A Phase II, Open-label, Two Arm, Investigator-initiated Trail of Stereotactic Radiotherapy (SBRT) in Combination With an Anti-PD-L1 Inhibitor Adbelimumab and Apatinib for Perioperative and Conversion Therapy of Hepatocellular Carcinoma

This is a Phase II , Open-label , Investigator-initiated Trail of SBRT in Combination With Adbelimumab and Apatinib in Patients With Hepatocellular Carcinoma(HCC).This study aims to evaluate the safety and efficacy of SBRT in Combination With Adbelimumab and Apatinib as a preoperative and conversion treatment of HCC.

开始日期2025-01-01

申办/合作机构

福建省肿瘤医院

NCT06666166 / Not yet recruiting临床2期IIT

Exploratory Clinical Study of SHR-A1811 Combined with Apatinib in the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer

To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

开始日期2024-12-01

申办/合作机构

中国医科大学

[+1]

NCT06188455 / Not yet recruiting临床3期IIT

Clinical Study of Fluzopalil Combined With Apatinib for Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer

Thirty-seven women aged 18-75 years with recurrent ovarian cancer were enrolled

开始日期2024-12-01

申办/合作机构

厦门大学附属第一医院（厦门市第一医院、厦门市红十字会医院、厦门市糖尿病研究所）

100 项与甲磺酸阿帕替尼相关的临床结果

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100 项与甲磺酸阿帕替尼相关的转化医学

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100 项与甲磺酸阿帕替尼相关的专利（医药）

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1,312

项与甲磺酸阿帕替尼相关的文献（医药）

2024-12-01·Critical Reviews in Oncology/Hematology

Sequencing of systemic therapy in unresectable hepatocellular carcinoma: A systematic review and Bayesian network meta-analysis of randomized clinical trials

Review

作者: Yu, Jianan ; Sun, Xuedong ; Cao, Shasha ; Zhang, Yonghong ; Wang, Haochen ; Li, Jianjun ; Wang, Qi ; Han, Yanjing ; Hu, Caixia ; Yang, Zeran ; Jin, Long ; Li, Jian

PURPOSEFor patients with advanced or unresectable hepatocellular carcinoma (HCC), safe and effective therapies are urgently needed to improve their long-term prognosis. Although the guidelines recommend first-line treatments such as sorafenib, lenvatinib, and atezolizumab in combination with bevacizumab (T+A) and second-line treatments such as regorafenib, the efficacy comparison between drugs is lacking, that is, a treatment is not recommended as the optimal or alternative choice for a specific patient population. Therefore, we will conduct a high-quality network meta-analysis based on Phase III randomized controlled trials (RCTs) to systematically evaluate and compare overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and serious adverse events (SAE) of different treatment protocols in the context of first-line and second-line therapies, which are critical for clinical decision making and prognostic improvement in advanced HCC patients.METHODSThe studies of interest were Phase III RCTs evaluating the efficacy or safety of first- or second-line therapies in patients with unresectable or advanced HCC. Literature published in English from the four databases of PubMed, Embase, Cochrane Library, and Web of Science was comprehensively searched from the inception to May 23, 2022. Outcomes of interest included OS, PFS, ORR, and SAE. A league table was developed to show the results of the comparison between different treatments. A histogram of cumulative probability was drawn to discuss the ranking probability of treatments based on different outcomes. The effectiveness and safety of various treatments were comprehensively considered and the two-dimensional diagram was plotted to guide clinical practice. The Gemtc package in R Studio was used for network meta-analysis in a Bayesian framework.RESULTSThe results showed that HAIC-FO was superior to T+A regimen, regardless of OS, PFS or ORR. TACE combined with lenvatinib performed better than T+A in PFS, and ORR. In addition to the T+A regimen, Sintilimab combined with IBI305 and camrelizumab combined with apatinib were also associated with longer OS, PFS, and ORR, and their SAE incidence was not higher than that of T+A, especially for camrelizumab combined with apatinib, its safety was better than that of T+A regimen. There were no new treatments or combinations that were more effective than regorafenib. It was important to note that for PFS, the efficacy of apatinib and cabozantinib was not statistically different from that of regorafenib, so these two treatments could be used as alternative treatment options in cases where regorafenib was not tolerated or treatment failed.CONCLUSIONSWe conducted a network meta-analysis to evaluate the efficacy and safety of multiple treatment modalities by integrating the results of direct and indirect comparisons. This study included high-quality multicenter Phase III RCTs, collated and summarized all treatments involved in advanced or unresectable HCC in first-line and second-line settings, and compared with T+A and regorafenib, respectively, and ranked based on efficacy and safety to support clinical decision making.

