A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Eltrombopag 25 mg tablets relative to Revolade 25 mg tablets in healthy Thai volunteers under fasting condition.

开始日期2026-01-29

申办/合作机构

Bio-innova Co., Ltd

NCT06630221

/ Not yet recruiting临床2期IIT

A Phase II Study of Eltrombopag as a Novel Therapeutic Approach for Patients With Low-risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) With TET2 Mutations

The purpose of this study is to evaluate if a study drug called eltrombopag can improve the blood cell counts in patients with low-risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML) with mutations in TET2 gene, observe changes in the TET2 gene over time, and evaluate the effectiveness of the treatment. TET2 gene is one of the most frequently mutated genes (altered parts of the DNA) in MDS and CMML.
Eltrombopag is a Food and Drug Administration (FDA) approved drug for the treatment of severe aplastic anemia and low levels of platelets in patients with persistent or chronic immune thrombocytopenia (ITP) and chronic hepatitis C. Eltrombopag is considered investigational (experimental) in this study because the FDA has not approved its use in the treatment of low-risk MDS or CMML. Eltrombopag is a drug that helps stimulate the body's process of making more platelets (small components of blood that help with clotting) by interacting with specific parts of cells. This interaction starts a series of signals that encourage the growth and development of the cells that produce platelets. It was found that this drug could stop the growth of TET2 mutated cells.

开始日期2025-04-01

申办/合作机构

The Case Comprehensive Cancer Center

CTR20250395

/ CompletedN/A

南京黄龙生物科技有限公司研制的艾曲泊帕乙醇胺片与持证商为Novartis Pharma Schweiz AG的艾曲泊帕乙醇胺片（商品名：瑞弗兰®/Revolade®）在中国健康受试者中进行的随机、开放、单剂量、两周期、双交叉、空腹状态下的生物等效性研究

以南京黄龙生物科技有限公司研制的艾曲泊帕乙醇胺片（规格：25 mg）为受试制剂，以持证商为Novartis Pharma Schweiz AG的艾曲泊帕乙醇胺片（商品名：瑞弗兰®/Revolade®，规格：25 mg）为参比制剂，考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

开始日期2025-03-01

申办/合作机构

南京黄龙生物科技有限公司

100 项与艾曲波帕乙醇胺相关的临床结果

登录后查看更多信息

100 项与艾曲波帕乙醇胺相关的转化医学

登录后查看更多信息

100 项与艾曲波帕乙醇胺相关的专利（医药）

登录后查看更多信息

1,608

项与艾曲波帕乙醇胺相关的文献（医药）

2025-12-31·Hematology

Sustained response off treatment after fostamatinib in refractory immune thrombocytopenia: A series of four case reports

Article

作者: Ghanima, Waleed ; Rackwitz, Stefan ; Lucas Boronat, Francisco Javier ; Carrai, Valentina

INTRODUCTION:

A goal of most primary immune thrombocytopenia (ITP) treatments is reducing or discontinuing treatment while maintaining a response including an absence of bleeding events. We present four cases describing treatment with the spleen tyrosine kinase (SYK) inhibitor, fostamatinib, that showed sustained response off treatment (SROT).

CASE PRESENTATIONS:

Case 1 was a 66-year-old male with chronic ITP. He was pre-treated with prednisone and rituximab before being in the FIT-2 clinical trial (placebo). He received fostamatinib in the FIT-3 open-label extension for seven weeks and maintained SROT for 2.5 years. Case 2 was a 54-year-old female patient with chronic, highly refractory ITP. SROT was achieved after 6 months of fostamatinib and was maintained for more than 16 months (in remission to date). Case 3 was a 60-year-old male with chronic ITP. He was successfully treated with cycles of corticosteroids for six years prior to fostamatinib. He was treated with fostamatinib plus prednisone for approximately two months. SROT was observed in this patient for one year. Case 4 was a 67-year-old male with persistent ITP. Before fostamatinib, he was unresponsive to high-dose dexamethasone, IVIG, eltrombopag and romiplostim. After 11 months of fostamatinib, his dose was tapered for three months and ultimately discontinued. SROT was observed for more than ten months (in remission to date).

