月, GC101组PFS获益稳健持续，中位PFS达4.37个月，显著优于化疗对照组1.61个月（HR=0.44, 95% Cl 0.28~0.70, P=0.0004）。而OS方面，数据依旧未成熟，但在化疗组59%患者交叉至GC101组的背景下，GC101组仍观察到OS获益信号，且较既往数据进一步加深，提示其生存获益具有持续性和稳健性。图3. GC101 全人群PFS数据 GC101组客观缓解率（ORR）为44%，较对照组8.2%大幅提升，之前数据显示，部分患者可达完全缓解（CR），本次延长随访，新观察到3例患者实现靶病灶CR，进一步验证GC101在晚期黑色素瘤患者治疗中的长效抗肿瘤活性和生存获益潜力。图4. 试验组和对照组瀑布图 03 诺吉仑赛安全性良好为广泛临床应用奠定坚实基础伴随随访时间延长，GC101组安全风险未增加。从整体安全性结果来看，GC101组不良反应可控，≥3级的治疗中出现的不良事件（TEAE）主要是预处理导致的血液学毒性，但中位持续时间甚至短于化疗对照组（8天 vs 13天）；延长随访期间，GC101组无TIL治疗相关不良事件的发生，进一步证实了诺吉仑赛的长期安全性，为下一步的临床实践提供了扎实的安全性证据支撑。凭借优异的安全性，不再依赖ICU，诺吉仑赛可以覆盖更多的医院、满足更多需求。这意味着创新 TIL 治疗不再必需高规格的特殊医护，临床使用门槛与医疗资源占用将被大幅降低，同时也为更广泛的联合疗法奠定坚实的基础。图5. GC101的安全性数据最新版《CSCO黑色素瘤诊疗指南(2026版)》中，针对皮肤黑色素瘤、肢端黑色素瘤（无脑转移患者）的晚期治疗，以及不可手术切除或晚期黏膜黑色素瘤的治疗中，诺吉仑赛均被列为二线治疗的推荐方案[4]。同时，相关研究荣获2026 CSCO年度优秀论文一等奖以及2026 创新研究奖。这些权威认可将加速诺吉仑赛走向临床实践，更快惠及晚期黑色素瘤患者。北京大学肿瘤医院副院长、黑色素瘤与肉瘤内科主任、泌尿肿瘤内科主任郭军教授表示，GC101关键II期项目在一年之内，连续获得ASCO、CSCO、ESMO三大权威学术会议认可，这是国内外医学界对研究创新价值与临床应用价值的认可。这项研究的入组患者大部分是晚期末线的肢端型与黏膜型黑色素瘤，是全球公认的难治性黑色素瘤，即便如此，诺吉仑赛依然取得ORR 44.0%，mPFS 4.37个月的好成绩，为临床实践积累了坚实的循证医学证据。当前，CSCO黑色素瘤诊疗指南（2026 版）已将诺吉仑赛纳入推荐，未来非常有潜力凭借其出色的疗效与安全性，改变晚期黑色素瘤的治疗格局。诺吉仑赛是全球首款无需高强度清淋化疗、无需IL-2给药的TIL疗法，已为多线治疗失败的晚期转移性实体瘤患者带来长期获益。目前，GC101针对恶性黑色素瘤的关键II期已达主要终点，治疗晚期非小细胞肺癌进入到II期研究，治疗脑胶质瘤的术后辅助治疗即将开展临床II期。参考文献： [1] Lu S, et al. ESMO 2026, Madrid, Spain. LBA55 [2] Lu S, et al. ASCO 2026, Chicago, IL, USA. LBA 9509. [3] Tang B, et al. Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial. Clin Cancer Res. 2020 Aug 15;26(16):4250-4259. [4] 中国临床肿瘤学会指南工作委员会. 中国临床肿瘤学会（CSCO）黑色素瘤诊疗指南2026[M]. 北京: 人民卫生出版社, 2026. 声明：本文内容仅作为信息分享和观点展示，旨在传递前沿专业信息和满足医疗专业人士的信息需求，无意做任何产品的推广或治疗方案推荐。本文所涉GC101处于临床试验阶段，尚未获批上市。任何关于疾病诊断和治疗等医疗行为，请遵从医疗卫生专业人士指导。

