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恩華藥業(002262.SZ):阿立哌唑片通過一致性評價
格隆匯 03-18 16:00

格隆匯 3 月 18日丨恩華藥業(002262.SZ)公佈,公司於近日收到國家藥監局核准簽發的關於“阿立哌唑片”的《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價(“一致性評價”)。

阿立哌唑片適應症:用於治療精神分裂症。在精神分裂症患者的短期(4周和6周)對照試驗中確立了阿立哌唑治療精神分裂症的療效。選擇阿立哌唑用於長期治療的醫生應定期重新評估該藥對個別患者的長期療效。

截至目前,公司在阿立哌唑片一致性評價項目上已投入研發費用約1111萬元人民幣。

根據國家相關政策規定,對於通過仿製藥一致性評價的藥品品種,在醫保支付方面予以適當支持,醫療機構應優先採購併在臨牀中優先選用。同品種藥品通過仿製藥一致性評價的生產企業達到3家以上的,在藥品集中採購等方面不再選用未通過仿製藥一致性評價的品種。因此,公司阿立哌唑片通過一致性評價,有利提升該藥品的市場競爭力,同時為公司後續產品開展仿製藥一致性評價工作積累了寶貴的經驗。

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