綠葉製藥(02186.HK):注射用醋酸戈舍瑞林緩釋微球(LY01005)中國上市許可申請獲受理
格隆匯12月29日丨綠葉製藥(02186.HK)公吿,集團創新制劑產品注射用醋酸戈舍瑞林緩釋微球("LY01005")的上市許可申請已獲中華人民共和國國家藥品監督管理局藥品審評中心受理。本次在中國提交上市許可申請的適應症為前列腺癌,同時該產品的乳腺癌III期臨牀亦同步在中國進行中。
LY01005是集團利用自身微球技術平台研發的每月一次採用肌肉注射的醋酸戈舍瑞林(一種促性腺激素釋放激素激動劑)緩釋微球製劑。作為前列腺癌治療的一線藥物,目前戈舍瑞林已上市的唯一劑型為皮下植入劑。LY01005通過創新微球技術,能夠有效減少注射部位不良反應,提高患者用藥感受,減輕護理難度,提升患者的耐受性和依從性,更利於藥物發揮治療作用,具有明顯的臨牀優勢。
據世界衞生組織國際癌症研究機構(IARC)於2020年全球最新癌症負擔數據顯示:前列腺癌為世界第二大男性高發的惡性腫瘤,2020年全球新發前列腺癌約141萬例,其中中國新發前列腺癌約12萬例。乳腺癌為世界第一大高發的惡性腫瘤,2020年全球新發乳腺癌約226萬例,其中中國新發乳腺癌約42萬例。
根據IQVIA的資料,2020年中國促性腺激素釋放激素激動劑產品的市場總值約為人民幣74.5億元,2018年至2020年的複合年均增長率為22.6%。
公司相信,LY01005解決了當前的臨牀需求,為前列腺癌和乳腺癌患者提供新的治療選擇,惠及更多病患羣體。同時,該產品在中國具備良好的市場潛力,預期可與集團的抗腫瘤產品形成豐富的產品組合,並協同集團於腫瘤領域現有的資源與優勢,加速推動公司在該領域的佈局和發展。
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