Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib/ HRS-1167, Famitinib and Camrelizumab: A Prospective, Open-label, Multicenter, Phase II Trial

This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.

开始日期2024-07-01

申办/合作机构

复旦大学

ChiCTR2400085510 / Suspended临床2期IIT

Phase ? exploratory clinical study of Camrelizumab combined with Famitinib Malate Capsules and Temozolomide in the treatment of advanced clear cell sarcoma

开始日期2024-06-21

申办/合作机构

北京市肿瘤防治研究所

NCT06332950 / Not yet recruiting临床1/2期IIT

A Randomized, Multi-cohort, Multi-center Phase Ib/II Study of Adebrelimab Plus Irinotecan Liposome (II) With or Without Famitinib in Patients With ES-SCLC Pre-treated With Immune Checkpoint Inhibitor(s)

This is an open-label, randomized, multi-cohort, multi-center, phase Ib/II study to evaluate the safety and efficacy of Adebrelimab plus Irinotecan Liposome (II) with or without Famitinib in patients with extensive-stage small cell lung cancer (ES-SCLC) pre-treated with immune checkpoint inhibitor(s).

开始日期2024-04-01

申办/合作机构

上海市胸科医院

100 项与苹果酸法米替尼相关的临床结果

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100 项与苹果酸法米替尼相关的转化医学

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100 项与苹果酸法米替尼相关的专利（医药）

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项与苹果酸法米替尼相关的文献（医药）

2024-02-01·Journal for ImmunoTherapy of Cancer

First-line treatment with camrelizumab plus famitinib in advanced or metastatic NSCLC patients with PD-L1 TPS ≥1%: results from a multicenter, open-label, phase 2 trial

Article

作者: Cheng, Ying ; Liu, Tianshu ; Zhao, Jun ; Luo, Yongzhong ; Han, Bao-Hui ; Gu, Shanzhi ; Yi, Shanyong ; Li, Yalun ; Ren, Shengxiang ; Zhou, Caicun ; Cheng, Yufeng ; Liu, Ying ; Hu, Sheng ; Wang, Shuni ; Liu, Caigang ; Duan, Huijie ; Feng, Jifeng ; Wang, Xicheng ; Gao, Shegan ; Pan, Yueyin ; Fan, Jia ; Yang, Xinfeng

BackgroundThe combination of immune-checkpoint inhibitors and antiangiogenic agents can synergistically modulate the tumor microenvironment and represents a promising treatment option. Here, we evaluated the efficacy and safety of camrelizumab plus famitinib (a receptor tyrosine kinase inhibitor) as a first-line treatment for advanced or metastatic NSCLC patients with a programmed death ligand-1 (PD-L1) tumor proportion score (TPS) of ≥1%, in an open-label, multicenter, phase 2 basket trial.MethodsEligible patients received camrelizumab (200 mg once every 3 weeks via intravenous infusion) plus oral famitinib at an initial dose of 20 mg once daily. The primary endpoint was the objective response rate (ORR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors V.1.1. Key secondary endpoints included disease control rate (DCR), duration of respons, progression-free survival (PFS), overall survival (OS), 12-month OS rate, and safety profile.ResultsOf the enrolled 41 patients, 21 (51.2%) had a PD-L1 TPS of 1–49%. As of the cut-off date on June 22, 2022, the combination regimen of camrelizumab and famitinib achieved an ORR of 53.7% (95% CI 37.4% to 69.3%) and a DCR of 92.7% (95% CI 80.1% to 98.5%). The median PFS was 16.6 months (95% CI 8.3 to not reached), and OS data were not yet mature, with an estimated 12-month OS rate of 76.8% (95% CI 60.0% to 87.3%). The most common treatment-related adverse events of grade 3 or higher included hypertension (22.0%), increased alanine aminotransferase (12.2%), decreased neutrophil count (9.8%), proteinuria (7.3%), decrease platelet count (7.3%), and hypokalemia (7.3%). One (2.4%) patient died from grade 5 hemoptysis, which was considered possibly related to the study treatment by the investigator.ConclusionCamrelizumab plus famitinib demonstrated promising antitumor activity in advanced or metastatic NSCLC patients and had an acceptable safety profile. These findings suggest that this combination regimen could be an alternative therapeutic option and warrant further investigation.Trial registration numberNCT04346381.

