上海醫藥(02607.HK):SPH3127片新適應症獲得II期臨試批准通知書
格隆匯8月3日丨上海醫藥(02607.HK)發佈公吿,近日,公司開發的“SPH3127片”(糖尿病腎病適應症;以下簡稱“該項目”)收到國家藥品監督管理局核准簽發的《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。
根據披露,SPH3127片是一種新型口服腎素抑制劑,具有降血壓作用,目前SPH3127片抗高血壓適應症正在中國開展Ⅲ期臨牀試驗;輕度至中度潰瘍性結腸炎適應症正在美國開展II期臨牀試驗。
本次藥品申報擬開展適應症為糖尿病腎病的臨牀試驗。臨牀前研究已證明SPH3127片在動物模型中具有降低蛋白尿和提高腎小球濾過率的作用。該項目於2019年5月啟動立項,2020年10月完成臨牀前研究。並於2021年5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834.94萬元人民幣。
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