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

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

NCT05982522

/ Not yet recruiting临床1/2期

A Multicenter, Open-Label, Randomized, Phase Ib/II Clinical Trial to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Taxane and Anti-PD-1/L1 Monoclonal Antibody in Previously-treated Solid Tumors

This is a phase Ib/II, randomized, open-label, multicenter clinical trial to evaluate the antitumor activities, safety, tolerability and pharmacokinetics (PK) of IN10018 in combination with taxane and anti-PD-1/L1 monoclonal antibody in patients with locally advanced or metastatic solid tumors who have failed in or been intolerant to at least one line of standard therapy. This study will be firstly carried out in previously-treated non-small cell lung cancer (NSCLC) population,

开始日期2025-08-13

申办/合作机构

应世生物科技（上海）有限公司

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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540

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

2025-08-01·Current Drug Safety

Treatment of Tislelizumab-Induced Toxic Epidermal Necrolysis and Agranulocytosis: A Case Report and Literature Review

Article

作者: Xu, Xiangqian ; Xue, Honghao ; Lu, Chenghua ; Guo, Xiaoyan ; Zhou, Yanshi ; Zhang, Yemin ; Zhang, Jun ; Wu, Qingyuan ; Xie, Shiyun

Background::

Non-small Cell Lung Cancer (NSCLC) makes up about 85% of lung cancer cases, mainly adenocarcinoma and squamous cell carcinoma. Recently, PD-1 inhibitors have become crucial in NSCLC treatment, significantly enhancing survival for some. However, side effects, like skin reactions and hematotoxicity, limit their use, with drug-induced TEN and immunotherapy-induced agranulocytosis as severe adverse effects.

Case Presentation::

Herein, we have reported the case of a 75-year-old male diagnosed with metastatic Lung Squamous cell Carcinoma (LUSC) in the left lung. He received first-line treatment with one cycle of tislelizumab in combination with nab-paclitaxel and carboplatin, after which he developed Toxic Epidermal Necrolysis (TEN) and granulocytopenia. To address these two serious immune-related Adverse Events (irAEs), the patient was administered methylprednisolone in combination with gamma globulin for TEN and dexamethasone in combination with G-CSF for agranulocytosis. Antibiotics were also administered according to the patient’s medication regimen. After treatment, the patient recovered and was discharged from the hospital. It was also noted that the lung tumor condition improved.

Conclusion::

Effective management of severe immune-related side effects from tislelizumab, including TEN and agranulocytosis, can be partly achieved through steroids, gamma globulin, GCSF, and antibiotics. This strategy not only alleviates these adverse effects, but also potentially improves tumor conditions, highlighting the crucial role of vigilant monitoring and management in immunotherapy.

