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安科生物(300009.SZ):人生長激素注射液獲批新增2種規格
格隆匯 08-02 16:29

格隆匯8月2日丨安科生物(300009.SZ)公佈,近日,公司收到國家藥監局下發的“人生長激素注射液”《藥品補充申請批准通知書》。

公司自主研發的治療用生物製品“人生長激素注射液”,於2019年6月獲得國家藥監局批准上市(規格:4IU/1.33mg/1ml/支、10IU/3.33mg/1ml/支)。目前共獲批6種適應症:1、用於因內源性生長激素缺乏所引起的兒童生長緩慢;2、用於因Noonan綜合徵所引起的兒童身材矮小;3、用於因SHOX基因缺陷所引起的兒童身材矮小或生長障礙;4、用於因軟骨發育不全所引起的兒童身材矮小;5、用於接受營養支持的成人短腸綜合徵;6、用於重度燒傷治療。

本品在原上市2種規格基礎上,該次獲得國家藥監局批准新增2種規格:6IU/2mg/0.6ml/支和8IU/2.66mg/0.8ml/支。至此,公司人生長激素注射液共計4種規格批准上市。

人生長激素在國內外已有多個適應症獲批,其中治療兒童矮身材是人生長激素的適應症之一,臨牀上依據患兒體重進行給藥。

根據國家鼓勵兒童用藥適用劑型、專用規格等開發政策,公司在已上市凍乾粉針劑型基礎上,陸續開發並獲批“人生長激素注射液”水針劑型和規格。本品獲批的4種規格選用預灌封注射器作為包裝材料,採用適當的針頭規格和注射器,具有準確的劑量預置,臨牀使用會更加方便、避免造成浪費,減輕家庭和社會負擔,提高患兒依從性。

公司表示,該次人生長激素注射液獲批新增2種規格,是對已獲批規格的補充,更大地滿足了市場的需求,有利於公司進一步加大該產品的市場推廣力度,提升公司的市場競爭力。

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