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羅欣藥業(002793.SZ):子公司泮托拉唑鈉腸溶片通過一致性評價
格隆匯 12-24 17:26

格隆匯12月24日丨羅欣藥業(002793.SZ)公佈,公司下屬子公司山東羅欣藥業集團股份有限公司(簡稱“山東羅欣”)於近日收到國家藥監局核准簽發的泮托拉唑鈉腸溶片《藥品補充申請批准通知書》。經審查,該藥品通過仿製藥質量和療效一致性評價。

泮托拉唑為質子泵抑制劑(PPI),通過與胃壁細胞的H+-K+ATP酶系統的兩個位點共價結合而抑制胃酸產生的最後步驟,該作用呈劑量依賴性並使基礎和刺激狀態下的胃酸分泌均受抑制。本品與H+-K+ATP酶的結合可導致其抗胃酸分泌作用持續24小時以上。泮托拉唑鈉腸溶片適用於十二指腸潰瘍、胃潰瘍以及中、重度反流性食管炎的治療,其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)配伍能夠根除幽門螺桿菌感染,以減少該微生物感染所致的十二指腸潰瘍與胃潰瘍的復發。

泮托拉唑鈉腸溶片最早由德國Byk Gulden公司研發,並於1994年首次在德國上市,商品名為潘妥洛克(Pantoloc)。1997年在中國批准上市,2000年在美國批准上市。山東羅欣於2007年首次獲得泮托拉唑鈉腸溶片(規格為40mg)的藥品註冊批件,批准文號為:國藥準字H20074147。山東羅欣本次提交的質量與療效一致性評價申請於日前獲得《藥品補充申請批准通知書》。

根據IQVIA數據,泮托拉唑鈉腸溶片2020年度全球市場規模為22.0億美元(以出廠價計算);根據IQVIA、IMS及米內網數據,泮托拉唑鈉腸溶片2020年度在我國境內銷售金額為33.3億人民幣(以招標價計算)。

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