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羅欣藥業(002793.SZ):注射用LX22001獲准開展臨牀試驗
格隆匯 06-30 16:39

格隆匯6月30日丨羅欣藥業(002793.SZ)公吿,近日,羅欣藥業集團股份有限公司(以下簡稱“公司”)下屬子公司山東羅欣藥業集團股份有限公司、羅欣藥業(上海)有限公司收到國家藥品監督管理局下發的注射用LX22001的《藥物臨牀試驗批准通知書》。

注射用LX22001是鉀離子競爭性酸阻滯劑類藥物(Potassium-Competitive Acid Blockers,P-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均可與結合。注射用LX22001是在已知活性成份替戈拉生基礎上的改良型新藥,臨牀擬用於(1)可作為當口服療法不適用時,用於下列病症的替代療法:反流性食管炎、十二指腸潰瘍;(2)消化性潰瘍出血。

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