智飛生物(300122.SZ):注射用母牛分枝桿菌新增適應症獲批
格隆匯6月16日丨智飛生物(300122.SZ)宣佈,公司近日收到全資子公司智飛龍科馬的報吿,智飛龍科馬收到國家藥監局下發的關於注射用母牛分枝桿菌的藥品註冊證書。根據審批結論,注射用母牛分枝桿菌符合藥品註冊的有關要求,獲批增加適應症,新增預防結核分枝桿菌潛伏感染人羣發生肺結核疾病。
結核病是由結核分枝桿菌感染引起的慢性傳染病,根據世界衞生組織評估,結核潛伏感染人羣約17億,約佔人口總數的四分之一,其中10-15%人羣一生可能發展為活動性結核病,結核潛伏感染人羣的篩查與預防是世衞終結結核病戰略最重要組成部分。
2015年WHO提出“終止結核病策略”,其目標是到2035年全球結核病發病率下降到10/10萬以下,首次提出了要在高危人羣中系統開展LTBI的檢測和預防性干預,減少結核發病;並指出如果結核潛伏感染問題不解決,終止結核病目標不可能實現。
截至該公吿日,該產品是國內外首個也是唯一一個批准上市可同時用於預防潛伏感染人羣發生肺結核疾病和輔助治療結核病的產品,並能與公司結核矩陣產品(重組結核桿菌融合蛋白(EC)等)形成協同效應。公司將積極做好產品上市推廣工作,若後續順利推廣、銷售,將對結核病防控工作貢獻力量,亦會對公司業績產生積極影響。
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