DISCUSSION:

These cases emphasize that SROT is achievable with fostamatinib in complex ITP cases unresponsive to multiple previous therapies. Additional research is needed to identify the magnitude of the underlying mechanisms, and the clinical factors associated with, and potentially predictive of, SROT.

2025-06-01·BRAIN RESEARCH

In silico screening to search for selective sodium channel blockers: When size matters

Article

作者: Gavernet, Luciana ; Orsi, Federico ; Fallico, Maximiliano José ; Enrique, Nicolás ; Prada Gori, Denis Nihuel ; Talevi, Alan ; Alberca, Lucas Nicolás ; Martín, Pedro

Dravet Syndrome is a severe childhood drug-resistant epilepsy. The predominant etiology of this condition is related to de novo mutations within the SCN1A gene, which codes for the alpha subunit of the NaV1.1 sodium channels. This dysfunction leads to hypoexcitability of GABAergic interneurons. In turn, the loss of electrical excitability in GABAergic interneurons leads to an imbalance of excitation over inhibition in many neural circuits. Notably, exacerbation of symptoms is observed when non-selective sodium channel blockers are administered to patients with Dravet. Recent studies in animal models of Dravet have highlighted the potential of highly specific sodium channel blockers capable of blocking other sodium channel subtypes without inhibiting NaV1.1 current and selective activators of NaV1.1 as viable therapeutic strategies for alleviating Dravet Syndrome symptoms. Here, we describe the development and validation of ligand-based machine learning models to identify ligands with inhibitory effects on sodium channel isoforms NaV1.1 and NaV1.2. These models were built based on in-house open-source routines and Mordred molecular descriptors. First, linear classifiers were inferred using a combination of feature-bagging and Forward Stepwise selection. Secondly, ensemble learning was applied to build meta-classifiers with improved predictive ability, whose performance was tested in retrospective screening experiments. After in silico validation, the models were applied to screen for drug repurposing opportunities in the DrugBank and Drug Repurposing Hub databases, to identify selective blocking agents of NaV1.2 devoid of NaV1.1 blocking activity, as potential compounds for the treatment of Dravet Syndrome. Forty in silico hits were later identified in a prospective screening experiment. Four of them were acquired and submitted to experimental confirmation via patch clamp: three of these candidates, Eltrombopag, Sufugolix, and Glesatinib, showed blocking effects on NaV1.2 currents, although no subtype selectivity was observed. The different predictive abilities of the NaV1.1 and NaV1.2 models may be attributed to the different sizes of the datasets used to train and validate the respective models.

2025-05-01·EUROPEAN JOURNAL OF HAEMATOLOGY

Avatrombopag for the Treatment of Immune Thrombocytopenia

Review

作者: Vigna, Ernesto ; Labanca, Caterina ; Martino, Enrica Antonia ; Gentile, Massimo ; Bruzzese, Antonella ; Olivito, Virginia ; Mendicino, Francesco ; Lucia, Eugenio ; Puccio, Noemi ; Neri, Antonino ; Caridà, Giulio ; Morabito, Fortunato

ABSTRACT:

Avatrombopag, a second‐generation thrombopoietin receptor agonist (TPO‐RA), represents a significant advancement in the treatment of chronic immune thrombocytopenic purpura (cITP) and a potential therapeutic option for other thrombocytopenic disorders. Approved in both the USA and Europe, avatrombopag offers a convenient oral dosing regimen, initiated at 20 mg daily with food, to achieve and maintain platelet counts ≥ 50 × 109/L. Its favorable safety profile, characterized by minimal hepatic toxicity and the absence of dietary restrictions, distinguishes it from older TPO‐RAs such as eltrombopag and romiplostim. Clinical trials and real‐world data support its efficacy, with over 90% of patients that fail to standard first‐ and second‐line treatments or become unresponsive, achieving target platelet counts, and its hepatotoxicity‐free profile makes it particularly advantageous for patients with liver disease or complex comorbidities. Economic evaluations, including a budget impact analysis for the Italian National Health Service, have projected significant healthcare cost savings associated with avatrombopag use, reinforcing its value as a cost‐effective therapeutic option. However, challenges remain, including limited data on long‐term safety. In this review, we aim to provide a comprehensive synthesis of clinical evidence and real‐world data on avatrombopag's efficacy, safety, and pharmacological advantages, while exploring its current and potential therapeutic applications, such as chemotherapy‐induced thrombocytopenia and aplastic anemia.

