The Efficacy and Safety of Herombopag in Treating Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Surgery - A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.

开始日期2024-07-31

申办/合作机构

江苏恒瑞医药股份有限公司

CTR20242559 / Recruiting临床3期

海曲泊帕乙醇胺片治疗拟择期侵袭性手术慢性肝病患者血小板减少症的有效性和安全性——多中心、随机双盲、安慰剂对照III期临床研究

Part A：分析海曲泊帕在拟择期侵袭性手术慢性肝病患者血小板减少症人群中的药代动力学（PK）/药效动力学（PD）特征，完善群体药代药效动力学（PopPK/PD）模型，探索该适应症剂量。 Part B：与安慰剂比较，评价海曲泊帕治疗拟择期侵袭性手术慢性肝病患者血小板减少症患者中给药的有效性。

开始日期2024-07-26

申办/合作机构

江苏恒瑞医药股份有限公司

100 项与海曲泊帕乙醇胺相关的临床结果

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100 项与海曲泊帕乙醇胺相关的转化医学

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100 项与海曲泊帕乙醇胺相关的专利（医药）

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项与海曲泊帕乙醇胺相关的文献（医药）

2024-11-01·ANNALS OF HEMATOLOGY

The effect of hetrombopag combined with conventional treatment on immune function and quality of life in patients with severe aplastic anemia

Article

作者: Tang, Rui-Mei ; Wang, Shu-Wen ; Wang, Gu-Yun ; Huang, Ying ; Liu, Dan ; Chen, Wen-Ting

This study aimed to investigate the effect of hetrombopag combined with conventional treatment on immune function in patients with severe aplastic anemia (SAA). Patients were categorized into the control group (n = 50, receiving conventional treatment only) and experimental group (n = 50, receiving hetrombopag combined with conventional treatment). Before treatment and at weeks 18, 24, and 52 after treatment, the two groups were compared in routine blood test indicators, natural killer (NK) cell activity, and peripheral blood inflammatory factor levels. The overall remission rate and incidence of adverse events were also compared between the two groups. Outpatient or telephone follow-up was performed before treatment and at weeks 18, 24, and 52 after treatment to observe patients' immune function, treatment outcome, quality of life, and adverse events. Hemoglobin (Hb), and platelet count (PLT) (P < 0.05), and a rise in NK cell activity (P < 0.05). Interleukin (IL-10) levels were significantly higher, while IL-6 levels were significantly lower in the experimental group compared to the control group (P < 0.05). After receiving the treatment, all scores of SF-36 domains in both groups were higher than before treatment, particularly with higher scores in the experimental group (P < 0.05). Hetrombopag combined with conventional treatment improved the immune function and hematopoiesis of patients with SAA.

2024-10-01·ANNALS OF HEMATOLOGY

Adding hetrombopag to cyclosporine a improved response of patients with newly diagnosed transfusion-dependent non-severe aplastic anemia

Article

作者: Shen, Shupei ; Jiang, Zeyu ; Chen, Miao ; Yang, Chen ; Hu, Qinglin ; Han, Bing

In this study, we aimed to assess adding HETROM to CsA for adult patients with transfusion dependent non-severe aplastic anemia (TD-NSAA).From Oct. 2021 to Oct. 2023, Patients who were eligible for the following descriptions were enrolled in this study.(1) 18 years of age or older; (2) diagnosed as TD-NSAA in 6 mo after a complete workup, including bone marrow biopsy, cytogenetic examination, next-generation sequencing of myelodysplastic syndrome(MDS)-associated genetic mutations, autoimmune antibody testing; (3) received HETROM + CsA or CsA as initial treatment.Patients in CsA control group were selected from patients receiving CsA monotherapy by matching the baseline data of age, sex and complete blood cell count.Baseline data including gender, age, baseline Hb (HGB), red blood cell (RBC) values, platelet (PLT) values and neutrophil (Neut) values were collected.

