港股異動丨聖諾醫藥高開近15%,治療原位鱗狀細胞癌療法獲FDA具體指導建議
聖諾醫藥-B(2257.HK)高開14.95%報6.92港元。消息面上,公司公佈已獲得美國食品藥監局(FDA)關於其用於進一步研發治療原位鱗狀細胞癌(isSCC)的新型siRNA療法STP705所要求的C類會議的書面答覆。
所要求的C類會議的目的是獲得FDA對擬議的非臨牀和臨牀開發計劃的建議和意見,為治療isSCC的II/III期及III期臨牀研究作準備。
針對公司的建議以及與相關非臨牀研究及臨牀研究設計有關的問題,FDA已為非臨牀及臨牀研究、對擬議的II/III期及III期臨牀研究的修訂,以及在候選藥物STP705中使用兩種活性成分所需的進一步論證提供明確的具體指導建議。目前,公司已根據FDA的指導建議啟動所需的臨牀前研究。
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