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

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

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100 项与特瑞普利单抗相关的专利（医药）

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708

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.

2026-08-01·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.

4,741

项与特瑞普利单抗相关的新闻（医药）

2026-09-08

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《大国新药》国际版02期｜ADC商业化时代：从CMC卓越到构建全球竞争力

《大国新药》为什么要做国际版自2021年《大国新药》正式开播以来，我们对谈了百余位嘉宾，记录了中国创新药从"跟跑"到"并跑"的每一步。如今，中国生物医药产业已完成范式升级：License‑out 交易总额突破千亿美元，实现从创新 “引进来” 到成果 “走出去” 的转变，本土临床、CDMO 供应链深度融入全球，从产品出海走向参与全球创新共建，收获海外药企主动合作。但中外仍存在认知壁垒，海外对中国创新仍存有低成本、快交付的刻板印象，国内企业也有 “授权出海即落地” 的误区，双方缺少平等深度的交流。在此背景下，《大国新药》正式推出国际版，由凯莱英生物、E药经理人、微解药联合主办，聚焦医药创新全球化，打造中西方创新者平等对话的专业平台。抗体药物偶联物（ADC）作为生物医药领域的王牌赛道，凭借精准靶向、高效抗肿瘤的核心优势，已迈入规模化商业化落地的关键新阶段。当下，全球ADC赛道竞争日趋白热化，靶点同质化、工艺迭代加速、全球监管标准趋严、供应链稳定性不足等问题，成为制约国内ADC企业从“临床突破”迈向“全球化商业化”的核心瓶颈。在ADC商业化下半场，创新不再局限于分子结构与药物设计，CMC工艺能力、商业化制造体系、全球合规布局、供应链战略已成为决定企业核心竞争力的关键底色，更是国内药企出海突围、对标国际顶尖企业的重要支点。 9月23日19:30，《大国新药·国际版》第二期节目将聚焦“ADC商业化时代：从CMC卓越到构建全球竞争力”，集结四位中美行业重磅嘉宾，涵盖中美Biotech、CMC咨询、CDMO多元视角，深度拆解ADC商业化全链路核心难题。中方嘉宾： ·冯辉，安领科生物创始人、CEO ·李铁军，凯莱英生物CMC负责人国际嘉宾： ·George Procopiou, Valink Therapeutics ADC化学与工程副总裁 ·Ray Sison，SCxCMC Solutions管理合伙人、联合创始人主持人：戚飞，君联资本执行董事嘉宾简介向上滑动查看 Hui Feng Founder & CEO Allink Biotherapeutics Dr. Hui Feng graduated from Tsinghua University in 1997 with a degree in Biological Sciences and Biotechnology. He subsequently earned a Ph.D. in Molecular Pharmacology from Albert Einstein College of Medicine at Yeshiva University in 2003. With nearly two decades of experience in innovative drug discovery and development, Dr. Feng has held a number of senior leadership and scientific positions, including ADPE Scientist at MedImmune, the U.S. biologics division of AstraZeneca; Chief Operating Officer of TopAlliance Biosciences in the United States; and Chief Operating Officer of Shanghai Junshi Biosciences. In 2023, he founded Allink Biotherapeutics, where he serves as Chief Executive Officer, focusing on the global development of highly differentiated bispecific antibodies and bispecific antibody-drug conjugates (ADCs). Dr. Feng brings extensive expertise in innovative drug development, global strategic planning, and the coordination and submission of IND and BLA applications in China and international markets. He is the inventor of more than 30 patents and has led the development of nearly 20 first-in-class antibody therapeutics. Among these, toripalimab became the first domestically developed PD-1 antibody to receive marketing approval from both China’s NMPA and the U.S. FDA, helping usher in a new era of cancer immunotherapy. In collaboration with the Institute of Microbiology of the Chinese Academy of Sciences and Eli Lilly, Dr. Feng also led the development and advancement of etesevimab, a neutralizing antibody targeting COVID-19. Etesevimab received emergency use authorization in 17 countries with exceeding one million doses distributed worldwide. George Procopiou Vice President of ADC Chemistry and Engineering, Valink Therapeutics George Procopiou is Vice President of ADC Chemistry and Engineering at Valink Therapeutics, leveraging over a decade of experience in the ADC oncology space. Prior to Valink, he served as Director of Chemistry at Pheon Therapeutics (formerly ‘Femtogenix’), where he supported multiple clinical programmes and the raising of $200M in Series A and B financing. He played a critical role in defining company-wide chemistry strategy, with end-to-end responsibilities spanning early pipeline discovery through IND-enabling activities. He has led numerous preclinical R&D