贝莫苏拜单抗(Benmelstobart) - 药物靶点：PDL1_在研适应症：子宫内膜癌，广泛期小细胞肺癌，晚期肺非小细胞鳞癌_专利_临床

概要

基本信息

药物类型

单克隆抗体

别名

Anti-PD-L1 monoclonal antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group)、PD-L1 antibody ( Apollomics/Chia Tai Tianqing Pharmaceutical Group)、APL 502

+ [7]

靶点

PDL1

作用方式

抑制剂、刺激剂

作用机制

PDL1抑制剂(程序性死亡配体1抑制剂)、T淋巴细胞刺激剂

治疗领域

肿瘤呼吸系统疾病泌尿生殖系统疾病+ [8]

在研适应症

子宫内膜癌广泛期小细胞肺癌晚期肺非小细胞鳞癌+ [36]

非在研适应症

肢端雀斑恶性黑色素瘤胆道腺癌晚期胆管癌+ [16]

原研机构

在研机构

+ [1]

非在研机构

浙江冠科美博生物科技有限公司

最高研发阶段批准上市

首次获批日期

中国 (2024-04-30),

广泛期小细胞肺癌

最高研发阶段(中国)批准上市

特殊审评优先审评 (中国)、附条件批准 (中国)、突破性疗法 (中国)

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结构/序列

Sequence Code 10067450H

来源: *****

Sequence Code 10067454L

来源: *****

关联

106

项与贝莫苏拜单抗相关的临床试验

NCT06848439

/ Not yet recruiting临床2期IIT

A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer

Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer
This is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:
Group A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy/5 weeks.
Group B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy/5 weeks.
Group C (Partial Pathological Response/No Pathological Response):
Low-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy/6 weeks.
High-risk patients (extracapsular nodal extension and/or positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy/6-6.6 weeks + Cisplatin: 60mg/m² every 3 weeks, 2-3 cycles.
Additionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).

开始日期2025-06-15

申办/合作机构

江苏省肿瘤防治研究所（江苏省肿瘤医院）

NCT06931145

/ Not yet recruiting临床4期IIT

A Real-world Study of Benmelstobart, Anlotinib and Chemotherapy Regimen as First-line Treatment for Extensive-stage Small-cell Lung Cancer

The goal of this clinical trial is to evaluate the efficacy and safety of benmelstobart in combination with anlotinib and chemotherapy sequential benmelstobart in combination with anlotinib for the first-line treatment of extensive-stage small cell lung cancer.

开始日期2025-04-15

申办/合作机构

北京协和医院

[+1]

NCT06914297

/ Not yet recruiting临床2期IIT

Immune Checkpoint Inhibitors Combined With Progestins for Fertility-sparing Treatment in Patients With MMRd Endometrial Cancer: a Multicenter Single-arm Prospective Clinical Trial

Based on the above situation, the investigators propose the following scientific hypothesis: In young patients with early MMRd type EC, the use of immune checkpoint inhibitors combined with progesterone for fertility retention therapy can improve the therapeutic efficacy, reduce recurrence, and improve tumor prognosis.
Based on the above assumptions, this project intends to conduct a prospective exploratory clinical study in EC patients limited to the endometrial layer or superficial myometrium (FIGO 2023 IA1-IA2 stage). The subjects were treated with TQB2450 periodic intravenous drip + high-potency progesterone daily oral therapy. During the treatment period, hysteroscopy was performed every 12 weeks to evaluate the therapeutic efficacy. The primary endpoint was the 12-week CR rate; the secondary endpoints included the 24-week CR rate, the 36-week CR rate, the median CR time, the 1-year relapse rate, the 2-year relapse rate, the median relapse time, the pregnancy rate, the live birth rate, and drug-related adverse reactions. The exploratory indicators were the response of different MMRd tumors to immune checkpoint inhibitors and their possible mechanisms. The development of this study will provide a clinical basis for improving the fertility-preserving treatment regimen of MMRd EC.

