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藥品工藝核查進一步利好龍頭

藥監局近日發佈《關於開展藥品生產工藝核對工作的公告》(徵求意見稿),規定對於已上市所有藥品進行工藝自查,限2016年10月1日前完成。自2016年11月1日起,國家局將啟動對藥品生產企業的飛行檢查。

可以預計的是,本次自查及飛檢將令生產工藝不過關的產品停產,同時有助於清理部分未銷售的僵屍批文。細分行業方面,我們認為中藥注射劑受影響較大,很多產品可能由於涉及工藝更改較多,將會面臨更大量的研究驗證工作。實際上,本次工藝核查將是藥監局繼臨床核查、藥品一致性評價之後的又一重磅改革措施,這將進一步利好規範生產的大型行業龍頭,部分不能完成工藝更改驗證研究的品種則面臨退市。個股方面,我們認為系列政策利好麗珠醫藥(1513 HK)、東陽光藥(1558 HK)、複星醫藥(2196 HK)等龍頭企業。

撰稿: 笵國和研究分析員
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