initiatives, with particular expertise in the development of novel linker–payload platforms. His work has encompassed: molecular and synthetic route design and optimisation, laboratory build-out and operations, procurement and outsourcing, bioconjugation, in vitro and in vivo profiling, pharmacology, and high-potency H&S. Under the CMC remit, he facilitated delivery of all CTM, including process development and regulatory submissions, as well as GMP resupplies of mAb, LP, DS and DP. Femtogenix was spun out following his Postdoctoral studies in Prof. David Thurston’s group at King’s College London (KCL). Previously, he has also completed placements at GlaxoSmithKline (GSK), Peakdale Molecular, and the University of Crete, along with his first Postdoc at the University of Nottingham – amassing 15 years’ overall experience as a bench scientist. George obtained his PhD also from the University of Nottingham, and his undergraduate degree from University College London (UCL). He has filed 14 patents, published 19 papers and review articles, and has presented regularly at international conferences (e.g., the AACR). Tiejun Li Head of CMC , AsymBio Dr. Tiejun Li leads the CMC and Project Management functions at AsymBio and is responsible for advancing the CMC strategy, driving technical innovation, and supporting cross-functional project execution. He received his Ph.D. in Chemistry from UCLA and his B.S. in Applied Chemistry from Peking University. With nearly 20 years of experience in the biopharmaceutical industry, Dr. Li brings extensive expertise in biologics development, including antibodies, ADCs, and fusion proteins. He has contributed to more than 20 IND and NDA/BLA submissions across global markets, with experience spanning technology transfer, process scale-up, cGMP manufacturing, and regulatory submissions to major agencies including the FDA, EMA, and NMPA. As a strategic technical leader, he supports AsymBio’s end-to-end CMC capabilities and high-quality project delivery across the portfolio. Ray Sison Managing Partner & Co-founder, SCxCMC Solutions Ray Sison, Managing Partner at SCxCMC Solutions, Founder and Executive Director of SOPPhC (Society of Professional Pharmaceutical Consultants), and Editor at Large at CDMO World. With over 30 years of experience in CMC strategy, tech transfer, and pharmaceutical manufacturing, Ray specializes in helping biotech companies scale from clinical to commercial supply. He has directed or advised on over $250 million in outsourced manufacturing and packaging contracts, and supported successful launches of products including Orgovyx®, Xhance®, Nuzyra®, and Onzetra Xsail®. Ray brings deep cross-project expertise in CDMO selection, supply chain optimization, commercial tech transfer, contract negotiation, and global manufacturing footprint strategy across North America, Europe, and Asia. 主持人： Qi Fei Executive Director, Legend Capital Dr. QI Fei Joined Legend Capital in 2014. Now he is an Executive Director of Legend Capital focusing on investments in innovative biotechnology, digital health and cross border. Dr. Qi led or participated in investments including Ribolia (HK:06938)，Baheal Pharmaceutical (SZ:301015), SIPAI HEALTH (HK:0314), UBC Medical (IDX:LABS)、Diastika Bio (IDX:CHEK), Navi Therapeutics, BeYang Therapeutics, DeliNova，LncTAC, Accuedit, Nuwacell，CR Therapeutics，BioMap, ETANA, Exegenesis, Innostellar, Genskey，Oncologynews, VCBeat etc. Dr. Qi holds a Ph. D. degree in cell biology and a bachelor degree in biotechnology from Peking University. Prior to joining Legend Capital, Dr. Qi worked as a visiting scholar at University of California, Los Angeles (UCLA). 一审| 石宛佳二审| 李芳晨三审| 李静芝

2026-09-08

·搜狐新闻

中国创新药“新战场”