开始日期2025-04-01

申办/合作机构

复旦大学

100 项与贝莫苏拜单抗相关的临床结果

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100 项与贝莫苏拜单抗相关的转化医学

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100 项与贝莫苏拜单抗相关的专利（医药）

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270

项与贝莫苏拜单抗相关的文献（医药）

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

HMGB1 assists the predictive value of tumor PD-L1 expression for the efficacy of anti-PD-1/PD-L1 antibody in NSCLC

Article

作者: Oga, Toru ; Masuda, Takeshi ; Horimasu, Yasushi ; Hattori, Noboru ; Yamaguchi, Kakuhiro ; Hamada, Hironobu ; Funaishi, Kunihiko ; Iwamoto, Hiroshi ; Tanahashi, Hiroki ; Oka, Mikio ; Nakashima, Taku ; Sakamoto, Shinjiro ; Kurose, Koji

Abstract:

Background:

The expression of anti-programmed cell death ligand-1 (PD-L1) in tumors is widely used as a biomarker to predict the therapeutic efficacy of anti-programmed cell death-1(PD-1)/PD-L1 antibodies. However, the predictive accuracy of this method is limited. High-mobility group box 1 (HMGB1) is known to modulate cancer immunity. Therefore, we investigated the potential of circulatory HMGB1 in combination with PD-L1 expression to predict the efficacy of anti-PD-1/PD-L1 antibody monotherapy.

Patients and methods:

This multicenter retrospective study analyzed blood samples collected from 114 patients with non-small cell lung cancer (NSCLC) prior to anti-PD-1/PD-L1 antibody monotherapy at two university hospitals (Hiroshima University Hospital and Kawasaki Medical School Hospital) between December 2015 and October 2020. We evaluated the association of serum HMGB1 levels with tumor response and progression-free survival (PFS).

Results:

Serum HMGB1 levels were significantly higher in patients with complete or partial response than in those with stable or progressive disease. Using receiver operating characteristic analysis, the cut-off level of serum HMGB1 to predict tumor response was determined to be 3.83 ng/mL. PFS was significantly longer in the HMGB1high group than that in the HMGB1low group in the entire cohort (4.3 months vs. 2.3 months) and in patients with NSCLC with PD-L1 tumor proportion score (TPS) ≥ 50% (12.4 months vs. 4.4 months), but not in those with PD-L1 TPS < 50% or unknown.

Conclusion:

HMGB1 may serve as a predictive biomarker for the efficacy of anti-PD-1/PD-L1 antibody therapy in the patients with NSCLC, especially in those with PD-L1 TPS ≥ 50%.

2025-04-01·Materials Today Bio

Improving ferroptosis-mediated immunotherapy for colorectal cancer through lysosome-targeted photodynamic therapy

Article

作者: Zhang, Qianbing ; Lu, Chuyue ; Lin, Zhenyu ; Zheng, Hua ; Wang, Yutong ; Li, Zhenhao ; Chen, Lujia ; Chen, Zhian ; Chen, Meijuan ; Li, Yingshi

Lysosomes is emerging as a promising therapeutic target for improving immunotherapy, which dysfunction would trigger lysosomal membrane permeabilization increase and subsequent leakage of reduced iron, which contributed to ferroptosis through cell-intrinsic Fenton chemistry. However, the integrity of lysosomal membranes is not susceptible to disrupt, owing to the presence of several Endo-lysosomal damage-response mechanisms. Herein, we developed a lysosome-targeted photosensitizer (TLA), which possessed robust light stability, good bio-compatibility, and high photodynamic therapy (PDT) effect. Upon internalized by cancer cells, TLA was specifically accumulated in lysosome, and which would destroy the integrity of lysosomal membranes and inhibit protective autophagy upon exposure to light irradiation. Subsequently, the cancer cells were suffered from ferroptosis through triggering cell-intrinsic Fenton chemistry and mitochondrial dysfunction, which would release damage-associated molecular pattern molecules (DAMPs) to induce immunogenic cell death and remodel immunosuppressive tumor microenvironment. Notably, combined with PD-L1 antibody and TLA could greatly potentiate the immune response and exhibit highest anti-tumor effects. In summary, this novel lysosome-targeted photosensitizer could serve as a promising strategy for the treatment of colorectal cancer.

