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上海醫藥(601607.SH):SPH3127獲得美國FDA藥品II期臨牀試驗資格
格隆匯 12-30 16:48

格隆匯 12 月 30日丨上海醫藥(601607.SH)公佈,公司全資子公司上海醫藥生物治療(美國)有限公司近日向美國食品藥品監督管理局(FDA)提交了SPH3127臨牀試驗申請並獲受理。按照美國藥品註冊相關法律法規的規定,美FDA自受理之日起30日內未下發暫停臨牀試驗暫停部分臨牀試驗通知的,可獲准進行臨牀試驗。日前,公司已獲得美國FDA藥品臨牀試驗資格,並將於近期開展相關臨牀試驗。

SPH3127是一種新型口服腎素抑制劑,目前在中國申報的適應症為抗高血壓,已在中完成II期臨牀研究(開展II臨牀研究情況詳見公司公吿臨2019-004號)擬在中國開展III期臨牀試驗

此次項目在美國申報的適應症為輕度至中度潰瘍性結腸炎,臨牀前研究已證明SPH3127 在潰瘍性結腸炎動物模型中具有活性。次美國藥品申報擬開展潰瘍性結腸炎的II期臨牀試驗

項目由公司和日本田邊三菱製藥株式會社合作研發,雙方共同擁有知識產權。公司已向中國、美國、日本、歐洲、澳大利亞、韓國、菲律賓等數十個國家/地區提交該項目的化合物專利申請,並已取得在中國、美國、日本、澳大利亞等數十個國家/地區的授權。

根據美國藥品註冊相關法律法規要求,項目在獲得臨牀試驗資格後,尚需開展臨牀試驗並經美國FDA審評審批通過後方可進行產業化生產上市。

SPH3127目前尚無同類產品上市。據EvaluatePharma數據庫顯示,2019年潰瘍性結腸藥品全球銷售額為62.64億美元。

截至目前,公司在項目已累計投入研發費用約人民幣232.83萬元(僅針對適應症為潰瘍性結腸炎的該項目研發費用)

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