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廣生堂(300436.SZ)抗乙肝病毒藥物拉米夫定片通過一致性評價
格隆匯 06-07 16:24

格隆匯6月7日丨廣生堂(300436.SZ)發佈公告,近日,公司收到國家藥品監督管理局核准簽發的關於拉米夫定片的《藥品補充申請批件》,公司拉米夫定片(賀甘定)通過仿製藥質量與療效一致性評價。

至此,公司四大抗乙肝病毒藥物富馬酸替諾福韋二吡呋酯膠囊(福甘定)、恩替卡韋膠囊(恩甘定)、拉米夫定片(賀甘定)和阿德福韋酯片(阿甘定)已全線通過仿製藥質量與療效一致性評價,有力增強了公司市場銷售的競爭優勢。

據悉,拉米夫定是核苷類似物,對病毒DNA鏈的合成和延長有競爭性抑制作用,適應症治療伴有丙氨酸氨基轉移酶持續(ALT)升高和病毒活動複製的、肝功能代償的成人慢性乙型肝炎,是《國家基本醫療保險、工傷保險和生育保險藥品目錄》中臨牀使用經驗豐富的抗乙肝病毒藥物。

公司拉米夫定(賀甘定)是唯一入選國家“重大新藥創制”科技重大專項“十二五”實施計劃的國產拉米夫定品種。根據國家相關政策,通過一致性評價的藥品品種在醫保支付及醫療機構採購等領域將獲得更大的支持力度。因此,公司拉米夫定片通過仿製藥一致性評價,有利於擴大該藥品的市場份額,提升市場競爭力。

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