2025-04-01·HEPATOLOGY

A randomized phase 2b study of subcutaneous PD-L1 antibody ASC22 in virally suppressed patients with chronic hepatitis B who are HBeAg-negative

Article

作者: Xie, Qing ; Yang, Yongfeng ; Fu, Lei ; Wu, Jinzi J. ; Mao, Qianguo ; Chen, Yongping ; Cui, Yimin ; Xie, Yao ; Qian, Jiandan ; Zhang, Qin ; Guo, Xiaolin ; Wang, Guiqiang ; Chen, Xinyue ; Lu, Jiajie ; Hou, Jinlin ; Gu, Ye ; Hu, Guoxin ; Yan, Yuemei ; Zou, Guizhou

Background and Aims::

Studies have shown that blocking the programmed cell death-1/programmed cell death ligand 1 pathway may lead to a potential cure for HBV infections. ASC22 (envafolimab) is a humanized, single-domain programmed cell death ligand 1 antibody administered subcutaneously. This study aimed to evaluate the efficacy and safety of ASC22 in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs.

Approach and Results::

This randomized, single-blind, phase IIb trial enrolled patients with chronic hepatitis B in 2 cohorts for a 24-week treatment with ASC22 or placebo (PBO) once every 2 weeks and 24-week follow-up. In total, 60, 59, and 30 patients were treated with 1.0, 2.5 mg/kg ASC22, and PBO, respectively. The mean changes in HBsAg from baseline at weeks 24 and 48 were −0.309 (p < 0.001) and −0.272 (p < 0.023) log10 IU/mL in the 1.0 mg/kg ASC22 group, −0.231 (p = 0.007) and −0.205 (p = 0.12) log10 IU/mL in the 2.5 mg/kg ASC22 group, and −0.003 and −0.063 log10 IU/mL in the PBO group, respectively (intent-to-treat population). Three out of 10 patients with baseline HBsAg levels ≤100 IU/mL in the 1.0 mg/kg group obtained on-treatment HBsAg loss. Most adverse events were mild (97.9%). There were no study drug–related serious adverse events in the 1.0 mg/kg ASC22 group.

Conclusions::

Subcutaneous administration of 1.0 mg/kg ASC22 once every 2 weeks for 24 weeks was shown to be safe and well-tolerated in virally suppressed patients with chronic hepatitis B on nucleos(t)ide analogs and can induce HBsAg decline, especially in patients with HBsAg ≤100 IU/mL.