临床结果ASCO会议临床2期

2026-10-24

·FOCUS临床科学家

ESMO 2026｜韩辉教授团队：特瑞普利单抗联合TIP新辅助治疗局部晚期阴茎鳞癌，ORR达84%、pCR率48%

2026年欧洲肿瘤内科学会年会（ESMO 2026）于当地时间10月23日至27日在西班牙马德里召开。作为全球肿瘤领域高规格、国际化的年度学术盛会，大会汇聚世界各地顶尖专家，集中分享肿瘤诊疗领域的最新突破，围绕精准诊疗、免疫治疗、创新药物研发与转化研究等前沿议题展开深入研讨。其中，中国学者的研究成果在国际舞台上尤为亮眼，备受瞩目。【FOCUS临床科学家】奔赴大会现场带来前沿学术报道，一项来自中山大学肿瘤防治中心韩辉教授团队的多中心、单臂Ⅱ期研究公布结果，探索特瑞普利单抗（toripalimab，抗PD-1单抗）联合TIP方案用于初治局部晚期阴茎鳞状细胞癌（locally advanced penile squamous cell carcinoma, La-PSCC）的新辅助治疗，显著提升历史数据客观缓解率（objective response rate, ORR）与病理完全缓解率（pathological complete response, pCR），为这类难治泌尿生殖系统肿瘤带来新的治疗思路。研究背景： La-PSCC（T4/N2-3 M0）患者单纯手术难以实现根治，新辅助降期是核心治疗策略。TIP是临床常用新辅助化疗方案，但缓解深度有限，历史中位总生存期（overall survival, OS）仅17.1个月。HERCULES研究推动化疗联合免疫纳入晚期PSCC一线治疗选择，为新辅助场景的免疫联合化疗提供理论依据。研究者提出假说：在TIP化疗基础上加用特瑞普利单抗，能够增强肿瘤退缩，提高新辅助降期、病理缓解概率。本研究为Simon两阶段设计的多中心单臂Ⅱ期临床试验，旨在评估特瑞普利单抗联合TIP新辅助治疗未经系统治疗La-PSCC的疗效与安全性。研究方法：入组标准：T4或N2-3 M0的阴茎鳞癌成人患者东部肿瘤协作组体能状态评分（Eastern Cooperative Oncology Group performance status, ECOG PS）0~2分，既往未接受任何系统抗肿瘤治疗。治疗方案：特瑞普利单抗240mg d1+TIP化疗，每3周1周期，术前最多接受4周期新辅助治疗；新辅助治疗结束后行根治性巩固手术，术后可继续特瑞普利单抗维持治疗，最长至术后1年（最多17周期）。研究终点：主要终点为根据RECIST v1.1评估的ORR；次要终点包括pCR率、无事件生存期（event-free survival, EFS）、OS、治疗相关不良事件（treatment-related adverse event, TRAE）。分析集：疗效、安全性分析基于全分析集（FAS，接受至少1剂研究药物的全部入组患者）。图1 疗效与生存结局图注：（A）肿瘤负荷自基线变化瀑布图；（B）连续治疗周期肿瘤动态变化泳道图；（C）EFS 生存曲线；（D）OS 生存曲线。缩写：CR，完全缓解；PR，部分缓解；SD，疾病稳定；PD，疾病进展；EFS，无事件生存期；OS，总生存期。研究结果： 1. 基线人群特征共纳入25例患者，全部为系统治疗初治；分期分布：T4期1例、N2期6例、N3期18例；HPV阳性12例；PD-L1 CPS≥1共23例，其中CPS≥20高表达15例。 2. 