Fosun Pharma Receives NMPA Approval to Initiate Phase III Clinical Trial for its Tenapanor Tables
（12 March, 2020, Shanghai）Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that its subsidiary Fosun Pharma Industrial has received the approval for clinical trial for Tenapanor tablets (dosage: 10mg/20mg/30mg) (the “New Drug”) for the treatment of hyperphosphatemia in end-stage renal disease — hemodialysis (ESRD-HD) patients from the National Medical Products Administration (the “NMPA”). Fosun Pharma Industrial intends to conduct phase III clinical trial for such indication in the PRC (excluding Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan Region, similarly hereinafter) upon meeting the conditions shortly.
Tenapanor, a chemical drug mainly developed for the treatment of irritable bowel syndrome with constipation and hyperphosphatemia in the terminal renal disease dialysis patients. In September 2019, Tenapanor was already approved by the NMPA for clinical trials for the treatment of irritable bowel syndrome with constipation; during the same month, the US Food and Drug Administration (“FDA”) granted approval to Ardelyx, Inc. (“Ardelyx”) for marketing Tenapanor as a medicine for the treatment of irritable bowel syndrome with constipation. Currently, the phase III clinical trial of Tenapanor tablets of Ardelyx for the treatment of hyperphosphatemia in the end-stage renal disease dialysis patients was ongoing in the United States. These clinical trial results have demonstrated strong evidence for the drug’s safety and clinical efficacy as well.
In December 2017, Fosun Pharma Industrial entered into an exclusive license with Ardelyx, Inc. (“Ardelyx”) for the clinical development and commercialization of Tenapanor in the regions including mainland China, Hong Kong SAR and Macau SAR. Up until February 2020, Fosun Pharma’s cumulative R&D investment in Tenapanor was approximately RMB 100.8million (unaudited; licensed fees included).
Tenapanor, a chemical drug mainly developed for the treatment of irritable bowel syndrome with constipation and hyperphosphatemia in the terminal renal disease dialysis patients. In September 2019, Tenapanor was already approved by the NMPA for clinical trials for the treatment of irritable bowel syndrome with constipation; during the same month, the US Food and Drug Administration (“FDA”) granted approval to Ardelyx, Inc. (“Ardelyx”) for marketing Tenapanor as a medicine for the treatment of irritable bowel syndrome with constipation. Currently, the phase III clinical trial of Tenapanor tablets of Ardelyx for the treatment of hyperphosphatemia in the end-stage renal disease dialysis patients was ongoing in the United States. These clinical trial results have demonstrated strong evidence for the drug’s safety and clinical efficacy as well.
In December 2017, Fosun Pharma Industrial entered into an exclusive license with Ardelyx, Inc. (“Ardelyx”) for the clinical development and commercialization of Tenapanor in the regions including mainland China, Hong Kong SAR and Macau SAR. Up until February 2020, Fosun Pharma’s cumulative R&D investment in Tenapanor was approximately RMB 100.8million (unaudited; licensed fees included).