1,702

项与替雷利珠单抗相关的新闻（医药）

20 小时之前

·米内网

53款国产1类新药“起飞”！3大超40亿品种领跑，6大品种涨逾100%，恒瑞大爆发

精彩内容近段时间，创新药领域风起云涌：1类新药密集获批，国产新药出海再现“天价”交易等。据不完全统计，2018年至今（截至5月27日，下同），国内有超150款国产1类新药获批上市，以抗肿瘤和免疫调节剂为主，恒瑞医药强势领跑。从销售额看，53款国产1类新药2024年在中国三大终端六大市场销售过亿，16个超10亿大爆品亮眼。随着创新药的逐步放量，以及BD项目不断刷新交易额记录，创新药企有望迎来扭亏为盈的密集期。超150款国产1类新药获批！恒瑞强势领跑近年来，随着药品审评审批制度改革、全链条支持创新药等系列政策出台，我国创新药进入全面爆发阶段。米内网数据显示，2018年至今，国内有超150款国产1类新药（按新版注册管理办法，不含中成药、原料药、疫苗等）获批上市，其中化学药占比超过65%，治疗用生物制品占比超过34%。从时间段看，2020年新版药品注册管理办法实施后，国产1类新药获批数量大幅提升，由2018及2019年的个位数，增长至2020年的13个，2021年突破20个，2022年有所回落，2023及2024年均达30个及以上，预计2025年有望再创新高。2018年至今获批上市的国产1类新药（不含中成药）注：以最早获批年份计从治疗领域看，超150款国产1类新药分布在11个治疗大类，集中在抗肿瘤和免疫调节剂，共计78个，占比超过49%；此外，全身用抗感染药物、消化系统及代谢药分别有29个、18个品种在列，占比分别超过18%、11%。虽然我国创新药仍有扎堆肿瘤领域的现象，但在代谢、麻醉、自免、心血管、抗病毒、皮肤等领域亦有涉及，逐渐呈现“全面开花”之势。超150款国产1类新药治疗大类分布情况米内网数据显示，近年来中国三大终端六大市场抗肿瘤和免疫调节剂（不含中成药，下同）、消化系统及代谢药销售额均超过2000亿元，全身用抗感染药物销售额均超过1600亿元。从企业看，20余家药企（按集团计）均有2个及以上的新药获批，其中恒瑞医药以16个品种强势领跑，正大制药、浙江我武生物以6个品种并列第二，豪森药业以5个品种排位第四，海思科、康方生物以4个品种并列第五。此外，百济神州、贝达药业、东阳光药、和黄医药、石药集团、再鼎医药、四环医药、君实生物、信达生物等均有3个品种在列。获批品种数TOP5集团注：以上市许可持有人计16个超10亿大爆品亮眼！这些品种上市即起飞从商业化后的销售额看，2018至2023年获批的国产1类新药中，有53款2024年在中国三大终端六大市场的销售额超过1亿元，合计销售额超过500亿元。16个超10亿大品种亮眼，百济神州的替雷利珠单抗注射液、信达生物的信迪利单抗注射液、豪森药业的甲磺酸阿美替尼片依次位列前三，销售额均超40亿元；正大天晴药业的盐酸安罗替尼胶囊以超38亿元紧接在后，恒瑞医药的注射用卡瑞利珠单抗、百济神州的泽布替尼胶囊、先声药业的依达拉奉右莰醇注射用浓溶液均超20亿元。从增长情况看，恒瑞医药的瑞维鲁胺片及脯氨酸恒格列净片、山东罗欣药业的替戈拉生片、华领医药的多格列艾汀片、成都微芯药业的西格列他钠片、荣昌生物的注射用泰它西普等涨幅均超过100%（2023年获批的品种不计在内）。2018至2023年获批且销售额超过1亿元的国产1类新药注：标红为增速超10%，2023年获批的品种不计在内来源：米内网综合数据库恒瑞医药以9个品种领跑。注射用卡瑞利珠单抗（PD-1单抗）、马来酸吡咯替尼片（多靶点激酶抑制剂）、海曲泊帕乙醇胺片（TPO受体激动剂）、瑞维鲁胺片（AR受体拮抗剂）、羟乙磺酸达尔西利片（CDK4/6抑制剂）、阿得贝利单抗注射液（PD-L1单抗）在上市首年或次年销售额即超过1亿元，其中2018年获批的马来酸吡咯替尼片，2019年销售额接近8亿元，2021年超过19亿元，之后有所波动，2025年超过16亿元；2021年获批的海曲泊帕乙醇胺片，2022年销售额接近6亿元，2023年突破12亿元，2024年突破15亿元；此外，脯氨酸恒格列净片（SGLT2抑制剂）最早于2021年获批，2024年销售额增速约达475%。