替雷利珠单抗(Tislelizumab) - 药物靶点：PD-1_在研适应症：食管癌，PD-L1阳性食管鳞状细胞癌，局部进展期胃腺癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Tirelizumab、Tiselizumab、Tislelizumab (USAN/INN)

+ [7]

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

肿瘤免疫系统疾病消化系统疾病+ [9]

在研适应症

食管癌PD-L1阳性食管鳞状细胞癌局部进展期胃腺癌+ [116]

非在研适应症

晚期三阴性乳腺癌肺泡软组织肉瘤间变性大细胞淋巴瘤+ [28]

原研机构

BeOne Medicines Ltd.

在研机构

BeOne Medicines Ltd.

Glenmark Pharmaceuticals Ltd.

百济神州（上海）生物科技有限公司

+ [12]

非在研机构

Novartis Pharmaceuticals Corp.

Celgene Corp.

江苏亚虹医药科技股份有限公司

+ [3]

权益机构

Glenmark Specialty SA

BeOne Medicines Ltd.

和记黄埔医药（上海）有限公司

+ [13]

最高研发阶段批准上市

首次获批日期

中国 (2019-12-26),

霍奇金淋巴瘤

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)、孤儿药 (欧盟)、附条件批准 (中国)、特殊审批 (中国)、优先审评 (中国)

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结构/序列

Sequence Code 577079733L

来源: *****

Sequence Code 616719194H

来源: *****

关联

685

项与替雷利珠单抗相关的临床试验

NCT06883552

/ Not yet recruiting临床2期IIT

An Open-label, Single-arm Clinical Study of Stapokibart Injection in Combination with Tislelizumab Injection in Patients with Non-Small Cell Lung Cancer

This is a single-arm study evaluating the efficacy and safety of Stapokibart Injection in combination with Tislelizumab Injection in patients with driver gene-negative NSCLC who have failed prior PD-1/PD-L1 inhibitor therapy.

开始日期2025-10-01

申办/合作机构

四川大学

NCT06364904

/ Not yet recruiting临床3期IIT

A Multicenter, III Stage, Randomized Controlled Trail on the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib in Untreated Unresectable and Metastatic Urothelial Carcinoma.

The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.

开始日期2025-10-01

申办/合作机构

中山大学孙逸仙纪念医院

NCT07043400

/ Not yet recruiting临床3期

A Phase 3, Multi-Center, Randomized, Open-Label Clinical Study of Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.

开始日期2025-09-01

申办/合作机构

BeOne Medicines Ltd.

100 项与替雷利珠单抗相关的临床结果

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100 项与替雷利珠单抗相关的转化医学

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100 项与替雷利珠单抗相关的专利（医药）

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575

项与替雷利珠单抗相关的文献（医药）

2025-12-31·Human Vaccines & Immunotherapeutics

Durable response to third-line combination therapy in a metastatic colorectal cancer patient with BRAF V600E mutation: A case report

Article

作者: Qian, Xiaoping ; Li, Li ; Zhang, Qun

In metastatic colorectal cancer (mCRC), the BRAFV600E mutation subtype is one of the subtypes with the worst prognosis. The long-term abnormal activation of multiple signaling pathways caused by the BRAF V600E mutation is closely related to the formation of BRAF inhibitor resistance and drug-resistant tumor cell subpopulations. These factors significantly impact the survival and prognosis of CRC patients. Therefore, treating mCRC patients with the BRAFV600E mutation, particularly in later stages, is challenging. We reported a case of an mCRC patient with the BRAF V600E mutation in the primary and metastatic tumors. After the failure of second-line treatment, this patient received a combination therapy including immunotherapy (tislelizumab), radiotherapy, and targeted therapy (fruquintinib). Through comprehensive imaging evaluations and continuous monitoring of tumor markers, we were astonished to observe that the patient has achieved and maintained a complete response (CR) for over 12 months. This case supports the efficacy of combination therapy in mCRC patients with the BRAF V600E mutation.

2025-12-31·ANNALS OF MEDICINE

Cost-effectiveness of PD-1 inhibitors combined with chemotherapy for first-line treatment of oesophageal squamous cell carcinoma in China: a comprehensive analysis

Article

作者: Zhang, Lingli ; Xu, Kai ; Yu, Man ; Lin, Yingtao ; Li, Xin ; Su, Dan ; Shang, Jingjing ; Sun, Qingli ; Gong, Jinhong ; Qian, Xiaodan

BACKGROUND:

Programmed death-1 (PD-1) inhibitors combined with chemotherapy have become a standard first-line treatment for advanced oesophageal squamous cell carcinoma (ESCC). Given the high costs associated with immunotherapy, evaluating the cost-effectiveness of different PD-1 inhibitors in the Chinese healthcare setting is essential for guiding treatment decisions and policy development.