主要疗效终点全部25例患者可评估疗效：ORR达84.0%（2/25 CR，19/25 PR），显著优于历史TIP单化疗50%的ORR；21例患者后续接受巩固手术，全分析集pCR率达48.0%（12/25），对比历史TIP化疗仅约10%的pCR率提升明显。 3. 生存结果中位随访21.4个月，中位EFS、中位OS均尚未达到；12个月EFS率为72.0%（95% CI 56.4~91.9），12个月OS率为88.0%（95% CI 76.1~100）。探索性分层：按HPV状态分层，HPV阳性患者相较HPV阴性患者，呈现pCR、生存获益的有利趋势，但差异未达统计学意义：HPV阳性pCR率66.7% vs HPV阴性33.3%（P=0.22）；1年OS率100% vs 75%（P=0.070）。（注：1例患者未完成HPV分型检测，未纳入该分层分析。） 4. 安全性与术后并发症治疗相关不良事件：所有25例患者均发生任意级别TRAE，3~4级TRAE发生率为84.0%；最常见3/4级TRAE为中性粒细胞减少（72%）；甲状腺功能减退发生率8%（均为1~2级）；无患者因毒性终止研究治疗。术后并发症（mClavien-Dindo分级）：21例接受手术，其中20例同期完成腹股沟+盆腔淋巴结清扫；85.7%（18/21）患者出现术后并发症，以Ⅰ/Ⅱ级淋巴瘘最常见；1例Ⅳa级肺炎、1例Ⅴ级死亡事件，该死亡患者既往合并精神分裂症，躁狂发作时自行服用阿普唑仑、氯氮平，后续发生吸入性死亡，经评估判定与研究药物无关。图2 安全性与术后并发症汇总图注：左侧为CTCAE 5.0标准TRAE分布；右侧为术后并发症类型及分级。缩写：TRAE，治疗相关不良事件；ILND，腹股沟淋巴结清扫；PLND，盆腔淋巴结清扫。研究局限性：本研究为单臂Ⅱ期研究，无对照，仅可和历史数据间接对比，不能直接证实免疫联合优于单纯TIP化疗；样本量偏小，HPV分层的获益趋势仅为探索性分析，统计效力不足；随访时间仍有限，成熟长期生存数据有待更长时间随访获取；同时手术并发症整体高发，需要关注围手术期管理。研究结论：对于未经系统治疗的T4/N2-3 M0局部晚期阴茎鳞癌，特瑞普利单抗联合TIP方案新辅助治疗展现出突出的抗肿瘤活性，ORR与pCR率大幅超越传统单纯TIP化疗历史数据，生存获益趋势可观，整体毒性可控，无因不良反应停药事件。该方案有潜力成为La-PSCC新辅助的新型标准方案，但本研究为Ⅱ期单臂探索，HPV阳性人群的潜在优势也仍待验证，需要更大规模Ⅲ期随机对照研究进一步确认该结论。参考文献： Han H, Xiong L, et al. Neoadjuvant toripalimab combined with chemotherapy for locally advanced penile squamous cell carcinoma: A multicenter prospective, single-arm, phase Ⅱ clinical trial. ESMO Congress 2026; Abstract 1209RO. ClinicalTrials.gov identifier: NCT06415318 文章采编：FOCUS临床科学家编辑部关于我们本文仅供医疗卫生专业人士了解最新医药资讯参考使用，文章所有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。原创文章版权属《FOCUS临床科学家》所有，若涉及版权问题，烦请与我们联系，我们将尽快处理。

