Fosun Pharma Announces the Acceptance of Tenapanor Clinical Trials Application for the Treatment of Hyperphosphatemia by NMPA
【6 Dec 2019, Hong Kong】 On 5 December 2019, Shanghai Fosun Pharmaceutical (Group) Co., Ltd (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that its subsidiary Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“Fosun Pharma Industrial”) received the acceptance letter (Approval No.: JXHL1900345, JXHL1900346 and JXHL1900347) from the National Medical Products Administration (“NMPA”) for its clinical trial application for Tenapanor (dosage: 10mg/20mg/30mg) for the treatment of hyperphosphatemia (ESRD-HD) in terminal renal disease dialysis patients.
Tenapanor, a chemical drug, is 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 for marketing Tenapanor as a medicine for the treatment of irritable bowel syndrome with constipation. Currently, Tenapanor is in the final stage of clinical trials in the US for the treatment of hyperphosphatemia in terminal renal disease dialysis patients. 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 October 2019, Fosun Pharma’s cumulative R&D investment in Tenapanor was approximately RMB 99.47 million (unaudited; licensed fees included).
Tenapanor, a chemical drug, is 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 for marketing Tenapanor as a medicine for the treatment of irritable bowel syndrome with constipation. Currently, Tenapanor is in the final stage of clinical trials in the US for the treatment of hyperphosphatemia in terminal renal disease dialysis patients. 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 October 2019, Fosun Pharma’s cumulative R&D investment in Tenapanor was approximately RMB 99.47 million (unaudited; licensed fees included).