METHODS:

A cost-effectiveness analysis was conducted comparing six PD-1 inhibitors-sintilimab, toripalimab, tislelizumab, camrelizumab, serplulimab, and pembrolizumab-combined with chemotherapy for first-line treatment of advanced ESCC. A partitioned survival model was used to calculate incremental cost-effectiveness ratios (ICERs) from healthcare system perspective, with a willingness-to-pay (WTP) threshold set at $36,598.19 per quality-adjusted life year (QALY). Sensitivity analyses were performed to evaluate the robustness of the results.

RESULTS:

The ICERs for toripalimab, camrelizumab, pembrolizumab, serplulimab, sintilimab, and tislelizumab were $32,356.79/QALY, $48,410.64/QALY, $312,743.54/QALY, $121,200.84/QALY, $29,663.42/QALY, and $35,304.33/QALY, respectively. Sintilimab, toripalimab, and tislelizumab were below the WTP threshold. Among all regimens, the top three in life years (LYs) gained were toripalimab, serplulimab, and tislelizumab. Sensitivity analysis showed that utility values and drug prices were key factors influencing ICERs. Probabilistic analysis indicated that toripalimab, sintilimab, and tislelizumab had the highest probabilities of being cost-effective, at 83.1%, 81.4%, and 70.0%, respectively.

CONCLUSION:

Sintilimab, toripalimab, and tislelizumab are the most cost-effective PD-1 inhibitors when combined with chemotherapy for the first-line treatment of advanced ESCC in China, with ICERs below the WTP threshold. While all six PD-1 inhibitors demonstrated clinical benefits, pembrolizumab and serplulimab were less favourable from a cost-effectiveness standpoint. Sensitivity analysis confirmed that drug prices and utility values are significant determinants of cost-effectiveness.

2025-09-01·MODERN PATHOLOGY

Concordance Between the PD-L1 Tumor Area Positivity Score and Combined Positive Score for Gastric or Esophageal Cancers Treated With Tislelizumab

Article

作者: Kato, Ken ; Xu, Wenjie ; Xu, Hui ; Du, Wenting ; Wagner, Daniel-Christoph ; Yang, Silu ; Yoon, Harry H ; Hu, Han ; Shi, Jingwen ; La Placa, Christopher ; Peng, Yanyan ; Huang, Ruiqi ; McCampbell, Adrienne ; Shen, Zhirong ; Zhang, Yun ; Moehler, Markus

Tumor Area Positivity (TAP) score is an emerging score measuring programmed death-ligand 1 (PD-L1) expression in tumors. However, the availability of concordance data between TAP score and other immunohistochemistry scoring methods is limited. We investigated concordance between TAP score and combined positive score (CPS) and the relationship between PD-L1 status and clinical outcomes using gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) and esophageal squamous cell carcinoma (ESCC) samples from patients subsequently treated with tislelizumab. Baseline tissue samples from RATIONALE-305 (GC/GEJC; NCT03777657), RATIONALE-302 (ESCC; NCT03430843), and RATIONALE-306 (ESCC; NCT03783442) were assessed for PD-L1 expression using an investigational use-only version of the VENTANA PD-L1 (SP263) CDx Assay. PD-L1 status was scored by TAP score and CPS. Concordance and correlation of both scores with clinical and safety outcomes were analyzed. Across all trials, agreement between TAP score and CPS was significant at PD-L1 cutoffs of ≥1%/≥1, ≥5%/≥5, and ≥10%/≥10 (Cohen's κ, 0.64-0.85). Similar outcomes for overall survival (OS), progression-free survival, objective response rate, and duration of response were observed between TAP score- and CPS-defined PD-L1-positive subgroups at analogous PD-L1 cutoffs. OS hazard ratios in the PD-L1-high subgroups were similar between protocol-defined TAP score and the same numeric CPS value (OS hazard ratio [95% CI]: RATIONALE-305, 0.72 [0.59-0.88] and 0.73 [0.60-0.89]; RATIONALE-302, 0.52 [0.35-0.76] and 0.54 [0.37-0.78]; and RATIONALE-306, 0.63 [0.45-0.89] and 0.58 [0.42-0.81], respectively). Safety outcomes were generally comparable between all PD-L1 subgroups. In conclusion, TAP score and CPS are clinically comparable immunohistochemistry measures of tumor PD-L1 expression in tislelizumab-treated patients with GC/GEJC or ESCC.

