四環醫藥(00460.HK):軒竹生物自主研發創新藥品安奈拉唑鈉腸溶片獲國家藥監局批准上市
格隆匯6月26日丨四環醫藥(00460.HK)公佈,集團旗下非全資附屬公司軒竹生物科技股份有限公司自主研發的質子泵抑制劑(PPI)安奈拉唑鈉腸溶片獲中國國家藥品監督管理局頒發的藥品註冊批件,用於治療十二指腸潰瘍。是軒竹生物首個獲批上市的藥物,標誌着軒竹生物從研發步入商業化發展的新里程。
安奈拉唑鈉腸溶片,為目前首個且唯一一箇中國完全自主研發的質子泵抑制劑(PPI),其I-III期臨牀研究均以中國人羣為對象,是適合中國患者的PPI。可有效抑制胃酸分泌,具有起效快、療效穩定,個體差異小、半衰期長等特點。臨牀數據顯示,安奈拉唑鈉腸溶片經多酶和非酶代謝,與其他藥物聯用時,藥物間相互作用的風險低;經腸腎雙通道排泄,對腎功能不全患者提供更安全的用藥選擇。
安奈拉唑鈉腸溶片除用於治療十二指腸潰瘍外,還拓展了新適應症用於成人反流性食管炎(RE)的治療,其II期臨牀試驗已完成受試者入組,計劃2023年底前啟動III期臨牀試驗。
PPI為消化性潰瘍首選藥物,據統計,2021年中國消化性潰瘍患者人數已達到7000多萬人,中國質子泵抑制劑市場總規模近300億元,其中口服質子泵抑制劑市場近130億元。安奈拉唑鈉腸溶片基於優異的臨牀表現未來更容易被醫生及患者接受,未來商業價值及臨牀價值巨大。
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