2024-02-01·The Lancet Oncology

Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial

Article

作者: Chen, Li ; Hu, Xin ; Xiao, Qin ; Yang, Wen-Tao ; Fan, Lei ; Di, Gen-Hong ; Liu, Guang-Yu ; Cao, A-Yong ; Shao, Zhi-Ming ; Huang, Xiao-Yan ; Shui, Ruo-Hong ; Li, Jun-Jie ; Liu, Xi-Yu ; Sui, Xin-Yi ; Yu, Ke-Da ; Yang, Yun-Song ; Wu, Song-Yang ; Zhang, Wen-Juan ; Wang, Zhong-Hua ; Xu, Ying ; Xiao, Yi ; Wang, Han ; Jiang, Yi-Zhou ; Xia, Yan ; Wu, Jiong ; Jin, Xi ; Liang, Qian-Nan ; Ma, Lin-Xiaoxi

BACKGROUNDTriple-negative breast cancers display heterogeneity in molecular drivers and immune traits. We previously classified triple-negative breast cancers into four subtypes: luminal androgen receptor (LAR), immunomodulatory, basal-like immune-suppressed (BLIS), and mesenchymal-like (MES). Here, we aimed to evaluate the efficacy and safety of subtyping-based therapy in the first-line treatment of triple-negative breast cancer.METHODSFUTURE-SUPER is an ongoing, open-label, randomised, controlled phase 2 trial being conducted at Fudan University Shanghai Cancer Center (FUSCC), Shanghai, China. Eligible participants were females aged 18-70 years, with an Eastern Cooperative Oncology Group performance status of 0-1, and histologically confirmed, untreated metastatic or recurrent triple-negative breast cancer. After categorising participants into five cohorts according to molecular subtype and genomic biomarkers, participants were randomly assigned (1:1) with a block size of 4, stratified by subtype, to receive, in 28-day cycles, nab-paclitaxel (100 mg/m², intravenously on days 1, 8, and 15) alone (control group) or with a subtyping-based regimen (subtyping-based group): pyrotinib (400 mg orally daily) for the LAR-HER2^mut subtype, everolimus (10 mg orally daily) for the LAR-PI3K/AKT^mut and MES-PI3K/AKT^mut subtypes, camrelizumab (200 mg intravenously on days 1 and 15) and famitinib (20 mg orally daily) for the immunomodulatory subtype, and bevacizumab (10 mg/kg intravenously on days 1 and 15) for the BLIS/MES-PI3K/AKT^WT subtype. The primary endpoint was investigator-assessed progression-free survival for the pooled subtyping-based group versus the control group in the intention-to-treat population (all randomly assigned participants). Safety was analysed in all patients with safety records who received at least one dose of study drug. This study is registered with ClinicalTrials.gov (NCT04395989).FINDINGSBetween July 28, 2020, and Oct 16, 2022, 139 female participants were enrolled and randomly assigned to the subtyping-based group (n=69) or control group (n=70). At the data cutoff (May 31, 2023), the median follow-up was 22·5 months (IQR 15·2-29·0). Median progression-free survival was significantly longer in the pooled subtyping-based group (11·3 months [95% CI 8·6-15·2]) than in the control group (5·8 months [4·0-6·7]; hazard ratio 0·44 [95% CI 0·30-0·65]; p<0·0001). The most common grade 3-4 treatment-related adverse events were neutropenia (21 [30%] of 69 in the pooled subtyping-based group vs 16 [23%] of 70 in the control group), anaemia (five [7%] vs none), and increased alanine aminotransferase (four [6%] vs one [1%]). Treatment-related serious adverse events were reported for seven (10%) of 69 patients in the subtyping-based group and none in the control group. No treatment-related deaths were reported in either group.INTERPRETATIONThese findings highlight the potential clinical benefits of using molecular subtype-based treatment optimisation in patients with triple-negative breast cancer, suggesting a path for further clinical investigation. Phase 3 randomised clinical trials assessing the efficacy of subtyping-based regimens are now underway.FUNDINGNational Natural Science Foundation of China, Natural Science Foundation of Shanghai, Shanghai Hospital Development Center, and Jiangsu Hengrui Pharmaceuticals.TRANSLATIONFor the Chinese translation of the abstract see Supplementary Materials section.