1,764

项与替雷利珠单抗相关的新闻（医药）

18 小时之前

·百济神州

欧盟委员会批准百泽安®联合化疗用于鼻咽癌患者一线治疗

新获批适应症基于RATIONALE-309研究结果，该研究证明无进展生存期取得了具有统计学显著性的改善这是百泽安®今年在欧盟获批的第二项适应症美国加州圣卡洛斯——百济神州有限公司（纳斯达克代码：ONC；香港联交所代码：06160；上交所代码：688235）是一家全球肿瘤治疗创新公司，今日宣布欧盟委员会（EC）已批准百泽安®（替雷利珠单抗）联合吉西他滨和顺铂用于不适合根治性手术或放疗的转移或复发性鼻咽癌（NPC）成年患者的一线治疗。鼻咽癌是一种罕见癌症，恶性肿瘤细胞在鼻咽部，即鼻腔后方的咽喉上部形成1。意大利米兰IRCCS基金会国家癌症研究所头颈癌肿瘤内科主任Lisa Licitra教授表示：替雷利珠单抗联合化疗的适应症在欧洲获批，对于复发或转移性鼻咽癌患者来说意义重大。鼻咽癌是一种罕见且极具挑战的疾病。得益于RATIONALE-309研究取得的积极成果，我们获得了一项有力的新疗法，它不仅能够延缓疾病进展，更能帮助患者延长生命。此次获批为那些迫切需要更有效治疗方法的患者带来了新希望和经过临床验证的治疗选择。此次鼻咽癌适应症获批是基于RATIONALE-309（NCT03924986）研究的结果。该研究是一项双盲、安慰剂对照、多中心3期研究，263例患者被随机分配接受替雷利珠单抗联合吉西他滨和顺铂或安慰剂联合吉西他滨和顺铂治疗作为初始治疗。在首次预设的期中分析时达到了研究主要终点，替雷利珠单抗显著延长了意向性治疗（ITT）人群的无进展生存期（PFS）（风险比[HR] 0.52 [95% CI：0.38，0.73] p<0.0001），疾病进展或死亡风险降低了48%。替雷利珠单抗联合化疗组中位PFS为9.2个月，而安慰剂联合化疗组为7.4个月。额外12个月随访更新分析显示，有效性结果与期中分析结果一致。总生存期（OS）获得了具有临床意义的持续改善，替雷利珠单抗联合化疗组中位OS为45.3个月，安慰剂联合化疗组为31.8个月。替雷利珠单抗联合化疗总体耐受性良好，未发现新的安全性信号。汇总安全性数据包括3,900多例患者，按照批准的给药方案接受了替雷利珠单抗单药治疗（n=1,952）或联合化疗治疗（n=1,950）。替雷利珠单抗联合化疗最常见的3级或4级不良反应（≥10%）为中性粒细胞减少症、贫血、血小板减少症。替雷利珠单抗此前在欧盟获批用于治疗广泛期小细胞肺癌患者，此次又获批用于治疗鼻咽癌，这凸显出我们将这一免疫疗法广泛应用于多种实体瘤的强劲发展态势。随着替雷利珠单抗在欧洲覆盖肺癌和胃肠道癌适应症，以及在全球获得100多项监管批准，我们正不断朝着为全球更多患者提供创新疗法的这一宏伟目标迈进。替雷利珠单抗已在欧盟获批的适应症包括：用于符合条件的胃或胃食管结合部（G/GEJ）腺癌患者一线治疗；用于不可切除的食管鳞状细胞癌（ESCC）患者一线治疗；用于既往接受过含铂化疗的ESCC患者二线治疗；用于广泛期小细胞肺癌（ES-SCLC）患者的一线治疗；三项非小细胞肺癌（NSCLC）适应症，涵盖一线和二线治疗。（上下滑动查看详情）关于鼻咽癌（NPC）鼻咽癌是一种头颈部肿瘤，起源于鼻咽部，即连接鼻腔和咽喉通道2。鼻咽癌可分为不同病理亚型：角化鳞状、非角化、基底细胞样鳞状3，由于其解剖位置较深，早期症状轻微且不典型，因此确诊时往往达到中晚期4。鼻咽癌全球每年约有13.3万例新发癌症病例和8万例死亡病例，且呈现独特地区分布特征，主要分布在亚洲5。鼻咽癌5年总生存率约为63%，但晚期患者生存率会降至49%6。关于百泽安®（替雷利珠单抗）百泽安®是一款具有独特设计的人源化免疫球蛋白G4（IgG4）抗程序性细胞死亡蛋白-1（PD-1）单克隆抗体，能够以高亲和力和特异性与PD-1结合；其设计旨在最大限度减少与巨噬细胞中Fcγ受体的结合，帮助人体免疫细胞识别并杀伤肿瘤细胞。作为百济神州实体瘤产品组合的基石药物，百泽安®是已在多种肿瘤类型和疾病领域中显示出潜力。其临床开发项目迄今已在35个国家和地区开展了70项试验，包括21项注册性研究，入组约14,000例患者。目前百泽安®已在全球46个国家和地区获批，并已惠及150多万例患者。关于百济神州百济神州是一家注册地位于瑞士的全球肿瘤治疗创新公司，专注于为全世界的癌症患者研发创新抗肿瘤药物。