10月17日，据国家药品监督管理局（NMPA）官网最新公示，科伦药业旗下科伦博泰申报的1类新药注射用博度曲妥珠单抗在国内获批上市；与此同时，科 伦药业按化药注册分类4类申报的罗替高汀贴片也获批上市，且视同通过一致性评价，一举拿下国内首仿。 | 截图 | | --- | 来源：NMPA 注射用博度曲妥珠单抗是科伦博泰自主研发的HER2 ADC单抗，适用于既往接受过一种及以上抗HER2药物治疗的不可切除或转移性HER2阳性成人乳腺癌患 者。该药于2017年首次在国内申报临床，2018年启动首个临床试验。2023年5月，科伦博泰提交的首个上市申请（针对既往经二线及以上抗HER2治疗失败的 HER2阳性不可切除局部晚期、复发或转移性乳腺癌）获CDE受理，目前仍在审评中；本次获批适应症为该药第二项上市申请，于2025年1月获CDE受理。 截图来源：摩熵医药全球药物研发数据库 | 截图来源：摩熵医药中国药品审评数据库 | | --- | 目前，全球已获批的5款原研HER2 ADC均在国内获批。ADC药物是科伦药业重点布局方向，据摩熵医药数据库显示，旗下已有芦康沙妥珠单抗、博度曲妥 珠单抗2款新药获批上市。此外，科伦药业（ ...

（文章来源：证券日报） 证券日报网讯 10月17日晚间，科伦药业发布公告称，公司的化学药品"罗替高汀贴片"于近日获得国家 药品监督管理局的药品注册批准。 ...

Core Viewpoint - Kolun Pharmaceutical has received drug registration approval from the National Medical Products Administration for its chemical drug "Rotigotine Patch," which is used for the treatment of early idiopathic Parkinson's disease symptoms and signs [1] Group 1 - The "Rotigotine Patch" was developed by UCB Pharma and was first approved in the European Union in 2006 [1] - The drug was imported into China in 2018, indicating its established presence in the market prior to this approval [1] - The approval marks a significant milestone for Kolun Pharmaceutical, enhancing its product portfolio in the neurology sector [1]

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罗替高汀贴片是全球首个治疗帕金森病的透皮贴剂，2006年欧盟首获批，2018年中国批准进口，用于早 期特发性帕金森病症状及体征的单药治疗，或与左旋多巴联合用于病程中的各个阶段。该品种2024年全 球销售3.3亿美元。公司在中枢神经领域已有多个产品获批上市，本次罗替高汀贴片是国内首仿获批， 将进一步提升公司在中枢神经领域的管线竞争力。 （文章来源：新华财经） ...

Core Viewpoint - Kolun Pharmaceutical has received approval from the National Medical Products Administration for its chemical drug "Rotigotine Transdermal Patch," marking it as the world's first transdermal patch for treating Parkinson's disease [1] Group 1: Product Approval - The "Rotigotine Transdermal Patch" is approved for the treatment of early idiopathic Parkinson's disease symptoms and can be used alone or in combination with Levodopa at various stages of the disease [1] - This product is the first domestic generic version approved, enhancing the company's competitiveness in the central nervous system field [1] Group 2: Market Potential - The patch is widely recommended in domestic and international guidelines and expert consensus [1] - Projected global sales for the "Rotigotine Transdermal Patch" are estimated at $330 million in 2024 [1]

Core Viewpoint - Kelun Pharmaceutical has received approval from the National Medical Products Administration for its transdermal patch "Rotigotine Patch," which is the world's first transdermal patch for treating Parkinson's disease, particularly for early-onset patients [1] Company Summary - The Rotigotine Patch is recognized as one of the first-line medications for early-stage Parkinson's disease [1] - Compared to oral medications, the transdermal patch reduces gastrointestinal adverse reactions, avoids fluctuations in blood drug concentration, and minimizes motor symptom variability, thereby enhancing patient safety and compliance [1]

智通财经APP讯，科伦药业(002422.SZ)公告，公司化学药品"罗替高汀贴片"于近日获得国家药品监督管 理局的药品注册批准。罗替高汀贴片是由UCB Pharma研发，2006年欧盟首获批，2018年中国批准进 口，用于早期特发性帕金森病症状及体征的单药治疗，或与左旋多巴联合用于病程中的各个阶段。 ...

科伦药业公告，公司的化学药品"罗替高汀贴片"于近日获得国家药品监督管理局的药品注册批准。罗替 高汀贴片是全球首个治疗帕金森病的透皮贴剂，2006年欧盟首获批，2018年中国批准进口，用于早期特 发性帕金森病症状及体征的单药治疗，或与左旋多巴联合用于病程中的各个阶段。该品种2024年全球销 售3.3亿美元。公司在中枢神经领域已有多个产品获批上市，本次罗替高汀贴片是国内首仿获批，将进 一步提升公司在中枢神经领域的管线竞争力。 ...