近年来中国三大终端六大市场恒瑞医药部分1类新药销售情况（单位：万元）来源：米内网格局数据库豪森药业有4个品种在列。甲磺酸阿美替尼片（三代EGFR抑制剂）、甲磺酸氟马替尼片（BCR-ABL抑制剂）、艾米替诺福韦片（核苷酸类逆转录酶抑制剂）在上市首年或次年销售额即超过1亿元，其中2020年获批的甲磺酸阿美替尼片，当年销售额即接近5亿元，2021年超过16亿元，2024年突破40亿元；2021年获批的艾米替诺福韦片，2022年销售额接近3亿元，2024年突破8亿元，作为一款非肿瘤药，该新药上市后的市场表现让人眼前一亮。近年来中国三大终端六大市场豪森药业部分1类新药销售情况（单位：万元）来源：米内网格局数据库作为国内首款获批的国产双抗，以及全球首款获批的PD-1/CTLA-4双抗，康方生物的卡度尼利单抗注射液不负众望，上市后市场表现亮眼。该药最早于2022年获批上市，当年销售额即超过3亿元，2023年突破12亿元，2024年突破15亿元。目前卡度尼利单抗注射液已有宫颈癌（二线）、胃癌（一线）等适应症获批，非小细胞肺癌、肝细胞癌等适应症处于III期临床。近年来中国三大终端六大市场卡度尼利单抗注射液销售情况（单位：万元）来源：米内网格局数据库激励政策频出，创新药企将迎业绩拐点近几年来，国家层面频频出台利好政策，创新药的研发、审评、生产和支付等环节的政策环境显著优化。2024年以来，创新药产业支持政策持续加码，从支付渠道拓展、目录动态调整到临床应用保障等方面构建了全链条支持体系，旨在缩短创新药上市周期并优化市场环境。在利好政策支撑下，越来越多的创新药在进入医保后实现快速放量，国产创新药在与MNC（跨国药企）合作中不断刷新交易额记录，并在海外市场陆续兑现商业化预期，这些都标志着我国医药产业的高质量创新已逐步迈入兑现期。据2024年业绩报告显示，以百济神州为代表的众多创新药企业绩相比往年显著好转，预示着整个创新药板块有望迎来盈利拐点。A股“研发投入一哥”百济神州表现亮眼，2024年营业收入272.14亿元（+56.2%），其中产品收入269.94亿元（+74.1%），亏损进一步收窄约26.9%。业绩增长的关键因素是其核心产品的出色表现，2024年泽布替尼销售额高达188.59亿元，在公司总营收中占比超六成；替雷利珠单抗销售额44.67亿元，同比增长17.4%。依靠产品收入增长和授权费收入增加，以及持续改善运营效率，信达生物2024年业绩大涨，其营业收入94.22亿元（+51.8%），其中产品收入82.28亿元（+43.6%），授权费收入则由4.47亿元翻倍增加至11亿元；年内亏损降至9463.1万元，同比缩窄90.8%，年内Non-IFRS（非国际财务报告准则）利润、Non-IFRS EBITDA（税息折旧及摊销前利润）双双首次转正。得益于卡度尼利单抗销售持续增长和依沃西单抗在2024年5月获批上市后带来的积极销售贡献，康方生物2024年扣除分销成本后的商业销售收入达20.02亿元，同比增长24.88%。康方生物董事会主席夏瑜表示：“2025年是公司产品进入医保的元年。到目前为止，还在非常快速放量起量的过程之中。”BD项目收入成为康宁杰瑞业绩扭亏为盈的关键，2024年公司实现总收入6.4亿元，同比增长192.58%，年内溢利约为1.66亿元，上年同期则为亏损2.11亿元。这一年，康宁杰瑞分别与ArriVent、Glenmark以及石药集团达成三笔合作，交易总金额超125亿元。资料来源：米内网数据库、公司公告注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至5月27日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

