和黄医药(HCM.US)上海创新药生产基地动工
长和(00001.HK)持股的和黄医药(HCM.US)公布,昨日(8日)於上海张江高科技园区举行开工仪式,展开公司大型创新药生产基地的兴建工程。上海基地将成为公司最大的生产设施,其占地面积达2.87万平方米。整个建设将分两期,总建筑面积近5.5万平方米,第一期主要为小分子化合物生产,建成後的年计画产能可达2.5亿片片剂、5.5亿粒胶囊,第二期工程有望扩展到大分子化合物的生产。
公司目前於苏州拥有GMP认证制剂生产设施,负责临床供药及爱优特((口夫)(口奎)替尼胶囊)的商业供应。公司将投入额外资源支援上海基地的建设,并逐步扩大上海基地的生产团队,届时产能可达现有苏州生产基地的五倍。
和黄医药首席执行官贺隽表示,公司自主研发的爱优特已在中国上市,其他两款候选药物索凡替尼(surufatinib)和赛沃替尼(savolitinib)也已经在中国递交了新药上市申请,有望於明年获批上市。公司又计划於今年年底前向美国食品药品监督管理局递交索凡替尼新药上市申请。
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