2024-07-01·ANNALS OF HEMATOLOGY

Switching from eltrombopag to hetrombopag in patients with primary immune thrombocytopenia: a post-hoc analysis of a multicenter, randomized phase III trial

Article

作者: Zhou, Hu ; Wu, Depei ; Zeng, Yun ; Liu, Li ; Yao, Yazhou ; Bai, Yuansong ; Luo, Jianmin ; Mei, Heng ; Zhou, Xin ; Shen, Xuliang ; Yang, Linhua ; Niu, Ting ; Wang, Yi ; Feng, Ying ; Gao, Guangxun ; Hu, Yu ; Jiang, Zhongxing ; Yang, Renchi ; Xia, Ruixiang ; Li, Yan ; Liu, Xiaofan ; Jin, Jie ; Hu, Jianda ; Cheng, Peng ; Hou, Ming ; Huang, Ruibin

Abstract:

While studies have explored the feasibility of switching between various thrombopoietin receptor agonists in treating immune thrombocytopenia (ITP), data on the switching from eltrombopag to hetrombopag remains scarce. This post-hoc analysis of a phase III hetrombopag trial aimed to assess the outcomes of ITP patients who switched from eltrombopag to hetrombopag. In the original phase III trial, patients initially randomized to the placebo group were switched to eltrombopag. Those who completed this 14-week eltrombopag were eligible to switch to a 24-week hetrombopag. Treatment response, defined as a platelet count of ≥ 50 × 109/L, and safety were evaluated before and after the switch. Sixty-three patients who completed the 14-week eltrombopag and switched to hetrombopag were included in this post-hoc analysis. Response rates before and after the switch were 66.7% and 88.9%, respectively. Among those with pre-switching platelet counts below 30 × 109/L, eight out of 12 patients (66.7%) responded, while eight out of nine patients (88.9%) with pre-switching platelet counts between 30 × 109/L and 50 × 109/L responded post-switching. Treatment-related adverse events were observed in 50.8% of patients during eltrombopag treatment and 38.1% during hetrombopag treatment. No severe adverse events were noted during hetrombopag treatment. Switching from eltrombopag to hetrombopag in ITP management appears to be effective and well-tolerated. Notably, hetrombopag yielded high response rates, even among patients who had previously shown limited response to eltrombopag. However, these observations need to be confirmed in future trials.