2024-12-01·Cytotechnology

E2F8—TPX2 axis regulates glycolysis and angiogenesis to promote progression and reduce chemosensitivity of liver cancer

Article

作者: Qing, Yun ; Deng, Min ; Sun, Lan ; Li, Xiao-Qing ; Cao, Zhen-Rui ; Wu, Zhong-Jun

Liver cancer (LC) is a global health concern, marked by its high prevalence and mortality rates and known for its resistance to chemotherapy. The treatment of LC patients is facing great challenges. Targeting protein for Xenopus kinesin-like protein 2 (TPX2) is a LC marker that has been discovered in recent years, and there are sporadic data suggesting that it has an impact on the level of chemoresistance, but the exact mechanism remains to be deciphered. Our investigation, grounded in bioinformatics strategies including the TCGA database, GEO database, K-M plot database, GSEA, Pearson correlation analysis, and detection of clinical samples, led to the identification of TPX2 and its upstream transcription factor E2F8 as differentially expressed elements in LC tissues. We also probed the role of the axis in glycolysis, angiogenesis, tumor progression, and chemoresistance in LC cells. This was achieved by a battery of molecular and cellular experiments, such as qRT-PCR, CCK-8, Transwell, flow cytometry, and angiogenesis assays. Both TPX2 and E2F8 were upregulated in LC tissues and cells with E2F8 being responsible for the upregulation of TPX2. Through bioinformatics analysis, we observed a significant enrichment of TPX2 in the glycolysis and angiogenesis pathways. Cell-based experiments corroborated these findings, demonstrating that TPX2 knockdown led to significant inhibition of glycolysis and angiogenesis, along with a suppression of the malignant progression of LC cells. This was mirrored by a reduction in the IC₅₀ values for cisplatin and apatinib to 0.8257 µM and 10.79 µM, respectively. In contrast, E2F8 overexpression reversed these effects in LC cells, increasing the IC₅₀ values to 3.375 and 16.06 µM, respectively. The E2F8-TPX2 axis promotes glycolysis and angiogenesis in LC cells, which in turn accelerates cancer progression and reduces chemosensitivity.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10616-024-00655-w.

2024-11-08·Medicine

Low-dose apatinib in combination with chemotherapy for hormone receptor-positive, HER2-negative breast cancer with pulmonary lymphangitic carcinomatosis: A case report

Article

作者: Du, Caiwen ; Chen, Xuelian ; Feng, Sha ; Chen, Liping

Rationale:Hormone receptor-positive, HER2-negative advanced breast cancer complicated by pulmonary lymphangitic carcinomatosis (PLC) poses significant therapeutic challenges due to the lack of standardized treatment protocols. Despite various therapeutic interventions and supportive care, prognosis remains dismal.Patient concerns:Herein, a 48-year-old Chinese woman presented with a persistent cough, unresponsive to anti-infective treatment for 1 month. A computed tomography (CT) scan revealed lymphatic vessel infiltration and a diffuse nodular pattern, suggestive of PLC.Diagnoses:Hormone receptor-positive, HER2-negative advanced breast cancer complicated by PLC.Interventions:The patient was treated with a regimen comprising low-dose apatinib, capecitabine, and albumin-bound paclitaxel.Outcomes:The patient achieved a partial response, with a progression-free survival exceeding beyond ten months. Symptoms of dyspnea and dry cough significantly improved, alongside a notable reduction in lymphangitic carcinomatosis.Lessons:This case highlights the potential antitumor activity of apatinib in breast cancer patients with presenting with PLC. While further studies are necessary, this therapeutic approach could represent a viable option for managing breast cancer in the context of a visceral crisis. The case also emphasizes the importance of individualized treatment strategies and further research to substantiate these promising findings.