238

项与贝莫苏拜单抗相关的新闻（医药）

18 小时之前

·医药观澜

正大天晴「贝莫苏拜单抗」+「安罗替尼」新适应症申报上市

今日（4月23日），中国国家药监局药品审评中心（CDE）官网最新公示，正大天晴申报的贝莫苏拜单抗注射液和盐酸安罗替尼胶囊的多项新适应症上市申请获得受理。贝莫苏拜单抗是一款创新人源化抗PD-L1单克隆抗体，盐酸安罗替尼胶囊是一款口服新型小分子多靶点酪氨酸激酶抑制剂。根据正大天晴公开资料，这项联合疗法已经在多项适应症中取得积极临床研究结果，处于上市申报阶段，包括：贝莫苏拜单抗注射液联合或不联合盐酸安罗替尼胶囊用于巩固治疗同步/序贯放化疗后未进展的、局部晚期/不可切除（Ⅲ期）的非小细胞肺癌患者；贝莫苏拜单抗联合化疗后序贯联合盐酸安罗替尼胶囊一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）；贝莫苏拜单抗注射液联合盐酸安罗替尼胶囊治疗晚期或不可切除腺泡状软组织肉瘤（该项适应症已经被CDE正式纳入优先审评）。截图来源：CDE官网贝莫苏拜单抗与安罗替尼联合疗法于2024年5月在中国获批，用于一线治疗广泛期小细胞肺癌（ES-SCLC）患者。于2024年11月在中国获批第二项适应症，用于治疗复发性或转移性子宫内膜癌。2024年8月，贝莫苏拜单抗联合安罗替尼用于一线治疗晚期不可切除或转移性肾细胞癌（RCC）的上市申请也已经获CDE受理。根据正大天晴公开资料梳理，除了已经获批的适应症，贝莫苏拜单抗与安罗替尼联合疗法还已经在多个其他适应症上取得积极结果：TQB2450-Ⅲ-05研究（NCT04325763）是一项随机、双盲双模拟、安慰剂平行对照、多中心的3期临床研究，旨在评估贝莫苏拜单抗联合或不联合盐酸安罗替尼胶囊作为巩固治疗在同步/序贯放化疗后未进展的、局部晚期/不可切除（Ⅲ期）NSCLC的有效性和安全性。本研究的期中分析结果显示，相比对照组，试验组可显著降低患者的疾病进展或死亡风险，延长患者无进展生存期（PFS）。其安全性数据与已知风险相符，未发现新的安全性信号。TQB2450-Ⅲ-12（NCT05718167）是一项多中心、随机、双盲、平行对照的3期临床研究，旨在评估贝莫苏拜单抗注射液联合化疗后序贯联合盐酸安罗替尼胶囊对比一款PD-1抑制剂注射液联合化疗一线治疗晚期鳞状非小细胞肺癌（sq-NSCLC）的有效性和安全性。经独立数据监查委员会（IDMC）判定，主要研究终点无进展生存期（PFS）达到方案预设的优效界值。本研究的期中分析结果显示，与对照组相比，贝莫苏拜单抗联合化疗后序贯联合安罗替尼可显著延长患者的mPFS，降低疾病进展或死亡风险。其安全性数据与已知风险相符，未发现新的安全性信号。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved Apr 23，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]贝莫苏拜单抗Ⅲ期临床研究取得阳性结果，Ⅲ期非小细胞肺癌治疗迎新曙光. Retrieved Dec 19，2024, From https://mp.weixin.qq.com/s/fendmwH-x3jFveu9kIj1-A[3]贝莫苏拜单抗联合安罗替尼再传喜讯！本月已有三个适应症计划申报上市 . Retrieved Dec 27，2024, From https://mp.weixin.qq.com/s/tI2PMoRPrtrpFWbw9LDo-A[4]贝莫苏拜单抗联合安罗替尼纳入优先审评，治疗腺泡状软组织肉瘤. Retrieved Jan 22，2025, From https://mp.weixin.qq.com/s/uy6rF81l-Hq8Y46R6HyBIg免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

