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和黃醫藥(00013.HK):美國FDA已受理索凡替尼用於治療晚期神經內分泌瘤的新藥上市申請
阿思達克 07-02 13:21
和黃醫藥(00013.HK)宣佈,美國食品藥品監督管理局(FDA)已受理索凡替尼用於治療胰腺和胰腺外(非胰腺)神經內分泌瘤(NET)的新藥上市申請。FDA就該新藥上市申請擬定的處方藥用戶付費法案(PDUFA)目標審評日期爲2022年4月30日。

索凡替尼於2020年4月獲授予快速通道資格,用於治療胰腺和非胰腺神經內分泌瘤,並於2019年11月獲授予「孤兒藥」資格,用於治療胰腺神經內分泌瘤。

和黃醫藥(國際)董事總經理兼首席醫學官Marek Kania表示:此次索凡替尼在美國的新藥上市申請獲受理,是和黃醫藥的一項重大成就。公司正不斷擴展全球業務版圖,致力將創新腫瘤藥物帶給全球癌症患者。FDA這次受理索凡替尼的新藥上市申請突顯該申請的臨牀價值,以及爲美國神經內分泌瘤患者提供更多治療方案的重要性。

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