221

项与艾曲波帕乙醇胺相关的新闻（医药）

2025-04-09

·GlobeNewswire-Health Care

Barbara Weber, M.D., Elected to ITM Supervisory Board

Garching / Munich, Germany, April 09, 2025 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced the election of Barbara Weber, M.D., to its Supervisory Board, effective May 01, 2025. The election occurred at ITM’s Extraordinary General Meeting. Dr. Weber is the President, Chief Executive Officer and Founder of Tango Therapeutics (Nasdaq: TNGX). She has over 25 years of executive and research and development leadership experience in biotech, venture capital and at major pharmaceutical companies, including Novartis (NYSE: NVS) and GlaxoSmithKline (NYSE: GSK). ITM’s Supervisory Board and the company overall will benefit from Dr. Weber’s deep expertise as it advances its lead Phase 3 candidate, n.c.a. 177Lu-edotreotide (ITM-11), and continues advancing its radiopharmaceutical pipeline and medical radioisotope manufacturing business. “Dr. Weber’s impressive track record in building transformative oncology biotech companies speaks volumes for her business acumen and her dedication to improving the lives of people living with cancer. Her profound industry and scientific knowledge, including her demonstrated ability to bring novel compounds through the clinic to FDA approval, will be an invaluable asset to ITM,” said Udo J. Vetter, Chairman of the Supervisory Board of ITM. “The expansion of our Supervisory Board and its insights ensures that ITM is optimally positioned to continue accelerating the growth of its radiopharmaceutical pipeline and medical radioisotope business.” Dr. Weber is a physician-scientist with a distinguished clinical and academic career and extensive leadership expertise in global pharmaceutical development. As the President, Chief Executive Officer and Founder of Tango Therapeutics, she led the company’s transition to being publicly listed and the development of its precision oncology product candidates based on the genetic principle of synthetic lethality. As a Venture Partner at Third Rock Ventures, she led teams in creating new oncology drug discovery companies, including Tango Therapeutics, Neon Therapeutics (acquired by BioNTech (Nasdaq: BNTX)) and Relay Therapeutics (Nasdaq: RLAY). “As a physician and business executive devoted to fighting cancer, I recognize the significant potential of targeted radiopharmaceutical therapy to improve the precision oncology treatment paradigm and outcomes for patients. I look forward to working with ITM’s Supervisory Board and Leadership Team as the company plans an NDA submission for ITM-11 and expands its pipeline with various promising alpha- and beta-emitting radioisotopes coupled with novel targeting agents,” said Dr. Weber. Prior to her tenure at Third Rock Ventures, Dr. Weber was Senior Vice President, Oncology Translational Medicine at Novartis and Vice President, Oncology Discovery and Translational Medicine at GlaxoSmithKline, where she was instrumental in leading clinical studies and obtaining FDA approvals for numerous drugs including Zykadia®, Kisqali®, Vijoice® and Promacta®. Dr. Weber received her Doctor of Medicine from the University of Washington and has been affiliated with the University of Pennsylvania, Yale University and the Dana-Farber Cancer Institute. She is a member of the Board of Directors at Tango Therapeutics, Revolution Medicines Inc. (Nasdaq: RVMD), Parabilis Medicines and Sesame Therapeutics. About ITM Isotope Technologies Munich SEITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life. www.itm-radiopharma.com ITM ContactCorporate CommunicationsKathleen Noonan/Julia WestermeirPhone: +49 89 329 8986 1500Email: communications@itm-radiopharma.com Investor RelationsBen OrzelekPhone: +49 89 329 8986 1009Email: investors@itm-radiopharma.com Attachments 20250409_Barbara Weber, M.D., Elected to ITM Supervisory Board Barbara Weber, M.D., Elected to ITM Supervisory Board

