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綠葉製藥(02186.HK)創新制劑注射用醋酸戈舍瑞林緩釋微球III期臨牀迅速推進
格隆匯 12-14 07:55

2020年12月14日,上海——綠葉製藥集團自主研發的創新制劑——注射用醋酸戈舍瑞林緩釋微球(LY01005)已取得多項積極的臨牀進展。目前,該藥物已在中國完成針對乳腺癌III期臨牀研究的首例患者入組,針對前列腺癌的III期臨牀亦進展順利。不僅如此,LY01005也在美國同步開展臨牀試驗,並已完成I期臨牀。

LY01005基於綠葉製藥(02186.HK)的長效及緩釋技術平台自主研發,公司在微球等新制劑技術研究領域已達到國際領先水平,並擁有一系列微球在研產品在中國、美國、日本等國際醫藥市場開展註冊及臨牀研究。

戈舍瑞林是一種促性腺激素釋放激素激動劑。LY01005用於乳腺癌、前列腺癌及子宮內膜異位症等多種病症的治療。該藥物通過肌肉注射的方式以每月一次的頻率給藥,在給藥週期內可實現平穩的藥物釋放。

前列腺癌和乳腺癌分別是威脅男性和女性健康的最常見的癌症之一,其發病率在全球範圍內均居於各項癌症發病率前列。與其他大多數國家一樣,該兩種疾病在中國的發病率也呈快速上升趨勢。從患者的用藥需求來看,據IQVIA數據統計:2019年,中國促性腺激素釋放激素激動劑產品的市場總值達到58.28 億元人民幣左右,同比增長為17.71%。綠葉製藥管理層相信:LY01005上市後將擁有良好的市場前景,也將為中國及全球更多患者提供更好的治療選擇。

目前,綠葉製藥已在中國獲得戈舍瑞林微球藥物組合物的專利,並於2014年提交戈舍瑞林微球藥物組合物的專利合作協議(PCT)申請,該申請已於2015年進入美國、歐洲、日本、及若干其他國家和地區,其中美國、歐洲和日本已經獲權。

綠葉製藥將加速LY01005在中國的研發及上市進程並將其推向國際市場。公司持續推進在腫瘤治療領域的戰略佈局,不斷豐富腫瘤領域的產品管線,以期進一步強化其在該治療領域的領先地位,併為全球市場的不斷拓展奠定堅實基礎。

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