临床3期优先审批申请上市

2025-04-15

·正大天晴药业集团

全国肿瘤防治宣传周 | 健康生活方式可预防30%癌症

4月15日-21日是第31个全国肿瘤防治宣传周。国家癌症中心数据显示[1]，我国每年新发癌症病例超480万，是威胁公众健康的主要疾病之一。但令人欣慰的是，随着医学的进步，癌症已从“不治之症”逐渐转变为可防可治的“慢性疾病”。作为普通人，我们该如何预防癌症？抓住早筛黄金时间？治疗后如何科学康复？我们将从以下5步，带大家了解“科学防癌、健康生活”全攻略。第一步、预防——筑牢健康防线世界卫生组织指出，超过30%的癌症可通过健康的生活方式避免[2]。第二步、筛查——把握黄金窗口许多癌症在早期阶段并无明显症状，通过科学的筛查手段，可以在疾病尚未恶化时及时干预[9]，以下是几种常见癌症的高危人群及筛查方法[10-14]：第三步、诊断——精准判断病情精准的诊断不仅能够明确癌症的类型和分期，还能为后续治疗方案的制定提供科学依据，常用诊断方法包括：第四步、治疗——科学选择方案现代医学为癌症患者提供了多种治疗手段，每种方法都有其适用场景和优势，关键在于根据患者情况选择个性化治疗：第五步、康复——回归正常生活癌症治疗的结束并不意味着战斗的终结，康复期的管理至关重要。癌症防治是一场需要全社会共同参与的持久战。通过健康的生活方式、科学的筛查手段、精准的诊断技术、个性化的治疗方案以及全面的康复管理，可以显著降低癌症威胁，提高生活质量。聚焦抗肿瘤领域，正大天晴药业集团已上市盐酸安罗替尼胶囊（福可维）、贝莫苏拜单抗注射液（安得卫）、贝伐珠单抗注射液（安倍斯）、艾贝格司亭α注射液（亿立舒）、格索雷塞片（安方宁）等20余款重要产品。多款创新药的上市，不仅为患者提供了更多的治疗选择，更通过联合疗法（如安罗替尼+贝莫苏拜单抗）将广泛期小细胞肺癌患者的中位总生存期延长至19.3个月，刷新全球同类研究的最长生存记录。此外，正大天晴还有多款双抗、ADC药物进入临床后期阶段，为构建全球卫生健康发展注入强劲动能。参考文献：[1] Bingfeng Han et al, Zhonghua Zhong Liu Za Zhi. 2024 Mar 23;46(3):221-231.[2] WHO. Cancer prevention.[3] WCRF. Diet, nutrition, physical activity and cancer. 2018.[4] Liu RH. Am J Clin Nutr. 2003;78(3):517S-520S.[5] McTiernan A. Nat Rev Cancer. 2008;8(3):205-211.[6] U.S. Surgeon General. The Health Consequences of Smoking. 2014.[7] Bagnardi V. Br J Cancer. 2015;112(3):580-593.[8] Irwin MR. Nat Rev Immunol. 2019;19(11):702-715.[9] American Cancer Society. Cancer screening guidelines. 2021.[10] 国家卫健委肺癌筛查与早诊早治方案（2024年版）.[11] 国家卫健委结直肠癌筛查与早诊早治方案（2024年版）.[12] 中国肿瘤整合诊治指南（CACA)-甲状腺癌-V2.0_2025.[13] CSCO 原发性肝癌诊疗指南2024.[14] 中国肿瘤整合诊治指南（CACA)-乳腺癌-V2.0_2025.[15] American Cancer Society. Surgery for cancer. 2022.[16] Baskar R. Int J Med Sci. 2012;9(3):193-199.[17] Baumann M. Nat Rev Cancer. 2016;16(5):273-282.[18] Chabner BA. Nat Rev Cancer. 2005;5(1):65-72.[19] DeVita VT. Cancer Res. 2008;68(21):8643-8653.[20] Wu SG. Mol Cancer. 2018;17(1):1-14.[21] Li Z, et al.2024 WCLC Abstract OA14.03.[22] CSCO 免疫检查点抑制剂临床应用指南2024.[23] Cheng, Y., Chen, J., Zhang, W. et al. Nat Med (2024).▲ 上下滑动查看更多声明：1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。2.本公司不对任何药品和/或适应症作推荐。3.本新闻稿中涉及的信息仅供参考，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。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。● 香港大学全球CEO课程首期班参访正大天晴谢承润围绕“人制户品”解读管理策略● 客观缓解率100%！安罗替尼联合化疗新辅助治疗头颈鳞癌表现出众● 1类新药再+1！正大天晴口服BTK蛋白降解剂TQB3019获批临床● 1类新药ST单抗获批临床按下过敏性鼻炎“反应暂停键”