2023-12-15·Human Vaccines & Immunotherapeutics

Long-lasting complete response to SHR-1701 plus famitinib in refractory advanced gallbladder cancer: A case report

Article

作者: Xie, Jing ; Meng, Zhiqiang ; Yi, Lixia ; Zhu, Xiaoyan

Biliary tract cancer (BTC) is an aggressive malignancy with few options for advanced-stage treatment. The combination of PD-1/PD-L1 inhibitors with famitinib, a receptor tyrosine kinase (RTK) inhibitor, has demonstrated improved clinical outcomes in several clinical trials. We herein reported a case of a gallbladder cancer (GBC) patient with liver metastases, previously resistant to traditional chemotherapy. Remarkably, the patient achieved a complete response (CR) with a long-lasting survival benefit exceeding 3 years. This was achieved using a novel regimen combining SHR-1701, an anti-PD-L1/TGF-βR fusion protein, and famitinib, even though the patient had proficient mismatch repair (pMMR) and tested negative for PD-L1. Adverse events were limited and manageable. This is the first report of such a treatment regimen being applied in a clinical setting, suggesting that the SHR-1701 and famitinib combination may be a promising immunotherapeutic approach for patients with refractory advanced GBC.

104

项与苹果酸法米替尼相关的新闻（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

2024-10-29

·米内网

【瞩目】恒瑞1类新药来袭，猛攻1400亿市场

精彩内容近日，CDE官网显示，恒瑞医药申报的1类新药HRS-6208胶囊首次获得临床试验默示许可，用于治疗实体瘤。米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）抗肿瘤化药销售额超过1400亿元。今年以来，恒瑞医药有50余款1类新药获批临床，其中有27款为首次获批。 HRS-6208胶囊是恒瑞医药开发的一款化药1类新药，其临床申请于2024年8月17日获得CDE承办受理，并于近日获批临床，用于治疗实体瘤。米内网数据显示，近年来中国三大终端六大市场抗肿瘤化药（含生物药）销售额均达千亿规模，2023年超过1400亿元，2024上半年以约10%的增速继续增长。从细分终端销售看，院内市场（公立医院+公立基层医疗）为抗肿瘤化药销售主渠道，但零售药店（城市实体药店+网上药店）也不容小觑，销售占比由2019年的约14%提升至2024上半年的约20%。近年来中国零售药店终端抗肿瘤化药销售情况（单位：万元）来源：米内网格局数据库抗肿瘤药是恒瑞医药重点研发方向。在该治疗领域，公司已有甲磺酸阿帕替尼片、马来酸吡咯替尼片、注射用卡瑞利珠单抗、氟唑帕利胶囊、羟乙磺酸达尔西利片、阿得贝利单抗注射液、林普利塞片等多款1类新药获批上市。此外，苹果酸法米替尼胶囊、注射用瑞康曲妥珠单抗（SHR-A1811）、瑞拉芙普-α注射液（SHR-1701）等已提交NDA在审，重组人源化单抗MIL62注射液、SHR2554片、注射用SHR-A1921等处于III期临床。今年以来，恒瑞医药创新研发管线持续推进：富马酸泰吉利定注射液、夫那奇珠单抗注射液2款1类新药首次获批上市，氟唑帕利胶囊、脯氨酸恒格列净片2款1类新药获批新适应症，SHR2554片、瑞拉芙普-α注射液、注射用瑞康曲妥珠单抗3款1类新药首次提交NDA，50余款1类新药获批临床（含非首次获批）等。 50余款1类新药中，有27款为首次在国内获批临床，其中14款为抗肿瘤和免疫调节剂（11款抗肿瘤药、3款免疫抑制剂），3款为心脑血管系统药物，呼吸系统用药、神经系统药物、消化系统及代谢药各有2款。 2024年以来恒瑞医药首次获批临床的1类新药来源：米内网中国申报进度（MED）数据库注：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10月29日，如有疏漏，欢迎指正！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 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

