安科生物(300009.SZ):重組人生長激素注射液獲藥品補充申請批件
格隆匯6月1日丨安科生物(300009.SZ)公佈,2020年5月29日,公司收到國家藥品監督管理局下發的《藥品補充申請批件》(受理號:CYSB2000063、CYSB2000064),藥品通用名稱:重組人生長激素注射液。
重組人生長激素在國外已批准10多種適應症,是國內外治療兒童矮身材的首選藥物。公司此次增加的“用於因軟骨發育不全所引起的兒童身材矮小”和“用於接受營養支持的成人短腸綜合症”適應症已分別在日本和美國獲批。
除上述2個新增適應症外,公司重組人生長激素注射液(商品名:安蘇萌)已獲批適應症有“用於因內源性生長激素缺乏所引致的兒童生長緩慢”、“重度燒傷”、“Noonan綜合徵引起的兒童身材矮小”、“SHOX基因缺陷所引起的兒童身材矮小或生長障礙”等適應症。
該批件為在原批准適應症的基礎上,增加2個新適應症的生產批件。公司將積極進行該產品新適應症的市場推廣工作,產品市場銷售受諸多因素的影響,存在銷售不達預期風險,敬請廣大投資者謹慎決策,注意防範投資風險。
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