復星醫藥(02196.HK)：用於便祕性腸易激綜合症治療新藥Tenapanor片獲臨牀試驗通知書
格隆匯12月12日丨復星醫藥(02196.HK)公告，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”)收到國家藥品監督管理局關於同意Tenapanor片(以下簡稱“該新藥”)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。
2017年12月，復星醫藥產業獲Ardelyx,Inc.(以下簡稱“Ardelyx”)關於該新藥在區域內(包括中國大陸、香港及澳門特別行政區，下同)的獨家臨牀開發和商業化等許可，Ardelyx仍為該新藥在區域內的權利人。該新藥為化學藥品，主要用於治療便祕性腸易激綜合症和終末期腎病透析患者高磷血癥。
2019年9月，該新藥用於便祕性腸易激綜合症治療獲國家藥監局臨牀試驗註冊審評受理；同月，Ardelyx的Tenapanor片用於便祕性腸易激綜合症治療獲美國食品和藥品監督管理局(以下簡稱“美國FDA”)上市批准。
2019年11月，該新藥用於終末期腎病透析患者高磷血癥治療獲國家藥監局臨2牀試驗註冊審評受理；截至本公告日，Ardelyx的Tenapanor片用於終末期腎病透析患者高磷血癥治療尚處於美國Ⅲ期臨牀試驗階段。
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IQVIAMIDASTM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)。
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