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+ [73]

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Topalliance Biosciences, Inc.

中国医学科学院肿瘤医院

+ [5]

非在研机构

德琪医药有限公司

泰州君实生物医药科技有限公司

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)

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结构/序列

Sequence Code 453640391L

来源: *****

Sequence Code 524455911H

来源: *****

关联

812

项与特瑞普利单抗相关的临床试验

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

NCT07808216

/ Not yet recruiting临床2期IIT

A Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Combined With Intravesical Gemcitabine as Adjuvant Therapy After Transurethral Resection of Bladder Tumor (TURBT) in Patients With High-Risk Urothelial Carcinoma

This is a prospective, open-label, single-center, single-arm phase II clinical study to evaluate the efficacy and safety of toripalimab combined with intravesical gemcitabine as adjuvant therapy in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) after transurethral resection of bladder tumor (TURBT). Patients with high-risk NMIBC are planned to be enrolled. Treatment consists of one immediate intravesical instillation of gemcitabine after TURBT, followed by induction intravesical chemotherapy with gemcitabine for 4-8 instillations, and then maintenance treatment with toripalimab combined with intravesical gemcitabine 2000 mg once monthly for 12 instillations.

开始日期2026-10-01

申办/合作机构

天津市第一中心医院

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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672

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 ; Shi, Lishuo ; Huang, Meijin ; Li, Yunfeng ; Hou, Yujie ; Hu, Huabin ; Li, Weiwei ; Zhou, Jiaming ; Luo, Shuangling ; Li, Fangqian ; He, Zhen ; Hu, Jiancong ; Ling, Li ; Zheng, Zhuoxin ; Deng, Weihao ; Huang, Liang ; Liu, Ping ; Lan, Ping ; Xie, Xiaoyu ; Zhang, Yan ; Yang, Tao ; Zhang, Jianwei ; Wang, Chao ; 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.

2026-08-01·Urologia Journal

Association between immune-mediated cystitis and PD-1, PD-L1, CTLA-4, and LAG-3 immune checkpoint inhibitors: A pharmacovigilance study from the FAERS database

Article

作者: Frey, Connor

Background::

Immune checkpoint inhibitors (ICIs) have transformed oncology but predispose patients to immune-related adverse events. Immune-mediated cystitis represents a rare yet clinically significant urological complication requiring enhanced surveillance. This studies characterizes the pharmacovigilance profile of immune-mediated cystitis across ICI classes using real-world post-market surveillance data.

Patients and methods::

This disproportionality analysis utilized the FDA Adverse Event Reporting System (FAERS) database, encompassing reports from Q4 2003 through Q3 2025. Fourteen ICIs were evaluated across four mechanistic classes: PD-1 ( n = 7), PD-L1 ( n = 4), CTLA-4 ( n = 2), and LAG-3 ( n = 1) inhibitors.

Results::

Among 14,104,743 adverse event reports, 69 cases of immune-mediated cystitis were identified. PD-1 inhibitors demonstrated the strongest signals: pembrolizumab (ROR 241.59; 95% CI 149.40–390.68; n = 28), nivolumab (ROR 118.56; 95% CI 68.56–205.02; n = 17), toripalimab (ROR 454.65; n = 2), and tislelizumab (ROR 266.31; n = 3). Ipilimumab exhibited robust disproportionality (ROR 297.28; 95% CI 167.73–526.89; n = 15). PD-L1 inhibitors showed minimal signals with isolated cases.

Conclusion::

Immune-mediated cystitis demonstrates strongest association with PD-1 and CTLA-4 inhibitors, warranting enhanced clinical surveillance, prompt recognition, and evidence-based management protocols.

