This study aims to identify HER2-positive early-stage breast cancer patients who could benefit from neoadjuvant treatment using PHESGO™ (pertuzumab and trastuzumab) without chemotherapy. The approach involves utilizing specific biomarkers (HR and HER2 IHC status) to select participants whose tumors strongly rely on the HER2 pathway, potentially benefiting from a HER2-targeted approach without chemotherapy concurrently.

开始日期2024-09-05

申办/合作机构

Roche Pharma AG

NCT06439693

/ Recruiting临床2期IIT

A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study

The purpose of this study is to test the safety and effectiveness of a sequence of drugs (a Taxane plus Trastuzumab plus Pertuzumab followed by Trastuzumab Deruxtecan, followed by Tucatinib plus Ado-Trastuzumab Emtansine (T-DM1), followed by Trastuzumab plus Pertuzumab plus Tucatinib) in HER2+ Breast Cancer. The study will help investigators understand whether first intensifying therapy for a specific period and then stopping treatment is safe and effective for participants.
The names of the study drugs involved in this study are:
* Paclitaxel (a type of anti-microtubule agent)
* Docetaxel (a type of anti-microtubule agent)
* Nab-Paclitaxel (a type of anti-microtubule agent)
* Trastuzumab (a type of IgG1 kappa monoclonal antibody)
* Pertuzumab (a type of monoclonal antibody)
* Trastuzumab Deruxtecan (a type of HER2-directed antibody drug conjugate)
* Tucatinib (Tyrosine Kinase HER2 Inhibitor)
* Ado-trastuzumab emtansine or T-DM1 (a type of HER2-targeted antibody-drug conjugate)

开始日期2024-08-08

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06172127

/ Recruiting临床2期

A Multicenter, Open-Label, Single-Arm, Phase II Trial Exploring the Maintenance of Trastuzumab and Pertuzumab Following Trastuzumab Deruxtecan as Induction Treatment for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

DEMETHER is a phase II trial exploring the maintenance of trastuzumab and pertuzumab fixed dose combination (FDC) for subcutaneous administration (SC, PHESGO) following trastuzumab deruxtecan (T-DXd) as induction treatment for HER2-positive unresectable locally recurrent or metastatic breast cancer (MBC) patients.

开始日期2024-07-22

申办/合作机构

Medica Scientia Innovation Research SL

100 项与曲妥珠单抗/帕妥珠单抗/透明质酸酶相关的临床结果

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100 项与曲妥珠单抗/帕妥珠单抗/透明质酸酶相关的转化医学

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100 项与曲妥珠单抗/帕妥珠单抗/透明质酸酶相关的专利（医药）

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项与曲妥珠单抗/帕妥珠单抗/透明质酸酶相关的文献（医药）

2024-12-01·Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society

Bilateral Optic Neuropathy Following Phesgo Injection for HER2+ Breast Cancer.

Article

作者: Malik, Alaa N ; Thompson, John P ; Puri, Sidharth

2024-07-01·Nihon yakurigaku zasshi. Folia pharmacologica Japonica

Pharmacological properties and clinical development overview of pertuzumab (genetical recombination), trastuzumab (genetical recombination) and vorhyaluronidase alfa (genetical recombination) (PHESGO<sup>®</sup> combination for ‍subcutaneous injection MA, IN)

Review

作者: Habara, Yuji ; Kotani, Naoki ; Zheng, Yue ; Sakaeda, Mariko ; Yoneya, Takaaki

Pertuzumab and trastuzumab are anti-HER2 humanized monoclonal antibodies with different mechanisms of action. Their combination is expected to suppress intracellular HER2 signaling additively or synergistically. Their combination is widely recommended worldwide and has been established as a standard of care for HER2-positive breast cancer. However, improvement is required because of the prolonged time of intravenous infusion. Vorhyaluronidase alfa (rHuPH20) depolymerizes hyaluronan in the subcutaneous connective tissue. It's reported to increase the permeability and absorption levels of drugs. PHESGO^® combination for subcutaneous injection MA/IN (PHESGO^®) is a fixed-dose combination of pertuzumab, trastuzumab, and rHuPH20. A confirmatory phase III study (FeDeriCa) was conducted following a dose-finding phase I study (BO30185). Patients with HER2-positive early breast cancer were randomly assigned to receive either intravenous infusion of pertuzumab and trastuzumab or subcutaneous injection of PHESGO^®, in combination with chemotherapy, to compare the pharmacokinetics (PK), efficacy and safety. A phase II study (PHranceSCa) was also conducted to assess patients' preference and satisfaction. Based on these results, population PK analysis, and other data, PHESGO^® obtained marketing approval in Japan in September 2023 with indications for "HER2-positive breast cancer" and "advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection". By reducing the administration time, PHESGO^® is expected to contribute to various needs of patients and improvement of their daily lives. Since drug preparation is not required, it can provide convenience to healthcare professionals, leading to stress reduction of medical resources as well.