619

项与甲磺酸阿帕替尼相关的新闻（医药）

2024-11-18

·恒瑞医药

2024 SABCS前瞻︱恒瑞医药创新药26项乳腺癌领域研究将闪耀国际学术盛会

2024年第47届圣安东尼奥乳腺癌研讨会（SABCS）将于12月10日至13日在美国圣安东尼奥举行。作为乳腺癌研究领域规模最大、最负盛名的学术盛会之一，SABCS旨在为国际学术界、医生和研究人员提供乳腺癌及癌前乳腺疾病的实验生物学、病因学、预防、诊断和治疗的最新相关信息。本次大会，恒瑞医药共有人表皮生长因子1/2/4（HER1/HER2/HER4）靶向药物吡咯替尼、CDK4/6抑制剂达尔西利、PD-1抑制剂卡瑞利珠单抗、多靶点受体酪氨酸激酶抑制剂法米替尼、TPO受体激动剂海曲泊帕、PARP抑制剂氟唑帕利、VEGFR2抑制剂阿帕替尼、HER2抗体偶联药物（ADC）SHR-A1811等8款创新药的26项研究入围[1]，其中3项口头报告，3项壁报焦点（Poster Spotlight），20项壁报展示。本文特做梳理，一同浏览恒瑞医药在乳腺癌领域的系列重磅创新成果。 1. 摘要号：GS3-06 文章题目：卡瑞利珠单抗联合化疗新辅助治疗早期或局部晚期三阴性乳腺癌：一项随机、双盲、III期试验 Neoadjuvant camrelizumab plus chemotherapy (chemo) for early or locally advanced triple-negative breast cancer (TNBC): a randomized, double-blind, phase 3 trial 汇报形式：口头报告作者：邵志敏单位：复旦大学附属肿瘤医院 2. 摘要号：GS1-03 文章题目：吡咯替尼或安慰剂联合曲妥珠单抗与多西他赛用于未经治疗的转移性HER2阳性乳腺癌：III期PHILA试验的无进展生存（PFS）预设最终分析 Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial 汇报形式：口头报告作者：徐兵河单位：中国医学科学院肿瘤医院 3. 摘要号：GS1-04 文章题目：HER2靶向抗体药物偶联物SHR-A1811新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、随机、开放标签的II期试验 HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial 汇报形式：口头报告作者：李俊杰单位：复旦大学附属肿瘤医院 4. 摘要号：PS2-01 文章题目：达尔西利联合来曲唑或阿那曲唑作为一线治疗HR+/HER2-晚期乳腺癌：III期DAWNA-2试验无进展生存（PFS）预设的最终分析 Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR+/HER2- advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial 汇报形式：焦点壁报作者：徐兵河单位：中国医学科学院肿瘤医院 5. 摘要号：PS3-07 文章题目：SHR-A1811新辅助治疗HR阳性、HER2低表达乳腺癌患者：一项开放标签、单臂、二阶段II期临床试验的第一阶段结果 SHR-A1811 as Neoadjuvant Treatment in Patients with HR-Positive, HER2-low Breast Cancer: The first-stage results from an open-label, single-arm, two-stage, phase II clinical trial 汇报形式：焦点壁报作者：刘真真单位：河南省肿瘤医院 6. 摘要号：PS8-08 文章题目：SHR-A1811（一种抗HER2 ADC）在391例经多线治疗的HER2表达或突变的晚期实体瘤中的疗效与安全性：一项全球多中心首次人体临床I期研究 Efficacy and safety of SHR-A1811, an anti-HER2 antibody-drug conjugate (ADC), in 391 heavily pretreated multiple solid tumors with HER2-expression or mutations: a global, multi-center, first-in-human, phase 1 study 汇报形式：焦点壁报作者：姚和瑞单位：中山大学孙逸仙纪念医院 7. 摘要号：P1-02-12 文章题目：海曲泊帕治疗乳腺癌患者癌症治疗引起的血小板减少症的疗效与安全性：一项前瞻性II期研究 Prospective phase II study on the efficacy and safety of hetrombopag for the treatment of cancer therapy-induced thrombocytopenia in patients with breast cancer 汇报形式：壁报展示作者：姜晗昉单位：北京大学肿瘤医院 8. 摘要号：P1-04-12 文章题目：优化吡咯替尼在HER2阳性早期高风险乳腺癌中的耐受性：一项多中心、随机、三队列研究 Optimizing Tolerability of Pyrotinib in HER2-Positive Early-Stage High-Risk Breast Cancer: A Multicenter, Randomized, Three-Cohort Study 汇报形式：壁报展示作者：厉红元、程巧单位：重庆医科大学附属第一医院 9. 摘要号：P1-05-24 文章题目：SHR-A1811在HER2阳性乳腺癌新辅助治疗中疗效的生物标志物与空间决定因素 Biomarkers and Spatial Determinants of SHR-A1811 Efficacy in Neoadjuvant Treatment for HER2-Positive Breast Cancer 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 10. 摘要号：P1-06-01 文章题目：卡瑞利珠单抗联合治疗三阴性乳腺癌的疗效与安全性：一项系统性综述与荟萃分析 Efficacy and Safety of Camrelizumab Combination Therapy in Triple-Negative Breast Cancer: A Systematic Review and Meta-Analysis 汇报形式：壁报展示作者：Moazzam Shahzad 11. 