通过在血液学和实体肿瘤领域丰富的产品组合，以及强大的自主研发能力和外部战略合作，我们不断加速开发多元、创新的药物管线，致力于为全球更多患者全面提升药物可及性和可负担性。在全球六大洲，我们拥有超过11,000人的团队。如需了解更多信息，请访问www.beigene.com.cn或关注“百济神州”微信公众号。前瞻性声明本新闻稿包含根据《1995年私人证券诉讼改革法案》（Private Securities Litigation Reform Act of 1995）以及其他联邦证券法律中定义的前瞻性声明，包括关于百泽安®联合化疗能显著降低复发或转移性鼻咽癌（NPC）患者疾病进展或死亡风险的能力；百济神州扩展癌症治疗可及性的能力；以及在“关于百济神州”标题下提及的百济神州计划、承诺、愿望和目标。由于各种重要因素的影响，实际结果可能与前瞻性声明中的结果存在实质性差异。这些因素包括：百济神州证明其候选药物功效和安全性的能力；候选药物的临床结果可能不支持进一步开发或上市审批；药政部门的行动可能会影响到临床试验的启动、时间表和进展以及药物上市审批；百济神州的上市药物及候选药物（如能获批）获得商业成功的能力；百济神州获得和维护对其药物和技术的知识产权保护的能力；百济神州依赖第三方进行药物开发、生产、商业化和其他服务的情况；百济神州取得监管审批和商业化医药产品的有限经验，及其获得进一步的营运资金以完成候选药物开发及实现并保持盈利的能力；以及百济神州在最近季度报告10-Q表格中“风险因素”章节里更全面讨论的各类风险；以及百济神州向美国证券交易委员会期后呈报中关于潜在风险、不确定性以及其他重要因素的讨论。本新闻稿中的所有信息仅及于新闻稿发布之日，除非法律要求，百济神州并无责任更新该等信息。关于百济神州更多媒体资源，请访问我们的新闻媒体网站。— 左右滑动查看更多 —*本材料中提及的适应症信息仅针对国外市场，全球不同国家/地区的适应症获批情况不一，处方信息请参考各地批准的药品说明书；本材料仅在于向公众传递疾病相关知识及医药前沿信息，非广告用途，不构成对任何药物的商业推广或对诊疗方案的推荐，亦不能代替医疗卫生专业人士的意见，如有任何问题请向医疗卫生专业人士咨询。参考资料1. National Cancer Institute at the National Institutes of Health. Nasopharyngeal Cancer Treatment (PDQ®)–Patient Version. https://www.cancer.gov/types/head-and-neck/patient/adult/nasopharyngeal-treatment-pdq2. Cleveland Clinic. Nasopharynx. https://my.clevelandclinic.org/health/body/22376-nasopharynx.3. American Cancer Society. What Is Nasopharyngeal Cancer? https://www.cancer.org/cancer/types/nasopharyngeal-cancer/about/what-is-nasopharyngeal-cancer.html4. Wei, X., et al. (2024) Nasopharyngeal cancer risk assessment by country or region worldwide from 1990 to 2019. BMC Public Health, 24, 1931. https://doi.org/10.1186/s12889-024-19228-95. Yang, Y., et al. (2023) Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell, 41(7): 1061–1072.6. American Cancer Society. Survival Rates for Nasopharyngeal Cancer. https://www.cancer.org/cancer/types/nasopharyngeal-cancer/detection-diagnosis-staging/survival-rates.html