4,827

项与特瑞普利单抗相关的新闻（医药）

2026-09-18

·医脉通

2026 CSCO | GC101 TIL研究荣膺优秀论文一等奖暨2026创新研究奖，斯璐教授解读GC101 TIL疗法如何破局PD-1耐药黑色素瘤

2026年9月17日至19日，第29届中国临床肿瘤学会（CSCO）学术年会在山东济南召开，本次大会聚焦肿瘤临床前沿，交流实践经验，分享研究成果。在恶性黑色素瘤专场，北京大学肿瘤医院主任医师、博士生导师斯璐教授，以“自体肿瘤浸润淋巴细胞（GC101 TIL）在PD-1抗体耐药晚期黑色素瘤中的疗效与安全性：一项多中心、开放标签、随机对照的关键Ⅱ期临床试验（MIZAR-003）”为题，汇报了GC101 Ⅱ期研究的数据结果。该研究凭借严谨的随机对照设计与突出的临床价值，荣获本届CSCO年会优秀论文一等奖，并同时斩获2026 CSCO创新研究奖，成为本届年会最受瞩目的肿瘤临床研究之一，引起现场专家的广泛关注。值得关注的是，该研究此前已入选2026年美国临床肿瘤学会（ASCO）年会最新突破性摘要（Late-Breaking Abstract, LBA），以口头报告形式公布（LBA 9509）[1]，成为今年63项LBA中唯一一项细胞疗法临床研究，也是ASCO历史上全球首个入选LBA的实体瘤细胞疗法临床研究。从ASCO年会的重磅口头报告，到CSCO年会优秀论文一等奖与2026创新研究奖“双奖”加身，这项由中国学者主导、源自中国原创细胞制备工艺的TIL研究，持续获得国际、国内顶级学术舞台的高度认可。正值CSCO年会召开之际，医脉通特邀斯璐教授，对MIZAR-003研究结果进行解读，分享黑色素瘤免疫治疗耐药的诊疗现状与展望。面对黑色素瘤后线治疗困境，细胞疗法带来新曙光中国黑色素瘤的疾病谱与欧美存在显著差异。欧美患者以皮肤型为主，而我国患者中肢端型约占一半，黏膜型约占四分之一，两者合计超过四分之三；相比之下，欧美人群中这两类亚型合计不足5%。这一流行病学特征不仅影响分子分型，也直接关系到免疫治疗的应答。既往研究显示，肢端型和黏膜型黑色素瘤对免疫检查点抑制剂（ICI）的敏感性低于皮肤型。研究显示[2]，中国晚期黑色素瘤患者对PD-1单抗的客观缓解率（ORR）约为17.3%，远不及西方人群。更值得注意的是，对于PD-1单抗治疗失败的患者，尤其是肢端型和黏膜型患者，后线治疗中临床可选方案十分有限，目前化疗的疗效欠佳，亟需新的治疗策略。对此，细胞疗法作为一种新型抗肿瘤手段，在血液肿瘤中取得研究成功后，近些年来逐步在实体瘤中进行探索。而TIL疗法在实体瘤中的尝试，也在黑色素瘤治疗中率先取得亮眼的成绩，有望为免疫治疗耐药黑色素瘤患者带来新治疗策略。全球首个黑色素瘤TIL疗法随机对照研究结果出炉：后线ORR 42.0%，中位PFS 4.3个月 MIZAR-003是一项开放标签、随机对照、多中心的关键Ⅱ期临床试验，于2024年12月启动，由北京大学肿瘤医院郭军教授牵头，在国内25家顶尖肿瘤中心开展，主要研究终点为经独立评审委员会（IRC）按RECIST v1.1评估的无进展生存期（PFS）。研究入组均为PD-1单抗治疗失败的晚期黑色素瘤患者，中位既往系统治疗线数为2线，肢端和黏膜型占比81.8%，中位靶病灶直径之和（SOD）为68.4 mm，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%。经随机化分组，试验组和对照组基线特征均衡。这是全球首个针对后线黑色素瘤开展的TIL疗法随机对照临床研究。2024年美国食品药品监督管理局（FDA）批准的首款TIL疗法主要基于单臂研究，而MIZAR-003采用随机对照设计，研究质量更高、证据等级更强、科学性更严谨。研究结果显示，GC101 TIL组中位PFS达4.3个月（95% CI 3.0～5.6），显著优于ICC组的1.6个月（95% CI 1.3～2.7）；HR为0.43（95% CI 0.26～0.68），P=0.0002，意味着接受GC101治疗的患者疾病进展或死亡风险降低57%，主要研究终点顺利达成。总生存期（OS）数据尚未成熟，GC101组中位OS尚未达到；值得注意的是，ICC组有高达57.1%的患者在进展后交叉接受GC101 TIL治疗，在这一交叉治疗的干扰下，GC101组仍显示出生存获益趋势。图1. MIZAR-003研究患者PFS数据在ORR方面，GC101 TIL组高达42.0%（21/50），而ICC组仅6.1%（3/49）。GC101组还有部分患者在长期PR后进一步转化为CR，最长缓解持续时间（DoR）已超过12个月，展现出深度且持久的缓解潜力。与国外历史数据[3]间接对比，在低强度清淋、免IL-2的方案下，GC101在肢端/黏膜为主、多线失败、高肿瘤负荷的更难治人群中取得相当的PFS、甚至更优的ORR，显示出令人鼓舞的疗效信号。