2023-01-01·European journal of cancer (Oxford, England : 1990)

Incidence and severity of anaphylaxis and hypersensitivity in trials of intravenous pertuzumab plus trastuzumab or the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection for HER2-positive breast cancer

Article

作者: Dang, Chau T ; Yang, Ke ; Liu, Haiying ; O'Shaughnessy, Joyce ; Tan, Antoinette R ; Restuccia, Eleonora ; Kuemmel, Sherko ; Macharia, Harrison ; Aguila, Christian ; Gianni, Luca ; Swain, Sandra M ; Heeson, Sarah ; Loibl, Sibylle ; Schneeweiss, Andreas

AIM:

To characterise risk of anaphylaxis/hypersensitivity with intravenous pertuzumab plus trastuzumab (PH IV), the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PH FDC SC) or concomitant chemotherapy to support potential administration of PH FDC SC by healthcare professionals outside clinics.

METHODS:

A cumulative search for anaphylaxis/hypersensitivity (Roche Standard Adverse Event Group Terms) was performed for all pivotal trials cited in the current EMA P IV/PH FDC SC summaries of product characteristics: MBC: NCT00567190, NCT02402712; EBC: NCT01358877, NCT00545688, NCT00976989, NCT02132949, NCT03493854 and NCT03674112. Occurrence, incidence and severity of events were analysed and a time-trend analysis (by cycle) was performed.

RESULTS:

This analysis includes 4772 patients who received PH IV and/or PH FDC SC. Incidence of all-grade (grade ≥3) anaphylaxis/hypersensitivity events: 3-11% (≤2%) for PH IV MBC trials; 1-13% (0-3%) for PH IV EBC trials; and 2-3% (<1%; not related to PH FDC SC) for PH FDC SC EBC trials. Discontinuations due to anaphylaxis/hypersensitivity were rare for PH IV (generally <1% except two arms of TRYPHAENA: 1% and 3%); no discontinuations of PH FDC SC have been recorded so far. Time-trend analysis showed that most events were reported during the first 6-8 cycles with concurrent chemotherapy, with a decrease in later cycles (except MetaPHER).

CONCLUSION:

PH IV and PH FDC SC were well tolerated, with few grade ≥3 anaphylaxis/hypersensitivity events reported with PH IV and no grade ≥3 related events with PH FDC SC. Most events occurred during chemotherapy.