临床2期免疫疗法临床结果

2026-10-24

·GlobeNewswire-Health Care

Junshi Biosciences Announces Completion of First Patient Dosing in the Phase 3 Clinical Trial of JS203 in Combination with Chemotherapy for the Treatment of Diffuse Large B-cell Lymphoma

SHANGHAI, China, Oct. 23, 2026 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the first patient dosing has been completed in a randomized, open-label, multicenter phase 3 clinical study of the company’s product, a recombinant humanized anti-CD20/CD3 bispecific antibody (code: JS203), in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) (the JS203-003-III-DLBCL Study; NCT07808827). This study is the first registrational clinical study for JS203. DLBCL is one of the most common types of non-Hodgkin lymphoma (NHL), accounting for approximately 40% of adult NHL cases in China. According to GLOBOCAN 2022 statistics, there are approximately 45,000 new cases of DLBCL in China each year, and the incidence rate shows a slow increasing trend. DLBCL is characterized by high aggressiveness and rapid progression. A retrospective study in an Asian population showed that, even after active treatment, patients with relapsed or refractory DLBCL had a median overall survival (mOS) of over one year and a 5-year survival rate of approximately 30%, which necessitates the exploration of more proactive and effective treatment options. JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi Biosciences. It consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively. Results from a phase 1 clinical study showed that, for JS203 monotherapy at the recommended phase 2 dose (RP2D) administered with step-up dosing (SUD) to 30 mg for the treatment of patients with CD20-positive relapsed or refractory B-cell non-Hodgkin lymphoma, the objective response rate (ORR) reached 72.4%. Among patients with DLBCL, the ORR was 69.7%, and the complete response rate CRR was 39.4%, with persistent relief observed. Meanwhile, the overall safety profile was manageable, with a cytokine release syndrome (CRS) incidence rate of only 27.3% and no occurrence of immune effector cell-associated neurotoxicity syndrome (ICANS). The JS203-003-III-DLBCL Study is a randomized, open-label, multicenter phase 3 clinical trial, with Professor Yuqin SONG of Beijing Cancer Hospital serving as the principal investigator. It aims to compare the efficacy and safety of JS203 in combination with chemotherapy compared to rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma. The study plans to enroll 282 subjects, with overall survival (OS) as its primary endpoint. This study is the first registrational clinical study for JS203. The JS203-003-III-DLBCL study team commented: “Early clinical studies have shown encouraging efficacy and a favorable safety profile for JS203 in combination with chemotherapy in patients with R/R DLBCL, reinforcing our confidence in the ongoing Phase 3 study. We are committed to advancing the study with rigor and efficiency, with the aim of making a new treatment option available to patients as soon as possible.” About JS203 JS203 is a recombinant humanized anti-CD20/CD3 bispecific antibody self-developed by Junshi Biosciences. CD20 is a B lymphocyte restricted differentiation antigen and one of the most successful targets for B-cell lymphoma treatment. CD3 is an important marker on the surface of T cells, and the main mechanism of T cell engaging bispecific antibodies is using CD3 as a mediator to activate T cells to specifically attack tumor cells. JS203 consists of anti-CD20 segment and anti-CD3 segment. By associating and activating lymphoma cells (binding to CD20) and T cells (binding to CD3), JS203 can enable T cells to kill lymphoma cells effectively. To date, a Phase 3 clinical study evaluating JS203 in combination with chemotherapy versus rituximab in combination with chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) is ongoing. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. With our outstanding capacity for innovative drug discovery, strong biotechnology R&D capability, and large-scale production capacity, we have successfully developed a drug candidate portfolio with global competitiveness and a well-structured research pipeline, which covers therapeutic areas including cancer, autoimmune, metabolic, and infectious diseases. Our innovative field spans cutting-edge therapeutic modalities, including mAbs, small-molecule drugs, ADCs, bsAb/msAb, fusion proteins, nucleic acid drugs and vaccines. Five of the company’s products have received marketing authorizations in China and international markets, one of which is toripalimab, China’s domestically developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 50 countries and regions including China, the US, and Europe. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” The company currently employs more than 3,000 people worldwide. Headquartered in Shanghai, China, it has a business presence in multiple countries and regions around the world. For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact Information IR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

临床3期临床1期临床结果上市批准临床2期

100 项与特瑞普利单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D12202	-	L04AG L01XC	DB15043