摘要号：P2-09-28 文章题目：达尔西利联合内分泌治疗晚期乳腺癌伴内脏危象患者：一项多中心、前瞻性、外部对照II期研究 Dalpiciclib plus endocrine therapy for visceral crisis in advanced breast cancer: a multicenter, prospective, external controlled phase 2 study 汇报形式：壁报展示作者：马飞、莫红楠单位：中国医学科学院肿瘤医院 12. 摘要号：P2-11-06 文章题目：新辅助化疗联合卡瑞利珠单抗对比单纯化疗治疗局部晚期免疫调节型三阴性乳腺癌患者：一项前瞻性、随机、开放标签II期试验 Neoadjuvant chemotherapy plus camrelizumab vs. chemotherapy in patients with locally advanced immunomodulatory triple-negative breast cancer: a prospective, randomized, open-label, phase 2 trial 汇报形式：壁报展示作者：陈力单位：复旦大学附属肿瘤医院 13. 摘要号：P2-12-22 文章题目：口服CDK4/6抑制剂达尔西利联合内分泌治疗在激素受体阳性、HER2阴性女性乳腺癌辅助治疗中的多中心、单臂Ⅱ期临床试验 A multicenter, single arm, phase II clinical trial of oral CDK4/6 inhibitor dalpiciclib in combination with endocrine therapy in adjuvant treatment for hormone receptor positive, HER2 negative female breast cancer 汇报形式：壁报展示作者：欧阳杰单位：东莞东华医院 14. 摘要号：P3-11-24 文章题目：白蛋白紫杉醇联合曲妥珠单抗和吡咯替尼新辅助治疗HER2阳性早期或局部晚期HER2富集亚型乳腺癌：一项多中心、单臂、II期试验 Neoadjuvant Nab-paclitaxel combined with Trastuzumab and Pyrotinib for HER2-enriched subtype of HER2-positive early or locally advanced breast cancer: A multicenter, single-arm, phase 2 trial 汇报形式：壁报展示作者：周文斌单位：江苏省人民医院 15. 摘要号：P3-11-26 文章题目：达尔西利联合来曲唑、帕妥珠单抗和曲妥珠单抗新辅助治疗HR+/HER2+乳腺癌的II期研究 A Phase II study of dalpiciclib combined with letrozole, pertuzumab and trastuzumab as neoadjuvant therapy in HR+/HER2+ breast cancer 汇报形式：壁报展示作者：曾晓华、梁新瑞单位：重庆市肿瘤医院 16. 摘要号：P3-12-22 文章题目：吡咯替尼、皮下曲妥珠单抗和卡培他滨新辅助治疗HER2阳性早期乳腺癌：一项前瞻性、单臂、多中心研究 Neoadjuvant Therapy with Pyrotinib, Subcutaneous Trastuzumab, and Capecitabine for HER2-Positive Early Breast Cancer: A Prospective, Single-Arm, Multicenter Trial 汇报形式：壁报展示作者：张丽娜单位：天津市肿瘤医院 17. 摘要号：P5-05-02 文章题目：GQ1001（新一代HER2靶向ADC）联合吡咯替尼治疗HER2阳性转移性乳腺癌经治患者的药代动力学特征和初步疗效：一项Ib期临床试验 Pharmacokinetic profile and preliminary efficacy of GQ1001, a next generation HER2-targeting ADC, combined with pyrotinib in pretreated patients with HER2-positive metastatic breast cancer: A phase 1b clinical trial 汇报形式：壁报展示作者：王碧芸单位：复旦大学附属肿瘤医院 18. 摘要号：P5-05-07 文章题目：伊尼妥单抗联合吡咯替尼和卡培他滨/长春瑞滨治疗曲妥珠单抗经治耐药的HER2阳性转移性乳腺癌的前瞻性、多中心、单臂临床研究 A prospective, multicenter, single-arm clinical study of inetetamab combined with pyrotinib and capecitabine/vinorelbine in the treatment of HER2-positive metastatic breast cancer resistant to previous trastuzumab treatment 汇报形式：壁报展示作者：薛妍单位：西安国际医学中心医院 19. 摘要号：P5-05-09 文章题目：德曲妥珠单抗联合吡咯替尼一线治疗HER2阳性不可切除或转移性乳腺癌：一项探索性、多中心、单臂、Ib/II期研究（TROPHY） Trastuzumab deruxtecan combined with pyrotinib in first-line HER2-positive unresectable or metastatic breast cancer: an exploratory, multi-center, single-arm, phase Ib/II study (TROPHY) 汇报形式：壁报展示作者：樊英单位：中国医学科学院肿瘤医院 20. 