上海醫藥(02607.HK):X842項目上市許可申請獲得受理
格隆匯2月20日丨上海醫藥(02607.HK)公吿,近日,上海醫藥集團股份有限公司(以下簡稱“上海醫藥”或“公司”)全資子公司上海上藥信誼藥廠有限公司(以下簡稱“上藥信誼”)合作開發的新型抑酸劑X842項目(以下簡稱“X842”)的上市許可申請正式獲得國家藥品監督管理局(以下簡稱“藥監局”)受理。
X842是新一代鉀離子競爭性酸阻斷劑(P-CAB)口服藥物,現有數據顯示具有起效迅速、抑酸作用強且持久、不良反應少等優點。
公司於2021年10月與貴州生諾生物科技有限公司及其全資子公司江蘇太瑞生諾生物醫藥科技有限公司(以下簡稱“江蘇太瑞生諾”)簽訂《合作協議》,獲得了X842項目原料藥及製劑在中國區域的獨家委託生產和所有適應症的工業銷售權(詳見公司公吿臨2021-084)。
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