182

项与曲妥珠单抗/帕妥珠单抗/透明质酸酶相关的新闻（医药）

2025-06-04

·罗氏制药

罗氏2025 ASCO聚焦：多瘤种肿瘤产品组合新数据亮相

在刚刚结束的第61届美国临床肿瘤学会（ASCO）年会上，罗氏公布了多项肿瘤领域的最新研究进展，重点展示了乳腺癌领域、肺癌领域和血液肿瘤领域的肿瘤产品组合新数据。这些关键研究结果，进一步突显了罗氏致力于为癌症患者开发变革性疗法的承诺。III期INAVO120研究显示，在内分泌耐药、PIK3CA突变HR+/HER2-局部晚期或转移性乳腺癌患者一线治疗中，伊那利塞（inavolisib）联合哌柏西利+氟维司群治疗组的中位OS长达34个月，较安慰剂联合对照组的27个月显著延长7个月。● 与哌柏西利（palbociclib）和氟维司群（fulvestrant）相比，基于Itovebi™ (inavolisib)的治疗方案将内分泌耐药、PIK3CA突变的HR阳性、HER2阴性晚期乳腺癌患者的死亡风险降低了30%以上[1]● 最新数据在2025年美国临床肿瘤学会（ASCO）年会的口头报告环节呈报，同期并发表于《新英格兰医学杂志》[1]PIK3CA突变存在于约40%的HR阳性晚期乳腺癌中，且与不良预后相关[2,3]。除INAVO120研究外，Itovebi目前还在三项公司申办的III期研究（INAVO121, INAVO122，INAVO123）中进行评估，这些研究均针对PIK3CA突变的局部晚期或转移性乳腺癌，采用不同的联合治疗方案。[4-7]罗氏正在乳腺癌和其他肿瘤类型中展开更多探索，希望能将这种靶向治疗的益处带给更多携带PIK3CA突变的患者。III期IMforte研究取得积极结果：Tecentriq联合Lurbinectedin治疗广泛期小细胞肺癌显示显著生存获益● 在该侵袭性强、生存期有限且治疗选择稀缺的癌症类型中，疾病进展或死亡风险降低46%，死亡风险降低27%[8]● 首个在广泛期小细胞肺癌（ES-SCLC）一线维持治疗中，证实无进展生存期和总生存期均取得临床意义改善的III期研究[9,10]● 研究数据已在2025年ASCO年会口头报告环节公布，并同步发表于《柳叶刀》[8,11]III期STARGLO研究随访两年的更新数据证实：Glofit-GemOx方案可延长复发或难治性弥漫性大B细胞淋巴瘤患者的总生存期● 对于不适合移植的复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者，总生存期持续显示出具有临床意义的改善，中位OS尚未达到，疾病死亡风险降低40%[12]● 更新的Landmark分析数据显示，在Glofit-GemOx方案治疗结束时获得完全缓解的患者中，82%未发生疾病进展[12]● 同时，完全缓解率达58.5%，且患者可持续获得完全缓解状态，目前随访两年数据显示DoCR仍未达到[12]所以，对于这种侵袭性、危及生命的疾病，在复发或初始治疗失败后及时启动有效治疗至关重要！Glofit-GemOx方案作为一种亟需的、固定疗程、“即用型”TCE疗法具有巨大潜力。“我们将集中端到端的资源，聚焦乳腺癌、肺癌和恶性血液肿瘤——这些存在大量未被满足临床需求的疾病领域，而我们在这方面已积淀深厚专业优势。在三大重点疾病领域之外，我们还将持续探索其他具有变革性治疗潜力的癌症类型，寻求突破性的创新。”参考文献：[1] Turner NC, et al. INAVO120 Phase III trial final overall survival (OS) analysis of first-line inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV) in patients (pts) with PIK3CA-mutated, hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC). Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, 2025 May 30-June 03; Chicago, USA. Abstract #1003.[2] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22(1):1002.[3] Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.[4] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04191499.[5] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05646862. [6] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 May]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT05894239. [7] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 May]. Available from: https://clinicaltrials.gov/study/NCT06790693.[8] Paz-Ares L, et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial. Presented at: ASCO Annual Meeting; 2025 May 30-Jun 03; Chicago, IL, USA. Abstract #8006.[9] Belluomini L, et al. Maintenance or consolidation therapy in small-cell lung cancer: an updated systematic review and meta-analysis. Seminars in Oncology. 2022; 49(5): 389-393. [10] Roviello G, et al. No advantage in survival with targeted therapies as maintenance in patients with limited and extensive-stage small cell lung cancer: a literature-based meta-analysis of randomized trials. Clin Lung Cancer. 2016; 17(5): 334–340.[11] Paz-Ares L, et al. Efficacy and safety of first-line maintenance therapy with lurbinectedin plus atezolizumab in extensive-stage small-cell lung cancer (IMforte): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2025 Jun 02. [Internet; cited June 2025]. Available from: https://doi-org.libproxy1.nus.edu.sg/10.1016/S0140-6736(25)01011-6.[12] Abramson J, et al. Glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 2-year (yr) follow-up of STARGLO. Presented at: ASCO Annual Meeting; 2025 May 30 - Jun 3. Abstract #7015.1.本新闻稿旨在分享研发前沿资讯，仅供中国境内医疗卫生专业人士参阅，非广告用途。2.罗氏不推荐任何未被批准的药品、适应症的使用。更多新闻罗氏宣布肝癌III期临床研究TALENTACE达到主要研究终点《新英格兰医学杂志》：研究证实速福达®(玛巴洛沙韦)可显著降低流感病毒传播