来源：药智网近日，驯鹿生物宣布澳大利亚药品管理局（TGA）已正式受理其CAR-T细胞产品伊基奥仑赛注射液（FUCASO）纳入澳大利亚治疗用品登记册（ARTG）的生物制品上市注册申请，并进入评估阶段，用于治疗既往经过至少3线治疗后进展的复发/难治性多发性骨髓瘤（r/r MM）成人患者。这一事件不仅是单家企业的国际化里程碑，更折射出中国创新药在澳大利亚（下称“澳洲”）战略定位的深刻转变：长期以来，澳洲一直是中国药企开展早期临床试验的“热土”与“跳板”，但真正在此实现商业化上市的案例寥寥无几。随着临床红利逐渐见顶、市场竞争日益激烈，以驯鹿生物为代表的中国药企正试图跨越临床数据与商业价值的鸿沟，将澳大利亚从验证全球数据的“试验田”，转变为兑现商业价值、积累国际监管信用的“新战场”。 01 FUCASO澳洲获受理：一条产品时间线里的行业信号 FUCASO是驯鹿生物自主研发的全球首款全人源靶向BCMA CAR-T细胞治疗产品，于2023年在国内获批上市，用于治疗既往经过至少3线治疗后进展的r/r MM成人患者。作为全球第一款商业化全人源CAR-T产品，自FUCASO获批上市以来，凭借其显著的疗效及安全性，已获多个国家和地区的监管批准。2025年1月，新加坡卫生科学局（HSA）受理FUCASO新药上市申请，2026年6月，新加坡正式批准FUCASO上市；2025年2月，中国香港卫生署受理，2025年11月，中国香港获批上市；2025年3月，中国澳门获批上市。同时，FUCASO还获得韩国食品药品安全部（MFDS）及沙特阿拉伯食品药品监督管理局（SFDA）授予孤儿药资格（ODD），加速当地注册审批。在此基础上，FUCASO进入澳大利亚TGA评估阶段，意味着其国际化版图进一步延伸到大洋洲市场。在此需要指出的是，在r/r MM赛道，澳洲市场已有强生/传奇生物的CARVYKTI（西达基奥仑赛，BCMA CAR-T细胞疗法）于2023年6月获批，适应症与FUCASO此次申报的高度一致。这意味着，FUCASO若未来获批，进入的将是一个高门槛市场。不过，FUCASO也有差异化基础。它是全球首个商业化的全人源靶向BCMA CAR-T，而CARVYKTI的scFv为人源化小鼠序列。全人源结构在理论上可能带来更低免疫原性和更持久的体内存续，但这一优势仍需真实世界数据和更大规模临床验证支持。从临床数据看，FUMANBA-1研究36个月随访显示，109例接受治疗的r/r MM患者中，可评估者总缓解率96.3%，完全缓解率83.2%，中位无进展生存期30.5个月；在既往未接受过CAR-T治疗的亚组中，总缓解率98.9%，完全缓解率88.4%，中位无进展生存期35.9个月，中位总生存期尚未达到。这些数据为FUCASO参与国际竞争提供了基础。进军澳洲，对驯鹿自己来说，不过是国际化棋局中顺理成章的一步；但放到整个中国创新药出海的大棋局里，这次澳洲获受理有着里程碑式意义：澳大利亚，过去中国药企扎堆做临床的地方，现在正在变成大家抢着做商业化的新战场。 02 澳大利亚为何先成为中国创新药的“临床热土” 从百济神州2014年首次在澳洲启动临床试验起，澳大利亚逐渐成为中国药企海外早期临床布局的重要目的地。据公开资料，截至2026年8月，已有超过70家中国创新药企业在澳大利亚开展临床试验，覆盖ADC、双抗/三抗、siRNA、GLP-1、CAR-T、疫苗、核药、CNS等多个热门赛道，其中约七成项目处于I期临床阶段。