澤璟製藥(688266.SH):重組人凝血酶獲批上市
格隆匯1月2日丨澤璟製藥(688266.SH)公佈,收到國家藥品監督管理局核准簽發的《藥品註冊證書》,公司自主研發的重組人凝血酶的新藥上市申請獲得批准,用於“成人經標準外科止血技術(如縫合、結紮或電凝)控制出血無效或不可行,促進手術創面滲血或毛細血管和小靜脈出血的止血”。
重組人凝血酶是基於公司複雜重組蛋白新藥和抗體新藥研發及產業化平台開發的一種高度特異性人絲氨酸蛋白酶,是目前國內唯一採用重組基因技術生產的重組人凝血酶,也是經過科學和規範的III期臨牀試驗並獲批上市的生物止血類產品。
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