CDK4/6 抑制剂

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化学制药创新药动态更新:BGB-43395:在既往三线治疗的乳腺癌及实体瘤患者具初步疗效和良好安全性
Shanxi Securities· 2025-06-30 04:28
Investment Rating - The report maintains an investment rating of "Leading the Market-B" for the chemical pharmaceutical industry [1]. Core Viewpoints - The report highlights the promising clinical efficacy and safety profile of BGB-43395, a CDK4 inhibitor developed by BeiGene, which shows potential as a best-in-class treatment for HR+/HER2- metastatic breast cancer [3][5]. - The global market for CDK4/6 inhibitors is substantial, projected to reach approximately $13 billion by 2024, indicating significant growth potential in this therapeutic area [5]. Summary by Sections Industry Performance - The chemical pharmaceutical industry has shown strong market performance over the past year, with a focus on innovative drug developments [1]. Drug Development Insights - BGB-43395 demonstrates high selectivity and inhibition of CDK4, with a favorable safety profile compared to existing CDK4/6 inhibitors [3][4]. - The drug is set to enter Phase III trials for HR+/HER2- metastatic breast cancer, with the second-line study expected to start in Q4 2025 [3]. Clinical Trial Results - Initial results from clinical trials indicate that BGB-43395, when combined with fulvestrant, shows preliminary anti-tumor activity in patients with solid tumors, particularly breast cancer [5][6]. - The overall response rate (ORR) for evaluable breast cancer patients was reported at 11% [5]. Market Context - The report emphasizes the challenges faced by current CDK4/6 inhibitors, including hematological toxicity and off-target effects, which BGB-43395 aims to address [5].
恒瑞医药(600276) - 恒瑞医药关于药品临床试验进展的公告
2025-02-23 07:45
证券代码:600276 证券简称:恒瑞医药 公告编号:临 2025-016 江苏恒瑞医药股份有限公司 关于药品临床试验进展的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 近日,江苏恒瑞医药股份有限公司(以下简称"公司")自主研发的羟乙磺 酸达尔西利片联合内分泌治疗在激素受体(HR)阳性、人表皮生长因子受体 2 (HER2)阴性女性乳腺癌辅助治疗中的一项多中心、随机、双盲的Ⅲ期临床试验 (研究方案编号:SHR6390-Ⅲ-303),首次期中分析主要终点达到统计学显著性。 研究结果显示,达尔西利联合内分泌治疗,较安慰剂联合内分泌治疗,可显著降 低患者复发风险,提高患者无侵袭性疾病生存期(IDFS)[1]。公司已于近期向国 家药品监督管理局药品审评中心递交上市前沟通交流申请。 一、 药品的基本情况 药品名称:羟乙磺酸达尔西利片 剂型:片剂 二、 药品的临床试验情况 达尔西利已于国内获批两项适应症,即本品适用于激素受体(HR)阳性、人 表皮生长因子受体 2(HER2)阴性局部晚期或转移性乳腺癌患者:1.与芳香化酶 抑制剂联合使 ...