百奧泰(688177.SH):阿達木單抗注射液獲得藥品補充申請批准通知書
格隆匯 2 月 21日丨百奧泰(688177.SH)公佈,公司於近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的關於阿達木單抗注射液(商品名稱:格樂立®)的《藥品補充申請批准通知書》(通知書編號:2021B00310),該藥品獲批新增適應症:兒童斑塊狀銀屑病。
格樂立®為公司研發的阿達木單抗生物類似藥,是由CHO細胞表達的重組全人源單克隆抗體。格樂立®通過與TNF-α特異性結合並中和其生物學功能,阻斷其與細胞表面TNF-α受體的相互作用,從而阻斷TNF-α的致炎作用。
截至公吿披露日,格樂立®獲批適應症為強直性脊柱炎、類風濕關節炎、銀屑病、克羅恩病、葡萄膜炎和兒童斑塊狀銀屑病。
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