普洛藥業(000739.SZ):子公司獲得甲苯磺酸多納非尼化學原料藥上市申請批准通知書
格隆匯6月30日丨普洛藥業(000739.SZ)公佈,近日,普洛藥業股份有限公司控股子公司浙江普洛康裕製藥有限公司收到國家藥品監督管理局簽發的甲苯磺酸多納非尼《化學原料藥上市申請批准通知書》。
甲苯磺酸多納非尼片(商品名:澤普生/Zepsun)是藥監局批准上市的Ⅰ類創新藥,上市許可持有人為公司戰略合作伙伴蘇州澤璟生物製藥股份有限公司(簡稱“澤璟製藥”);用於治療既往未接受過全身系統性治療的不可切除肝細胞癌,以及進展性、局部晚期或轉移性放射性碘難治性分化型甲狀腺癌。
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