摘要号：P5-05-14 文章题目：伊尼妥单抗联合吡咯替尼和化疗治疗HER2阳性转移性乳腺癌患者的真实世界治疗模式与临床结果：一项多中心回顾性研究 Real-World Treatment Patterns and Clinical Outcomes of Inetetamab combined with pyrotinib plus chemotherapy in Her-2 positive metastatic breast cancer patients : a multi-center retrospective study 汇报形式：壁报展示作者：周欢欢单位：浙江省肿瘤医院 21. 摘要号：P5-05-24 文章题目：维迪西妥单抗（RC48-ADC）联合吡咯替尼治疗曲妥珠单抗经治的HER2阳性复发或转移性乳腺癌：一项Ib/II期研究 RC48-ADC (Disitamab vedotin, a HER2-directed antibody-drug conjugate) in Combination with Pyrotinib for Trastuzumab-treated HER2-Positive Recurrent or Metastatic Breast Cancer: A Phase Ib/II Study 汇报形式：壁报展示作者：周鑫、梁新瑞单位：重庆市肿瘤医院 22. 摘要号：P5-07-20 文章题目：伊尼妥单抗联合吡咯替尼和白蛋白结合型紫杉醇新辅助治疗HER2阳性早期及局部晚期乳腺癌患者的前瞻性、开放标签、单臂II期临床研究：临床试验最新进展 A prospective, open-label, single-arm phase II clinical study of inetetamab in combination pyrotinib & albumin-bound paclitaxel for neoadjuvant treatment of patients with HER2+ early & locally advanced breast cancer: updates on clinical trial 汇报形式：壁报展示作者：李南林单位：空军军医大学西京医院 23. 摘要号：P5-07-23 文章题目：吡咯替尼联合曲妥珠单抗和芳香化酶抑制剂新辅助治疗HER2+/HR+乳腺癌的疗效与安全性：一项单臂、多中心、II期探索性研究 Efficacy and Safety of Pyrotinib Combined with Trastuzumab and Aromatase Inhibitor in Neoadjuvant Treatment of HER2+/HR+ Breast Cancer: A Single-Arm, Multi-Center Phase II Exploratory Study 汇报形式：壁报展示作者：葛洁单位：天津市肿瘤医院 24. 摘要号：P5-09-17 文章题目：基于SNF分型的多组学精准医学在CDK4/6抑制剂治疗失败的HR+/HER2-晚期乳腺癌中的应用：Linux试验（产品：卡瑞利珠单抗、法米替尼、氟唑帕利、阿帕替尼） Precision medicine based on similarity network fusion (SNF) subtypes of multi-omics in CDK4/6 inhibitor failed HR+/ HER2- advanced breast cancer: the Linux trial 汇报形式：壁报展示作者：邵志敏单位：复旦大学附属肿瘤医院 25. 摘要号：P5-09-28 文章题目：吡咯替尼联合曲妥珠单抗及达尔西利、来曲唑术前治疗早期或局部晚期HR阳性、HER2阳性乳腺癌的Ⅱ期前瞻性探索性临床研究（Chefoo-TP48） A phase Ⅱ, prospective exploratory clinical study of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for patients with HR-positive, HER2-positive early or locally advanced breast cancer (Chefoo-TP48) 汇报形式：壁报展示作者：乔广东、丛义滋单位：烟台毓璜顶医院 26. 摘要号：P5-09-29 文章题目：曲妥珠单抗联合吡咯替尼和卡培他滨作为HER2阳性早期乳腺癌新辅助治疗后未达病理完全缓解的术后辅助治疗：一项多中心II期研究 Trastuzumab Combined with Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in NonPathological Complete Response HER2-Positive Early Breast Cancer Following Neoadjuvant Therapy: A Multicenter Phase II study 汇报形式：壁报展示作者：王川单位：福建医科大学附属协和医院本次SABCS，恒瑞医药将亮相的8款创新药的26项重磅研究，覆盖了多种乳腺癌亚型，涉及一线、辅助、新辅助等多个疾病阶段适应症人群，将展现公司多款不同作用机制的创新产品布局乳腺癌治疗领域的实力，也将向世界展示中国乳腺癌领域的研发创新力量。作为创新型国际化制药企业，恒瑞医药多年来深入践行“科技为本、为人类创造健康生活”的使命，针对高发肿瘤领域持续进行创新研发，已在国内获批上市17款1类创新药、4款自研2类新药。未来，恒瑞医药将继续坚持“以患者为中心”的理念，重创新，强研发，力争研制出更多更好的新药，努力守护患者健康生活和生命质量。参考资料： 1.https://sabcs.org/FullProgram 声明： 1.本新闻旨在分享学术前沿动态，仅供医疗卫生专业人士基于学术目的参阅，非广告用途。 2.恒瑞医药不对任何药品和/或适应症作推荐。 3.本新闻中涉及的信息仅供参考，请遵从医生或其他医疗卫生专业人士的意见或指导。医疗卫生专业人士作出的任何与治疗有关的决定应根据患者的具体情况并遵照药品说明书。撰稿：中央医学事务部排版：程梦真责编：李玉莹往期精选 | 研发创新 | 慢病创新里程碑！恒瑞首个自免创新药夫那奇珠单抗获批上市恒瑞医药新突破！中国首个自研阿片类镇痛创新药富马酸泰吉利定获批上市 | 国际化 | 海外BD再传捷报！恒瑞医药GLP-1类创新药组合实现海外许可恒瑞医药与默克达成合作，携手推进癌症创新疗法 | 重磅奖项 | 喜报！恒瑞医药荣获2023年度国家科技进步奖恒瑞医药连续六年入选全球制药企业50强榜单！ | 社会公益 | “健康中国行·重走长征路”项目启动仪式圆满举行！恒瑞提供公益支持，助力健康中国恒瑞医药集团向中国扶贫基金会捐赠3000万设立“健康帮扶基金”