高管变更临床3期

2025-03-28

·微信

正大天晴开挂了！拿下16个重磅品种，85款1类新药霸屏，12款创新药上市可期

精彩内容近日，正大天晴的1类新药注射用TQB2101、TQB2210注射液获批临床，公司创新药管线进展不断。2024年至今，正大天晴已有6款创新产品、10款仿制药获批上市。除了已上市的8款创新药，公司还有85款1类新药处于申报临床及以上阶段，12款处于NDA或Ⅲ期临床阶段；12款高端创新药物在研，4款上市可期；71个品种过评（23个首家），8个备战第十一批集采。1类新药进展不断！拿下16个重磅品种近日，正大天晴的1类新药注射用TQB2101（治疗晚期恶性肿瘤）、TQB2210注射液（治疗晚期恶性肿瘤）、注射用TQB2934（治疗轻链型淀粉样变）相继获得临床试验默示许可。其中，TQB2210是一款靶向FGFR2b的人源化单克隆抗体，全球尚未有同靶点药物上市。今年以来，正大天晴创新药管线进展不断，已有10款1类新药申报IND、4款1类新药获批临床。2024年至今，正大天晴研发管线持续推进，1类新药、生物类似药、仿制药获批上市的消息不断，进一步丰富公司的产品种类，拓展公司的产品布局。1类新药注册许可方面，正大天晴有4款1类新药富马酸安奈克替尼胶囊（治疗ROS1阳性非小细胞肺癌）、贝莫苏拜单抗注射液（治疗一线小细胞肺癌、子宫内膜癌）、枸橼酸依奉阿克胶囊（治疗ALK阳性非小细胞肺癌）、格索雷塞片（治疗二线KRAS G12C非小细胞肺癌）相继获批上市。其中，安奈克替尼、依奉阿克获纳入2024版医保目录。目前，公司累计已有8款1类新药获批上市。2024年至今正大天晴获批产品生物类似药注册许可方面，正大天晴的利拉鲁肽注射液（治疗2型糖尿病）、帕妥珠单抗注射液（治疗HER2乳腺癌）先后获批上市。其中，利拉鲁肽注射液为国产第3家，帕妥珠单抗注射液为国产第2家。目前，正大天晴累计已有7款生物类似药获批上市。仿制药注册许可方面，正大天晴有10个品种获批上市并视同过评，包括艾曲泊帕乙醇胺片、注射用磷酸特地唑胺、碘普罗胺注射液、钆特醇注射液、比卡鲁胺片、恩曲他滨丙酚替诺福韦片（II）、甲磺酸艾立布林注射液、注射用紫杉醇（白蛋白结合型）、艾地骨化醇软胶囊、注射用头孢他啶阿维巴坦钠。10个品种中，艾曲泊帕乙醇胺片为国内首仿，碘普罗胺注射液、钆特醇注射液为国产第2家，甲磺酸艾立布林注射液为国产第3家。85款1类新药霸屏！12款上市可期除了已获批上市的8款1类新药，目前正大天晴还有85款1类新药处于申报临床及以上研发阶段，创新研发项目处于行业前列。其中，小分子化学创新药有60个、大分子生物创新药有25个，涉及肿瘤、肝病、呼吸、代谢、自免等疾病领域，覆盖融合蛋白、单抗、双抗、ADC等药物形式。公司创新药管线蓄势待发！85款1类新药中，库莫西利胶囊（CDK2/4/6抑制剂）、TQ05105片（JAK/ROCK抑制剂）、宗格替尼片（口服HER2抑制剂）上市申请在审中，最快有望于2025年内获批上市；注射用TQB2102（HER2双抗ADC）、TQB3823片（PARP抑制剂）、AL2846胶囊（c-Met抑制剂）、TQB3454片（IDH-1抑制剂）等9款1类新药已处于Ⅲ期临床阶段，上市可期。