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羅欣藥業(002793.SZ):取得替戈拉生片1類新藥上市申請受理通知書
格隆匯 01-04 15:16

格隆匯 1 月 4日丨羅欣藥業(002793.SZ)公佈,近日公司下屬子公司山東羅欣藥業集團股份有限公司(山東羅欣)收到國家藥品監督管理局發的替戈拉生1類新藥上市申請受理通知書

替戈拉生片是鉀離子競爭性酸阻滯劑類藥物(Potassium-Competitive Acid BlockersP-CAB),抑制酸分泌的作用機制為競爭性結合壁細胞內H+/K+-ATP酶(質子泵)的鉀離子結合部位。與質子泵抑制劑(PPI)不同,P-CAB可直接抑H+/K+-ATP酶,而無需在強酸環境下活化。而且,無論H+/K+-ATP酶活化與否,P-CAB與之結合。

201510月,山東羅欣與韓國CJ HealthCare Corporation (“CJHC”)達成協議,獲得替戈拉生中國境內開發、生產及商業化權益。

201612山東羅欣按照化學藥品1註冊分類向原國家食品藥品監督管理總局遞交了替戈拉生新藥臨牀試驗申請,20176月獲得臨牀試驗批件。目前,替戈拉生片上市申請獲得受理

公司在消化領域一直具備較強的市場競爭力,此次替戈拉生1類新藥上市申請獲得受理,體現了公司該領域的技術優勢加快豐富產品管線和拓展業務的能力,彰顯了公司科技創新能力,豐富產品儲備,提升公司核心競爭力,符合公司戰略發展需要。

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