羅欣藥業(002793.SZ):注射用LX22001新增適應症獲準開展臨牀試驗
格隆匯3月11日丨羅欣藥業(002793.SZ)公佈,近日,羅欣藥業集團股份有限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新增適應症“預防重症患者應激性潰瘍出血”《藥物臨牀試驗批準通知書》。
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爲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均可與之結合。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)可作爲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;(3)預防重症患者應激性潰瘍出血。2024年6月,公司首次獲得注射用LX22001臨牀試驗批準通知書。
公司1類新藥替戈拉生片是中國首款自研的鉀離子競爭性酸阻滯劑(PCAB),其“反流性食管炎”適應症於2022年4月獲批上市,緊接着在2023年11月、2024年10月新適應症“十二指腸潰瘍”、“與適當的抗生素聯用以根除幽門螺桿菌”分別獲批上市。
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