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麗珠醫藥(01513.HK)注射用醋酸曲普瑞林微球境內生產藥品註冊上市許可獲藥監局受理
格隆匯 09-13 17:03

格隆匯9月13日丨麗珠醫藥(01513.HK)公吿,近日,公司收到國家藥品監督管理局下發的《受理通知書》(受理號:CXHS2101039國),公司申請的注射用醋酸曲普瑞林微球的境內生產藥品註冊上市許可獲藥監局受理。

注射用醋酸曲普瑞林微球歷經多年研發,是公司自主開發的高端長效微球製劑。本產品是每月一次肌肉注射的一種促性腺激素釋放激素激動劑。曲普瑞林製劑的適應症為前列腺癌、子宮內膜異位症(I至IV期)、女性不孕症、子宮肌瘤的術前治療、性早熟。相比普通醋酸曲普瑞林注射劑,曲普瑞林長效緩控釋製劑起效時間長,減少用藥次數可減輕患者痛苦和用藥負擔,提高用藥耐受性和可及性。

注射用醋酸曲普瑞林微球III期臨牀研究評價了本品治療局部晚期或轉移性前列腺癌患者的有效性和安全性。臨牀研究結果顯示,相較於已上市的曲普瑞林長效緩控釋製劑,本品具有:(1)更高的去勢達成和維持率;(2)常見不良反應的發生率有較大降低,臨牀安全耐受性有較大的優勢。本品是按照改良型新藥報產,要求比已上市產品在臨牀應用上有優勢。截至本公吿披露日,注射用醋酸曲普瑞林微球研發累計直接投入的金額為人民幣5,019.12萬元。

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