中国药企选择澳洲作为出海的重要早期试验场，是因为澳洲在早期临床阶段具备几个高度契合创新药全球化需求的条件。第一张牌：快。创新药临床研发最昂贵的成本之一，是时间。在美国，新药临床试验通常需要经历IND申报、pre-IND沟通、研究中心启动、患者入组等环节，整体周期较长。FDA新药临床试验申请审批需要60个工作日，算上pre-IND会议，从递交到实际启动临床，常常需要半年以上。澳大利亚则提供了另一条更轻量的路径。当地临床试验可以采用CTN（临床试验通知）模式：企业获得人类研究伦理委员会批准后，再向TGA备案即可开展试验。相比美国IND模式，这一流程更简化，也更适合早期临床快速启动。在CTN路径下，监管备案流程可在5至7个工作日完成。早期项目从伦理审查到实际启动，往往可在4至8周内推进。这种速度在具体案例中体现得很明显。百济神州的泽布替尼2014年在澳大利亚启动首例患者入组，仅用3个月便完成从方案确定到首例入组，半年完成剂量爬坡。对于现金流有限、需要尽快拿到首次人体数据的企业而言，澳洲的“快”具有至关重要的意义。第二张牌：认。澳洲临床的第二大优势，是数据的国际认可度。澳大利亚临床研究体系遵循ICH（国际人用药品注册技术协调会）规范，并采用GCP（药品临床试验规范）。这意味着在澳洲产生的临床数据，不只是“海外患者数据”，而是可被FDA、EMA等主流监管机构接受，用于支持国际申报和监管沟通。这也是澳洲区别于部分低成本新兴市场的重要地方。东南亚一些国家在成本和入组速度上有优势，但监管框架和ICH-GCP贴合程度参差不齐，FDA和EMA在审查数据时可能存在隐性门槛。因此，澳洲早期临床的价值，不只是“在海外做了试验”，而是帮助中国管线更快从“中国资产”向“全球资产”迈进。例如，国内盟科药业自主开发的抗生素新药MRX-5，依托在澳洲完成的I期临床试验数据，直接在美国启动IIa期临床试验。在BD交易中，这种国际认可度同样重要。2025年12月，复星医药与辉瑞达成全球独家许可合作，以总价高达20.85亿美元将旗下口服小分子GLP-1受体激动剂YP05002的全球权益授予辉瑞。该药在协议签署时已在澳大利亚进入临床I期阶段，降低了买方决策风险。第三张牌：省。澳洲吸引中国药企的第三张牌，是成本与研发税收激励。澳大利亚政府设有研发税收激励政策。对于符合条件的企业，尤其是年营业额低于2000万澳元的中小企业，最高可返还43.5%的研发支出。这一政策直接改变了澳洲早期临床的成本结构。叠加研发税收激励后，澳洲I期临床综合成本较美国可降低约50%至60%，这也是为什么澳洲尤其适合I期临床。澳洲并不是只靠政策和成本吸引中国药企。经过多年发展，当地已经形成较完整的早期临床服务生态。在CRO和I期临床机构方面，Nucleus Network、CMAX、Novotech、乔治临床等机构长期活跃于澳洲早期临床市场。科研和医疗基础设施也是澳洲的重要优势。澳大利亚拥有阿德莱德生物医学城、墨尔本生物医学区、黄金海岸健康与知识产业园区等医疗健康产业集群，并在传染病、免疫疾病、神经科学、癌症等领域具备较强科研基础。此外，Medicare公立医疗体系和全国性电子病历系统，也为临床研究和医疗数据管理提供了基础条件。据公开资料，2019年至2023年，澳洲承接了国内药企海外I期临床试验的38.8%，仅次于美国；也就是说每10项国内药企在境外开展的I期临床试验中，就有近4项发生在澳洲。