免疫疗法临床3期临床结果

2025-07-10

·Firstwordpharma

BeOne’s Tevimbra gains EU nod for front-line nasopharyngeal cancer

The European Commission authorised yet another indication for BeOne Medicines’ anti-PD-1 antibody Tevimbra (tislelizumab), this time in combination with chemotherapy for first-line treatment of metastatic or recurrent nasopharyngeal carcinoma (NPC) not amenable to curative surgery or radiotherapy."This new authorisation…reflects strong momentum in broadening access to our immunotherapy across solid tumours," said Mark Lanasa, chief medical officer, solid tumours at BeOne, formerly known as BeiGene.The expanded EU approval — which succeeds a positive opinion by the EU drug advisory body in May — stems from favourable Phase III RATIONALE-309 data. Results showed that the Tevimbra in combination with gemcitabine and cisplatin reduced the risk of disease progression or death by 48% compared with placebo plus chemotherapy, with a median progression-free survival of 9.2 months versus 7.4 months. An additional 12-month follow-up showed sustained efficacy, with median overall survival reaching 45.3 months for the Tevimbra arm versus 31.8 months for the placebo arm.Tevimbra is already approved in the EU for first-line gastric or gastroesophageal junction adenocarcinoma, unresectable oesophageal squamous cell carcinoma (ESCC), second-line ESCC after platinum chemotherapy, first-line extensive-stage small-cell lung cancer, and multiple non–small-cell lung cancer indications across first- and second-line settings.