ASCO会议临床结果临床3期

2025-05-18

·微信

【医苑观畴】GLP1也撑不起来：MNC中国区业绩持续疲软

MNC中国区业绩的垮塌仍在继续（前期分析参见【医苑观畴】隔壁家的孩子：医保控费下的MNC中国区众生相和【医苑观畴】外资是在撤出吗：MNC中国业绩似现拐点），前几大明确披露中国区收入的MNC，在2025年一季度又同比下滑了7%，这还是考虑到有GLP-1这种大品种增量的情况下。整体而言，多数MNC中国区业务都出现了增速放缓或慢于全球增速，导致中国区在全球的占比持续下降。 1）礼来LLY：依靠Tzp带动中国区销售额同比大增，但受限于产能和销售能力，中国区增速仍不及全球增速； 2）诺和诺德NVO：Ozempic增长已放缓、Wegovy在中国新上市带动新的增长，特别是最近季度，美国增长放缓，中国一跃成为全球增长最快的地区； 3）默沙东MRK：原本依靠K药+HPV疫苗成为MNC中国区业绩增长最快的之一，而2024年HPV爆雷后几乎一夜回到解放前； 4）罗氏ROG：随着众多肿瘤药物的专利到期，中国区业绩受生物类似药冲击严重，最近季度靠着Xofluza和Phesgo回了一口血； 5）阿斯利康AZN：以前一直是中国区业务体量最大且增长最稳健的MNC，2024年底中国区高管被查事件确实造成一波冲击，目前看起来已有效恢复； 6）诺华NVS：当前MNC中国区表现的唯一真神，明确将中国定位为仅次于美国的第二重要的区域市场； 7）赛诺菲SNY：中国区业务长期依靠Dupilumab保持稳定增长，而2024年中决定暂停中国区的流感疫苗业务，直接导致同比持续下滑。原以为像GLP-1这样的超重磅品种一放量，MNC能一举扭转在中国的颓势，然而从目前形势来看，Sema和Tzp也就带来区区数十亿增量，远不足以让MNC重现雄风，就真像“总舵主来了”吗？

