9月11日，药捷安康-B盘中强势拉升，现涨近18%，股价再刷上市以来新高。
药捷安康-B公布，公司核心产品替恩戈替尼(Tinengotinib, TT-00420)联合氟维司群治疗经治失败的激素受体阳性(HR+)且人表皮生长因子受体2阴性或低表达(HER2-)的复发或转移性乳腺癌II期临床试验，已于2025年9月 10日获得了中国国家药品监督管理局的临床默示许可。
本试验为在中国开展的一项评价替恩戈替尼片联合氟维司群注射液用于经治失败的HR+/HER2-的复发或转移性乳腺癌患者的安全性、疗效及药代动力学的开放标签、多中心、II期临床研究。
替恩戈替尼早期临床研究结果表明，替恩戈替尼单药在经歷过多种治疗(例如内分泌治疗、CDK4/6抑制剂治疗和化疗)的HR+╱HER2-乳腺癌患者中，有令人鼓舞的临床效果。临床前实验结果表明，替恩戈替尼与氟维司群的联合用药针对内分泌治疗耐药的乳腺癌细胞具有药理学协同作用。因此替恩戈替尼联合氟维司群的临床治疗策略将可能为此类乳腺癌患者的治疗带来新的突破。
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