临床热土的另一面：中国创新药在澳获批上市仍然不多。澳洲临床火热，并不自动等于商业化成熟。过去几年，中国创新药在澳大利亚获批上市的数量仍然有限。目前，国产药品通过TGA审批上市的种类主要涵盖化药、生物药及中药。代表性产品有百济神州的泽布替尼（套细胞淋巴瘤及华氏巨球蛋白血症）、复宏汉霖的汉曲优（曲妥珠单抗生物类似药，HER2阳性乳腺癌及胃腺癌）、诺诚健华的奥布替尼（BTK抑制剂，复发/难治性套细胞淋巴瘤）、君实生物的特瑞普利单抗（鼻咽癌）、以及众生药业治疗心脑血管的中成药——复方血栓通等。除此之外，能够明确列举的中国创新药在澳获批案例并不多。据行业发布的《2026年中国创新药出海行业研究报告》，截至2024年末，国产原创新药海外获批品种累计18个，绝大多数集中在欧美。因此，过去澳大利亚对中国创新药的主要角色，不是上市目的地，而是临床试验的前沿阵地。如今，新剧本缓缓展开，澳洲正在变成“商业化战场”。为什么澳洲正在变成商业化新“战场”？澳洲从“跳板”到“战场”的转变，是多重因素叠加的结果。澳大利亚人口目前约2800万，单看人口，它无法与美国、欧盟相比。但澳洲市场有几个不能忽视的特征。第一，医药支出持续增长。2024年澳大利亚医药市场规模约247亿美元，咨询机构IMARC预计到2033年将达到311亿美元。第二，疾病负担和老龄化带来持续需求。澳大利亚老龄化趋势明显，65岁以上人口比例预计达17%；癌症、心血管、代谢、免疫调节等领域需求持续增长。第三，澳大利亚约90%的药品依赖进口，大多数原料药也依赖进口；目前约有400种药品短缺，其中约30种被列为关键药品。支付端，澳大利亚药品福利计划（PBS）为公民和永久居民提供PBS清单内处方药补贴，保障居民的基本用药，目前约90%的处方药市场由PBS覆盖等。2022—2023财年，PBS共补贴约2.231亿份处方，总支出达170亿澳元，占全国药品费用的60%。这意味着，澳洲不是单纯的“临床跳板”，也是一个具备真实支付能力、进口依赖和高值药品通道的细分市场。 03 结语：对中国药企意味着什么？当然，澳大利亚终究只是一个约2800万人口的市场，其容量有限，不可能替代美国或欧盟。但正如过去十年它作为临床跳板的价值一样，今天它作为商业化战场的价值，恰恰在于其“小而完整”的生态：严格监管、国际认可、有支付体系、有真实竞争。对于中国创新药企来说，能够在这样一个市场证明自己，就意味着在全球市场的牌桌上，可以坐得更稳。澳大利亚未必是终点，但正在成为中国药企走向全球时越来越重要的一站。参考来源： 1.San-Miguel J,Dhakal B,Yong K,et al.Cilta-cel or standard care in lenalidomide-refractory multiple myeloma[J].N Engl J Med,2023,389(4):335-347. 2.中国药房《澳大利亚药品可及性政策介绍及对我国的启示》 3.https://www.mordorintelligence.com/industry-reports/australia-pharmaceutical-market. 声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。返回搜狐，查看更多