正大天晴主要在研1类新药此外，正大天晴还有12款高端创新制剂处于申报临床及以上阶段，涉及7款生物类似药、4款改良型化药及一款血液制品。其中，注射用重组人凝血因子Ⅶa（治疗血友病）上市申请在审中，有望于2025年内获批上市；多聚糖超顺磁氧化铁注射液（治疗缺铁性贫血）、德谷胰岛素注射液（治疗2型糖尿病）、司美格鲁肽注射液（治疗2型糖尿病、体重控制）已处于Ⅲ期临床阶段，上市可期。值得一提的是，正大天晴是港股上市公司中国生物制药的核心子公司。3月20日，中国生物制药发布2024年业绩，公司全年营收达288.7亿元，同比增长10.2%，创历史新高；经调整归母净利润达34.6亿元，同比增长33.5%。作为传统药企转型创新的标杆，中国生物制药2024年创新产品收入达120.6亿元，增长21.9%，创新产品占总收入比例达到41.8%。得益于“自研+BD”的双轮驱动，中国生物制药预计未来三年将进入创新成果收获的爆发期，近20款创新产品有望获批上市，涵盖双抗、ADC等前沿疗法。预计到2027年，公司创新产品数量将突破30个，将实现收入结构的持续优化，实现业绩稳健、高质量增长。71个品种过评，8个备战第十一批集采仿制药业务方面，目前正大天晴已有71个品种通过/视同通过一致性评价，其中23个品种为国内首家过评。在国家已开展的九批化药集采中，正大天晴无一缺席，累计有30个品种中标。正大天晴通过/视同通过一致性评价品种71个过评品种涵盖10个治疗大类，主要集中在抗肿瘤和免疫调节剂（23个）、全身用抗感染药物（15个）、消化系统及代谢药（14个）。米内网数据显示，2023年中国城市公立医院、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）终端抗肿瘤和免疫调节剂、全身用抗感染药物、消化系统及代谢药的销售额均超过1500亿元。在研仿制药方面，正大天晴还有13个品种上市申请在审，获批生产后将视同过评。其中，6个品种酒石酸阿福特罗雾化吸入溶液、盐酸帕洛诺司琼软胶囊、乌美溴铵维兰特罗吸入粉雾剂、注射用卡非佐米、奥贝胆酸片、注射用醋酸地加瑞克在国内暂无仿制药获批上市，正大天晴将与多家企业竞争国内首仿。第十一批集采拟于2025年上半年开展，正大天晴已有8个品种符合申报资格企业数达7家及以上，包括碘普罗胺注射液、沙库巴曲缬沙坦钠片、注射用头孢他啶阿维巴坦钠(4:1)、恩曲他滨丙酚替诺福韦片(Ⅱ)、艾曲泊帕乙醇胺片、注射用丁二磺酸腺苷蛋氨酸、索磷布韦片、注射用福沙匹坦双葡甲胺。8个品种中，沙库巴曲缬沙坦钠片2023年在中国公立医疗机构终端销售额超过30亿元、碘普罗胺注射液销售额超过16亿元，注射用头孢他啶阿维巴坦钠(4:1)销售额超过10亿元。正大天晴这3个品种分别在2023年、2024年、2025年获批上市，可借助集采中标迅速抢占市场。资料来源：米内网数据库、公司公告注：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。免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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