抗体药物偶联物免疫疗法

2025-04-02

·癌度

开眼界，IDH1基因突变会发生在肺癌，使用艾伏尼布实现了神奇的逆转！

癌度医学临床招募资讯微信群（点击）一般来说，恶性肿瘤都存在驱动基因突变的问题，不过驱动基因是否有对应的靶向药则是不一定，不过非小细胞肺腺癌有80%的概率能找到对应基因突变的靶向药，因此如果确诊非小细胞肺腺癌，那么最为重要的一点是通过二代基因测序技术将驱动这个疾病发生的基因突变找出来，以找到最适合的靶向药治疗策略。今天癌度给大家介绍IDH1基因，这是一个首次报道发生在肺腺癌的基因突变。异柠檬酸脱氢酶（IDH1）基因很少在非小细胞肺癌发生，但是在其他种类的恶性肿瘤则很常见，比如神经胶质瘤、急性髓细胞白血病、胆管癌和软骨肉瘤。患者通过使用靶向药ivosidenib（艾伏尼布）进行靶向治疗，实现了较好的病情控制。1、艾伏尼布治疗IDH1基因突变的肺癌2024年5月，一名43岁很少吸烟的男性因为持续咳嗦约2个月而入院检查，胸部CT扫描检查发现右肺占位性病变，患者最初表现为咳嗦、咳痰，随后偶尔出现胸痛和右腰痛，呼吸困难加重。影像学检查发现右上叶肺部肿块达到了7厘米×4厘米，右锁骨上窝以及纵膈淋巴结肿大，PET-CT扫描显示多处转移，最终临床分期为IIIC期，多学科评估后确定无手术机会。肺腺癌确诊为IDH1基因突变对于右锁骨淋巴结穿刺活检进行病理性诊断发现为肺腺癌，血液样本进行二代基因测序（76个基因）发现IDH1基因的R132H突变，突变频率为3.87%。2024年6月，身体状况不佳的患者开始使用艾伏尼布治疗，每日用药一次每次500毫克，从治疗开始每4周使用影像学检查做疗效评估。CT图像的疗效评估如上面图示，2024年7月至9月的一系列影像学检查发现，肿瘤病灶持续缩小，从7厘米×4厘米缩小至2.7厘米×1厘米，在整个治疗过程中肿瘤负荷不断减少，患者的吞咽困难、咳嗦、胸闷和疼痛均得到了改善，状态良好。患者在整个治疗过程没有出现任何的不良事件，也就是对这款药的耐受性良好。2、跨适应用药的典型应用上面是一个肺癌跨适应症用药的典型应用，艾伏尼布这款药在国外和国内都获批上市，但是用于IDH1基因突变的胆管癌和胶质瘤，没有批准肺腺癌的适应症。因为IDH1基因出现在肺癌的概率不是很高，所以这款药即便是想在肺癌开展临床试验也是很需要时间，但是对于肺癌患者则不同，因为大家等不起。因此如果确诊了肺癌这个疾病，一定要通过二代基因测序技术将肿瘤的基因突变找出来，不能只是测一个EGFR或ALK就放弃了，因为放弃了靶向药的治疗机会就只能是化疗和PD-1抑制剂了，而这两者并不能保证给到很长的生存期。所以生病了就将病情的原因搞明白，如果恰好发现是IDH1基因突变，则可以完全参考上面的治疗案例，通过使用艾伏尼布实现跨适应症用药，这样可能会出现神奇的效果，而将化疗和免疫治疗往后延迟。基因检测、肿瘤临床试验问题欢迎关注癌度咨询！参考文献：Yuyue Zhang, et al., First Report of NSCLC With IDH1 Mutation: A Case Report, Clinical Lung Cancer.(2025). 往期推荐抗癌需要光？所以LS-HB来了，光动力疗法招募多种实体肿瘤免费用，癌魔以“光”灭之！PD-1和化疗都无效了，适用于驱动基因阴性肺癌的AL2846联合TQB2450来了，确证有效！癌症治疗疫苗系列：树突状细胞疫苗治疗乳腺癌，部分患者病灶完全消失！大长见识，EGFR基因黄金突变19号外显子缺失分4类，用靶向药的总生存时间相差3倍！