2026-09-08

·肿瘤界

中国创新药出海19大标杆案例启示：从本土研发到全球获批的产业新征程

点击蓝字关注我们从2019年泽布替尼叩开FDA大门、实现中国创新药出海“零的突破”，到2025年派安普利单抗、斯鲁利单抗、舒沃替尼三款新药接连斩获国际监管批准，中国创新药的国际化征程已驶入密集收获期。截至2025年底，累计已有19个中国药企自主研发的创新药成功实现海外获批，成为中国医药创新“走出去”的标杆样本。近期发布的《创新药全球同步研发策略及实践案例研究》系统复盘了这19个标杆案例，深度拆解其全球研发策略、市场准入路径与监管适配经验，勾勒出中国创新药从“仿制跟随”到“全球创新”的崛起脉络，也为行业提供了可复用的出海实操指引。案例基本信息 1 19个出海标杆：从“单兵突进”到“集团作战” 从领域分布看，抗肿瘤药是绝对主战场：19例中13款为抗肿瘤药，占比68.4%，覆盖肺癌、淋巴瘤、多发性骨髓瘤等重点瘤种；同时，非肿瘤赛道也在稳步拓展，覆盖艾滋病、高血压、眼科等6个品类，形成"肿瘤主导+多元突破"的格局。从时间轴看，出海浪潮持续高涨。以2019年泽布替尼获FDA批准实现"零的突破"为起点，2021-2022年稳步增长，2023年集中爆发（4款），2024年再添5款，2025年派安普利单抗、斯鲁利单抗、舒沃替尼3款获批，进入密集收获期，研发实力与国际认可度同步提升。从市场准入路径看，策略分层清晰：10款药物首站选择FDA（占比52.6%），以最严格监管体系验证全球价值；8款获EMA批准，巩固欧美双线布局；同时也覆盖PMDA及俄罗斯、厄瓜多尔等新兴市场，形成"主流市场突破+新兴市场拓展"的双轨打法。从企业类型看，创新驱动特征鲜明：15家为创新型生物科技公司（如百济神州、君实生物、传奇生物、和黄医药、贝达药业等），贡献了15个案例，凭借机制灵活、聚焦前沿靶点的优势，在新分子实体、CAR-T、PD-1/PD-L1等领域屡有斩获；此外，传统大型药企（石药集团）、科研院所+企业联合转化（旺山旺水）、专业生物制药平台/生产型企业（通化安睿特）、中外合资/合作开发（复宏汉霖）等多元主体也各自贡献了差异化路径，说明出海并非只有一条模式。 2 成功基石：精准锚定“未被满足的临床需求” 19个案例并非偶然成功，其共同底层逻辑是：精准识别并回应了全球监管机构和临床一线共同关注的"未满足临床需求"（Unmet Clinical Need）。监管机构（如NMPA、FDA、EMA）对此的评估通常围绕四个维度展开：疾病严重性与治疗现状、疗效升级需求、安全耐受与生活质量需求、作用机制与用药可及性需求。表：各监管机构判定产品未满足临床需求的评估维度评估维度核心描述判断标准疾病严重性与治疗现状判定临床缺口基础，病症重、现有治疗效果差，则需求缺口大 ①病症危重，危及生命、预后差或大幅降低生活质量 ②暂无合规有效治疗方案 ③常规标准治疗疗效偏弱疗效升级需求已有治疗方案下，新法疗效大幅提升，即存在临床缺口 ①显著提升ORR、PFS、OS等核心疗效指标 ②适配耐药、复发病患治疗 ③提升疾病完全缓解比例安全耐受与生活质量需求现有疗法药效尚可，但毒副作用大，患者难以耐受 ①相较传统方案毒性更低、安全性更高 ②精简诊疗流程，减轻病痛，改善生活质量 ③适配老年、体弱等不耐受常规治疗人群作用机制与用药可及性需求同类药物存在，但机制、给药方式、普及度仍有短板 ①具备全新作用机理，填补靶点治疗空白 ②给药形式更简便，提升患者用药依从性 ③拓宽药品适用范围，提升各地用药可得性 19个案例中，超过68.4%的适应证为预后极差的晚期或转移性恶性肿瘤，患者已对标准治疗失败或不耐受，治疗选择有限——这构成了最基础、最共通的临床缺口。