君實生物(01877.HK)癌症新藥上市申請獲受理
君實生物(01877.HK)公布,與上海瑛派藥業共同投資的上海君派英實藥業,收到國家藥品監督管理局核准簽發的《受理通知書》,有關聚腺(甘)二磷酸核糖聚合(酉每)抑制劑senaparib的新藥上市申請已獲得受理。
該新藥用於國際婦產科聯盟3至4期上皮性卵巢癌、輸卵管癌或原發性腹膜癌患者,對一線含鉑化療達到完全或部分緩解後的維持治療。
由於藥品研發周期長,審批環節多,容易受到不確定因素影響,相關新藥上市申請能否獲批,存在不確定性。
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