上市批准生物类似药临床3期

2025-03-27

·米内网

第十一批国采54个超“卷”品种备战！448亿市场倍特、齐鲁蓄力，13个超10亿大品种或承压

精彩内容近日，有消息称，第十一批国采在规则上或有变化。米内网数据显示，截至3月25日，已有100余个品种满足国采入围门槛，其中有54个符合申报资格企业数（以集团计）达10家及以上，448亿市场波澜欲起，倍特、华润、科伦、石四药、齐鲁等蓄势待发。符合申报资格企业数≥10家且暂未纳入国采的品种（详细表格见文末）注：部分药品因专利期、产品属性等可能不会被纳入集采，一切信息以官方为准！手工整理，如有疏漏，欢迎指正。来源：米内网综合数据库 13个超10亿大品种！448亿市场激战在即从销售额看，54个品种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）终端销售规模合计接近448亿元。超10亿大品种有13个，占比约24%；超过5亿元但低于10亿元的品种有14个，占比约26%；超过1亿元但不足5亿元的品种有20个，占比约37%；低于1亿元的品种有7个，占比约13%。 54个品种销售额分布情况从治疗领域看，54个品种涵盖11个治疗大类，集中在血液和造血系统药物、消化系统及代谢药、呼吸系统用药，分别有11个、10个、9个品种在列，占比均超过10%。米内网数据显示，上述3个治疗大类2023年在中国公立医疗机构终端的销售额分别超过1100亿元、1200亿元、460亿元。 54个品种治疗大类分布情况从剂型分布看，54个品种中有20个为口服常释剂型，占比约37%；注射剂、口服液体剂则分别有14个、12个，占比均超过20%。在2023年中国公立医疗机构化学药终端，注射剂、口服液体剂销售额分别超过4400亿元、230亿元。 54个品种剂型分布情况 “卷王”之战！7大品种达25家以上从竞争情况看，54个品种中，有7个品种符合申报资格企业数超过25家，4个品种在20-24家之间，14个品种在15-19家之间，29个品种在10-14家之间。 54个品种竞争情况乳果糖口服液体剂为最“卷”品种，目前符合申报资格企业数已达31家；此外，法莫替丁注射剂、二羟丙茶碱注射剂、氨溴特罗口服液体剂均达29家，氨溴索口服液体剂达28家，头孢唑肟注射剂达27家，乙酰半胱氨酸吸入剂达26家，地氯雷他定口服液体剂、达格列净口服常释剂型均达23家，米诺地尔外用液体剂达22家，沙库巴曲缬沙坦口服常释剂型达21家。乳果糖口服液体剂是一款渗透性泻药，为全国医保乙类、OTC甲类（双跨）品种，2023年在中国公立医疗机构终端的销售额超过17亿元，在治疗便秘的化药产品排名中稳居首位。从厂家格局看，雅培（原研）、韩美（已过评）、费森尤斯卡比依次位列前三，市场份额均超过10%。目前国内已有31家药企（以企业名称计）的乳果糖口服溶液获批生产并视同过评，此外还有30余家企业的产品以新注册分类报产在审，竞争激烈。近年来中国公立医疗机构终端乳果糖口服液体剂销售情况（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法莫替丁注射剂为组胺H2受体阻滞剂，用于治疗与胃酸分泌相关疾病，目前已有29家药企的法莫替丁注射液过评或视同过评。米内网数据显示，近年来中国公立医疗机构终端法莫替丁注射剂市场有所承压，2023年销售额超过27亿元。从厂家格局看，山西威奇达光明制药（已过评）、江西赣南海欣药业（未过评）、开封康诺药业（未过评）依次位列前三，市场份额均超过10%。近年来中国公立医疗机构终端法莫替丁注射剂销售情况（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 10个及以上！倍特、科伦、石四药蓄力从企业层面看，倍特药业、科伦药业、华润医药、福安药业、江苏万高药业、石家庄四药、齐鲁制药、山东京卫制药、新和成均有10个以上的品种在列。有10个以上品种在列的集团倍特药业有15个品种在列，包括6个口服常释剂型、4个口服液体剂、3个注射剂及2个吸入剂。有13个品种以新分类报产获批而视同过评，其中瑞巴派特片、盐酸去氧肾上腺素注射液、罗沙司他胶囊、富马酸福莫特罗吸入溶液、马来酸氟伏沙明片、达格列净片、盐酸丙卡特罗口服溶液、马来酸阿伐曲泊帕片为2024年新获批上市的品种。科伦药业有15个品种在列，包括7个注射剂、6个口服常释剂型、1个外用液体剂及1个软膏剂。有9个品种以新分类报产获批而视同过评，艾曲泊帕乙醇胺片、马来酸阿伐曲泊帕片为2024年新获批上市的品种，罗沙司他胶囊、米诺地尔搽剂、利丙双卡因乳膏、阿戈美拉汀片为2025年新获批上市的品种。符合申报资格企业数≥10家且暂未纳入国采的品种资料来源：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。数据统计截至3月25日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，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