在此基础上，不同产品在四个维度上呈现出差异化的价值主张，大致可归纳为四类打法：首创与突破型：解决"有靶无药"的空白问题。舒沃替尼针对EGFR 20号外显子插入突变肺癌，谷美替尼针对MET跳跃突变肺癌，均是相关靶点下国内首个、疗效显著优于传统化疗的精准治疗选择；西达基奥仑赛作为全球首款全人源BCMA CAR-T，为复发难治多发性骨髓瘤患者提供了"从无到有"的颠覆性细胞疗法；重组人血白蛋白注射液打破了传统人血白蛋白依赖血浆提取的产业瓶颈；艾博韦泰作为全球首个长效HIV融合抑制剂，将每日口服给药革新为每周一次注射给药，直击患者依从性痛点。优化与迭代型：解决"从有到优"的升级问题。泽布替尼作为新一代BTK抑制剂，可克服一代药物耐药问题；恩沙替尼作为新一代ALK抑制剂，入脑性更佳、安全谱更优；左旋氨氯地平作为改良型钙通道阻滞剂，降压效果更平稳持久且具心脑血管保护作用。可及与选择型：解决"降本提质"的可及性问题。曲妥珠单抗生物类似药与艾贝格司亭α，核心价值在于降低治疗成本、提升基层可及性；康柏西普通过技术输出拓展缅甸等新兴市场，填补当地眼科精准治疗药物空白。适应证开拓型：特瑞普利单抗、斯鲁利单抗分别在鼻咽癌、小细胞肺癌等特定癌种中率先验证了免疫治疗价值，填补了细分领域治疗空白。这提示行业一个清晰信号：出海成功的第一步，从来不是"跟随式模仿"，而是回到临床需求本身，找准现有治疗格局中真正的缺口。 3 战术复盘：三个维度看透出海路径选择在临床需求之上，具体的出海路径选择还需结合三个战术维度综合研判。其一，流行病学特征决定主战场选择。19个案例呈现"全球性主流疾病+地域性特色疾病+技术前沿赛道"三位一体的布局。全球高发疾病（如高血压、多种实体瘤）是市场空间最大的主战场；地域性特色疾病（如中国及东南亚高发的鼻咽癌、结直肠癌，非洲及东南亚高发的艾滋病）则是差异化突破口，中国企业往往依托本土患者资源和临床经验形成"不对称竞争优势"；而CAR-T、重组蛋白等技术前沿赛道，则是通过技术本身实现"跟跑到领跑"跨越的关键。其二，全球标准治疗差异决定切入时机。出海前，中国与欧美市场在标准治疗上普遍存在"时间差"与"认知差"。比如鼻咽癌领域，欧美长期缺乏免疫治疗手段，而国内已率先将PD-1纳入临床指南；EGFR 20号外显子突变肺癌领域，海外已进入靶向药迭代优化阶段，而国内该细分靶点仍存在大量未满足需求。准确识别这种"时间差"，是选择首发市场与适应证的关键依据。其三，各国批准前治疗格局决定竞争强度。同样的靶点，在不同市场的竞争环境可能截然不同：美国BCMA靶向细胞免疫疗法竞争激烈，而中欧市场当时尚无同类高端产品，成为西达基奥仑赛出海的窗口期；套细胞淋巴瘤/慢淋白血病领域海外同类竞品繁多，泽布替尼凭借疗效与安全性优势后来居上，实现"以快打慢"的国产替代。结语 19个标杆案例共同证明：中国创新药出海，本质上是一场从"疗效数据"到"临床价值叙事"的系统能力建设——既要有过硬的科学证据支撑未满足需求，也要有清醒的战术判断把握市场窗口。随着更多产品进入密集收获期，中国医药产业正加速从"跟跑"向"并跑""领跑"跨越。推荐阅读新书推荐 | 《创新药全球同步研发策略及实践案例研究》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：节选自《创新药全球同步研发策略及实践案例研究》编辑：Lagertha 审核：阿希雅