图2-3. MIZAR-003研究GC101组和化疗组患者疗效瀑布图药物设计优化：低强度清淋、免IL-2，治疗相关死亡0% 由于传统的TIL细胞对IL-2有依赖性，在体内存活与扩增能力有限，且需清除内源性淋巴细胞竞争、补充细胞因子支持，传统TIL疗法需要高强度清淋化疗并联合大剂量IL-2给药。GC101颠覆了传统TIL疗法的这种固有给药模式，从根源上减少相关不良事件（AE）。这来源于GC101在药物设计与制备工艺上的优化，主要体现在以下方面：第一，优化清淋预处理方案。传统清淋药物如氟达拉滨具有极强的骨髓抑制作用，不仅损伤免疫系统，还会影响TIL细胞生长。GC101采用低强度预处理，并通过免疫调节策略上调肿瘤细胞表面主要组织相容性复合体I类（MHC-I）分子表达，使抗原呈递更加活跃，回输的TIL细胞能更精准地识别抗原并杀伤肿瘤。这不仅降低了清淋毒性，还起到免疫增效作用；第二，革新细胞培养工艺，去除对IL-2的依赖。传统TIL体外培养需加入高浓度IL-2和滋养细胞，导致产出的TIL细胞对IL-2产生巨大依赖，回输后必须补充大剂量IL-2（如60 kg患者单次需约3600万单位），中国患者往往难以耐受多次大剂量输注。GC101在培养过程中将IL-2浓度降至常规的10%左右，并采用由多种细胞因子、抗体和小分子化合物组成的“鸡尾酒”配方进行联合培养。这种工艺不仅使TIL细胞的扩增倍数与传统方法相当，而且产出的TIL细胞表面抑制性分子如PD-1、T细胞免疫球蛋白和黏蛋白结构域分子3（TIM-3）表达明显下降，细胞活性更优。整个生产周期保持在21天左右。从整体安全性结果显示，GC101组不良反应可控，≥3级不良事件主要是预处理导致的血液学毒性。这些不良事件多集中在预处理阶段、呈一过性，中位持续时间仅8天，短于化疗对照组的13天（其中血液学毒性均为9天，非血液学毒性为7天 vs 16天）。相较于既往数据，GC101的安全性表现更加亮眼：未发生治疗相关死亡事件（0% vs 7.5%），无患者出现持续30天以上的≥3级血细胞减少（0% vs 45.5%），红细胞和血小板输注率均低于5%，多数患者无需额外干预即可恢复，实现快速出院。凭借优异的安全性，GC101组未观察到大剂量IL-2相关的毛细血管渗漏综合征、低血压以及发热性中性粒细胞减少等毒性，临床应用不再依赖ICU，住院时间更短、恢复更快，可以覆盖更多医院、满足更多患者的治疗需求。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大幅降低，同时也为更广泛的联合疗法奠定基础。从后线到前线，从黑色素瘤到其他实体瘤，期待GC101为更多肿瘤患者带来新治疗方法 GC101采用了低强度清淋、免IL-2的创新方案，在保障优异疗效的前提下大幅降低毒副作用，代表着“下一代TIL疗法”，充分展示了中国在细胞治疗工艺创新上的硬核实力。随着该研究在ASCO年会和CSCO年会的相继报道，并荣膺CSCO优秀论文一等奖与2026创新研究奖，GC101后续有望获得国家药品监督管理局（NMPA）批准上市。当前，2026版CSCO黑色素瘤诊疗指南已将GC101纳入推荐。GC101针对多种实体瘤的一线治疗、辅助治疗也已获批IND，即将开展临床试验。更令人期待的是，GC101的未来不会仅仅局限于黑色素瘤，其他实体瘤的探索也已提上日程，正在开展治疗NSCLC的II期研究。以TIL疗法为代表的细胞免疫治疗，从黑色素瘤出发，未来必将惠及更多实体瘤患者。参考文献 [1]Lu S, et al. A multicenter, randomized, controlled, open-label, phase II trial of autologous tumor-infiltrating lymphocytes (GC101 TIL) in patients with advanced melanoma. 2026 ASCO. LBA 9509. [2]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. [3] Theresa Medina, et al. Long-Term Efficacy and Safety of Lifileucel Tumor-Infiltrating Lymphocyte Cell Therapy in Patients With Advanced Melanoma: A 5-Year Analysis of the C-144-01 Study. J Clin Oncol 43, 3565-3572 (2025). 审校：Leon 排版：Atai 执行：Atai 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，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。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

