華潤雙鶴(600062.SH):全資孫公司雙鶴潤創DC50292A片獲得藥物臨牀試驗批準通知書
格隆匯2月16日丨華潤雙鶴(600062.SH)公佈,近日,公司全資孫公司北京雙鶴潤創科技有限公司(以下簡稱"雙鶴潤創")收到了國家藥品監督管理局(以下簡稱"國家藥監局")頒發的DC50292A片(以下簡稱"該藥品")《藥物臨牀試驗批準通知書》(通知書編號:2025LP00364、2025LP00365)。
DC50292A片處於臨牀研發早期階段,有待臨牀試驗確證安全性、療效和質量可控性,存在客觀失敗率等風險。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批準通知書後,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。由於醫藥產品的前期研發以及產品從研製、臨牀試驗報批到投產的週期長、環節多,可能受到國家政策、市場環境變化等不確定因素影響,具有較大不確定性。敬請廣大投資者謹慎決策,注意防範投資風險。
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