百奧泰(688177.SH):BAT2206(烏司奴單抗)注射液獲得美國FDA上市批准
格隆匯5月23日丨百奧泰(688177.SH)公佈,近日收到了美國食品藥品監督管理局(簡稱“美國FDA”)簽發的關於BAT2206(烏司奴單抗)注射液(美國商品名稱:STARJEMZA)上市批准的通知,BAT2206是百奧泰根據中國NMPA、美國FDA、歐洲EMA生物類似藥相關指導原則開發的烏司奴單抗注射液,烏司奴單抗是一款靶向白細胞介素IL-12和IL-23共有的p40亞基的全人源單克隆抗體。IL-12和IL-23是天然產生的細胞因子,能夠參與炎症和免疫應答過程,可以與p40亞基以高親和力特異性地結合,阻斷其與細胞表面受體結合,從而破壞IL-12和IL-23介導的信號傳導和細胞因子的效應。
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