167

项与海曲泊帕乙醇胺相关的新闻（医药）

2024-12-02

·ioncology

SABCS 2024丨盛幕将启，中国专家入选壁报展示（Poster Session 1）

点击蓝字，关注我们编者按：第47届圣安东尼奥乳腺癌研讨会（SABCS）将于当地时间2024年12月10日至13日在美国得克萨斯州圣安东尼奥举行。SABCS是全球最大的乳腺癌领域盛会，来自102个国家的超过1万名注册参会者将在为期四天的会议中展示1886篇被接受的论文摘要。肿瘤瞭望特别整理中国专家被收录的壁报内容，以飨读者。（注：因官网未公布详细作者单位，如有遗漏或错误，欢迎留言指正。） Poster Session 1 日期：12月11日时间：12:30～2:00 p.m 地点：Halls 2-3 P1-01-04：EPLIN and EPLIN responsive protein APOC3 in breast cancer EPLIN及其应答蛋白APOC3在乳腺癌中的作用报告作者：Cai Wang P1-02-12: Prospective phase II study on the efficacy and safety of hetrombopag for the treatment of cancer therapy-induced thrombocytopenia in patients with breast cancer 在乳腺癌患者中应用海曲泊帕治疗癌症治疗诱导的血小板减少症的有效性和安全性的前瞻性II期研究报告作者：Hanfang Jiang P1-02-18: Cancer-Associated Fibroblast-Mediated Suppression of T Cell Activity as a mechanism of Resistance to Immunoradiotherapy in Breast Cancer 癌症相关成纤维细胞介导的T细胞活性抑制作为乳腺癌免疫放疗抵抗的机制报告作者：Rongrong Wu P1-04-04: evelopment and validation of a nomogram for axillary lymph node metastasis risk in breast cancer 乳腺癌腋窝淋巴结转移风险列线图的建立和验证报告作者：Xiaoyun Mao P1-04-12: Optimizing Tolerability of Pyrotinib in HER2-Positive EarlyStage High-Risk Breast Cancer: A Multicenter, Randomized, ThreeCohort Study 优化吡咯替尼治疗HER2阳性早期高危乳腺癌的耐受性：一项多中心、随机、三队列研究报告作者：Qiao Cheng P1-04-22: Loss of SMAD4 Drives Breast Cancer Invasion and Metastasis through E2F1-Mediated Activation of the PEG10-ERK Axis SMAD4缺失通过E2F1介导的PEG10-ERK轴激活驱动乳腺癌的侵袭和转移报告作者：Dan Shu P1-04-25: Fast and accurate detection of tumor-immune cell interactions with deep learning 利用深度学习快速准确地检测肿瘤-免疫细胞相互作用报告作者：Huiping Liu P1-05-07: Expression of ATP6AP2 in clinical breast cancer and the prognostic and therapeutic value in ERBB2 subtype of breast cancer ATP6AP2在临床乳腺癌中的表达及其在ERBB2亚型乳腺癌中的预后和治疗价值报告作者：Jia Tong P1-05-24: Biomarkers and Spatial Determinants of SHR-A1811 Efficacy in Neoadjuvant Treatment for HER2-Positive Breast Cancer SHR-A1811在HER2阳性乳腺癌新辅助治疗中疗效的生物标志物和空间决定因素报告作者：Zhi-Ming Shao P1-05-27: Analytical comparison of tissue-based next-generation sequencing assays for the detection of PIK3CA, AKT1, and PTEN tumor alterations in breast cancer 基于组织的二代测序检测乳腺癌中PIK3CA、AKT1和PTEN肿瘤改变的分析比较报告作者：Xiaodun Li P1-06-04: Psychological stress and its correlations to patients with acute lymphedema after breast cancer surgery 心理应激与乳腺癌术后急性淋巴水肿的相关性研究报告作者：Li-Chen Tang P1-06-06: Oral cyclophosphamide-induced hemorrhagic cystitis from metronomic Cyclophosphamide/Methotrexate/5-Fluorouracil for treatment of synchronous bilateral breast cancer – A case report 口服环磷酰胺导致出血性膀胱炎：一例应用节拍化疗方案环磷酰胺/甲氨蝶呤/5-氟尿嘧啶治疗同期双侧乳腺癌的病例报告报告作者：Jina Yun P1-06-24: Single-cell RNA sequencing reveals the role of HSPA1B+ immune cells in breast cancer microenvironment remodeling during neoadjuvant chemotherapy 单细胞RNA测序揭示HSPA1B+免疫细胞在乳腺癌新辅助化疗微环境重塑中的作用报告作者：Zihan Zhai P1-06-29: Targeting NRP1 reduces triple-negative breast cancer lung metastasis and improves immunotherapy efficacy 靶向NRP1可降低三阴性乳腺癌肺转移，并提高免疫治疗疗效报告作者：Zhuxi Duan P1-07-20: Mechanism of miR-221-3p/PARP1 regulating the progression of triple-negative breast cancer through the NF-κB pathway miR-221-3p/PARP1通过NF-κB通路调控三阴性乳腺癌进展的机制报告作者：Qianqian Lei P1-07-21: Efficacy of CDK4/6 Inhibitor Abemaciclib in Metastatic Triple-Negative Breast Cancer CDK4/6抑制剂阿贝西利治疗转移性三阴性乳腺癌的疗效报告作者：Chuling Zhuang P1-07-25: E3 ubiquitin-protein ligase RNF40 promotes triplenegative breast cancer progression and metastasis by promoting