临床3期临床结果抗体药物偶联物临床2期临床成功

2024-11-15

·赛柏蓝

第十批集采，抗肿瘤药竞争格局（附名单）

编者按：本文来自米内网，作者可颂；赛柏蓝授权转载，编辑凯西第十批集采拟纳入4个抗肿瘤药，38亿大品种在列。 01 超670亿化药抗肿瘤药市场，蛋白激酶抑制剂领跑受集采等政策影响，近年来化药抗肿瘤药市场承压。化药抗肿瘤药2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额超过677亿元，同比下滑4.98%；2024年上半年销售额超过360亿元，同比增长3.42%。中国公立医疗机构终端化药抗肿瘤药销售情况（单位：万元）从治疗类别上看，化药抗肿瘤药涉及8个治疗大类，其中蛋白激酶抑制剂（替尼类药物）是销售主力，占据的市场份额均达45.91%，植物生物碱和其它天然药、抗代谢药占比分别为12.35%、11.54%。令人瞩目的是，近十年来国内蛋白激酶抑制剂市场持续上升，从2013年的超过37亿元增长至2023年的接近300亿元。化药抗肿瘤药一级集团销售额排名中，阿斯利康位列第一，销售额超过30亿元；恒瑞医药位列第二，销售额超过27亿元；正大制药位列第三，销售额超过25亿元；位列第四的豪森药业销售额大涨25.17%；位列第九、第十的贝达药业、赛诺菲销售额分别增长13.42%、13.77%。 2024H1中国公立医疗机构终端化药抗肿瘤药销售额TOP10一级集团 02 4大超10亿品种领跑，明星药暴涨111.87% 化药抗肿瘤药销售额TOP20品牌中，阿斯利康的甲磺酸奥希替尼片位列第一，销售额超过22亿元；正大天晴的盐酸安罗替尼胶囊位列第二，销售额超过16亿元；豪森药业的甲磺酸阿美替尼片、石药欧意的盐酸多柔比星脂质体注射液分别位列第三、第四，销售额均超过10亿元。 2024H1中国公立医疗机构终端化药抗肿瘤药销售额TOP20品牌 12个品牌销售额实现正增长，其中5个品牌销售额增逾10%，艾力斯的甲磺酸伏美替尼片暴涨111.87%、豪森药业的甲磺酸阿美替尼片大涨44.04%、百济神州的泽布替尼胶囊大涨21.88%、赛诺菲的注射用奥沙利铂增长13.78%、再鼎医药的甲苯磺酸尼拉帕利胶囊增长11.47%。从企业层面上看，恒瑞医药有3个品种马来酸吡咯替尼片、注射用紫杉醇(白蛋白结合型)、甲磺酸阿帕替尼片上榜；阿斯利康有2个品种甲磺酸奥希替尼片、奥拉帕利片上榜；石药欧意有2个品种盐酸多柔比星脂质体注射液、注射用紫杉醇(白蛋白结合型)上榜。 20个品牌中，国产1类新药逐渐崭露头角，上榜品牌多达8个，进口原研药有5个，早期集采的原研药多数跌出榜单。紫杉醇白蛋白为第二批集采品种、卡培他滨片为第三批集采品种，上榜企业均为本土企业，注射用奥沙利铂为第五批集采品种，赛诺菲持续领跑市场。盐酸多柔比星脂质体注射液、瑞戈非尼片为第十批拟集采品种，市场格局将迎变化。 03 38亿大品种在列！4个品种备战第十批集采已落地执行的八批化药集采中，化药抗肿瘤药分别有3个、2个、2个、3个、6个、6个、0个、0个药品被纳入，合计22个品种。其中12个为注射剂，10个为口服常释剂型，包括吉非替尼、伊马替尼、培美曲塞、替吉奥、紫杉醇白蛋白等重磅品种。抗肿瘤药国家集采品种 11月1日，国家组织药品联合采购办公室发布通知，开展第十批国家组织药品集中采购相关药品信息填报工作，62个品种（263个品规）被纳入填报范围。化药抗肿瘤药有4个品种氟尿嘧啶注射剂、盐酸多柔比星脂质体注射液、哌柏西利胶囊、瑞戈非尼片在列。第十批拟集采抗肿瘤药竞争格局 4个通用名药品2023年在中国公立医疗机构终端的销售额合计接近60亿元。其中，盐酸多柔比星脂质体注射液销售额超过38亿元，氟尿嘧啶注射剂、瑞戈非尼片销售额均超过9亿元。氟尿嘧啶注射剂、哌柏西利胶囊过评企业均已有14家，竞争较为激烈；瑞戈非尼片在TOP20品牌排名第20，过评企业已有9家，原研厂家拜耳在过往的国采中仅中标了第二批集采的阿卡波糖片、盐酸莫西沙星片，本次集采拜耳是否会竞标值得关注。盐酸多柔比星脂质体注射液是一款重磅广谱抗肿瘤药，也是国家集采开展以来首个入选的脂质体。该品种2023年院内市场销售额超过38亿元，过评企业共有8家，包括复旦张江、石药欧意、齐鲁制药、常州金远药业、印度瑞迪博士实验室等，其中齐鲁制药该产品于今年5月获批上市，预计将积极竞标迅速抢占市场。从过评企业上看，本次集采的4个抗肿瘤药齐鲁制药均已过评，科伦药业、重庆药友、豪森药业、上海创诺制药、青峰医药、正大制药等企业均有2个品种过评。资料来源：米内网数据库 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