专利到期生物类似药疫苗

2025-05-15

·医药地理

速报！2025 Q1各大药企财报汇总：创新与挑战并存

随着2025年第一季度的结束，各大药企纷纷公布了其最新的财务报告。医药行业作为关乎人类健康的重要领域，其发展态势一直备受关注。从A股到跨国药企，无论是国内还是国际，医药行业在2025年第一季度都展现出了不同的增长势头和创新活力。本文将对各大药企的财报进行汇总分析，并探讨其中的增长引擎和未来趋势。一、 A股医药企业：创新引领，业绩分化截至目前，A股医药企业已有100家披露了2025年第一季度业绩情况。整体来看，超五成企业业绩报喜，但业绩分化明显。部分企业在创新和国际化方面取得了显著进展，而另一些企业则面临挑战。华海药业在2025年第一季度继续保持强劲增长，实现营业收入23.69亿元，同比下降5.21%。归母净利润为2.96亿元，同比增长8.07%。华海药业营收下降但净利润上升，整体处于稳定水平，而其在创新药和仿制药领域均有显著突破，特别是在心血管和精神障碍类药物方面，进一步巩固了其市场地位。片仔癀则在第一季度实现了营业收入31.41亿元，同比下降0.92%，净利润为10亿元，同比增长2.59%。虽然公司整体营收微降，但其核心业务肝病用药仍然保持了21.83%的增长。下图为片仔癀2025年第一季度的主要财务数据和指标：来源：片仔癀2025年第一季度财报图：肝病用药历年毛利润康龙化成在2025年第一季度实现营业收入 30.99 亿元，同比增长 16.03% ，但归母净利润为 2.5 亿元，同比下降 10%。康龙化成表示，尽管收入增长显著，但由于研发投入增加和市场推广费用上升，导致净利润有所下降。图为康龙化成2025年第一季度的主要财务数据和指标：来源：康龙化成2025年第一季度财报该公司是一家领先的全流程一体化医药研发服务平台，业务遍及全球，致力于协助客户加速药物创新，提供从药物发现到药物开发的全流程一体化药物研究、开发及生产服务。2025年第一季度，公司位于中国的、服务于全球客户的实验室和工厂，收入同比增长 15.71%，占公司营业收入的 87.74%；公司位于海外的实验室和工厂，收入同比增长 18.33%，占营业收入的12.26%。图：2025年第一季度各板块营业收入、营业成本、毛利率及同比变动来源：康龙化成2025年第一季度财报恒瑞医药在第一季度恒瑞实现营业收入72.06亿元，同比增长20.14%；归属于上市恒瑞股东的净利润达到18.74亿元，同比大幅增长36.90%；归属于上市恒瑞股东的扣非净利润为18.63亿元，同比增长29.35%，创下史上最佳业绩。下图为恒瑞药业2025年第一季度的主要财务数据和指标：来源：恒瑞药业2025年第一季度财报二、跨国药企：稳健增长，创新引领在跨国药企方面，GSK、罗氏、辉瑞等巨头也交出了亮眼的成绩单。尽管面临市场竞争和价格压力，这些企业通过创新和市场拓展，依然实现了稳健增长。1. 罗氏：肿瘤业务持续增长罗氏 2025 年第一季度实现营业收入 154.40 亿瑞士法郎（约 186 亿美元），同比增长 6%。其中制药业务收入 119.49 亿瑞士法郎，同比增长 8%；诊断业务收入 34.91 亿瑞士法郎，与去年 Q1 持平。肿瘤领域营收增长 2%，营收 TOP 产品仍然是 HER2 产品组合（Phesgo、Perjeta 和 Kadcyla）和阿替利珠单抗（Tecentriq）。其中明星产品Phesgo（乳腺癌）全球销售额59.3亿瑞士法郎（+52%），中国市场表现突出。下图为罗氏2025年第一季度的主要财务数据和指标：来源：罗氏2025年第一季度财报 2. GSK：肿瘤产品成为新增长点 GSK在2025年第一季度实现营业收入75.16 亿英镑（95.04 亿美元），同比增长 4%。研发投入 14.62 亿英镑（18.49 亿美元），同比增长 3%。特药方面，GSK 在HIV、呼吸/免疫和肿瘤疾病领域分别斩获了 17 亿英镑（+7%）、8 亿英镑（+28%）、4 亿英镑（+53%）。值得一提的是，肿瘤产品的增长态势极为突出，已然成为 GSK 业绩增长的全新驱动力，为公司的持续发展注入了强劲动力。下图为GSK 2025年第一季度的主要财务数据和指标：来源：GSK2025年第一季度财报3. 辉瑞：新冠影响减弱，肿瘤业务增长辉瑞在2025年第一季度总营收137.15亿美元（-8%），其中产品收入112.94亿美元（-9%）。研发费用方面，第一季度费用为21.73亿美元，较去年同期下降12%，主要得益于研发管线的优化和重点聚焦。下图为辉瑞2025年第一季度的主要财务数据和指标：来源：辉瑞2025年第一季度财报三、肿瘤业务：增长引擎与未来趋势从上述药企的财报中可以看出，肿瘤业务已成为多家药企业绩增长的重要驱动力。随着全球癌症发病率的不断上升和患者需求的日益增长，肿瘤药物市场展现出巨大的发展潜力。1. 创新药物是关键以和黄医药的呋喹替尼为例，该药物在美国上市后的市场表现极为亮眼，成为推动和黄医药肿瘤业务增长的重要力量。同样，GSK的Jemperli等创新药物也在肿瘤领域取得了显著成效。这些创新药物的推出不仅丰富了肿瘤治疗的选择，也为患者带来了更好的治疗效果和生存希望。2. 合作与共赢随着肿瘤药物市场的不断扩大和竞争的加剧，合作成为药企发展的重要趋势。通过合作开发海外市场和销售许可授予等方式，药企可以共同分享市场资源和技术成果，实现互利共赢。这种合作模式不仅有助于提升药企的市场竞争力，也有助于推动整个肿瘤药物市场的健康发展。3. 市场挑战与机遇尽管肿瘤业务增长迅速，但药企也面临诸多挑战。市场竞争加剧、价格压力增大、研发投入增加等因素都对药企的盈利能力提出了更高要求。然而，随着技术的不断进步和市场需求的变化，药企也在不断寻找新的增长点和突破口。四、结语2025年第一季度，各大药企的财报显示了医药行业的强劲增长势头和创新活力。尽管面临市场竞争和价格压力，药企通过创新和市场拓展，依然实现了稳健增长。未来，随着技术的不断进步和市场需求的增长，医药行业将继续在创新和国际化方面发力，迎来更多机遇和挑战。END如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

