復星醫藥(600196.SH):便祕性腸易激綜合症治療藥獲臨牀試驗通知書
格隆匯12月12日丨復星醫藥(600196.SH)公佈,近日,公司控股子公司上海復星醫藥產業發展有限公司(以下簡稱“復星醫藥產業”)收到國家藥監局關於同意Tenapanor片用於便祕性腸易激綜合症治療開展臨牀試驗的通知書。復星醫藥產業擬於近期條件具備後於中國境內(不包括港澳台地區,下同)開展針對該適應症的I期臨牀試驗。
截至本公告日,於全球上市的用於治療便祕性腸易激綜合症的藥品主要包括Trulance®(Plecanatide,普卡那肽)、Amitiza®(Lubiprostone,魯比前列酮)、Linzess®(Linaclotide,利那洛肽)、Ardelyx的Tenapanor片。根據IQVIA MIDAS最新數據(由IQVIA提供,IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商),2018年度,上述藥品於全球的銷售額約為22.2億美元(於中國境內尚未有銷售額)。
截至2019年11月,集團現階段針對該新藥(用於便祕性腸易激綜合症和終末期腎病透析患者高磷血癥治療)累計研發投入為人民幣約9947萬元(未經審計;包括許可費)。
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