九典制藥(300705.SZ):泮托拉唑鈉腸溶片通過一致性評價
格隆匯 7 月 31日丨九典制藥(300705.SZ)公佈,公司於近日收到國家藥品監督管理局核准下發的《藥品補充申請批准通知書》,公司產品“泮托拉唑鈉腸溶片”通過仿製藥質量與療效一致性評價(“一致性評價”)。
藥品名稱:泮托拉唑鈉腸溶片;劑型:片劑;規格:40mg(以C16H15F2N3O4S計);註冊分類:化學藥品;原藥品批准文號:國藥準字H20093501;通知書編號:2020B04182;申請內容:一致性評價申請。審評結論:經審查,本品通過仿製藥質量和療效一致性評價。
泮托拉唑鈉腸溶片是第三代新型質子泵抑制劑,主要用來治療十二指腸潰瘍、胃潰瘍、中、重度反流性食管炎等,與克拉黴素和阿莫西林,或克拉黴素和甲硝唑,或阿莫西林和甲硝唑合用能夠根除幽門螺桿菌感染。
泮托拉唑鈉腸溶片為德國百克頓公司(BydGulden)首先研製並於1994年首次在德國上市,商品名為潘妥洛克(Pantoloc®)。我國已於1998年仿製成功,並相繼批准了泮托拉唑鈉原料藥、腸溶片、腸溶膠囊劑、注射劑等劑型上市。米內網終端數據顯示:相應零售和醫療終端市場2019年泮托拉唑口服制劑銷售額約為25億元。根據中國醫藥工業信息中心PDB藥物綜合數據庫的數據,2019年公司在我國22個地區重點城市醫院統計樣本中泮托拉唑鈉腸溶片的市場佔有率較小,具有較大的上升空間。
截至公告日,公司為國內2家通過泮托拉唑鈉腸溶片一致性評價的企業之一。
根據國家相關政策,通過一致性評價的藥品品種,質量和療效等同原研產品,在醫保支付方面將予以適當支持,醫療機構應優先採購併在臨牀中優先選用,因此泮托拉唑鈉腸溶片通過一致性評價,有利於提升該藥品的市場競爭力,同時為公司後續一致性評價產品研究甚至仿製藥開發積累了寶貴經驗。
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