财报

100 项与曲妥珠单抗/帕妥珠单抗/透明质酸酶相关的药物交易

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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
HER2阳性结直肠癌	日本	Chugai Pharmaceutical Co., Ltd.	2023-09-25
转移性乳腺癌	加拿大	Hoffmann-La Roche Ltd.	2021-03-01
早期乳腺癌	欧盟	Roche Registration GmbH	2020-12-21
早期乳腺癌	冰岛	Roche Registration GmbH	2020-12-21
早期乳腺癌	列支敦士登	Roche Registration GmbH	2020-12-21
早期乳腺癌	挪威	Roche Registration GmbH	2020-12-21
HER2阳性转移性乳腺癌	欧盟	Roche Registration GmbH	2020-12-21
HER2阳性转移性乳腺癌	冰岛	Roche Registration GmbH	2020-12-21
HER2阳性转移性乳腺癌	列支敦士登	Roche Registration GmbH	2020-12-21
HER2阳性转移性乳腺癌	挪威	Roche Registration GmbH	2020-12-21
HER2阳性乳腺癌	美国	Genentech, Inc.	2020-06-29

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
PIK3CA突变/HER2阳性乳腺癌	临床3期	中国	F. Hoffmann-La Roche Ltd.	2023-08-04
PIK3CA突变/HER2阳性乳腺癌	临床3期	中国	罗氏（中国）投资有限公司	2023-08-04
ER阳性乳腺癌	临床2期	美国	Hoffmann-La Roche, Inc.	2021-06-22
ER阳性乳腺癌	临床2期	澳大利亚	Hoffmann-La Roche, Inc.	2021-06-22
ER阳性乳腺癌	临床2期	以色列	Hoffmann-La Roche, Inc.	2021-06-22
ER阳性乳腺癌	临床2期	西班牙	Hoffmann-La Roche, Inc.	2021-06-22
晚期恶性实体瘤	临床2期	美国	Genentech, Inc.	2021-01-13
不可切除的实体瘤	临床2期	美国	Genentech, Inc.	2021-01-13
HER2阳性食管癌	临床2期	荷兰	Roche Pharma AG	2014-01-01
晚期乳腺癌	临床1期	-	Genentech, Inc.	2023-01-30

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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


NCT05275010 (CTgov)	临床1期	-	151	Handheld Syringe+Fixed-Dose Combination of Pertuzumab and Trastuzumab SC (Arm 1: PH FDC SC Using a Handheld Syringe)	鏇夢壓醖鹽鏇醖壓鬱觸(艱淵鏇築範醖構網餘獵) = 繭壓餘醖蓋觸鬱淵獵顧廠膚顧壓簾襯艱觸襯鏇 (餘膚餘鬱衊衊鑰鹹艱艱, 27.5) 更多	-	2024-09-23
				Trastuzumab+On-Body Delivery System (Arm 2: PH FDC SC Using the OBDS)	鏇夢壓醖鹽鏇醖壓鬱觸(艱淵鏇築範醖構網餘獵) = 築網齋網壓鹹鹽鑰選觸廠膚顧壓簾襯艱觸襯鏇 (餘膚餘鬱衊衊鑰鹹艱艱, 23.2) 更多
NCT02000596 (CTgov)	临床2期	转移性乳腺癌	2	Trastuzumab plus Pertuzumab (Cohort 1: T+P)	窪繭齋顧遞簾鬱醖製憲 = 淵獵夢鏇簾餘窪蓋餘窪築壓範餘壓鹹獵選鏇簾 (餘願觸遞繭顧願願鑰膚, 鹹顧夢憲蓋壓顧憲簾鹹 ~ 鑰淵餘鹽淵鑰餘壓夢鏇) 更多	-	2022-05-27
				Trastuzumab plus Pertuzumab+Fulvestrant+Anastrozole (Cohort 2 - Arm A)	製鹹鹽鏇醖選夢構鬱窪(簾衊壓網獵窪餘構糧蓋) = 鏇簾選簾積齋顧艱淵窪製廠醖膚鑰窪願餘構壓 (鬱膚築餘鹹簾製構齋窪, 襯窪獵艱鑰顧膚襯廠夢 ~ 顧醖簾餘餘窪艱範顧糧) 更多