免疫疗法上市批准疫苗

2025-05-27

·DIA资讯

2025 DIA中国年会丨中国创新药十年飞跃：从跟跑到领跑，全球新药实现“中国首发”格局加速成型

点击“DIA资讯” 关注我们2025 DIA CHINA ANNUAL MEETING上海，2025年5月24日——在2025年DIA中国年会上，来自全球三十多个地区的卫生监管机构和医药行业的千余名专家与领袖齐聚一堂，共同见证中国创新药发展的“黄金十年”。自2015年以来，中国通过系统性政策改革，实现了从“仿制跟跑”到“创新领跑”的历史性跨越，现已成为全球医药创新的核心枢纽。统计显示，截至2024年底，中国企业研发的活跃创新药数量已达3575个，超越美国，成为全球第一。全球新药如百济神州的替雷利珠单抗、罗氏的可伐利单抗和勃林格殷格翰的佩索利单抗等在中国实现了首发上市，标志着本土创新的崛起和产业生态的重构。政策改革十年：构建全球领先的创新生态过去十年，中国药品审评审批制度经过一系列改革，打通了创新的堵点，促成了中国医药产业从“赶潮人”、“弄潮人“到“领潮人”的转变。王海南国家药监局药品注册司副司长国家药监局药品注册司王海南副司长在演讲中回顾了过去取得的卓有成效的改革举措，包括优化药品上市审批机制，审评、核查、检验、通用名核准并联进行；注册检验可前置；基于风险的核查工作机制。临床试验申请默示许可制度以后，2024年又开展IND试点工作，试点将创新药审评时限缩短至30个工作日，临床试验启动用时缩短至12周。建立药品加快上市制度。完善变更管理制度，优化补充申请审评审批程序。鼓励放射性药品、儿童用药、罕见病药物研发。建立专利纠纷早期解决机制等。王司长特别提到，2024年国务院发布的53号文件（《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》）为行业注入了新动力，加大药品创新支持力度，坚持“提前介入、一企一策、全程指导、药审联动”；加快临床急需药品审批上市，优化临床试验审评审批机制、优化药品补充申请审评审批，加快罕见病用药品审评审批；支持医药产业扩大对外开放合作，探索生物制品分段生产；构建适合产业发展和安全需要的监管体系。秦晓岺国家药监局科技和国际合作司司长国家药监局科技和国际合作司秦晓岺司长强调，NMPA全面参与国际监管规则制定，不断提升药品监管的国际化水平和国际影响力，ICH指导原则已经全部在国内转化实施；持续扩大对外开放合作，2024年国家药监局发布《关于优化已在境内上市的境外生产药品转移至境内生产的药品上市注册申请相关事宜的公告》，商务部国家卫健委会同药监局发布关于在医疗领域开展扩大开放试点工作的通知。秦晓岺司长强调，NMPA不断深化与世界卫生组织（WHO）在药品监管等领域开展交流合作；积极参与国际人用药品注册技术协调会（ICH）、国际药品监管机构联盟（ICMRA）活动，全面参与国际监管规则制定并转化实施，不断提升中国药品监管的国际化水平和国际影响力。李璐国家药监局政策法规司法规处处长国家药监局政策法规司法规处李璐处长：药品全生命周期管理法律法规体系的“四梁八柱”基本建立。后续加快推动重点立法项目包括《药品管理法实施条例》等。全球创新格局的重塑：中国力量的崛起与2015年相比，中国已成为全球研发的重要策源地。2024年中国创新药海外授权交易总额达482亿美元，是2015年（23亿美元）的21倍。截至 2024 年底，全球共有923款创新药首次获批，其中美国首发的占49%，中国接近 38%，这一比例较2015年的4%提升了近10倍。谢松梅药品审评中心（CDE）化药临床二部部长药品审评中心（CDE）化药临床二部谢松梅部长介绍了改革成效及新进展。2024年国家药监局共批准48个新药上市。重大慢性病防治领域，仑卡奈单抗为我国首批用于阿尔茨海默症的1类创新药。自身免疫性皮肤疾病领域，我国自主研发的新药本维莫德乳膏为国内新机制、新靶点，2019年全球首批，2024年11月我国优先程序全球率先批准新适应症特异性皮炎，随后美、日同品种上市；2款口服小分子JAK抑制剂（乌帕提尼缓释片、阿布昔替尼片）全球同步研发、同步上市。通过加快路径批准上市了多款新药极大满足了我国患者临床迫切需求。最后分享了临床试验改革试点、临床急需优化、罕见病等监管改革新进展。2025 DIA CHINA ANNUAL MEETING刘艳玮武田大中华区注册事务副总裁武田大中华区注册事务副总裁刘艳玮女士回顾了十年行业发展变化。从药品上市迟滞角度，从2015-2024年，中美药品上市时间差从8年缩短至2年以内。