TRIM28 expression and stabilizing TWIST1 protein E3泛素蛋白连接酶RNF40通过促进TRIM28表达和稳定TWIST1蛋白促进三阴性乳腺癌的进展和转移报告作者：Junjiang Fu P1-07-28: Real-World Study on Efficacy and Safety of SG Alone and Combined with Immunotherapy in Metastatic Triple Negative Breast Cancer Patients SG单药及联合免疫治疗转移性三阴性乳腺癌患者的疗效和安全性的真实世界研究报告作者：Jianli Zhao P1-08-02: HIF-1-dependent expression of integrin β3 incorporated into extracellular vesicles promotes metastasis of breast cancer cells to the brain HIF-1依赖的整合素β3表达整合入细胞外囊泡中，促进乳腺癌细胞向脑的转移报告作者：Yongkang Yang P1-08-05: The mechanism of FOXO3a in coping with oxidative stress to promote TNBC progression FOXO3a应对氧化应激促进TNBC进展的机制报告作者：Manqing Cao P1-08-21: Synchronous female breast cancer and follicular lymphoma in a single patient: A case report 女性乳腺癌同时合并滤泡性淋巴瘤一例报告报告作者：Zijun Zhao P1-09-05: Simultaneous 3D Mapping of RNA and Protein to Advance Personalized Medicine in Breast Cancer 同时进行RNA和蛋白质的3D绘图以推进乳腺癌的个体化治疗报告作者：Yue Li P1-09-11: Machine Learning based analysis in chemotherapy resistant triple negative breast cancer 基于机器学习的化疗耐药三阴性乳腺癌分析报告作者：Dongling Wu P1-09-24: Cancer cell-derived exosomal miR-20a-5p inhibits CD8+ T-cell function and confers anti-programmed cell death 1 therapy resistance in triple-negative breast cancer 三阴性乳腺癌细胞衍生的外泌体miR-20a-5p抑制CD8+ T细胞功能并导致抗程序性细胞死亡1治疗耐药报告作者：XIANGDONG BAI P1-10-17: HER2+ breast cancer diagnosed in the 2nd trimester of pregnancy 妊娠中期诊断的HER2+乳腺癌报告作者：Shiliang Zhang P1-11-01: Immune Infiltration Correlates with Transcriptomic Subtypes in Primary ER+ Invasive Lobular Breast Cancer 原发性ER+浸润性小叶乳腺癌的免疫浸润与转录组亚型相关报告作者：Fangyuan Chen P1-11-07: Associations between Breast Cancer Index Classifications and MSK-IMPACT Genomic Profiles in HR+/HER2- Breast Cancer HR+/HER2-乳腺癌中乳腺癌指数分类与MSK-IMPACT基因组谱的相关性报告作者：Hong Zhang P1-11-11: Pathological Complete Response and Survival Outcomes ofSingle Hormone Receptor-Positive/HER2-Negative Breast Cancer after Neoadjuvant Treatment and Further analysis of its Intrinsic Biological Features and Immune Landscape. 新辅助治疗后单激素受体阳性/HER2阴性乳腺癌的病理完全缓解及生存结局，以及对其内在生物学特征和免疫图谱的进一步分析报告作者：Lei Ji P1-11-12: Early-stage HR+/HER2- breast cancer patients under 50 years old with a low-risk identified by the 70-gene signature (MammaPrintTM) could benefit from ovarian function suppression: A real-world study in China. 基于70基因特征（MammaPrintTM）鉴定为低风险的50岁以下早期HR+/HER2-乳腺癌患者可从卵巢功能抑制中获益：一项中国真实世界研究报告作者：Weijuan Jia P1-11-13: Development and Validation of a Deep Learning Model for HR+/HER2- Early-stage Breast Cancer Recurrence Prediction (HERPAI) using Conventional Clinical and Pathological Data: A Realworld Study in Chinese Population 基于常规临床和病理数据构建并验证用于HR+/HER2-早期乳腺癌复发预测的深度学习模型（HERPAI）：一项针对中国人群的真实世界研究报告作者：Ruixin Pan P1-12-09: Real-world prescribing patterns and outcomes of CDK4/6 inhibitors in elderly patients with metastatic HR+/HER2- breast cancer CDK4/6抑制剂在老年转移性HR+/HER2-乳腺癌患者中的真实世界处方模式和结局报告作者：Xiao-Wei Tan P1-12-26: Clinical Case Vignette - Molecular PET Imaging to Guide Selection for Endocrine Therapy in Estrogen-Receptor Positive Metastatic Breast Cancer 临床病例简述——分子PET成像指导雌激素受体阳性转移性乳腺癌内分泌治疗的选择报告作者：Wenhui Zhou P1-12-27: Clinical Case Vignette: Estrogen Receptor Targeting PET Imaging to Monitor Treatment Response to Endocrine Therapy in Lobular Breast Cancer 临床病例简述：雌激素受体靶向PET显像监测乳腺小叶癌内分泌治疗的疗效报告作者：Wenhui Zhou （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床结果