临床结果临床3期上市批准免疫疗法

2025-07-07

·VIP说

PD-1 Plus 概念引爆全场

今日创新药板块表现亮眼，尤其是布局 PD-1 Plus 领域的企业股价涨幅显著。截止收盘，信达生物涨6.68%，再创今年新高，市值近1400亿。康方生物涨14%，收952亿。三生制药涨3.7%，今年以来涨幅超313%。华海药业涨10%。君实港股涨11.6%。荣昌生物港股涨6.7%。何为 PD-1 Plus？这一概念由国盛医药在去年12月3日的年度策略首次定义，指的是在传统 PD-1 单抗基础上，通过与 VEGF、IL-15、IL-2 等其他靶点结合或融合形成的新型药物，目前全球 MNC 的deal不断验证这一产业趋势。传统 PD-1 单抗通过阻断免疫检查点激活 T 细胞杀伤肿瘤，但存在患者响应不足和耐药问题。而 PD-1 Plus 药物通过多靶点结合显著提升疗效：如 PD-1/VEGF 双抗，既能阻断免疫逃逸，又能抑制肿瘤血管生成，切断营养供给，与免疫激活协同增效；PD-1/IL-15 融合蛋白则激活 T 细胞与 NK 细胞，强化免疫杀伤。PD-1/IL-2融合蛋白则通过阻断PD-1并激活免疫细胞发挥协同抗肿瘤作用。此外，PD-1 Plus 还能拓展适用人群，减少全身毒性，通过靶向肿瘤微环境实现精准治疗。从当下市场布局和临床进展来看，不少企业在 PD-1 Plus 领域还有重磅 BD机会。IBI363是信达生物自主研发的全球首创（First-in-Class）PD-1/IL-2α偏向性双特异性抗体融合蛋白。在2025年ASCO年会上，信达生物公布的IBI363在肺癌、肠癌、黑色素瘤等实体瘤中的I期临床数据充分展现了其突破性潜力。公布的数据显示IBI363在肺癌中显著的“拖尾”效应，多个瘤种的OS数据均大幅领先现有标准疗法，显示出其作为下一代免疫治疗药物的巨大潜力。凭借双重机制，IBI363在多个大适应症中展现出突破性疗效，其全球首创地位使其成为下一代免疫治疗的领跑者。多个业内人士认为，凭借差异化机制和广泛的适应症布局，IBI363可能比当前热门的PD-1/VEGF更具重磅潜力，为千亿级市场带来无限想象空间。另外，信达生物于 6 月 25 日完成了 5.5 亿美元配售融资，来加速国际化。AK112 依沃西单抗注射液是康方生物自主研发的全球首创PD-1/VEGF双特异性肿瘤免疫治疗药物，于2024年5月在中国获批上市，用于EGFR-TKI治疗进展的局部晚期或转移性非鳞状非小细胞肺癌（nsq-NSCLC），成为全球首个获批的“肿瘤免疫+抗血管生成”协同抗肿瘤机制的双特异性抗体新药，并于同年11月被纳入国家医保目录。在临床研究方面，依达方®单药对比帕博利珠单抗单药一线治疗PD-L1阳性晚期NSCLC的III期研究期中分析达到无进展生存期（PFS）主要终点，获优先审评并于2025年4月获批上市。此外，依达方®联合化疗对比替雷利珠单抗联合化疗一线治疗鳞状NSCLC的III期研究也达到PFS主要终点，显示出显著的临床获益。国际多中心III期研究HARMONi、HARMONi-3和HARMONi-7研究正在进行中。目前，依达方®已在包括肺癌、头颈鳞癌、胆道癌、胰腺癌、乳腺癌、肝细胞癌、结直肠癌等18个适应症领域开展了27+项临床试验，其中12项为III期临床试验，展现了其在多种肿瘤治疗中的广泛潜力。早在2022年12月，康方生物就以高达50亿美元的交易金额，将依沃西单抗在美国、欧洲、加拿大和日本的独家开发和商业化权益授予Summit公司，引发全球关注。三生制药的SSGJ-707是基于其专有CLF2双抗平台开发的药物，能同时靶向PD-1和VEGF双靶点，通过解除免疫抑制和抑制肿瘤血管生成的双重机制发挥抗肿瘤作用。在非小细胞肺癌的Ⅱ期数据显示，无论单药还是联用化疗，其客观缓解率（ORR）和疾病控制率（DCR）表现优异，均展示出显著的抗肿瘤活性和良好的安全性，具有同类最优（best-in-class）的潜力。目前，SSGJ-707已获国家药监局突破性疗法认定，用于一线治疗PD-L1阳性局部晚期或转移性NSCLC，Ⅲ期临床已启动，并在美国获得FDA的IND批准。除了NSCLC，该药在结直肠癌、妇科肿瘤等领域的临床研究也在推进中。2025年5月20日，三生制药宣布与辉瑞达成一项总额高达60.5亿美元的授权协议，将SSGJ-707的全球（除中国内地）开发、生产和商业化权益独家授予辉瑞，再次验证了该双抗药物的潜力。 