NDA同步递交，2024年同步递交占比达42.3%，67%与全球首递时间差小于3个月。这些成绩离不开鼓励药物创新的一系列新举措。2025 DIA CHINA ANNUAL MEETING何静医学博士阿斯利康全球高级副总裁、全球研发中国负责人2024年全球授权大型交易中，1/3来自中国本土创新，中国创新正在成为全球解决方案。阿斯利康全球高级副总裁、全球研发中国负责人何静博士表示，这是多年积累水到渠成的结果。阿斯利康在北京建立全球第六个战略研发中心，中国已成为与美国并列的创新策源地。中国研发生态蓬勃发展得益于药监改革释放创新活力。阿斯利康已将同步研发作为默认策略，深化临床研究合作，探索Discovery research新道路，结合AI重塑研发过程，加强跨国企业与本土生态圈合作。2025 DIA CHINA ANNUAL MEETING张鹏康方生物联合创始人康方生物联合创始人张鹏则以PD-1产品派安普利单抗成功出海为例，接受FDA全面检查，中国的监管体系已与国际接轨。此次经历锻炼了公司团队，为未来的双抗出海积累经验。2025 DIA CHINA ANNUAL MEETING闻增玉泰格医药科技股份有限公司联席总裁杭州泰格医药科技股份有限公司联席总裁闻增玉先生表示泰格医药作为创新型CRO公司，过去几年，服务了超过60%的中国一类创新药研发，为助力中国创新药全球同步开发，完成了全球37个国家一体化布局，采用“global team with local activity”策略。2025 DIA CHINA ANNUAL MEETING董艳平罗氏中国临床注册事务负责人谈到罗氏中国临床注册事务负责人董艳平女士在分享可伐利单抗中国首发的经验时介绍，基于突阵发性睡眠性血红蛋白尿（PNH）在中国未满足的临床需求，监管机构以临床价值为导向，给予极大灵活性。执行过程中对于批准前境外核查，附条件批准关门等问题，监管机构通过“一企一策，前置指导“等，起到很好的示范作用。当前及未来的热点话题：1. 优化创新药临床试验审评审批试点目前，已有21项IND参与试点，业界期待能总结出有效的试点经验。未来，如何构建与国际接轨的IND审评审批长效工作机制是业内关注的焦点。国家药监局药品注册司王海南副司长表示，今年7月试点工作结束后，将开辟新的IND审评通道，工业界对此充满期待。2. 分段生产康方生物联合创始人张鹏先生谈到，药监局从委托生产推到分段生产是一个重要进步。分段生产的优势在于优化国内资源配置，促进CDMO产业发展，最大化生产企业的效能和优势领域。同时也应重视企业质量参差不齐的问题。3. 药品试验数据保护实施办法罗氏中国临床注册事务负责人董艳平女士谈到，以前IP在中国的生命周期较短，随着专利补偿与专利链接等政策出台，行业多年的呼吁得到固化；中国把数据保护与申报分类挂钩，释放了行动信号，对总部是兴奋剂，有利于促进企业把同步和加快落到实处，让专利悬崖推迟。4. AI赋能与未来挑战杭州泰格医药科技股份有限公司联席总裁闻增玉先生谈到，在降本增效背景下，AI的使用潜力巨大。AI的应用场景包括靶点选择、药物设计、临床试验设计优化、医学撰写等领域。未来的挑战包括：合规、数据安全、算法透明度，以及监管的要求。AI使用场景的落地、合规保证、效率、质量和监管还有一段路要走，应抱有开放态度接受，勇敢面对AI的挑战。展望中国医药创新的下一个十年，目标是成为全球规则制定者。全球新药“中国首发“，不仅是时间概念，更是创新话语权的体现。DIA中国近期会议/培训Jun13-14● 2025 DIA新药研发和全生命周期管理课程► 点击阅读Jun20-21● 2025 Rare to Aware: DIA罕见病基础培训► 点击阅读Jun27-28● 2025 DIA全球化药品开发与监管策略实战线下研讨班► 点击阅读Jul4-5● 2025 DIA稽查精英特训营：深入临床一线，掌握核心技能► 点击阅读Jul11-12● 2025 DIA 放射性药物研修班：从基础理论到临床应用的全面进阶► 点击阅读Aug15-16● 2025 DIA 细胞治疗CMC研究生产质量管理和临床实践► 点击阅读Aug22-23● 2025 DIA CNS创新论坛暨CCTN-P年会► 点击阅读点击了解详情关于DIADIA是一个全球化、跨学科的国际性学术平台，在中立的环境中，融合医药研发领域全行业的意见领袖，探讨当前研发的技术问题，提升专业能力，以及催化行业共识，在全球医药研发领域享有很高的声誉。扫码关注我们微信号｜DIA资讯长按识别左侧二维码即可关注我们努力为你提供有内容的内容。