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

·恒瑞医药

恒瑞医药上榜“2024福布斯中国创新力企业50强”，创新实力再获认可

11月13日，福布斯中国发布了2024年度创新力企业50强榜单，恒瑞医药凭借在医药研发领域出色的科技创新能力和丰硕的创新成果入选该榜单，成为医药健康领域上榜企业之一。福布斯中国表示，此次榜单的评价维度包括创新能力、企业治理、企业成长性、创新驱动的市场优势以及企业社会形象等方面。同时，以关注创新力为核心，评估企业发展与组织扩张。近3年来，福布斯中国创新力企业50强榜单的更新率逐年提高，今年已达到惊人的80%。这也对应着中国创新赛道的激烈更迭，生物医药板块就是这一变化的代表。恒瑞医药凭借持续的研发投入和卓越的创新成果上榜，彰显公司创新实力。 01 坚持做难而正确的事，不断加码研发创新高强度研发投入是高水平研发创新的重要保障。恒瑞医药今年前三季度研发费用达45.49亿元，同比大增22%，累计研发投入超400亿元，位居全国医药行业前列。目前，公司在连云港、上海、美国和欧洲等地设立14个研发中心，全球研发团队达5000余人。随着持续高强度研发投入，公司创新成果也不断涌现。第三季度，公司自免领域的首个创新药那奇珠单抗注射液上市。至此，恒瑞医药已在国内获批上市17款1类创新药、4款2类新药。另有90多个自主创新产品正在临床开发，300余项临床试验在国内外开展，涵盖抗肿瘤、代谢性疾病、自身免疫疾病、呼吸系统疾病、神经系统疾病等多个疾病领域，研发成果稳居行业领先地位。随着创新成果的不断落地转化，公司业绩稳健增长。公司2024年前三季度实现营业收入201.89亿元，同比增18.67%，归属于上市公司股东的净利润46.20亿元，同比增32.98%。专利是药企最有价值的资产之一，是企业发展的基石。多年来专注研发创新，公司在专利布局方面也硕果累累。截至今年6月底，公司累计申请发明专利2527件，PCT专利691件，拥有国内有效授权发明专利585件，欧美日等国外授权专利705件。公司先后荣获中国发明专利金奖1项，中国发明专利银奖2项，中国发明专利优秀奖2项。公司先后承担57项国家重大专项课题，核心技术获得国家科技进步二等奖3项，其他科技进步奖10项。 02 开拓出海新模式，走稳国际化创新道路大水大鱼，恒瑞医药在科技创新与国际化双轮驱动战略的引领下，坚持自主研发与开放合作并重，逐渐更深层次地迈向国际。公司在内生发展的基础上着力加强国际合作，以全球化的视野积极寻求与全球领先医药企业的合作机会，加速融入全球药物创新网络。目前公司已实现11项创新药海外授权。今年5月，公司将具有自主知识产权的GLP-1类创新药HRS-7535、HRS9531、HRS-4729许可给美国Kailera公司，首付款加里程碑付款累计可高达60亿美元，公司还取得美国Kailera公司19.9%的股权。与此同时，公司开展近20项创新药国际临床试验，其中“双艾”组合美国重新申报上市已获受理；SHR-A2009、SHR-A1912、SHR-A1921、SHR-A2102等4款ADC创新药获得美国FDA快速通道资格认定；卡瑞利珠单抗、海曲泊帕等3款创新药获美国FDA孤儿药资格认定。此外，上半年恒瑞医药已有31项重要研究成果相继在 BMJ（英国医学杂志）、Journal of Clinical Oncology（临床肿瘤学杂志）、Cancer Cell（癌症细胞杂志）、Lancet Oncology（柳叶刀·肿瘤学）等全球顶级期刊发表，累计影响因子达 627.1分，全球学术影响力不断提升。凭借丰厚的研发创新成果，恒瑞医药的行业地位不断获得国际认可。美国制药经理人杂志公布的全球制药企业TOP50榜单中，恒瑞医药连续六年上榜；国际知名咨询机构Citeline评选的“全球制药公司管线规模TOP25”，连续三年上榜，今年排名跃升至第8位，再创中国药企排名新高。未来，恒瑞医药将继续践行科技创新和国际化发展战略，秉持“科技为本、为人类创造健康生活”的使命，重创新，强研发，力争研制出更多更好的新药，服务健康中国，惠及全球患者。撰稿：史松坡排版：程梦真责编：史松坡往期精选 | 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”

