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景峯醫藥(000908.SZ):安非他命混合鹽口服緩釋膠囊獲美國ANDA批准文號
格隆匯 12-12 08:30

格隆匯12月12日丨景峯醫藥(000908.SZ)公佈,近日,公司的控股子公司Sungen Pharma,LLC(“尚進”)收到美國FDA的通知,尚進向美國FDA申報的安非他命混合鹽口服緩釋膠囊的簡略新藥申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准表示申請者可以生產並在美國市場銷售該產品)已獲得批准。

審批主要結論:已經確定安非他命混合鹽口服緩釋膠囊所有規格(5mg、10mg、15mg、20mg、25mg和30mg)的簡略新藥同原研參比製劑是生物等效的,因此,治療等效於夏爾(Shire)公司已上市的阿得拉爾緩釋膠囊(Adderall XR)原研(RLD)產品的所有規格(5mg、10mg、15mg、20mg、25mg和30mg)。

安非他命混合鹽是強效的中樞神經系統刺激劑,被用於治療注意力不足過動症、嗜睡症以及極端的肥胖症等。安非他命混合鹽口服緩釋膠囊不僅是管控制藥品,而且是長效緩控釋製劑、規格較多,在美國研發、生產壁壘很高,不僅受FDA法規審查同時受嚴格的濫用藥物機構監管。目前美國市場的主要生產商有梯瓦(Tava)、益邦(Impax)、山多士(Sandoz)等。根據IMS數據顯示,安非他命混合鹽口服緩釋膠囊2018年在美國市場的銷售額為15.5億美元,2017為15.6億美元。

此次安非他命混合鹽口服緩釋膠囊獲得美國FDA批准文號標誌着公司具備了在美國市場銷售該產品的資格,將對公司拓展美國製劑市場、提升公司業績帶來積極的影響。

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