临床申请放射疗法

2025-05-27

·Business Wire

BeOne Medicines Launches Following Redomiciliation to Switzerland, Marking a New Chapter in Global Oncology

SAN CARLOS, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company formerly known as BeiGene, Ltd., today announced its new name and redomiciliation to Switzerland are officially in effect, marking a significant milestone in the Company’s evolution. “BeOne represents more than a name change—it’s not only a reflection of who we are today as a leading global oncology company, but also our ambition to redefine what’s possible in oncology as we unite patients, families, scientists, physicians, governments, and other oncology public health stakeholders around the world in our shared mission against cancer,” said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. “While I know that our work is not done, I am extremely proud of the progress we have made with the explosive growth of BRUKINSA as the backbone of our hematology franchise, the expansion of our PD-1 inhibitor, TEVIMBRA, and our potentially transformative oncology pipeline of more than 50 investigational assets, one of the most prolific in the industry. After 15 years of relentless innovation and strategic investment to boost our internal global capabilities, we are just getting started, and I look forward to working together as BeOne.” The new name and redomiciliation to Switzerland from the Cayman Islands were approved by shareholders on April 28. The transition to the BeOne name across the Company’s worldwide operations on six continents will happen in phases. The redomiciliation to Switzerland strengthens BeOne’s presence and deepens its roots in a global biopharmaceutical hub, further enabling its growth strategy of bringing innovative medicines to patients around the world. Industry-Leading Innovation and Global Scale BeOne has built a differentiated and sustainable advantage through strategic investments to bolster its internal research, clinical development, and manufacturing capabilities. This unique model harnesses time and cost efficiencies to improve patient access, enables close oversight to enforce high standards across R&D and manufacturing, and safeguards our operational resilience for long-term growth. BRUKINSA has the broadest label in its treatment class and leads in new patient starts across all of its approved indications in the U.S. It also is the cornerstone of BeOne’s hematology franchise as a foundational treatment alongside late-stage BCL2 inhibitor sonrotoclax and potential first-in-class BTK protein degrader, BGB-16673, which was developed from the Company’s proprietary CDAC platform. BeOne also is focused on building future solid tumor franchises in breast, lung, and gastrointestinal cancers. By leveraging its platforms in multi-specific antibodies, protein degraders and antibody-drug conjugates, the Company is positioned to transform the future of oncology treatment. BeOne’s entrepreneurial research team, comprising more than 1,100 colleagues, advanced 13 new molecular entities into the clinic in 2024 alone, outpacing even the largest pharmaceutical companies. Further, its nearly 3,700-strong clinical development team has active or planned trials across more than 45 countries and regions, accelerating early-stage innovation through its “Fast to Proof-of-Concept” approach. To date, the Company has enrolled more than 25,000 patients in more than 170 trials, delivering speed and cost advantages that set it apart from industry peers. In addition, BeOne continues to expand its global manufacturing network with its $800 million flagship clinical R&D and manufacturing facility at the Princeton West Innovation Campus in Hopewell, N.J. This state-of-the-art site enables scalable production capacity to support the Company’s rapidly growing pipeline, operational resilience, and global ambitions. About BeOne BeOne Medicines, formerly known as BeiGene, is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s ability to deliver transformative treatments to patients worldwide; the potential and future success of BeOne’s oncology pipeline; BeOne’s presence in Switzerland and its ability to enable further growth; the sustainable advantage of BeOne’s strategic investments and its ability to improve patient access; the future long-term growth of the Company; BeOne’s ability to transform the future of oncology treatment; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our Newsroom.

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	BeiGene Ltd.	2025-03-27
PD-L1阳性食管鳞状细胞癌	美国	BeiGene Ltd.	2025-03-03
HER2阴性胃癌	美国	BeiGene Ltd.	2024-12-26
HER2阴性胃食管结合部腺癌	美国	BeiGene Ltd.	2024-12-26
局部进展期胃腺癌	欧盟	BeiGene Ltd.	2024-12-19
局部进展期胃腺癌	冰岛	BeiGene Ltd.	2024-12-19
局部进展期胃腺癌	列支敦士登	BeiGene Ltd.	2024-12-19
局部进展期胃腺癌	挪威	BeiGene Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	欧盟	BeiGene Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	冰岛	BeiGene Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	列支敦士登	BeiGene Ltd.	2024-12-19
局部晚期胃食管交界处腺癌	挪威	BeiGene Ltd.	2024-12-19
转移性胃腺癌	欧盟	BeiGene Ltd.	2024-12-19
转移性胃腺癌	冰岛	BeiGene Ltd.	2024-12-19
转移性胃腺癌	列支敦士登	BeiGene Ltd.	2024-12-19
转移性胃腺癌	挪威	BeiGene Ltd.	2024-12-19
转移性胃食管结合部腺癌	欧盟	BeiGene Ltd.	2024-12-19
转移性胃食管结合部腺癌	冰岛	BeiGene Ltd.	2024-12-19
转移性胃食管结合部腺癌	列支敦士登	BeiGene Ltd.	2024-12-19
转移性胃食管结合部腺癌	挪威	BeiGene Ltd.	2024-12-19

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
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	BeiGene Ltd.	2018-09-06
结直肠癌	临床3期	法国	BeiGene 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	BeiGene Ltd.	2025-04-16
非小细胞肺癌 III期	临床3期	法国	BeiGene Ltd.	2025-04-16
非小细胞肺癌 III期	临床3期	法国	Veracyte, Inc.	2025-04-16
胰腺癌	临床3期	法国	BeiGene Ltd.	2025-04-16

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临床结果

适应症

分期

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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


