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港股異動 | 和黃醫藥(0013.HK)低開逾14% 公司新藥上市申請被否
格隆匯 05-03 09:22
格隆匯5月3日丨和黃醫藥(0013.HK)低開14.6%,報21.95港元,總市值189.8億港元。公司昨日公吿稱,美國FDA已就索凡替尼用於治療胰腺和非胰腺神經內分泌瘤的新藥上市申請發出完整回覆函。FDA認為當前基於兩項成功的中國III期研究以及一項美國橋接研究的數據包尚不足以支持藥品現時於美國獲批。

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