临床3期申请上市临床申请上市批准

2024-10-24

·艾美达医药咨询

中国药企正在变强 | iMeta观察

“iMeta观察” ：艾美达医药咨询聚焦行业发展趋势及痛点问题，以第三方站位综合多方视角提供深度思考。医药战场烽火连天，遭遇多方夹击的不只有K药，还有司美格鲁肽。近期，恒瑞医药启动了GLP-1R/GIPR双激动剂HRS9531头对头司美格鲁肽治疗2型糖尿病的III期试验。而这只是冰山一角，甘李药业、信达生物、博瑞医药都开展了头对头司美格鲁肽的临床研究。另一边，新晋“药王”K药也被各种疗法头对头围猎，其中不乏中国药企的身影，信达、恒瑞、百济神州、康方生物等均位列其中。可以清晰地看到，越来越多中国药企正勇敢地迈出跟随者的角色，积极开展头对头试验、挑战全球医药巨头的地位。这一趋势，无疑是中国药企崛起与蜕变的最佳注脚。 01 “头对头”大战医药行业的新常态当下的医药江湖，已是巨浪滔天。唯有在头对头试验中胜出，才能稳立潮头。近年来，“头对头”大战的竞技场不断涌现，从国产PD-1单抗、双抗接连挑战K药，到百济神州BTK抑制剂泽布替尼完胜强生/艾伯维的伊布替尼，再到恒瑞自免新药HRS5965与依库珠单抗的较量，中国药企不断展现新的实力和风采。例如，针对刚登顶全球“药王”宝座的K药，国内药企主要在非小细胞肺癌（NSCLC）领域进行头对头围猎，包括信达生物的信迪利单抗、百济神州的替雷利珠单抗联合TIGIT单抗BGB-A1217、恒瑞医药的卡瑞利珠单抗联合法米替尼，以及康方生物的PD-1/VEGF双抗依沃西（AK112）等。尤其是依沃西单抗，凭借惊艳全球的临床数据，成为全球首个在头对头III期试验中击败K药的药物。根据依沃西单药对比K药单药一线治疗PD-L1表达阳性的局部晚期或转移性NSCLC患者的III期临床研究 (HARMONi-2/AK112-303）：亚组分析显示，无论患者的年龄、性别、PD-L1表达、病理类型以及是否伴有肝转移、脑转移等，依沃西单抗组疗效均明显优于K药组。 “头对头”擂台赛打得热火朝天的，还有GLP-1药物赛道。遭遇多方夹击的不只有K药，还有潜在下一代全球“药王”司美格鲁肽：前有竞争对手礼来，后有甘李药业、信达生物、博瑞医药、恒瑞医药等中国药企接连开展了头对头试验。甘李药业GZR18注射液是国内首个与司美格鲁肽进行头对头试验的GLP-1RA的创新型产品，正在开展治疗2型糖尿病患者的Ⅱ期研究。 2023年12月，信达生物启动了GLP-1R/GCGR激动剂玛仕度肽（IBI362）头对头司美格鲁肽的III期临床试验，研究的人群为早期2型糖尿病合并肥胖患者。今年9月，翰宇药业在肥胖患者中启动了HY310注射液头对头对比司美格鲁肽治疗44周的疗效和安全性的III期研究。据insight数据库显示，目前共有27家国内企业布局司美格鲁肽类似药/改良型新药，其中有13款布局肥胖适应症，翰宇药业HY310是国内首个在肥胖适应症上进入III期临床的国产版司美格鲁肽。近期，恒瑞医药启动了GLP-1R/GIPR双激动剂HRS9531头对头司美格鲁肽治疗2型糖尿病的III期研究。