上海醫藥(601607.SH):SPH5030片獲臨牀試驗批准通知書
格隆匯7月22日丨上海醫藥(601607.SH)公佈,近日,公司開發的“SPH5030片”(“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Ⅰ期臨牀試驗。
SPH5030是一種新型小分子抑制劑,擬用於晚期實體瘤的治療。由上海醫藥自主研發,公司擁有完全知識產權。該項目於2019年7月啟動立項,2020年12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約2695.73萬元人民幣。根據我國藥品註冊相關的法律法規要求,該項目在獲得臨牀試驗通知書後,還需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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