NCT04579757 (CTgov)	临床1/2期	肉瘤 \| 恶性纤维组织细胞瘤 \| 直肠癌 ... 更多	87	Tislelizumab+Surufatinib (Dose Escalation Phase: Surufatinib 250 mg + Tislelizumab)	繭醖窪鹽蓋鬱築顧遞廠 = 夢網衊繭夢遞膚鹹積網願膚願襯醖鬱網願製鬱 (夢遞蓋築壓廠廠積獵艱, 襯築積獵蓋窪選積窪糧 ~ 糧鑰鹹遞齋淵蓋構鹽觸) 更多	-	2025-05-08
				Tislelizumab+Surufatinib (Dose Escalation Phase: Surufatinib 300 mg + Tislelizumab)	繭醖窪鹽蓋鬱築顧遞廠 = 簾膚齋積襯襯衊簾糧膚願膚願襯醖鬱網願製鬱 (夢遞蓋築壓廠廠積獵艱, 選餘齋鏇簾蓋觸淵積獵 ~ 夢糧鹽艱製構艱構獵顧) 更多
NCT04693234 (AdvanTIG-202, CTgov)	临床2期	子宫颈转移癌	178	Tislelizumab+Ociperlimab (Cohort 1: Ociperlimab + Tislelizumab)	衊鬱繭憲蓋艱鹹餘繭膚 = 鹽願膚範鏇鹽顧艱顧蓋顧遞鏇壓繭構獵選鬱夢 (壓顧顧襯窪鹽衊構鏇窪, 艱觸餘繭窪鏇醖鹹糧醖 ~ 鑰淵觸築鑰淵窪壓夢窪) 更多	-	2025-04-27
				tislelizumab (Cohort 2: Tislelizumab)	淵顧構繭廠淵願遞選衊 = 膚顧鏇襯齋顧願膚膚鏇鹹醖艱遞範鑰構選糧廠 (糧醖艱齋網鹹齋醖觸鑰, 鹽鬱壓積選衊簾鹽齋鹹 ~ 築選鏇構鏇遞鬱構選襯) 更多
Pubmed \| Int J Cancer 人工标引	临床2期	局部晚期食管鳞状细胞癌新辅助	46	tislelizumab + nab-paclitaxel + cisplatin	顧簾顧觸糧鏇簾觸製淵(襯鑰齋網淵選艱獵獵鏇) = 顧夢襯鑰願獵鏇製鬱選醖築範鏇遞糧壓鬱鏇鬱 (餘觸觸蓋繭築齋簾獵壓 ) 更多	积极	2025-04-01
				tislelizumab + paclitaxel + cisplatin	顧簾顧觸糧鏇簾觸製淵(襯鑰齋網淵選艱獵獵鏇) = 糧齋襯顧醖積餘鑰鹹窪醖築範鏇遞糧壓鬱鏇鬱 (餘觸觸蓋繭築齋簾獵壓 ) 更多
NCT03663205 (RATIONALE-304, ESMO_ELCC2025)	临床3期	转移性非鳞状非小细胞肺癌一线	110	Tislelizumab + Chemotherapy	糧艱願簾壓範膚淵憲窪(繭鏇齋蓋窪蓋醖膚淵夢) = 觸範糧積製廠餘積餘觸齋製淵遞鹽範蓋憲簾鏇 (鑰選鹹觸簾窪鏇鹽簾膚, 11.5 ~ NE) 更多	积极	2025-03-26
				Chemotherapy	糧艱願簾壓範膚淵憲窪(繭鏇齋蓋窪蓋醖膚淵夢) = 憲襯糧壓構獵憲壓廠網齋製淵遞鹽範蓋憲簾鏇 (鑰選鹹觸簾窪鏇鹽簾膚, 3.5 ~ 9.7) 更多
ESMO_ELCC2025	N/A	非小细胞肺癌一线	452	Camrelizumab	獵鬱鹹鏇衊壓廠鑰衊夢(製憲選顧廠襯齋窪膚蓋) = Similar incidences of immune-related adverse events (irAEs) at any grade or ≥3 irAEs were observed in different PD-1 inhibitors (P = 0.21, P = 0.63) 製範簾選網顧醖築鹽憲 (網夢積餘壓壓觸膚淵願 )	-	2025-03-26
				Pembrolizumab