2025年6月2日，BioNTech（BNT）与Bristol Myers Squibb（BMS）达成90亿美元战略合作协议，共同开发和商业化下一代PD-L1/VEGF双特异性抗体BNT327。BMS将支付15亿美元预付款、20亿美元非或有性周年付款，BioNTech可获最高76亿美元里程碑付款，双方平分成本与利润。BNT327由普米斯开发，原名PM8002，2023年11月普米斯将全球（大中华区除外）权益授权给BioNTech，2024年11月BioNTech又以8亿美元预付款收购普米斯全部股权。普米斯早期投资者获得丰厚回报，但失去对BNT327的主导权，错失后续巨大商业价值。2025年7月1日，华海药业子公司上海华奥泰生物药业股份有限公司（以下简称“华奥泰”）宣布：其自主研发的PD-L1/VEGF双特异性融合蛋白HB0025，联合标准治疗（SOC）用于晚期或复发的子宫内膜癌，已正式向CDE递交确证性III期临床试验启动前会议申请。君实生物的JS207是一种重组人源化抗PD-1/VEGF双特异性抗体，目前已开展多项II期临床研究。AWT020是由君实生物研发的PD-1/IL-2双功能性抗体融合蛋白，在一期入组中。荣昌生物的PD-1/VEGF双特异性抗体RC148是其双特异性抗体平台首个进入IND阶段的产品。目前，RC148正在中国开展多项临床试验。总体而言，PD-1 Plus 领域发展前景广阔，相关企业在资本市场的良好表现反映了市场对其未来潜力的看好。随着临床研究的深入和 BD 机会的逐步兑现，这一领域有望持续为投资者带来惊喜，也将为肿瘤治疗领域带来更多创新疗法。

优先审批ASCO会议上市批准突破性疗法

100 项与替雷利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11487	替雷利珠单抗	L01XC	DB14922

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
食管癌	日本	BeOne Medicines Ltd.	2025-03-27
PD-L1阳性食管鳞状细胞癌	美国	Beigene International GmbH	2025-03-03
局部进展期胃腺癌	欧盟	BeOne Medicines Ltd.	2024-12-19
局部进展期胃腺癌	冰岛	BeOne Medicines Ltd.	2024-12-19
局部进展期胃腺癌	列支敦士登	BeOne Medicines Ltd.	2024-12-19
局部进展期胃腺癌	挪威	BeOne Medicines Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	欧盟	BeOne Medicines Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	冰岛	BeOne Medicines Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	列支敦士登	BeOne Medicines Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	挪威	BeOne Medicines Ltd.	2024-12-19
转移性胃腺癌	欧盟	BeOne Medicines Ltd.	2024-12-19
转移性胃腺癌	冰岛	BeOne Medicines Ltd.	2024-12-19
转移性胃腺癌	列支敦士登	BeOne Medicines Ltd.	2024-12-19
转移性胃腺癌	挪威	BeOne Medicines Ltd.	2024-12-19
转移性胃食管结合部腺癌	欧盟	BeOne Medicines Ltd.	2024-12-19
转移性胃食管结合部腺癌	冰岛	BeOne Medicines Ltd.	2024-12-19
转移性胃食管结合部腺癌	列支敦士登	BeOne Medicines Ltd.	2024-12-19
转移性胃食管结合部腺癌	挪威	BeOne Medicines Ltd.	2024-12-19
可切除非小细胞肺癌	中国	广州百济神州生物制药有限公司	2024-10-16
广泛期小细胞肺癌	中国	广州百济神州生物制药有限公司	2024-06-25

