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麗珠醫藥(01513.HK):注射用醋酸丙氨瑞林微球獲得臨牀試驗批准
格隆匯 12-29 21:29

格隆匯12月29日丨麗珠醫藥(01513.HK)公佈,2021年12月28日,公司控股子公司上海麗珠製藥有限公司收到國家藥品監督管理局核准簽發的《藥物臨牀試驗批准通知書》,同意注射用醋酸丙氨瑞林微球開展臨牀試驗。

注射用醋酸丙氨瑞林微球歷經4年研發,本次申請臨牀試驗的適應症為前列腺癌,本品是每月一次皮下注射的促性腺激素釋放激素激動劑,可減少患者的用藥次數和用藥負擔。活性成分醋酸丙氨瑞林(上海麗珠獨家批文,原化學藥品第一類)有明確的作用機制和治療機理,通過劑型優化,開發成長效緩釋微球(2.2類新藥,指含有已知活性成分的新劑型、新處方工藝及新給藥途徑,且具有臨牀優勢的藥品),同時研究開發本品的新適應症(2.4類新藥),除前列腺癌適應症外,本品還可以申報治療子宮內膜異位症、子宮肌瘤、乳腺癌、性早熟、輔助生殖等適應症,因此可進一步豐富公司相關治療領域研發管線。

截至本公吿日,注射用醋酸丙氨瑞林微球累計直接投入的研發費用約為人民幣1,781.85萬元。

截至本公吿日,注射用醋酸丙氨瑞林微球在國內外均無其他廠家取得生產批件。目前國內用於抗腫瘤的瑞林類產品主要包括注射用醋酸亮丙瑞林微球,醋酸戈舍瑞林緩釋植入劑,注射用醋酸曲普瑞林等。根據IQVIA抽樣統計估測數據,2020年瑞林類藥物國內終端銷售金額約為人民幣74.49億元,其中注射用醋酸亮丙瑞林微球的銷售金額約為32.27億元,醋酸戈舍瑞林緩釋植入劑的銷售金額約為30.50億元,注射用醋酸曲普瑞林的銷售金額約為11.67億元。

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