专利到期带量采购

100 项与艾曲波帕乙醇胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	艾曲波帕乙醇胺	B02BX05	DB06210

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
肝素诱导血小板减少	澳大利亚	Novartis Pharmaceuticals Australia Pty Ltd.	2024-09-12
再生障碍性贫血	欧盟	Novartis Europharm Ltd.	2010-03-11
再生障碍性贫血	冰岛	Novartis Europharm Ltd.	2010-03-11
再生障碍性贫血	列支敦士登	Novartis Europharm Ltd.	2010-03-11
再生障碍性贫血	挪威	Novartis Europharm Ltd.	2010-03-11
免疫性血小板减少症	欧盟	Novartis Europharm Ltd.	2010-03-11
免疫性血小板减少症	冰岛	Novartis Europharm Ltd.	2010-03-11
免疫性血小板减少症	列支敦士登	Novartis Europharm Ltd.	2010-03-11
免疫性血小板减少症	挪威	Novartis Europharm Ltd.	2010-03-11
血小板减少症	美国	Novartis Pharmaceuticals Corp.	2008-11-20

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
实体瘤	临床3期	中国台湾	Novartis AG	2014-03-01
出血	临床3期	美国	GSK Plc	2012-03-01
出血	临床3期	阿根廷	GSK Plc	2012-03-01
出血	临床3期	捷克	GSK Plc	2012-03-01
出血	临床3期	德国	GSK Plc	2012-03-01
出血	临床3期	中国香港	GSK Plc	2012-03-01
出血	临床3期	以色列	GSK Plc	2012-03-01
出血	临床3期	意大利	GSK Plc	2012-03-01
出血	临床3期	波兰	GSK Plc	2012-03-01
出血	临床3期	俄罗斯	GSK Plc	2012-03-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASH2024 人工标引	临床2期	免疫性血小板减少症一线	23	Low-Dose Corticosteroids (LD-CIS) + Low-Dose Eltrombopag (LD-EPAG)	鑰觸築網網觸艱醖醖獵(鹹糧簾窪簾築範顧廠窪) = 鹽網艱顧糧齋構選鏇築餘構鏇積鏇構製繭淵鹹 (餘鏇廠積壓鏇淵構顧積 ) 更多	积极	2024-12-09
ASH2024	N/A	免疫性血小板减少症	-	Eltrombopag	築夢選網簾繭糧壓選淵(衊範網廠醖醖壓廠築構) = 選積網艱艱選網願積膚廠餘廠窪築膚積襯餘觸 (膚選築艱鬱鹹衊壓繭艱 ) 更多	-	2024-12-08
				Romiplostim	築夢選網簾繭糧壓選淵(衊範網廠醖醖壓廠築構) = 顧淵蓋廠範簾蓋醖廠積廠餘廠窪築膚積襯餘觸 (膚選築艱鬱鹹衊壓繭艱 ) 更多
RACE trial (ASH2024)	临床3期	再生障碍性贫血一线	-	Eltrombopag plus IST	艱壓顧獵積獵顧鏇觸艱(憲膚窪艱觸淵壓艱襯鹹) = 廠襯窪獵範蓋蓋齋夢簾構鹽鹽壓襯齋鏇顧願築 (簾齋醖窪膚顧糧糧窪糧 )	不佳	2024-12-08