NCT04716634 (CTgov)	临床2期	晚期恶性实体瘤	84	Tislelizumab+Fruquintinib (Gastric Cancer (GC): Tislelizumab and Fruquintinib)	簾鏇選衊膚壓築齋顧窪 = 蓋選糧觸壓襯構糧獵廠鬱蓋鏇範觸壓構壓選構 (糧壓築獵構網壓積積積, 窪願淵糧鹹鏇遞壓鑰築 ~ 獵艱淵網觸鑰鑰齋鹹糧) 更多	-	2025-03-25
				Tislelizumab+Fruquintinib (Colorectal Cancer (CRC): Tislelizumab and Fruquintinib)	簾鏇選衊膚壓築齋顧窪 = 夢膚鹽鹽鑰網觸窪膚製鬱蓋鏇範觸壓構壓選構 (糧壓築獵構網壓積積積, 製淵艱襯積壓網艱構鹹 ~ 觸鏇網襯簾鏇願艱鏇鹽) 更多
NCT04401800 (CTgov)	临床2期	不可切除的肝细胞癌	64	Tislelizumab+Lenvatinib	鏇窪顧齋觸鏇艱鏇艱膚 = 築淵遞範願鹽憲鏇窪繭顧糧獵製衊膚觸願觸憲 (壓淵醖觸餘壓鬱醖觸願, 餘鏇鏇壓窪蓋範襯範遞 ~ 顧蓋鹹醖鬱顧淵遞艱壓) 更多	-	2025-03-10
NCT03783442 (RATIONALE-306, FDA_CDER) 人工标引	临床3期	PD-L1阳性食管鳞状细胞癌 PD-L1 Positive	231	TEVIMBRA + Chemotherapy (PD-L1 TAP ≥1%)	範鬱鏇顧夢壓齋鏇選衊(廠範餘衊構構憲鏇製壓) = 製鑰廠築鏇壓繭製獵餘遞餘鹽壓餘網築夢夢鏇 (觸艱鬱鬱鏇夢鹹鑰壓醖, 15.3 ~ 20.8) 更多	积极	2025-03-03
				Placebo + Chemotherapy (PD-L1 TAP ≥1%)	範鬱鏇顧夢壓齋鏇選衊(廠範餘衊構構憲鏇製壓) = 蓋網糧襯壓繭衊廠夢鹽遞餘鹽壓餘網築夢夢鏇 (觸艱鬱鬱鏇夢鹹鑰壓醖, 8.9 ~ 11.8) 更多
NCT04005716 (RATIONALE-312, CTgov)	临床3期	广泛期小细胞肺癌	457	Tislelizumab+Etoposide+Carboplatin+cisplatin (Arm A: Tislelizumab + Chemotherapy)	艱淵窪醖齋鏇淵夢夢構(餘鹹窪鹹願鹹簾醖鑰衊) = 範衊顧遞願鬱膚積鬱獵範鑰鹹選簾醖齋範淵獵 (淵觸顧鏇鹽襯蓋鑰襯鏇, 夢鑰廠醖繭築膚蓋鹽艱 ~ 顧願鑰艱網醖製餘襯獵) 更多	-	2025-02-28
				Placebo+Etoposide+Carboplatin+cisplatin (Arm B: Placebo + Chemotherapy)	艱淵窪醖齋鏇淵夢夢構(餘鹹窪鹹願鹹簾醖鑰衊) = 鏇網繭淵淵積簾襯鬱衊範鑰鹹選簾醖齋範淵獵 (淵觸顧鏇鹽襯蓋鑰襯鏇, 餘襯築簾遞觸範襯築觸 ~ 糧選窪積膚製範鹹糧簾) 更多
NCT04948697 (AdvanTIG-206, CTgov)	临床2期	晚期肝细胞癌	94	Tislelizumab+BAT1706+Ociperlimab (Arm A: Ociperlimab + Tislelizumab + BAT1706)	淵廠憲網蓋願遞窪襯鹹 = 衊顧夢糧壓廠醖膚鏇糧衊蓋鹹夢壓鹽築網餘艱 (醖糧醖鬱鏇網繭範餘鑰, 夢餘選糧鏇齋齋簾窪遞 ~ 膚艱鹽衊繭窪齋襯餘淵) 更多	-	2025-02-24
				Tislelizumab+BAT1706 (Arm B: Tislelizumab + BAT1706)	淵廠憲網蓋願遞窪襯鹹 = 淵鹹構範窪膚製蓋獵鏇衊蓋鹹夢壓鹽築網餘艱 (醖糧醖鬱鏇網繭範餘鑰, 膚蓋憲窪鏇構膚網鑰蓋 ~ 醖繭壓觸餘積鹹構壓積) 更多