Core Viewpoint - Kelong Pharmaceutical's subsidiary Sichuan Kelong Botai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its antibody-drug conjugate (ADC) A166 (also known as Trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] Group 1 - The approved drug targets the human epidermal growth factor receptor 2 (HER2) [1] - The indication is specifically for adult patients with a history of treatment with one or more anti-HER2 agents [1] - This approval represents a significant advancement in the treatment options available for HER2-positive breast cancer patients [1]

科伦博泰已启动博度曲妥珠单抗用于治疗既往接受过有效载荷为拓扑异构酶抑制剂 ADC 治疗的 HER2+不可切除或转移性 BC 的开放、多中心2期临床研究。 博度曲妥珠单抗是一款用于治疗晚期 HER2+实体瘤的差异化HER2 ADC。作为一款由科伦博泰开发的 创新 HER2 ADC，其通过稳定的酶可裂解连接子将新型单甲基奥瑞他汀 F(MMAF)衍生物（高细胞毒性 微管蛋白抑制剂Duo-5）与HER2 单克隆抗体偶联，药物抗体比(DAR)为 2。博度曲妥珠单抗特异性地结 合肿瘤细胞表面的 HER2，并被肿瘤细胞内吞，在胞内释放毒素分子Duo-5。Duo-5诱导肿瘤细胞周期阻 滞在 G2/M 期，引起肿瘤细胞凋亡。博度曲妥珠单抗靶向结合 HER2 后也可抑制 HER2 介导的信号通 路；其具有抗体依赖细胞介导细胞毒作用(ADCC)活性。 格隆汇10月17日丨科伦药业(002422.SZ)公布，公司控股子公司科伦博泰靶向人类表皮生长因子受体 2(HER2)的抗体偶联药(ADC)博度曲妥珠单抗(亦称A166)获国家药监局(NMPA)批准用于既往接受过一种 或一种以上抗HER2 药物治疗的不可切除或转移性 HER2 阳性成 ...

博度曲妥珠单抗是一款用于治疗晚期 HER2+实体瘤的差异化HER2 ADC。作为一款由科伦博泰开发的 创新 HER2 ADC，其通过稳定的酶可裂解连接子将新型单甲基奥瑞他汀 F(MMAF)衍生物（高细胞毒性 微管蛋白抑制剂Duo-5）与HER2 单克隆抗体偶联，药物抗体比(DAR)为 2。博度曲妥珠单抗特异性地结 合肿瘤细胞表面的 HER2，并被肿瘤细胞内吞，在胞内释放毒素分子Duo-5。Duo-5诱导肿瘤细胞周期阻 滞在 G2/M 期，引起肿瘤细胞凋亡。博度曲妥珠单抗靶向结合 HER2 后也可抑制 HER2 介导的信号通 路；其具有抗体依赖细胞介导细胞毒作用(ADCC)活性。 格隆汇10月17日丨科伦药业(002422.SZ)公布，公司控股子公司科伦博泰靶向人类表皮生长因子受体 2(HER2)的抗体偶联药(ADC)博度曲妥珠单抗(亦称A166)获国家药监局(NMPA)批准用于既往接受过一种 或一种以上抗HER2 药物治疗的不可切除或转移性 HER2 阳性成人乳腺癌(BC)患者。 科伦博泰已启动博度曲妥珠单抗用于治疗既往接受过有效载荷为拓扑异构酶抑制剂 ADC 治疗的 HER2+不可切除或转移性 BC 的开放 ...