财报上市批准医药出海临床研究

100 项与海曲泊帕乙醇胺相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B02BX	DB16184

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
再生障碍性贫血	中国	江苏恒瑞医药股份有限公司	2021-06-16
慢性血小板减少症	中国	江苏恒瑞医药股份有限公司	2021-06-16
免疫性血小板减少症	中国	江苏恒瑞医药股份有限公司	2021-06-16

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
慢性肝病	临床3期	中国	江苏恒瑞医药股份有限公司	2024-07-31
肿瘤	临床3期	-	江苏恒瑞医药股份有限公司	2022-04-15
血小板减少症	临床3期	美国	江苏恒瑞医药股份有限公司	2022-01-11
血小板减少症	临床3期	澳大利亚	江苏恒瑞医药股份有限公司	2022-01-11
血小板减少症	临床3期	欧洲	江苏恒瑞医药股份有限公司	2022-01-11
实体瘤	临床3期	中国	江苏恒瑞医药股份有限公司	2019-11-06
难治性重度再生障碍性贫血	临床3期	中国	江苏恒瑞医药股份有限公司	2019-03-05
急性髓性白血病	临床2期	-	江苏恒瑞医药股份有限公司	2023-07-01
晚期乳腺癌	临床2期	中国	江苏恒瑞医药股份有限公司	2022-08-19
第二原发肿瘤	临床2期	-	江苏恒瑞医药股份有限公司	2022-06-01

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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