带量采购核酸药物申请上市医药出海

2024-11-14

·米内网

第十批集采4个抗肿瘤药亮了！670亿市场大洗牌，38亿大品种承压，齐鲁、科伦发力

精彩内容第十批集采拟纳入4个抗肿瘤药，38亿大品种在列。米内网数据显示，2024H1中国公立医疗机构终端化药抗肿瘤药销售额同比增长3.42%，阿斯利康、恒瑞医药、正大制药领跑市场。品牌TOP20中，4大超10亿品种领跑，国产1类新药暴涨112%。4个拟集采抗肿瘤药，齐鲁制药均已过评，科伦、重庆药友、豪森等各有2个品种过评。超670亿化药抗肿瘤药市场，蛋白激酶抑制剂领跑受集采等政策影响，近年来化药抗肿瘤药市场承压。米内网数据显示，化药抗肿瘤药2023年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额超过677亿元，同比下滑4.98%；2024年上半年销售额超过360亿元，同比增长3.42%。中国公立医疗机构终端化药抗肿瘤药销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局从治疗类别上看，化药抗肿瘤药涉及8个治疗大类，其中蛋白激酶抑制剂（替尼类药物）是销售主力，占据的市场份额均达45.91%，植物生物碱和其它天然药、抗代谢药占比分别为12.35%、11.54%。令人瞩目的是，近十年来国内蛋白激酶抑制剂市场持续上升，从2013年的超过37亿元增长至2023年的接近300亿元。化药抗肿瘤药一级集团销售额排名中，阿斯利康位列第一，销售额超过30亿元；恒瑞医药位列第二，销售额超过27亿元；正大制药位列第三，销售额超过25亿元；位列第四的豪森药业销售额大涨25.17%；位列第九、第十的贝达药业、赛诺菲销售额分别增长13.42%、13.77%。 2024H1中国公立医疗机构终端化药抗肿瘤药销售额TOP10一级集团来源：米内网中国公立医疗机构药品终端竞争格局 4大超10亿品种领跑，明星药暴涨111.87% 化药抗肿瘤药销售额TOP20品牌中，阿斯利康的甲磺酸奥希替尼片位列第一，销售额超过22亿元；正大天晴的盐酸安罗替尼胶囊位列第二，销售额超过16亿元；豪森药业的甲磺酸阿美替尼片、石药欧意的盐酸多柔比星脂质体注射液分别位列第三、第四，销售额均超过10亿元。 2024H1中国公立医疗机构终端化药抗肿瘤药销售额TOP20品牌来源：米内网中国公立医疗机构药品终端竞争格局 12个品牌销售额实现正增长，其中5个品牌销售额增逾10%，艾力斯的甲磺酸伏美替尼片暴涨111.87%、豪森药业的甲磺酸阿美替尼片大涨44.04%、百济神州的泽布替尼胶囊大涨21.88%、赛诺菲的注射用奥沙利铂增长13.78%、再鼎医药的甲苯磺酸尼拉帕利胶囊增长11.47%。从企业层面上看，恒瑞医药有3个品种马来酸吡咯替尼片、注射用紫杉醇(白蛋白结合型)、甲磺酸阿帕替尼片上榜；阿斯利康有2个品种甲磺酸奥希替尼片、奥拉帕利片上榜；石药欧意有2个品种盐酸多柔比星脂质体注射液、注射用紫杉醇(白蛋白结合型)上榜。 20个品牌中，国产1类新药逐渐崭露头角，上榜品牌多达8个，进口原研药有5个，早期集采的原研药多数跌出榜单。紫杉醇白蛋白为第二批集采品种、卡培他滨片为第三批集采品种，上榜企业均为本土企业，注射用奥沙利铂为第五批集采品种，赛诺菲持续领跑市场。盐酸多柔比星脂质体注射液、瑞戈非尼片为第十批拟集采品种，市场格局将迎变化。 38亿大品种在列！4个品种备战第十批集采已落地执行的八批化药集采中，化药抗肿瘤药分别有3个、2个、2个、3个、6个、6个、0个、0个药品被纳入，合计22个品种。其中12个为注射剂，10个为口服常释剂型，包括吉非替尼、伊马替尼、培美曲塞、替吉奥、紫杉醇白蛋白等重磅品种。抗肿瘤药国家集采品种 11月1日，国家组织药品联合采购办公室发布通知，开展第十批国家组织药品集中采购相关药品信息填报工作，62个品种（263个品规）被纳入填报范围。化药抗肿瘤药有4个品种氟尿嘧啶注射剂、盐酸多柔比星脂质体注射液、哌柏西利胶囊、瑞戈非尼片在列。第十批拟集采抗肿瘤药竞争格局 4个通用名药品2023年在中国公立医疗机构终端的销售额合计接近60亿元。其中，盐酸多柔比星脂质体注射液销售额超过38亿元，氟尿嘧啶注射剂、瑞戈非尼片销售额均超过9亿元。氟尿嘧啶注射剂、哌柏西利胶囊过评企业均已有14家，竞争较为激烈；瑞戈非尼片在TOP20品牌排名第20，过评企业已有9家，原研厂家拜耳在过往的国采中仅中标了第二批集采的阿卡波糖片、盐酸莫西沙星片，本次集采拜耳是否会竞标值得关注。盐酸多柔比星脂质体注射液是一款重磅广谱抗肿瘤药，也是国家集采开展以来首个入选的脂质体。该品种2023年院内市场销售额超过38亿元，过评企业共有8家，包括复旦张江、石药欧意、齐鲁制药、常州金远药业、印度瑞迪博士实验室等，其中齐鲁制药该产品于今年5月获批上市，预计公司将积极竞标迅速抢占市场。从过评企业上看，本次集采的4个抗肿瘤药齐鲁制药均已过评，科伦药业、重庆药友、豪森药业、上海创诺制药、青峰医药、正大制药等企业均有2个品种过评。资料来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，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

核酸药物医药出海上市批准

100 项与甲磺酸阿帕替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	甲磺酸阿帕替尼	L01XE	DB14765

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
肝细胞癌	中国	江苏恒瑞医药股份有限公司	2021-01-07
胃食管交界处腺癌	中国	江苏恒瑞医药股份有限公司	2014-10-17
胃腺癌	中国	江苏恒瑞医药股份有限公司	2014-10-17

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
转移性肝细胞癌	申请上市	美国	Elevar Therapeutics, Inc.	2024-10-21
gBRCA突变/HER2阴性乳腺癌	申请上市	中国	江苏恒瑞医药股份有限公司	2024-04-23
不可切除的肝细胞癌	申请上市	美国	Elevar Therapeutics, Inc.	2023-05-17
晚期胃癌	临床3期	中国	江苏恒瑞医药股份有限公司	2011-01-01
转移性HER2阴性乳腺癌	临床3期	-	江苏恒瑞医药股份有限公司	-
胃腺癌	临床前	俄罗斯	Elevar Therapeutics, Inc.	2017-03-14
胃腺癌	临床前	韩国	Elevar Therapeutics, Inc.	2017-03-14
胃腺癌	临床前	美国	Elevar Therapeutics, Inc.	2017-03-14
复发性胃癌	临床前	中国	江苏恒瑞医药股份有限公司	2015-07-01
转移性胃癌	临床前	中国	江苏恒瑞医药股份有限公司	2011-01-01

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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