Core Viewpoint - Kelong Pharmaceutical's subsidiary, Kelong Botai, received approval for its HER2-targeted antibody-drug conjugate, Boduocutuzumab (舒泰莱®), for treating adult patients with HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [2] Group 1 - The drug Boduocutuzumab has shown significant statistical and clinical improvement in progression-free survival (PFS) compared to T-DM1 in a pre-specified interim analysis [2] - There is a trend observed in the overall survival (OS) benefit for Boduocutuzumab [2] - Kelong Botai has initiated a Phase II open-label, multicenter clinical study for Boduocutuzumab in patients with HER2-positive, unresectable, or metastatic breast cancer who have previously received effective payloads of topoisomerase inhibitor ADC therapy [2]

Core Viewpoint - The company, Kelun Pharmaceutical, announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) A166 (also known as Trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 therapies [1] Group 1 - The ADC A166 targets the human epidermal growth factor receptor 2 (HER2) [1] - The approval is specifically for patients with unresectable or metastatic HER2-positive breast cancer [1] - The indication is for those who have previously undergone treatment with one or more anti-HER2 drugs [1]

Core Viewpoint - The approval of the antibody-drug conjugate (ADC) by the National Medical Products Administration (NMPA) for treating HER2-positive breast cancer represents a significant advancement in targeted therapy for patients who have previously received one or more anti-HER2 treatments [1] Group 1: Company Developments - Kolun Pharmaceutical's subsidiary, Kolun Botai, received NMPA approval for the ADC, Bodu Trastuzumab, aimed at treating unresectable or metastatic HER2-positive adult breast cancer patients [1] - The approval is based on the results of a multicenter, randomized, open-label, controlled Phase III study (KL166-III-06), which demonstrated significant statistical and clinical improvement in progression-free survival (PFS) compared to T-DM1 [1] Group 2: Industry Implications - The approval of Bodu Trastuzumab highlights the growing importance of targeted therapies in oncology, particularly for patients with specific genetic markers such as HER2 [1] - This development may enhance competition in the market for HER2-targeted therapies, potentially impacting pricing and accessibility for patients [1]

证券代码：002422 证券简称：科伦药业 公告编号：2025-076 四川科伦药业股份有限公司 关于子公司核心产品博度曲妥珠单抗治疗 2L+ HER2+乳腺癌 获国家药品监督管理局批准上市的公告 新型单甲基奥瑞他汀 F(MMAF)衍生物（高细胞毒性微管蛋白抑制剂 Duo-5）与 HER2 单克隆抗体偶联，药物抗体比(DAR)为 2。博度曲妥珠单抗特异性地结合 肿瘤细胞表面的 HER2，并被肿瘤细胞内吞，在胞内释放毒素分子 Duo-5。Duo-5 诱导肿瘤细胞周期阻滞在 G2/M 期，引起肿瘤细胞凋亡。博度曲妥珠单抗靶向结 合 HER2 后也可抑制 HER2 介导的信号通路；其具有抗体依赖细胞介导细胞毒作 用(ADCC)活性。 三、风险提示 创新药物商业化具有一定的不确定性，敬请广大投资者谨慎决策，注意防范 投资风险。公司将根据后续进展情况及时履行信息披露义务。 特此公告。 四川科伦药业股份有限公司董事会 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误 导性陈述或重大遗漏。 四川科伦药业股份有限公司（以下简称"公司"）近日获悉，公司控股子公 司四川科伦博泰生物医药股份有限公司（以下 ...

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]

Core Insights - The article discusses the recent financial performance of a leading technology company, highlighting a significant increase in revenue and net income compared to the previous year [1] Financial Performance - The company reported a revenue of $50 billion, representing a 20% increase year-over-year [1] - Net income reached $10 billion, which is a 25% increase compared to the same period last year [1] - Earnings per share (EPS) rose to $5, up from $4 in the previous year, indicating strong profitability growth [1] Market Position - The company has strengthened its market position, capturing an additional 5% market share in the last quarter [1] - The growth is attributed to increased demand for its cloud services and innovative product offerings [1] Future Outlook - Analysts project continued growth, with expected revenue growth of 15% for the next fiscal year [1] - The company plans to invest $2 billion in research and development to enhance its product lineup and maintain competitive advantage [1]

Core Insights - Rotigotine patch is the world's first transdermal patch for treating Parkinson's disease, approved in the EU in 2006 and imported to China in 2018 for monotherapy or in combination with levodopa [2] - The global sales forecast for the Rotigotine patch is $330 million in 2024, indicating significant market potential [2] - The approval of the Rotigotine patch as the first domestic generic version enhances the company's competitive position in the central nervous system (CNS) product pipeline [2]