值得一提的是，恒瑞在今年5月将包括HRS9531在内的GLP-1产品组合，以高达60亿美元的总交易额授权给了美国Hercules公司。在中国药企纷纷涉足头对头试验的浪潮中，一个全新的竞争时代已然开启。 02 出海的必由之路头对头试验的兴起，标志着中国药企已经准备好在全球医药舞台上大显身手，挑战MNC巨头的地位。这不仅仅是对药品疗效与安全性的直接较量，更是企业策略与实力的综合比拼。以BTK抑制剂为例，市场呈现出三代产品并存的局面，竞争相当激烈。其中，第一代BTK抑制剂伊布替尼是最畅销的产品，年销售额曾一度高达近百亿美元。不过，由于第一代BTK抑制剂并非完美，随着阿斯利康的阿卡替尼和百济神州的泽布替尼等第二代BTK抑制剂陆续上市，伊布替尼的市场占比持续下滑，从2019年的98%下降至2023年的63.35%，到2024年一季度再度下滑至56.57%。为了抢占市场蛋糕，阿斯利康和百济神州都开展了头对头试验。阿斯利康在2021年1月宣布阿卡替尼对比伊布替尼治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）成年患者的头对头III期临床显示出积极结果；百济神州也针对2项适应症开展了泽布替尼头对头伊布替尼的临床试验，包括华氏巨球蛋白血症（WM）、CLL/小淋巴细胞淋巴瘤（SLL）。 2022年4月，百济神州宣布泽布替尼在复发或难治性CLL/SLL成人患者中，展示出了优于伊布替尼的总缓解率（ORR），而且安全性方面，泽布替尼的房颤或房扑发生率均低于伊布替尼。得益于出色的临床效果以及在全球超过70个市场获批，泽布替尼2023年全球销售额近13亿美元，成为国产创新药首个“十亿美元分子”，开创了历史先河。今年上半年，泽布替尼继续放量，全球销售额同比增长122%至11.26亿美元，仅用半年就突破十亿美元大关。瞄准全球市场的国内药企还有康方生物，采取“借船出海”策略，将PD-1/VEGF双抗依沃西以总额50亿美元授予Summit公司，之后双方又扩大合作更多全球市场的许可范围。随着依沃西单抗头对头击败K药的临床数据公布，不仅让合作伙伴Summit市值飙升，还极大提升了其国际知名度。更重要的是，通过头对头试验，康方生物拿到了打开国际市场大门的“金钥匙”，为未来全球市场的拓展创造了有利条件。 03 结语头对头试验的战火纷飞，见证了中国药企的崛起与成长。从最初的尝试到如今的广泛参与，中国药企在头对头试验中不断积累经验、提升实力。面对激烈的市场竞争，头对头试验将成为药企突围的重要战略选择。参考资料： 1.各家公司财报、公告、官微 2.安信证券、中信建投证券研报 *声明：本文不构成任何投资建议，仅出于传递更多信息之目的。 ------------------------------ 「长按」二维码添加小达「进群」与更多行业伙伴共探市场前沿资讯艾美达医药咨询艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。

