百奧泰(688177.SH):阿達木單抗注射液獲批新增適應症
格隆匯8月10日丨百奧泰(688177.SH)宣佈,公司於近日收到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:2020B04337),該新藥獲批新增適應症:葡萄膜炎。
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。
公司表示,此次《藥品補充申請批准通知書》的獲得是對格樂立®適應症的進一步補充,將有利於發揮該藥品未來市場銷售和市場競爭的潛力。
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