【华东医药:独家市场推广产品塞纳帕利胶囊获批上市】华东医药公告,公司全资子公司杭州中美华东制药有限公司独家市场推广产品塞纳帕利胶囊(商品名:派舒宁 ,研发代号:IMP4297)获得国家药品监督管理局批准上市,用于晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在一线含铂化疗达到完全缓解或部分缓解后的维持治疗。塞纳帕利胶囊的获批是基于FLAMES研究,该研究结果显示,塞纳帕利维持治疗能够显著延长晚期卵巢癌患者的无进展生存期(PFS),且不论患者的BRCA基因表达如何,均能从塞纳帕利治疗中获益。同时,塞纳帕利耐受性良好,安全性可控。

金融界
20 Jan
华东医药公告,公司全资子公司杭州中美华东制药有限公司独家市场推广产品塞纳帕利胶囊(商品名:派舒宁 ,研发代号:IMP4297)获得国家药品监督管理局批准上市,用于晚期上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者在一线含铂化疗达到完全缓解或部分缓解后的维持治疗。塞纳帕利胶囊的获批是基于FLAMES研究,该研究结果显示,塞纳帕利维持治疗能够显著延长晚期卵巢癌患者的无进展生存期(PFS),且不论患者的BRCA基因表达如何,均能从塞纳帕利治疗中获益。同时,塞纳帕利耐受性良好,安全性可控。

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