上海醫藥(601607.SH):SPH4336片獲臨牀試驗通知書
格隆匯6月1日丨上海醫藥(601607.SH)公佈,近日,公司及其全資子公司上海醫藥集團(本溪)北方藥業有限公司開發的“SPH4336片”收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》,並將於近期啟動I期臨牀試驗。
SPH4336片屬化藥1類小分子創新藥,由上海醫藥自主研發,公司擁有完全知識產權。臨牀前研究表明該項目具有更優的體內外抗腫瘤活性和更好的安全性,擬用於晚期實體瘤的治療。
SPH4336片於2015年3月啟動立項,2019年10月完成臨牀前研究,其後向國家藥監局提交臨牀試驗申請,並於2020年3月25日獲得國家藥監局受理。近日,該項目獲得國家藥監局核准簽發的《臨牀試驗通知書》,同意按照已提交的方案開展臨牀試驗。
截至目前,該項目已累計投入研發費用約4650.47萬元人民幣。
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,還須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。
截至公告日,與該項目同靶點的藥品已於全球上市。根據EvaluatePharma數據顯示,2019年與該項目同靶點的藥品全球銷售總額為60.27億美元。
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