恩華藥業(002262.SZ):加巴噴丁膠囊通過一致性評價
格隆匯5月20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“加巴噴丁膠囊”的《藥品補充申請批件》,公司加巴噴丁膠囊通過仿製藥質量和療效一致性評價。
加巴噴丁膠囊適應症:1、皰疹感染後神經痛:用於成人皰疹後神經痛的治療。2、癲癇:用於成人和12歲以上兒童伴或不伴繼發性全身發作的部分性發作的輔助治療。也可用於3~12歲兒童的部分性發作的輔助治療。
截至目前,公司在加巴噴丁膠囊一致性評價項目上已投入研發費用約792萬元人民幣。
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。因此公司加巴噴丁膠囊通過一致性評價,有利於擴大產品的市場銷售,提高市場競爭力,對公司未來的經營業績產生積極的影響。
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