復星醫藥(600196.SH)：Tenapanor片用於終末期腎病透析患者高磷血癥治療獲臨牀試驗註冊審評受理
格隆匯12月5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(“復星醫藥產業”)收到《受理通知書》(受理號：JXHL1900345國、JXHL1900346國、JXHL1900347國)，其獲許可的Tenapanor片(規格：10mg/20mg/30mg)用於終末期腎病透析患者高磷血癥(ESRD-HD)治療獲國家藥品監督管理局(“國家藥監局”)臨牀試驗註冊審評受理。
2017年12月，復星醫藥產業獲Ardelyx, Inc.(“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(“美國FDA”)上市批准。
截至公告日，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。
截至公告日，於中國境內(不包括港澳台地區，下同)上市的用於終末期腎病透析患者高磷血癥治療的藥品包括Renvela®(Sevelamer，司維拉姆)和Fosrenol®(Lanthanum，碳酸鑭)。根據IQVIA CHPA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，上述藥品於中國境內的銷售額為人民幣約35,322萬元。
截至2019年10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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