ASH2024	N/A	造血干细胞移植	-	Hetrombopag	膚夢齋醖憲蓋襯鏇齋艱(鹹繭夢顧憲範遞選範鏇) = one patient experienced HAPG-related liver damage 蓋淵繭製窪餘鹽遞窪蓋 (獵壓願餘網網餘範願鹹 ) 更多	-	2024-12-08
				rhTPO
ASH2024	N/A	再生障碍性贫血	-	Hetrombopag + IST	製襯蓋觸選衊顧鑰構醖(鹹窪襯鏇齋繭製積製築) = 積糧顧積鹽廠築築簾觸築積醖獵範築窪糧衊膚 (構顧鏇選網衊製鬱壓範, 21.2 ~ 35.1) 更多	-	2024-12-07
				Placebo + IST	製襯蓋觸選衊顧鑰構醖(鹹窪襯鏇齋繭製積製築) = 糧構顧鑰積齋繭壓獵範築積醖獵範築窪糧衊膚 (構顧鏇選網衊製鬱壓範, 6.2 ~ 21.3) 更多
ChiCTR2200057846 (ESMO2024) 人工标引	临床2期	实体瘤 \| 血小板减少症	28	Hetrombopag 7.5 mg QD	積廠淵鑰襯壓顧艱範艱(廠窪鹹夢窪衊願積糧鹹) = 蓋艱築築醖選鹹積廠選鑰夢衊製淵衊鏇蓋膚餘 (範餘窪鹽醖構繭範築鹽 ) 更多	积极	2024-09-15
NCT05160857 (EHA2024) 人工标引	N/A	血小板减少症	23	Hetrombopag	簾鑰構襯網鏇簾襯壓淵(積積鹹簾憲鹽構廠網餘) = 齋憲蓋獵範築齋淵構齋築網積顧築範積壓襯簾 (糧蓋願膚鬱願築範窪醖 ) 更多	积极	2024-05-14
EHA2024 人工标引	N/A	再生障碍性贫血	21	Hetrombopag	醖鏇夢遞獵齋蓋鏇襯網(鑰簾願繭遞繭觸廠夢築) = 壓鏇淵選繭餘蓋鹽網齋蓋觸遞網鏇窪鑰遞獵鑰 (鬱憲壓築顧顧願鏇築鏇 ) 更多	积极	2024-05-14
				Hetrombopage A	醖鏇夢遞獵齋蓋鏇襯網(鑰簾願繭遞繭觸廠夢築) = 觸膚夢網膚遞築艱膚淵蓋觸遞網鏇窪鑰遞獵鑰 (鬱憲壓築顧顧願鏇築鏇 ) 更多
NCT06099925 (EHA2024) 人工标引	临床2期	血小板减少症	20	Hetrombopag 5mg	糧襯糧壓鏇鏇遞餘鑰艱(築鏇糧遞鹹餘獵蓋壓築) = 夢膚觸壓鹹簾淵淵鹹簾淵顧願壓顧積鬱選壓積 (窪遞餘鏇醖鏇鏇鑰蓋選, 0.1812 ~ 0.5671) 更多	积极	2024-05-14
EHA2024 人工标引	N/A	血小板减少症	22	Hetrombopag 5mg	齋鹽範構襯願積醖製願(醖簾願窪壓衊鹽獵鹹壓) = 淵鹹製餘壓襯醖鬱廠鹹顧淵齋積齋簾膚簾壓獵 (鹽繭夢壓製膚鹽衊構願 ) 更多	积极	2024-05-14
				Placebo	齋鹽範構襯願積醖製願(醖簾願窪壓衊鹽獵鹹壓) = 壓鑰遞鏇鏇鑰廠艱衊鹹顧淵齋積齋簾膚簾壓獵 (鹽繭夢壓製膚鹽衊構願 ) 更多
EHA2024 人工标引	临床3期	血小板减少症巩固	32	Hetrombopag 5 mg	獵獵餘網顧繭齋衊繭壓(衊鑰淵齋構獵糧襯壓艱) = 衊壓襯選襯衊選憲網鹽製鹽衊餘蓋觸觸獵簾鹽 (壓衊襯夢艱醖餘願遞蓋, 5.83 ~ 7.73) 更多	积极	2024-05-14
EHA2024 人工标引	N/A	血小板减少症	18	Hetrombopag	構獵淵積積鏇膚積廠餘(網齋淵憲膚窪獵蓋艱鹹) = None 醖願衊淵窪獵糧構襯鬱 (襯鏇憲窪餘艱餘鹽襯憲 ) 更多	积极	2024-05-14
CECGA (EHA2024)	N/A	再生障碍性贫血	62	Hetrombopag (HETROM) + Cyclosporin A (CsA)	蓋觸艱鏇遞廠鑰窪艱廠(夢獵網襯淵製觸築齋鑰) = 簾艱鏇鬱壓夢壓壓鏇鏇顧膚遞顧憲餘淵蓋膚遞 (繭繭製觸憲鏇鹽築網襯 ) 更多	积极	2024-05-14
				Eltrombopag (EPAG) + Cyclosporin A (CsA)	(鑰壓憲遞鹹衊膚積製醖) = 艱壓鑰糧繭遞窪壓襯糧壓鬱願選艱蓋積遞鹽鬱 (簾顧築窪憲襯鹽鏇廠夢 ) 更多