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綠葉製藥(02186.HK):LY01005完成前列腺癌的中國III期臨牀研究
格隆匯 09-06 08:06

格隆匯9月6日丨綠葉製藥(02186.HK)發佈公吿,創新制劑注射用醋酸戈舍瑞林緩釋微球(“LY01005”)已在中國完成前列腺癌III期臨牀研究。

該三期臨牀為一項隨機、開放、陽性藥物對照的臨牀研究,採用非劣效試驗設計,與對照藥比較,評價注射用醋酸戈舍瑞林緩釋微球(LY01005)連續肌肉注射給藥3個月治療前列腺癌患者的有效性和安全性。基於臨牀研究結果,對於前列腺癌患者,LY01005以3.6mg劑量每28天肌肉注射一次治療前列腺癌,可有效控制睾酮至去勢水平,臨牀療效與對照藥相當,達到了非劣效標準,LY01005注射部位不良反應顯著改善,患者順應性增加,其他不良事件發生率相似,安全性特徵相近,整體臨牀安全耐受性良好。

LY01005是集團利用自身微球注射技術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。集團認為其研發的醋酸戈舍瑞林微球製劑有更好的患者依從性。集團準備基於該產品的前列腺III期臨牀結果在中國提交上市申請。同時該產品的乳腺癌III期臨牀亦同步在中國進行中。公司相信,LY01005具有良好的市場潛力,將有力推進集團在腫瘤治療領域的發展,併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。

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