临床3期上市批准基因疗法

100 项与贝莫苏拜单抗相关的药物交易

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批准上市

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适应症	国家/地区	公司	日期
子宫内膜癌	中国	正大天晴药业集团南京顺欣制药有限公司	2024-11-22
广泛期小细胞肺癌	中国	正大天晴药业集团南京顺欣制药有限公司	2024-04-30

未上市

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适应症	最高研发状态	国家/地区	公司	日期
晚期肺非小细胞鳞癌	申请上市	中国	中國生物製藥有限公司	2024-12-27
转移性肾细胞癌	申请上市	中国	正大天晴药业集团南京顺欣制药有限公司	2024-08-01
不可切除的肾细胞癌	申请上市	中国	正大天晴药业集团南京顺欣制药有限公司	2024-08-01
鳞状非小细胞肺癌	临床3期	中国	正大天晴药业集团股份有限公司	2023-01-18
复发性铂耐药性卵巢癌	临床3期	中国	正大天晴药业集团股份有限公司	2021-09-26
晚期非小细胞肺癌	临床3期	中国	正大天晴药业集团股份有限公司	2021-07-21
非小细胞肺癌	临床3期	中国	正大天晴药业集团股份有限公司	2021-07-21
非鳞状非小细胞肺癌	临床3期	中国	正大天晴药业集团股份有限公司	2021-07-21
晚期胆道癌	临床3期	中国	正大天晴药业集团股份有限公司	2021-01-26
肾肿瘤	临床3期	中国	正大天晴药业集团股份有限公司	2020-08-25

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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