GASTO-1093 (ESMO2024) 人工标引	临床2期	食管鳞状细胞癌新辅助	70	Camrelizumab + Albumin-Paclitaxel + Carboplatin + Apatinib	(糧鬱糧選夢膚淵繭積夢) = 窪蓋選鹹鏇獵壓糧衊鏇願壓願鑰壓廠鑰網壓遞 (製糧醖積獵構觸廠鏇網 ) 更多	积极	2024-09-16
NCT03764293 (ESMO2024) 人工标引	临床3期	不可切除的肝细胞癌	543	Camrelizumab + Rivoceranib (Cam+Rivo)	築蓋製憲網積廠醖遞艱(齋衊糧襯廠窪鬱選遞糧) = 鑰鏇製觸壓網網製糧鬱顧範糧範獵夢淵範糧鹽 (構鏇繭構齋觸鹹蓋醖遞, 0.31) 更多	积极	2024-09-16
NCT03764293 (ESMO2024) 人工标引	临床3期	不可切除的肝细胞癌	543	Sorafenib (Sora)	築蓋製憲網積廠醖遞艱(齋衊糧襯廠窪鬱選遞糧) = 餘窪窪壓膚構窪製糧積顧範糧範獵夢淵範糧鹽 (構鏇繭構齋觸鹹蓋醖遞, 0.29) 更多	积极	2024-09-16
ESMO2024 人工标引	临床2期	甲状腺未分化癌 \| 甲状腺癌	15	Camrelizumab+apatinib mesylate	(製衊齋艱襯夢鬱製襯遞) = 觸淵醖願顧範鬱積齋鑰顧網繭簾淵淵選積鏇衊 (構廠簾憲繭糧鏇糧鹽遞 ) 更多	积极	2024-09-16
ChiCTR1900021684 (PATHER2, ESMO2024)	临床2期	非小细胞肺癌 TP53 \| DNMT3A \| ARID1B ... 更多	27	Pyrotinib plus apatinib	(鹹選範築鬱鑰觸遞鑰艱) = 鑰積鏇蓋鹹夢鏇製範餘膚齋遞鹽憲憲艱構糧鹹 (簾壓遞壓醖窪艱構積壓 )	积极	2024-09-15
NCT03396211 (ESMO2024) 人工标引	临床1期	肿瘤	30	Rivoceranib + Nivolumab	(積鹹鬱簾網遞淵鏇襯範) = 膚衊鏇遞壓選鏇願襯襯繭憲鏇積鹹獵願鬱淵襯 (衊簾製醖壓鬱齋築廠鏇 ) 更多	积极	2024-09-14
NCT03396211 (ESMO2024) 人工标引	临床1期	肿瘤	30	oral daily doses Rivoceranib 400 mg + Nivolumab 240 mg IV q2w	(積鹹鬱簾網遞淵鏇襯範) = 齋衊築齋蓋醖艱範憲選繭憲鏇積鹹獵願鬱淵襯 (衊簾製醖壓鬱齋築廠鏇 ) 更多	积极	2024-09-14
ChiCTR1900023277 (ESMO2024) 人工标引	临床2期	黏膜黑色素瘤	32	Camrelizumab+apatinib	(艱壓餘蓋襯簾顧願醖艱) = 鏇築鹹窪壓積廠襯鏇網選齋簾壓鏇鹹醖繭鬱壓 (醖觸顧膚鏇築齋網構糧, 11.56 ~ 24.54) 更多	积极	2024-09-14
ChiCTR2100052156 (ESMO2024) 人工标引	临床2期	非小细胞肺癌一线 \|	21	pyrotinib and apatinib	(艱餘簾夢網餘膚壓築醖) = 廠繭醖遞糧艱鹹鹽壓窪鏇壓顧鏇夢鏇窪繭範餘 (夢鬱願鹽蓋鬱選膚糧鹽 ) 更多	积极	2024-09-14
NCT03742193 (PROACH, ESMO2024) 人工标引	临床2期	骨肉瘤新辅助 \| 维持	43	neoadjuvant Apatinib(Apa) plus Gemcitable-docetaxel(Gem-tax), followed by Apa-monotherapy maintenance	糧夢構願構壓繭淵選壓(遞齋鬱鑰夢構積獵範衊) = 顧簾範範艱淵願餘醖遞膚膚蓋夢積憲獵觸願糧 (窪遞顧積製廠夢鹽衊餘 ) 达到更多	积极	2024-09-13
ChiCTR2200059608 (WCLC2024) 人工标引	临床2期	非小细胞肺癌IIIA期新辅助	29	Chemotherapy+Camrelizumab+Apatinib	(範淵壓範淵網築淵鹽鹹) = 製築窪憲齋選獵膚鹹範夢製顧衊繭憲鹽願廠壓 (簾糧鹹膚糧淵餘繭鹹夢, 72.2 ~ 97.8) 更多	积极	2024-09-08
ChiCTR2200059608 (WCLC2024) 人工标引	临床2期	非小细胞肺癌IIIA期新辅助	29	Chemotherapy+Camrelizumab+Apatinib (underwent surgery)	(遞遞築壓構顧夢願繭夢) = 鏇觸範範鹹遞製餘鑰鹹鹹繭選觸鹽艱鑰築襯艱 (蓋鹽鑰顧膚網鬱鑰艱繭, 16.3 ~ 58.7) 更多	积极	2024-09-08
NCT03417895 (PASSION, CTgov)	临床2期	广泛期小细胞肺癌	59	Apatinib+SHR-1210 (A(SHR-1210+Apatinib))	(艱積夢簾壓齋廠窪遞襯) = 積餘鏇醖壓蓋廠鹹範淵顧鬱憲構願鑰鏇夢積簾 (鹹衊鏇鏇襯顧獵壓淵獵, 遞鬱願糧簾鹽鏇築願廠 ~ 襯蓋壓繭淵齋窪遞遞夢) 更多	-	2024-08-07
NCT03417895 (PASSION, CTgov)	临床2期	广泛期小细胞肺癌	59	Apatinib+SHR-1210 (B(SHR-1210+Apatinib))	(艱積夢簾壓齋廠窪遞襯) = 窪鬱觸製構簾範衊糧範顧鬱憲構願鑰鏇夢積簾 (鹹衊鏇鏇襯顧獵壓淵獵, 簾夢簾顧願範膚鹽淵鏇 ~ 鏇艱簾願餘積廠壓選鹽) 更多	-	2024-08-07