2026-09-17

·今日头条

张江药谷释放信号：59款新药+千亿BD，A股看这些

2026张江药谷大会暨上海国际生物医药产业周9月17日在张江科学会堂开幕，主题“AI驱动创新，打造全球健康共同体”。大会披露两组硬数据：今年以来全国批准上市创新药59个，其中13个为新机制、新靶点药物；1—8月全国生物医药BD交易113起，总金额1199.97亿美元，上海37起、占全国33%，位列第一。上半年口径曾为获批38款、新机制11款，8个月增至13款，原始创新从“量变”走向“质变”的轨迹清晰。 BD金额破千亿美元、上海占比超三成，说明中国创新药不再只拼国内医保，而是把管线、临床数据、海外权益打包进全球交易。张江会场同步设美国、英国、爱尔兰、澳大利亚、东南亚专场，直接对接监管、临床与资本，产业从“研发内循环”切到“出海外循环”。上海1—8月融资125起、披露185.36亿元，1—7月生物医药制造业产值1208.27亿元、同比增7.1%，1—8月6个国产1类创新药、19个三类创新器械获批，区域底盘扎实。按“获批放量—BD出海—研发外包”三层映射A股，仅作产业梳理，不构成买卖建议。一、综合创新药龙头恒瑞医药（600276）：多技术平台、商业化底座稳，海外BD持续落地，属于创新药中军。百济神州（688235）：全球化商业与临床体系成熟，泽布替尼等海外收入占比高，对BD高景气敏感。复星医药（600196）：自研加引进并行，复宏汉霖单抗与生物类似药管线有出海基础。二、ADC、双抗、新靶点弹性标的百利天恒（688506）：双抗ADC与海外大药企合作，首付款及里程碑弹性大。荣昌生物（688331）：维迪西妥单抗有海外授权基础，ADC与自免管线后续BD预期强。科伦药业（002422）：科伦博泰ADC授权默沙东，管线兑现度较高。君实生物（688180）：特瑞普利单抗多国获批，PD-1及新管线继续推进国际化。迪哲医药（688192）：小分子差异化新靶点，舒沃替尼海外授权落地，弹性伴随临床数据波动。三、CXO“卖水人” BD每新增一笔，前端发现、安评、全球多中心临床、商业化生产都会产生订单。药明康德（603259）一体化CRDMO，承接小分子、多肽、ADC、小核酸等外包；泰格医药（300347）做临床CRO，海外授权后多中心试验需求直接增厚；凯莱英（002821）小分子与多肽CDMO，GLP-1、ADC商业化样品受益；康龙化成（300759）药物发现到临床前一体；昭衍新药（603127）非临床安评刚需；益诺思（688710）上海本地非临床安评，直接承接张江及全国申报；博腾股份（300363）化学与基因/细胞治疗CDMO；普洛药业（000739）原料药加CDMO，承接放量后供应链订单。四、上海本地与产业链配套上海医药（601607）：分销加工业一体，创新药获批后放量渠道受益；浦东、张江相关研发与转化资源密集，本地CRO、器械、AI制药企业间接受大会生态带动。东富龙（300171）、楚天科技（300358）属设备端，药企扩产与CDMO建产能带动采购，节奏慢于CXO，只作观察。创新药研发周期长，临床失败、BD首付款不及预期的、海外监管与医保价格、汇率及地缘合规都会影响股价。59款获批、1199.97亿美元BD是行业景气证据，不等于单家公司当年利润兑现。仓位按“龙头打底、ADC/双抗做弹性、CXO做 Beta”分配，回避无管线、纯概念、频繁蹭热点标的。