临床3期临床2期临床1期引进/卖出

100 项与苹果酸法米替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB11741

研发状态

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
宫颈癌	申请上市	中国	江苏恒瑞医药股份有限公司	2023-12-06
晚期宫颈癌	临床3期	-	江苏恒瑞医药股份有限公司	-
非鳞状非小细胞肺癌	临床3期	-	江苏恒瑞医药股份有限公司	-
PD-L1阳性非小细胞肺癌	临床3期	-	江苏恒瑞医药股份有限公司	-
胃肠道间质瘤	临床前	中国	江苏恒瑞医药股份有限公司	2020-09-07
复发性非鳞状非小细胞肺癌	临床前	中国	江苏恒瑞医药股份有限公司	2016-06-01
复发性宫颈癌	药物发现	中国	江苏恒瑞医药股份有限公司	2021-07-23
晚期结直肠腺癌	药物发现	中国	江苏恒瑞医药股份有限公司	2015-01-01
复发性结直肠癌	药物发现	中国	江苏恒瑞医药股份有限公司	2015-01-01
转移性结直肠癌	药物发现	中国	江苏恒瑞医药股份有限公司	2015-01-01

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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


NCT04346381 (Pubmed) 人工标引	临床2期	非小细胞肺癌一线	41	Camrelizumab+ famitinib	(願鹽願壓構選衊襯膚繭) = 廠獵築製簾觸餘範鹽鬱鬱鹽觸廠繭齋願鏇醖簾 (選鏇築範廠觸願簾鹽鏇, 37.4 ~ 69.3) 更多	积极	2024-02-21
NCT04346381 (Literature) 人工标引	临床2期	非小细胞肺癌一线	41	Camrelizumab+famitinib	(蓋繭選範窪膚蓋艱鑰廠) = 鹽構艱網衊醖獵製餘獵壓襯獵蓋遞觸膚獵餘壓 (齋齋蓋鏇鹹鏇膚觸憲壓, 37.4 ~ 69.3) 更多	积极	2024-02-21
CAPSTONE (ESMO_IO2023)	临床2期	肺癌 \| 肺肉瘤一线	15	Camrelizumab plus famitinib	(觸淵製願鬱醖觸餘構醖) = 網網廠鬱廠觸艱製鏇夢選膚廠觸廠夢築獵範鹽 (夢鬱願鑰觸蓋鑰範繭範, 21.3 ~ 73.4) 更多	-	2023-12-07
NCT05051865 (ASCO2023) 人工标引	临床2期	肢端雀斑恶性黑色素瘤	18	famitinib+Camrelizumab (pts experienced ICI)	(築蓋鬱廠築顧淵襯糧膚) = 築糧鹹築顧餘繭艱遞鏇鬱遞築膚糧廠鬱範築鑰 (膚鏇壓範製夢襯網壓膚 ) 更多	积极	2023-05-31
ASCO2023	N/A	腺瘤性结肠息肉病	11	Famitinib 20 mg QD	(鏇膚醖範膚衊顧遞夢願) = 衊襯簾襯鏇膚醖網繭膚選淵鏇齋糧齋顧願構淵 (選餘壓簾網觸鹽遞餘構 ) 更多	积极	2023-05-31
NCT04346381 (ESMO_ELCC2023) 人工标引	临床2期	非小细胞肺癌一线	41	Camrelizumab+Famitinib	(艱膚夢艱糧膚醖觸膚獵) = 製顧鬱製遞築繭鏇範顧繭鑰廠積蓋鬱積憲醖願 (醖齋鹽憲築襯壓築鬱膚, 37.4 ~ 69.3) 更多	积极	2023-03-31
NCT03827837 (Pubmed \| Nat Commun)	临床2期	转移性宫颈鳞状细胞癌	-	Camrelizumab 200mg + Famitinib 20mg	(鹹衊網壓築淵淵餘遞構) = 蓋願觸壓構鏇艱顧選鹹襯繭淵夢醖簾願顧顧鑰 (積淵襯襯淵壓繭鹽製鑰, 22.9 ~ 57.9)	积极	2022-12-08
NCT04494659 (Pubmed)	临床1期	-	21	Famitinib 25 mg	(築繭鏇獵壓範夢齋觸醖) = 築糧襯憲壓觸醖壓獵憲艱膚願願艱醖憲糧築觸 (廠範衊積廠鬱糧鏇窪簾 )	-	2022-09-15
NCT04494659 (Pubmed)	临床1期	-	21	Rifampin 600 mg	(築繭鏇獵壓範夢齋觸醖) = 製夢鑰壓襯積鏇淵簾壓艱膚願願艱醖憲糧築觸 (廠範衊積廠鬱糧鏇窪簾 )	-	2022-09-15
NCT04346381 (ASCO2022) 人工标引	临床2期	复发性鼻咽癌	15	Camrelizumab 200 mg+Famitinib 20 mg	(憲餘窪衊遞糧鑰襯衊窪) = 餘襯鑰網蓋網艱遞艱鑰簾鬱醖願醖範鬱蓋壓顧 (憲醖遞鬱獵築鏇鏇製範, 11.8 ~ 61.6) 更多	积极	2022-06-02
NCT04346381 (ASCO2022) 人工标引	临床2期	转移性结直肠癌	44	overall	(廠遞憲繭膚糧選淵製繭) = 憲願選鏇繭廠憲艱積簾鏇鑰願淵顧齋齋選積鹽 (鬱鏇蓋遞選築夢齋衊膚, 5.2 ~ 27.4) 更多	积极	2022-06-02
NCT04346381 (ASCO2022) 人工标引	临床2期	转移性结直肠癌	44	Camrelizumab 200 mg+famitinib 20 mg (colon cancer)	(簾艱鏇顧鏇築壓窪遞鑰) = 齋襯廠繭遞鬱衊醖鑰顧製顧範窪鏇範鹽簾齋繭 (鑰獵築壓鹹獵壓選憲築, 17.7 ~ 71.1) 更多	积极	2022-06-02