和黃醫藥(HCM.US)上海創新藥生產基地動工
長和(00001.HK)持股的和黃醫藥(HCM.US)公布,昨日(8日)於上海張江高科技園區舉行開工儀式,展開公司大型創新藥生產基地的興建工程。上海基地將成為公司最大的生產設施,其佔地面積達2.87萬平方米。整個建設將分兩期,總建築面積近5.5萬平方米,第一期主要為小分子化合物生產,建成後的年計畫產能可達2.5億片片劑、5.5億粒膠囊,第二期工程有望擴展到大分子化合物的生產。
公司目前於蘇州擁有GMP認證製劑生產設施,負責臨床供藥及愛優特((口夫)(口奎)替尼膠囊)的商業供應。公司將投入額外資源支援上海基地的建設,並逐步擴大上海基地的生產團隊,屆時產能可達現有蘇州生產基地的五倍。
和黃醫藥首席執行官賀雋表示,公司自主研發的愛優特已在中國上市,其他兩款候選藥物索凡替尼(surufatinib)和賽沃替尼(savolitinib)也已經在中國遞交了新藥上市申請,有望於明年獲批上市。公司又計劃於今年年底前向美國食品藥品監督管理局遞交索凡替尼新藥上市申請。
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