新華製藥(00719.HK)成為國內第三家通過卡託普利片(25mg)仿製藥一致性評價企業
格隆匯11月21日丨新華製藥(00719.HK)公告,於近日收到國家藥品監督管理局核准簽發的卡託普利片(25mg)(“該產品”)的《藥品補充申請批件》,該產品通過仿製藥質量和療效一致性評價(“仿製藥一致性評價”)。公司成為國內第三家通過卡託普利片(25mg)仿製藥一致性評價的企業。
本次一致性評價的參比製劑為原研百時美施貴寶公司生產的卡託普利片(CAPOTENTM),該藥品1981年獲美國FDA批准上市。該產品屬於甲類醫保藥。目前,於中國境內已上市的該產品企業包括中美上海施貴寶製藥、新華製藥、上海旭東海普藥業、山東羅欣藥業等。
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。通過一致性評價後,將會享受國家“4+7”帶量採購帶來的紅利。新華製藥的卡託普利片(25mg)通過仿製藥一致性評價,有利於提升該產品的市場競爭力,同時為後續仿製藥一致性評價產品的研發工作積累了寶貴的經驗。
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