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羅欣藥業(002793.SZ):替戈拉生片獲准開展新適應症臨牀試驗
格隆匯 06-25 19:12

格隆匯6月25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LXI-15028(替戈拉生)新適應症藥物臨牀試驗補充申請批准通知

審評結論同意開展十二指腸潰瘍適應症III期臨牀試驗,同意免除十二指腸潰瘍適應症II期臨牀試驗。

替戈拉生是鉀離子競爭性酸阻滯劑類藥物(Potassium-Competitive Acid BlockersP-CAB),其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。與傳統抑酸藥物質子泵抑制劑(PPI)不同,P-CAB可直接抑制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均可與之結合。

替戈拉生片具有開發胃食管反流、消化性潰瘍等酸相關疾病適應症的潛力具有起效快、作用時間長、酸性條件下穩定、可同時抑制激活和靜息狀態質子泵等特點。

替戈拉生片在韓國2019年正式上市,目前僅在韓國上市銷售根據IQVIA數據,替戈拉生片2020年度在全球的銷售金額為0.5億美元(以出廠價計算),在我國境內暫無產品上市

公司在消化領域一直具備較強的市場競爭力,201510月,山東羅欣與HK inno.N Corporation達成協議,獲得替戈拉生片在中國境內獨家開發、生產及商業化權益目前適應症糜爛性食管炎替戈拉生片1類新藥上市申請獲得受理獲准開展臨牀試驗替戈拉生適應症十二指腸潰瘍

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