NCT05252078 (ALTER-E005, ASCO_GI2025) 人工标引	临床2期	食管鳞状细胞癌辅助	30	Anlotinib + Benmelstobart	鹹窪簾獵選衊積夢遞觸(鬱願壓鬱構鹽夢鏇窪簾) = not reached 餘遞遞繭窪廠襯顧範築 (繭選積選廠範積鹽鹹範 ) 更多	积极	2025-01-23
NCT04325763 (TQB2450-Ⅲ-05, NEWS) 人工标引	临床3期	非小细胞肺癌巩固	-	贝莫苏拜单抗	遞築壓襯醖壓夢壓範淵(鏇夢鏇壓範憲選顧夢淵) = 積衊製遞顧襯夢鏇糧願築遞願鏇範願餘鬱齋繭 (鑰獵顧製積齋範構積鑰 )	积极	2024-12-19
				贝莫苏拜单抗 + 安罗替尼	-
NCT04574284 (TQB2450-II-08, IGCS2024 \| NEWS) 人工标引	临床2期	子宫内膜癌 non-MSI-H/dMMR	85	Benmelstobart+anlotinib (stage 2 of cohort 1)	膚齋淵醖壓願廠窪觸鑰(製糧壓鏇襯夢製蓋齋壓) = 餘糧製網壓醖網膚構醖網網淵製鬱願鑰糧鬱廠 (膚餘餘簾齋遞獵鹽製觸 ) 更多	积极	2024-11-05
NCT05111366 (ALTER-H006, ESMO2024) 人工标引	临床2期	肝细胞癌辅助	38	AnlotinibTQB2450	廠衊壓構夢壓鹽顧淵鬱(蓋壓遞壓簾網鹹築遞鹹) = 遞遞糧壓顧鏇衊構襯製艱淵衊獵夢觸憲憲簾衊 (齋淵遞艱範積積觸齋選, 28.61 ~ 72.50) 更多	积极	2024-09-16
NCT06116240 (Pubmed \| Cancer) 人工标引	临床1期	肝细胞癌 \| 食管鳞状细胞癌	33	AL2846 + TQB2450 (ESCC)	壓築簾襯餘鹽淵夢壓淵(壓築鑰廠淵簾餘獵衊餘) = 艱製夢遞壓獵艱選願膚鬱構簾網鬱廠選壓糧鹹 (鏇衊顧繭鹹醖糧築鬱憲, 3.1 ~ 32.8) 更多	积极	2024-09-15
				AL2846 + TQB2450 (HCC)	壓築簾襯餘鹽淵夢壓淵(壓築鑰廠淵簾餘獵衊餘) = 艱遞鏇積憲醖壓觸鹹構鬱構簾網鬱廠選壓糧鹹 (鏇衊顧繭鹹醖糧築鬱憲 ) 更多
NCT04523272 (ETER100, ESMO2024) 人工标引	临床3期	晚期肾细胞癌一线	531	Benmelstobart (BMSB) + Anlotinib (ALTN)	遞壓顧憲簾鑰壓鏇餘糧(鬱選廠蓋簾願艱襯觸鏇) = 製艱積憲積膚鑰鹽繭齋遞觸餘構築鹹鹹鑰顧膚 (範構糧選鹽艱觸壓築齋 ) 更多	积极	2024-09-15
				Sunitinib	遞壓顧憲簾鑰壓鏇餘糧(鬱選廠蓋簾願艱襯觸鏇) = 簾窪鏇憲網艱餘餘蓋簾遞觸餘構築鹹鹹鑰顧膚 (範構糧選鹽艱觸壓築齋 ) 更多
ESMO2024	N/A	ER低表达乳腺癌	-	PD-L1 (ER-low (ER=1-9%/HER2-))	淵衊範鹹願糧鏇廠憲憲(鹹蓋積製艱積鹽淵衊鹹) = 築廠鹽範鑰簾夢顧糧築鏇鹹選糧觸繭鏇築膚蓋 (齋壓願鬱構網餘窪築鹹 )	-	2024-09-15
				PD-L1 (Triple-negative (TN) (ER=0%/HER2-))	淵衊範鹹願糧鏇廠憲憲(鹹蓋積製艱積鹽淵衊鹹) = 遞糧獵齋觸鹹網齋遞壓鏇鹹選糧觸繭鏇築膚蓋 (齋壓願鬱構網餘窪築鹹 )
WCLC2024 人工标引	N/A	广泛期小细胞肺癌一线	6,178	Anlotinib+Benmelstobart+Chemotherapy	鏇衊齋繭鑰襯窪積醖顧(襯選齋觸襯選鹹鬱遞鏇): HR = 0.32 (95% CI, 0.25 ~ 0.4) 更多	积极	2024-09-07
				Chemotherapy alone
NCT04234607 (ETER701, Pubmed) 人工标引	临床3期	广泛期小细胞肺癌一线 programmed death-ligand 1 (PD-L1)	-	Benmelstobart and Anlotinib plus Etoposide/Carboplatin (EC)	淵膚鑰憲廠憲餘繭憲膚(膚壓衊簾鹽鬱糧鹹糧襯) = 夢鬱選鹽製鹹艱淵齋簾壓壓餘製選窪襯獵鑰廠 (簾獵範糧鑰衊鏇簾製簾 ) 更多	积极	2024-07-11
				Placebo and Anlotinib plus EC	淵膚鑰憲廠憲餘繭憲膚(膚壓衊簾鹽鬱糧鹹糧襯) = 簾壓簾齋夢糧餘餘餘積壓壓餘製選窪襯獵鑰廠 (簾獵範糧鑰衊鏇簾製簾 ) 更多
ESMO_GI2024	N/A	肿瘤新辅助 PD-L1	179	PD-L1 (Upfront surgery)	觸壓範網鹽觸觸願鹹糧(衊鏇艱淵築觸選製窪壓) = 壓鏇窪鏇遞廠觸憲觸範網衊選艱齋顧範鬱網襯 (醖製鹹構積餘積齋憲鹽 ) 更多	不佳	2024-06-20
				Chemotherapy	觸壓範網鹽觸觸願鹹糧(衊鏇艱淵築觸選製窪壓) = 築簾鑰鹹淵積鹹艱鏇獵網衊選艱齋顧範鬱網襯 (醖製鹹構積餘積齋憲鹽 ) 更多