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港股異動丨綠葉製藥大漲8.63% 創新制劑距在美獲批上市再近一步
格隆匯 11-04 13:38
格隆匯11月4日丨綠葉製藥(2186.HK)大漲8.63%,報6.42港元,成交2.72億港元,總市值210億港元。

綠葉製藥集團自主研發的創新制劑——注射用利培酮緩釋微球(LY03004)距離在美獲批上市又近一步。目前,公司已收到美國食品藥品監督管理局(FDA)正式檢查報告。報告顯示,公司位於中國煙台的用於生產LY03004的長效製劑生產基地以零483成功通過上市批准前檢查。
綠葉製藥今日午間宣佈,集團腫瘤線產品LY01008 (Avastin的生物類似藥)已於2019年5月在中國完成一項與Avastin療效和安全性對比的III期臨牀試驗的入組,共計入組648例患者,目前在盲態下已完成主要療效指標客觀緩解率(ORR)的觀察。LY01008的研發進展將推動該產品的上市進度並進一步豐富集團的腫瘤產品線。而集團於腫瘤領域強大的行銷能力和廣闊的市場覆蓋將為LY01008未來的上市提供強勁的支持。
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