				IST alone	艱壓顧獵積獵顧鏇觸艱(憲膚窪艱觸淵壓艱襯鹹) = 蓋餘廠遞製顧觸壓築積構鹽鹽壓襯齋鏇顧願築 (簾齋醖窪膚顧糧糧窪糧 )
ASH2024	N/A	免疫性血小板减少症	-	Eltrombopag	蓋壓艱膚壓顧艱鏇蓋顧(選築壓簾淵範鹹鑰膚艱) = 簾鏇窪醖廠蓋壓鑰襯製鹹繭壓蓋獵構窪夢繭選 (糧淵醖憲鹹襯鏇範憲廠 ) 更多	-	2024-12-08
				Romiplostim	蓋壓艱膚壓顧艱鏇蓋顧(選築壓簾淵範鹹鑰膚艱) = 觸衊獵製鏇鬱憲構淵獵鹹繭壓蓋獵構窪夢繭選 (糧淵醖憲鹹襯鏇範憲廠 ) 更多
SOHO2024	N/A	免疫性血小板减少症	-	Eltrombopag (twice-weekly dosing)	衊鹹構襯憲鬱遞築襯選(遞餘鹹餘鏇範鑰壓蓋艱) = mild transient hepatotoxicity 積衊觸獵網繭醖製製構 (鹽繭鬱窪獵製壓窪鏇構 )	-	2024-09-04
NCT04917679 (Pubmed \| Blood) 人工标引	临床2期	免疫性血小板减少症	102	Eltrombopag plus diacerein	蓋衊製憲壓製齋齋鏇糧(簾鏇廠獵壓獵醖繭積鑰) = 蓋築觸膚糧選齋鑰蓋築積淵膚製簾簾積衊餘選 (艱選獵窪鏇簾膚製夢醖 ) 更多	积极	2024-07-03
				Eltrombopag	蓋衊製憲壓製齋齋鏇糧(簾鏇廠獵壓獵醖繭積鑰) = 積憲醖獵繭糧膚夢壓壓積淵膚製簾簾積衊餘選 (艱選獵窪鏇簾膚製夢醖 ) 更多
NCT05466201 (EHA2024) 人工标引	临床2期	骨髓衰竭疾病	63	Eltrombopag	膚窪膚蓋積壓簾鹽鑰淵(遞鏇醖壓構廠構顧鹽壓) = 積製淵膚築築憲窪製蓋壓廠襯鏇襯夢網遞築壓 (衊夢鑰鬱齋壓蓋願窪壓 ) 更多	积极	2024-05-14
				Eltrombopag (Supportive Care)	膚窪膚蓋積壓簾鹽鑰淵(遞鏇醖壓構廠構顧鹽壓) = 簾鬱構遞製糧齋鬱齋簾壓廠襯鏇襯夢網遞築壓 (衊夢鑰鬱齋壓蓋願窪壓 ) 更多
EHA2024	N/A	难治性重度再生障碍性贫血	-	Eltrombopag	憲憲獵構網襯構築壓顧(醖襯積壓憲襯餘築簾齋) = 齋餘願鹽鹽襯遞製窪鏇艱膚憲顧餘選範襯蓋製 (壓鏇餘窪衊鑰鹹衊顧顧 ) 更多	-	2024-05-14
				Avatrombopag	憲憲獵構網襯構築壓顧(醖襯積壓憲襯餘築簾齋) = 餘選選鹹製廠廠範觸鑰艱膚憲顧餘選範襯蓋製 (壓鏇餘窪衊鑰鹹衊顧顧 ) 更多
CECGA (EHA2024)	N/A	再生障碍性贫血	62	Hetrombopag (HETROM) + Cyclosporin A (CsA)	獵夢鑰觸選艱壓襯築製(選築壓襯顧簾積簾醖窪) = 憲構鏇遞顧廠鹽夢憲襯築鹽顧淵夢選膚衊顧網 (夢淵範齋憲醖鹽憲糧夢 ) 更多	积极	2024-05-14
				Eltrombopag (EPAG) + Cyclosporin A (CsA)	壓膚鹽餘鏇淵鑰醖鏇糧(醖膚網願願淵蓋觸糧鹽) = 構獵網淵築醖積齋繭選願衊構窪襯選艱構膚鑰 (鬱襯構窪網淵築範獵淵 ) 更多
EHA2024	N/A	血小板减少症	21	Eltrombopag 50 mg/day	鏇廠齋膚窪鏇憲鹽鹹齋(齋廠鏇鏇遞遞繭淵齋範) = 鏇顧齋鬱窪範醖構膚願製憲鑰繭鹽構齋築網餘 (選夢艱艱窪廠壓廠鹹範 )	积极	2024-05-14