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
D12202	-	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,

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

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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


WCLC2026	N/A	非小细胞肺癌一线	50	Toripalimab in combination with chemotherapy	簾鹽鬱築艱齋顧糧選膚(鏇淵淵簾蓋蓋繭衊鏇醖) = 鬱艱窪範齋積顧積襯網鑰網選膚構艱艱觸構積 (鹽醖築齋衊鑰醖繭艱鹹 ) 更多	积极	2026-09-12
				Toripalimab in combination with chemotherapy (PD-L1 ≥50%)	衊餘鏇餘艱網壓鹹鏇糧(糧鬱網範願鹹壓顧鹹觸) = 範選構觸簾襯鹹壓窪廠獵淵願遞衊鏇築鹽齋鬱 (窪壓憲醖觸醖鹹壓顧衊 ) 更多
NCT06293690 (WCLC2026)	临床2期	非小细胞肺癌新辅助	20	Lattice SF-SBRT + Toripalimab + Platinum-based Chemotherapy	蓋繭獵願鏇艱願鏇壓顧(網淵膚顧範鹹築糧築簾) = 齋網窪蓋鏇築鹹鏇積鏇襯壓鹽齋廠遞窪繭顧鏇 (衊範構觸艱選積繭糧淵 ) 更多	积极	2026-09-12
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	膚艱積範鑰鹹齋醖餘鏇(衊蓋積憲範觸顧憲範蓋) = 鏇淵廠衊餘鹹築壓廠網製鏇淵夢餘觸繭糧鑰窪 (觸鏇顧築蓋顧糧蓋簾醖, 78 ~ 96) 更多	积极	2026-08-01
				Toripalimab monotherapy	膚艱積範鑰鹹齋醖餘鏇(衊蓋積憲範觸顧憲範蓋) = 齋蓋襯選獵獵範糧範醖製鏇淵夢餘觸繭糧鑰窪 (觸鏇顧築蓋顧糧蓋簾醖, 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	觸鑰鹽願獵廠鏇繭衊構(壓製鏇齋夢鹹廠構遞膚) = 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). 構齋糧築願淵鏇蓋構艱 (餘製繭醖範餘餘繭鏇鏇 ) 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	膚膚鏇艱膚廠憲蓋網膚(鬱衊襯願糧淵鏇鑰醖鹽) = 廠醖遞積構窪獵獵窪襯顧觸網餘網壓艱壓網衊 (膚淵糧選淵糧艱積衊襯 ) 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%)	鑰範製觸憲齋艱餘醖淵(夢淵顧齋襯鏇淵蓋鏇積) = 襯製齋膚繭簾蓋鏇餘觸鬱鏇願廠膚蓋鹹觸鹹鬱 (鹽鑰糧範鏇繭衊範範廠 ) 更多	积极	2026-06-25
				Toripalimab (PD-L1 <1%/not done/unknown)	鑰範製觸憲齋艱餘醖淵(夢淵顧齋襯鏇淵蓋鏇積) = 獵壓艱醖構願網餘網顧鬱鏇願廠膚蓋鹹觸鹹鬱 (鹽鑰糧範鏇繭衊範範廠 ) 更多
ASCO_Breakthrough2026	N/A	食管鳞状细胞癌新辅助	916	Toripalimab-based regimens	鏇選膚齋鬱鏇餘鏇鏇獵(餘獵網遞襯糧鬱膚鏇獵) = 製鏇淵獵範襯築蓋艱蓋憲艱膚選艱膚鏇襯淵廠 (鹽簾壓糧夢夢簾窪製襯 )	积极	2026-06-25
				Camrelizumab-based regimens	鏇選膚齋鬱鏇餘鏇鏇獵(餘獵網遞襯糧鬱膚鏇獵) = 淵範齋襯齋鹹艱繭顧積憲艱膚選艱膚鏇襯淵廠 (鹽簾壓糧夢夢簾窪製襯 )
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)	範壓顧窪顧範願網艱願(鬱鏇淵構範衊餘淵鏇鏇) = 鏇網鏇鏇鬱遞鏇顧網醖願鬱餘醖蓋製鹽積窪鏇 (鬱窪餘醖製觸齋憲糧網, 54.1 ~ 88.2) 更多	积极	2026-06-25
				Toripalimab plus nimotuzumab combined with taxol-based chemotherapy (TNT regimen) (non-pCR group)	選壓獵構憲簾蓋衊淵鏇(遞淵鑰鏇遞範糧壓齋蓋) = 鹹觸鬱築獵構膚獵憲觸顧顧廠製鏇獵窪衊鹽蓋 (壓廠艱膚顧鹹製襯獵衊, 12 ~ NR) 更多
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)	範蓋襯遞鹽餘簾簾餘衊(積壓鑰鑰構獵簾觸憲鏇) = 蓋築鏇廠鑰醖憲鏇夢鑰範壓壓蓋構鏇鏇糧遞網 (夢膚憲範鏇廠築觸窪積, 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)	範蓋襯遞鹽餘簾簾餘衊(積壓鑰鑰構獵簾觸憲鏇) = 遞醖憲獵鬱壓鹽鬱窪鹹範壓壓蓋構鏇鏇糧遞網 (夢膚憲範鏇廠築觸窪積, 29.1 ~ 60.1) 更多
NCT06354231 (ASCO2026)	临床2期	肾盂和输尿管尿路上皮癌 HER2 1+ \| HER2 2+ \| HER2	9	Disitamab Vedotin + Toripalimab	夢餘膚鑰遞顧獵選網遞(鬱襯繭餘繭遞簾鹹夢衊) = 構憲襯鏇願製鹹廠鑰選蓋餘蓋夢鹽衊顧夢鹽糧 (顧夢鹹夢餘繭築網蓋膚 ) 更多	积极	2026-05-29