中國生物製藥(01177.HK)依達拉奉氯化鈉注射液獲批新增適應症
格隆匯5月27日丨中國生物製藥(01177.HK)宣佈,集團研發的腦神經保護劑“依達拉奉氯化鈉注射液”(商品名稱:依必坦;規格:100ml),繼早前國內首仿獲批上市後,剛獲得中國國家藥品監督管理局頒發藥品補充申請批件,批准新增適應症,用於抑制肌萎縮側索硬化症(俗稱漸凍症,ALS)的功能障礙進展。依必坦成為國內唯一同時擁有腦梗塞和ALS兩大適應症的依達拉奉製劑。
ALS是一種不可逆性、致死性的運動神經元疾病,由於患者大腦、腦幹和脊髓中運動神經細胞受到侵襲,患者逐漸出現肌無力以至癱瘓,漸漸失去説話甚至是吞嚥能力,最終因呼吸衰竭導致死亡。
治療ALS藥物方面,利魯唑是美國食品藥品監督管理局(FDA)批准的第一款治療ALS藥物,依達拉奉注射液是二十多年來FDA唯一批准用於治療ALS的新藥。依達拉奉是一種自由基清除劑,其抗氧化作用能為神經系統提供神經保護性支持,潛在延緩ALS疾病發展或限制額外傷害。
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