上海醫藥(601607.SH):SPH3127片獲得II期臨牀試驗批准通知書
格隆匯9月8日丨上海醫藥(601607.SH)公佈,近日,公司開發的“SPH3127片”(“該項目”)收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,將於近期啟動國內II期臨牀試驗。
SPH3127片是一種新型口服腎素抑制劑,具有降血壓作用,目前該項目正在中國開展治療原發性輕中度高血壓的III期臨牀試驗。另外,上海醫藥創新研發團隊還在積極拓展SPH3127片的新適應症,其中糖尿病腎病適應症正在中國開展II期臨牀試驗(詳見公司公吿臨2021-071號),潰瘍性結腸炎適應症正在美國開展II期臨牀試驗(詳見公司公吿臨2020-073號)。
該項目由上海醫藥和日本田邊三菱製藥株式會社合作研發,已向美國、日本、歐洲、澳大利亞、韓國、菲律賓、中國等數十個國家/地區提交該產品的化合物專利申請,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;上海醫藥亦已提交慢性腎病和潰瘍性結腸炎適應症的國際專利申請,擁有獨立的自主知識產權。
本次藥品申報擬開展潰瘍性結腸炎中國臨牀試驗。臨牀前研究已證明SPH3127片在潰瘍性結腸炎動物模型中具有活性。同時,SPH3127片在健康志願者和輕中度高血壓患者中的初步臨牀研究結果為潰瘍性結腸炎患者的II期臨牀研究提供了依據。
該項目於2019年12月啟動立項,2021年9月完成臨牀前研究(遞交pre-IND)。並於2022年6月獲得國家藥監局正式受理。近日,該項目獲得了國家藥監局核准簽發的《藥物臨牀試驗批准通知書》,同意按照已提交的方案開展新藥臨牀試驗。
截至目前,該項目已累計投入研發費用1114.13萬元人民幣。
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