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
胃腺癌	申请上市	欧盟	BeiGene Ireland Ltd.	2024-10-17
不可切除的非小细胞肺癌	申请上市	加拿大	BeiGene Switzerland GmbH	2024-02-01
鳞状细胞癌	申请上市	中国	BeOne Medicines Ltd.	2018-09-06
结直肠癌	临床3期	法国	BeOne Medicines Ltd.	2025-04-16
结直肠癌	临床3期	法国	Veracyte, Inc.	2025-04-16
肺癌	临床3期	法国	Veracyte, Inc.	2025-04-16
肺癌	临床3期	法国	BeOne Medicines Ltd.	2025-04-16
非小细胞肺癌 III期	临床3期	法国	Veracyte, Inc.	2025-04-16
非小细胞肺癌 III期	临床3期	法国	BeOne Medicines Ltd.	2025-04-16
胰腺癌	临床3期	法国	BeOne Medicines Ltd.	2025-04-16

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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


NCT04921358 (SAFFRON-301, CTgov)	临床3期	局部晚期非小细胞肺癌	377	Tislelizumab+Sitravatinib (Tislelizumab + Sitravatinib)	膚觸壓鏇膚艱憲鹽鹽獵(夢糧窪繭鹽窪夢鏇簾繭) = 艱鏇顧窪廠構觸製鹹觸鑰鹽顧遞壓糧構願製築 (窪鑰鏇鏇衊繭餘選製淵, 願窪齋醖築獵積鏇願鏇 ~ 艱觸獵範淵鏇獵齋壓選) 更多	-	2025-06-29
				Docetaxel (Docetaxel)	膚觸壓鏇膚艱憲鹽鹽獵(夢糧窪繭鹽窪夢鏇簾繭) = 壓鬱遞獵淵網壓廠遞鬱鑰鹽顧遞壓糧構願製築 (窪鑰鏇鏇衊繭餘選製淵, 壓觸鏇衊顧願憲夢簾觸 ~ 壓艱廠鹽繭鏇餘醖遞構) 更多
NCT05461794 (CTgov)	临床2期	转移性食管鳞状细胞癌	96	Tislelizumab+Sitravatinib (Arm A: Tislelizumab + Sitravatinib)	齋構憲遞遞艱願獵鹽遞 = 糧顧遞淵觸糧顧蓋廠醖艱艱齋窪衊願餘醖淵醖 (窪鏇範夢襯餘蓋餘遞網, 廠窪糧廠夢顧網顧憲鬱 ~ 鬱製願願鏇鏇築選糧鏇) 更多	-	2025-06-13
				Docetaxel+Irinotecan (Arm C: Investigator-chosen Chemotherapy (ICC))	齋構憲遞遞艱願獵鹽遞 = 鬱顧膚願膚鏇願鹹願構艱艱齋窪衊願餘醖淵醖 (窪鏇範夢襯餘蓋餘遞網, 襯鏇築遞窪築願觸鹹齋 ~ 網鑰獵衊遞衊襯鹹選獵) 更多
NCT03430843 (RATIONALE-302, Pubmed \| J Clin Oncol)	临床3期	转移性食管鳞状细胞癌二线 NOTCH1 mutation \| neutrophil signatures	-	Tislelizumab (NOTCH1 mutation)	鹹蓋鏇廠壓選顧簾餘糧(膚鹹壓選鬱艱範鏇窪製) = 構積壓鏇鏇鏇壓範積醖觸鹹觸壓襯膚顧鬱壓襯 (蓋廠糧顧窪遞餘網簾網 )	积极	2025-06-01
				Tislelizumab	鹹蓋鏇廠壓選顧簾餘糧(膚鹹壓選鬱艱範鏇窪製) = 簾窪選襯餘齋觸鑰夢築觸鹹觸壓襯膚顧鬱壓襯 (蓋廠糧顧窪遞餘網簾網 )
ASCO2025	N/A	局部晚期宫颈癌 T lymphocyte subsets	53	tislelizumab (CCRT)	艱築糧膚選艱齋構夢觸(餘壓壓鹽襯醖遞廠憲觸) = 網齋醖憲衊夢網顧壓網構醖鹽築構網齋鹹觸夢 (製構範獵簾築淵觸網鹽 ) 更多	积极	2025-05-30
				tislelizumab (CCRT+T)	艱築糧膚選艱齋構夢觸(餘壓壓鹽襯醖遞廠憲觸) = 鑰窪糧簾獵選顧鏇餘淵構醖鹽築構網齋鹹觸夢 (製構範獵簾築淵觸網鹽 ) 更多
ASCO2025	N/A	晚期非小细胞肺癌一线 HIV-positive	-	Tislelizumab combined with platinum-containing chemotherapy	壓淵積夢廠獵獵艱壓獵(衊窪餘鬱獵艱簾憲衊鑰) = 5.9% vs 5.4% in HIV-positive group and HIV-negative group 繭顧顧鏇艱觸衊網壓網 (選艱窪簾鹹製繭觸齋醖 ) 更多	积极	2025-05-30
				Placebo
NCT04215978 (Phase 1 study of BGB-A445, ASCO2025)	临床1期	头颈部鳞状细胞癌 \| 非小细胞肺癌	-	BGB-A445 monotherapy	襯醖蓋廠築衊遞網積簾(鬱糧鏇醖齋醖齋鹽鑰襯) = 鹽糧鏇獵廠鹹醖糧衊願獵選齋窪壓鬱製網鹹廠 (築鹽鏇簾鬱選顧獵鬱鑰 )	积极	2025-05-30
				BGB-A445 combined with tislelizumab and chemotherapy	糧蓋築膚獵構壓顧夢衊(製齋艱遞襯繭觸憲選廠) = 鏇獵糧構齋範壓憲繭糧鹽獵遞積壓網獵鑰鹽衊 (積壓膚簾壓網鑰鑰製遞 ) 更多
ChiCTR2300068140 (A prospective, single-arm, phase II study to evaluate the efficacy and safety of perioperative tislelizumab in resectable non-small-cell lung cancer (NSCLC), ASCO2025)	临床2期	可切除非小细胞肺癌新辅助 \| 辅助	30	Tislelizumab + Chemotherapy	範製憲鏇網壓築膚鑰繭(糧醖選繭範獵淵憲簾範) = 觸蓋選齋簾醖壓遞廠醖鏇鬱鏇積觸鬱製鹽願衊 (鬱淵願繭繭簾網淵襯膚 ) 更多	积极	2025-05-30
NCT05807776 (ASCO2025)	临床2期	肝细胞癌新辅助	36	Tislelizumab monotherapy	鑰鬱獵齋餘選構齋壓製(醖願淵觸夢簾壓製鹽網) = 繭鹹餘壓憲齋願艱鏇窪獵醖鬱顧構積鏇築鑰醖 (鏇艱範憲衊選餘餘夢觸 ) 更多	积极	2025-05-30
				Tislelizumab + Lenvatinib combination therapy	製網蓋艱構築築餘積糧(蓋廠鑰廠鑰夢衊齋願構) = 簾築築獵醖鏇廠夢憲願鏇襯獵壓餘艱窪簾簾廠 (艱淵製簾醖鹹鹽鬱製夢 )
ASCO2025	N/A	胆道癌	-	Tislelizumab combined with other chemotherapy agents	鹹簾憲鹽繭夢積壓積製(鬱膚製餘積網繭選願遞) = 鏇艱鑰積範鹽積夢壓糧醖獵網網網蓋衊遞遞蓋 (襯觸觸膚夢觸艱艱餘蓋, 71.8 ~ 87.8) 更多	积极	2025-05-30
ASCO2025	N/A	新辅助 T3-4 \| N positive \| EMVI positive ... 更多	29	Neoadjuvant chemoradiotherapy + Tislelizumab	夢醖選膚製鏇獵構鏇鏇(夢壓鹽壓襯餘積餘範網) = 簾獵鑰壓廠衊積網鹹壓觸鹹蓋選艱鑰壓衊構醖 (餘憲範觸襯廠淵鑰獵廠 ) 更多	积极	2025-05-30
				tislelizumab (Surgery only)	艱鑰膚鑰鏇選鏇製襯夢(鹹衊齋製鑰選築壓鑰夢) = 簾選壓鑰膚願糧艱糧願鑰選艱願壓餘觸簾鹽齋 (窪構廠夢糧鏇觸鏇積製 ) 更多