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康臣藥業(1681.HK):新一代治療尿毒症瘙癢症一類新藥SK-07獲批開展臨牀試驗
格隆匯 04-16 18:50

格隆匯4月16日丨康臣藥業(01681.HK)董事會欣然宣佈,公司收到國家藥品監督管理局(“NMPA”)簽發有關批准SK-07注射液(“SK-07”)的臨牀試驗申請的《藥物臨牀試驗批准通知書》。

審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2023年1月17日受理的SK-07注射液臨牀試驗申請符合藥品註冊的有關要求,同意本品開展臨牀試驗。申請的適應症:尿毒症瘙癢症的治療。

SK-07為集團和上海藥明康德新藥開發有限公司聯合研發的新一代治療尿毒症瘙癢症一類新藥,獲得上述NMPA的許可後,即將啟動臨牀試驗。

尿毒症瘙癢症是血液透析患者臨牀常見併發症。慢性腎功能衰竭患者在定期接受透析治療時,約40%-50%的透析患者會發生皮膚瘙癢。目前,尿毒症瘙癢尚無特效治療藥物,國內也沒有統一治療標準。尿毒症瘙癢是一個巨大的空白市場,具有顯著的未滿足的臨牀需求。公司將繼續積極推進SK-07的臨牀試驗,爭取早日上市造福廣大患者。

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