抗体药物偶联物上市批准

2026-09-17

·癌度

癌度晚报：ALK漏检，招募PD-1耐药黑色素瘤

🗞️ 癌度晚报 · 9月17日一、ALK融合漏检警示：常规“全阴性”后，全外显子组揪出Y染色体融合患者：43岁，不吸烟，肺腺癌IVB，常规小panel基因检测全阴性，免疫组化ALK微弱信号被忽略。经过：一线化疗+免疫、二线多西他赛+特瑞普利单抗、三线安罗替尼+长春瑞滨均失败，CEA飙至438，肝损伤。转机：重新活检，全外显子组测序发现ALK与Y染色体罕见融合，断裂点在ALK第19内含子，保留激酶功能。洛拉替尼一个月起效，病灶快速缩小。启示：年轻、不吸烟、肺腺癌，常规检测阴性≠真的没有靶点，应讨论全外显子组检测免疫组化微弱/局灶信号，可能是复杂融合的线索多线失败时，重新活检比盲目换药更有价值 ALK属“冷肿瘤”，免疫治疗获益有限，先免疫后靶向可能增加毒性二、PD-1耐药黑色素瘤：国产溶瘤病毒OH2 III期招募药物：OH2（重组人GM-CSF溶瘤II型单纯疱疹病毒），瘤内注射机制：敲除神经毒和免疫抑制基因，插入GM-CSF，在肿瘤内复制裂解癌细胞，同时激活全身免疫 I期数据：安全性：无≥3级TRAE，无SAE Ia期：1年OS 92.9%，中位OS 28.9个月 Ib期：ORR 37% PD-1经治亚组：ORR 58.3%，DCR 75% III期研究（NCT05868707，全国30家中心）：入组：≥18岁，III/IV期黑色素瘤，至少二线失败，有可注射病灶，ECOG 0-1 对照：挽救化疗或最佳支持治疗 ⚠️ 黏膜型比例≤22%，需提前确认名额 📞 扫码咨询癌度｜解读报告 · 评估入组

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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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适应症

