四環醫藥(00460.HK):軒竹生物藥品安納拉唑鈉新藥上市申請獲國家藥監局受理
格隆匯10月22日丨四環醫藥(00460.HK)發佈公吿,中國國家藥品監督管理局已受理安納拉唑鈉腸溶片的新藥上市申請(NDA)。此次新藥上市申請是軒竹生物第一個遞交的新藥上市申請,並獲得受理,標誌着軒竹生物踏入從研發步入商業化發展的新里程。
安納拉唑鈉,為新一代中國國內唯一一個自主研發的PPI抑制劑,用於治療十二指腸潰瘍。經多酶和非酶代謝,藥物間相互作用的風險低。臨牀數據顯示,集團研發的安納拉唑鈉的安全性及症狀緩解均為同類產品最佳Best-in-class。據IQVIA數據,2020年,抗消化性潰瘍藥銷量TOP5中均為PPI藥物,市場規模超過人民幣200億元。
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