研发状态

批准上市

10 条最早获批的记录,

登录

后查看更多信息

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,

登录

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT07279597 (ESMO2026)	临床2期	HER2阳性肌层浸润性膀胱癌 HER2-positive	19	Induction chemotherapy followed by toripalimab + disitamab vedotin and radiotherapy	襯鹹構夢製鹹廠願築遞(選簾膚構窪遞淵夢鹹網) = 構鏇簾艱選鬱網構製夢夢鬱繭遞網積構糧齋蓋 (鬱簾膚簾鏇襯醖積願廠, 74.0 ~ 99.9) 更多	积极	2026-10-23
ESMO2026	N/A	肌层浸润性膀胱癌新辅助 HER-2 Expression	44	Neoadjuvant Disitamab Vedotin (DV) + Toripalimab (achieved cCR)	齋獵積鏇夢獵艱遞夢構(鹽獵餘夢鏇築淵構鹹遞) = After neoadjuvant therapy, both CTC and HER-2+ CTC counts were significantly lower in the cCR group (P=0.006 and <0.001, respectively). All pts with negative post-treatment CTC achieved cCR, whereas detectable post-treatment CTCs were observed in all non-cCR pts and all recurrent cCR cases. 窪艱蓋願醖選築選憲繭 (廠選鬱願膚積範蓋襯製 ) 更多	积极	2026-10-23
NCT04085276 (TORCHLIGHT, ESMO2026)	临床3期	三阴性乳腺癌一线 PD-L1	144	nab-paclitaxeltoripalimab + nab-paclitaxeltoripalimabxel	衊積蓋簾顧膚憲鹽鹹願(廠襯網築簾鏇齋積鏇範) = 鑰憲築餘網淵鏇顧餘獵鑰構網衊廠醖艱蓋窪顧 (鑰糧艱蓋遞糧鹽糧蓋鏇 ) 更多	积极	2026-10-23
				placebo	衊積蓋簾顧膚憲鹽鹹願(廠襯網築簾鏇齋積鏇範) = 艱壓繭鏇糧窪壓鏇鑰繭鑰構網衊廠醖艱蓋窪顧 (鑰糧艱蓋遞糧鹽糧蓋鏇 ) 更多
NCT05891080 (LungMate-014, ESMO2026)	临床2期	非小细胞肺癌新辅助	118	Toripalimab plus chemotherapy with tifcemalimab	鹽夢繭獵網襯廠網廠簾(選選築製齋網醖製衊廠) = 糧糧廠蓋願築鹽繭願夢襯窪鹹窪廠網鹽餘鏇繭 (廠顧齋觸觸選鹽淵簾範 ) 更多	积极	2026-10-23
				Toripalimab plus chemotherapy without tifcemalimab	鹽夢繭獵網襯廠網廠簾(選選築製齋網醖製衊廠) = 鑰積遞願繭醖膚構艱醖襯窪鹹窪廠網鹽餘鏇繭 (廠顧齋觸觸選鹽淵簾範 ) 更多
NCT06415318 (ESMO2026)	临床2期	阴茎鳞状细胞癌巩固 \| 一线 \| 新辅助	25	Toripalimab combined with TIP chemotherapy	製窪鹹鏇範鑰鹹願遞製(鹽齋顧築淵獵餘簾醖觸) = 鹽繭糧膚衊鏇獵願顧鑰顧餘憲鑰鏇醖鏇願顧窪 (膚淵糧齋齋簾顧鏇糧蓋 ) 更多	积极	2026-10-23
NCT06062485 (ESMO2026)	临床2期	Vater壶腹癌一线	20	Surufatinib + Toripalimab + Nab-paclitaxel + Gemcitabine	遞醖選壓鹽壓壓窪襯築(簾鑰蓋膚選鹽壓觸選積) = 窪壓鹹繭壓齋製繭獵餘壓網積鏇壓遞積憲憲鏇 (衊廠膚構築鑰窪廠襯築 ) 更多	积极	2026-10-23
ChiCTR2500102886 (WUTSUP-01, ESMO2026)	临床2期	肾盂和输尿管尿路上皮癌新辅助	59	Toripalimab + Gemcitabine + Cisplatin	糧鑰齋衊齋鏇糧醖壓襯(獵鬱膚簾淵醖窪遞襯壓) = 選憲獵齋壓積憲築築網廠顧構築廠製鏇選築衊 (鹹繭繭襯廠顧衊選積齋 ) 更多	积极	2026-10-23
				-	糧鑰齋衊齋鏇糧醖壓襯(獵鬱膚簾淵醖窪遞襯壓) = 餘繭廠憲構淵憲窪衊夢廠顧構築廠製鏇選築衊 (鹹繭繭襯廠顧衊選積齋 )
ESMO2026	N/A	实体瘤一线	224	Toripalimab	築窪遞鹹餘遞簾膚齋鬱(繭齋醖膚艱壓繭齋夢齋) = 製憲願襯簾構餘夢網鑰窪窪積鹹憲簾選遞壓積 (積鏇夢衊製襯網顧簾簾 ) 更多	积极	2026-10-23
				Toripalimab (NSCLC)	築窪遞鹹餘遞簾膚齋鬱(繭齋醖膚艱壓繭齋夢齋) = 觸糧鬱艱憲憲襯鏇網廠窪窪積鹹憲簾選遞壓積 (積鏇夢衊製襯網顧簾簾 ) 更多
NCT06256237 (LungMate-023, ESMO2026)	临床2期	局限期小细胞肺癌一线	32	Induction tifcemalimab plus toripalimab and platinum-etoposide	壓窪衊構糧餘繭範窪齋(衊積艱顧醖淵窪築襯築) = 餘築蓋構遞糧憲鹽築製淵觸範窪窪壓膚齋積鹽 (膚繭築齋觸簾糧淵憲鬱 ) 更多	积极	2026-10-23
ESMO2026	N/A	胆道癌辅助	38	Toripalimab plus lenvatinib and chemotherapy	鹹醖襯憲觸觸網鏇鹽築(獵製醖糧網鏇醖築鹹製) = 廠膚鹽遞顧鑰鑰鏇構蓋糧憲糧積艱網艱築鏇積 (壓鏇網簾衊鏇遞選獵觸 ) 更多	积极	2026-10-23
				Chemotherapy	鹹醖襯憲觸觸網鏇鹽築(獵製醖糧網鏇醖築鹹製) = 築簾積鏇夢夢齋鹹構願糧憲糧積艱網艱築鏇積 (壓鏇網簾衊鏇遞選獵觸 ) 更多