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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	遞積淵衊獵製製醖餘膚(蓋繭選衊築築廠衊夢觸) = 觸範築鬱淵餘廠齋觸鑰衊艱鏇糧衊廠衊醖顧夢 (觸顧衊繭獵鑰選顧積觸 ) 更多	积极	2026-09-12
WCLC2026	N/A	非小细胞肺癌一线	50	Toripalimab in combination with chemotherapy	艱選壓鹹糧簾鬱網齋鹽(淵鬱鏇積夢衊製鬱獵憲) = 齋築願觸夢範淵鏇艱選鏇憲糧選構餘鏇積艱繭 (鬱築遞網範築衊蓋艱鹽 ) 更多	积极	2026-09-12
				Toripalimab in combination with chemotherapy (PD-L1 ≥50%)	餘網鏇膚範廠選糧遞鏇(廠觸鹹艱選窪淵製鑰網) = 壓積衊夢築壓壓鹽網範醖醖觸壓顧構範繭艱憲 (鬱窪鹹窪鏇鑰鑰淵獵齋 ) 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	簾築餘鑰遞襯廠艱襯夢(簾憲壓簾餘糧觸積鏇願) = 齋構鏇積願淵鬱衊築鑰遞構憲膚選構夢築繭淵 (蓋憲廠鬱簾遞觸廠餘廠, 78 ~ 96) 更多	积极	2026-08-01
				Toripalimab monotherapy	簾築餘鑰遞襯廠艱襯夢(簾憲壓簾餘糧觸積鏇願) = 鬱淵製廠遞簾願製艱製遞構憲膚選構夢築繭淵 (蓋憲廠鬱簾遞觸廠餘廠, 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	醖夢夢壓選餘衊壓構鬱(築構選艱窪鹹艱衊壓夢) = 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). 膚淵構構窪選遞範網製 (顧餘齋鹽鹽鑰選鑰鬱夢 ) 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	憲襯壓觸醖簾膚繭憲膚(壓選膚憲膚獵繭膚憲憲) = 糧憲齋壓衊壓窪簾淵夢壓製觸積積遞鑰製蓋獵 (鑰顧範簾淵艱顧簾鏇遞 ) 更多	积极	2026-07-14
ESMO_GI2026	N/A	食管鳞状细胞癌一线	42	Toripalimab + chemotherapy	壓齋鏇憲夢積夢膚獵簾(艱膚壓簾願顧積餘簾顧) = 膚糧衊壓範淵鬱壓顧簾範獵遞衊廠觸簾壓膚壓 (鏇淵齋淵網獵夢蓋鏇觸 ) 更多	积极	2026-07-02
				Toripalimab + chemotherapy (PD-L1 ≥1%)	壓齋鏇憲夢積夢膚獵簾(艱膚壓簾願顧積餘簾顧) = 願衊壓膚獵製鏇艱糧網範獵遞衊廠觸簾壓膚壓 (鏇淵齋淵網獵夢蓋鏇觸 ) 更多
ASCO_Breakthrough2026	N/A	食管鳞状细胞癌新辅助	916	Toripalimab-based regimens	簾糧鑰齋鏇構齋顧範鬱(蓋鏇積繭淵壓蓋窪獵遞) = 糧鬱獵獵蓋鹹鏇鹹願鏇築願鑰網襯淵醖餘蓋網 (鹽窪積範鹹壓鬱窪構齋 )	积极	2026-06-25
				Camrelizumab-based regimens	簾糧鑰齋鏇構齋顧範鬱(蓋鏇積繭淵壓蓋窪獵遞) = 鑰餘鬱餘夢淵壓廠築艱築願鑰網襯淵醖餘蓋網 (鹽窪積範鹹壓鬱窪構齋 )
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	鏇膚製餘醖鏇鑰夢壓鏇(襯淵築積選築選廠壓積) = 願襯糧獵夢獵鏇顧構鏇網製鏇網觸觸製繭壓壓 (範夢淵齋鹹蓋顧鹹糧積 ) 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%)	鹽蓋艱遞窪鑰積壓鏇衊(願鏇鏇繭壓餘襯醖製鬱) = 襯齋鹽窪遞醖艱築顧蓋淵衊蓋製壓齋網願築膚 (窪網壓醖選襯遞選壓齋 ) 更多	积极	2026-06-25
				Toripalimab (PD-L1 <1%/not done/unknown)	鹽蓋艱遞窪鑰積壓鏇衊(願鏇鏇繭壓餘襯醖製鬱) = 憲鏇淵觸繭齋糧鬱廠淵淵衊蓋製壓齋網願築膚 (窪網壓醖選襯遞選壓齋 ) 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)	夢簾觸築積遞觸構壓範(淵繭鏇憲淵窪繭壓餘積) = 壓廠艱築壓築齋糧鏇獵糧襯繭窪願鹹鬱膚製艱 (顧鏇顧網觸鏇鏇顧網積, 54.1 ~ 88.2) 更多	积极	2026-06-25
				Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen) (non-pCR group)	齋糧糧夢製鏇衊餘鑰醖(夢獵鏇積壓夢鹹顧衊製) = 觸鏇淵繭鏇醖積構繭網遞獵淵繭糧淵膚衊顧鏇 (觸鬱蓋夢願廠構觸襯觸, 12 ~ NR) 更多