恆瑞醫藥(600276.SH):SHR2285片獲臨牀試驗通知書
格隆匯 6 月 23日丨恆瑞醫藥(600276.SH)公佈,公司近日收到國家藥品監督管理局核准簽發的《臨牀試驗通知書》,同意SHR2285片藥學變更,公司將繼續開展臨牀試驗。
2018年9月5日,公司向國家藥監局遞交的臨牀試驗申請獲受理,並於同年獲得《臨牀試驗通知書》。後因藥學變更,公司於2020年3月11日向國家藥監局遞交的臨牀試驗補充申請獲受理。SHR2285片擬適用於預防或治療動靜脈血栓,以及降低介入治療或體外循環引起的血栓栓塞風險。經查詢,目前有同類產品處於臨牀試驗階段,國內外未有同類產品獲批上市,亦無相關銷售數據。
截至目前,該產品項目已投入研發費用約為3,889萬元人民幣。
根據我國藥品註冊相關的法律法規要求,藥物在獲得臨牀試驗通知書後,尚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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