·The phase III
study in China has shown that Tenapanor significantly reduces elevated serum
phosphorus (sP) levels in hemodialysis patients.
(12 July, 2023, Shanghai, China）Recently, Shanghai Fosun Pharmaceutical (Group) Co., Ltd
(“Fosun Pharma”; stock code: 600196.SH, 02196.HK) announced that the New Drug Application
(“NDA”) for Tenapanor Hydrochloride Tablets (the “New Drug”) for the control of
hyperphosphatemia in adult patients with chronic kidney disease (CKD) on
hemodialysis, which was submitted by its holding subsidiary Shanghai Fosun
Pharmaceutical Industrial Development Co., Ltd. ("Fosun Pharma
Industrial") through license-in, was accepted for review by the National
Medical Products Administration (“NMPA”).
Tenapanor is a First-in-class oral intestinal sodium/hydrogen exchanger 3 (NHE3) inhibitor licensed by
Fosun Pharma Industrial from Ardelyx, Inc.In December 2017,
whereby Fosun Pharma Industrial was granted exclusive rights for the clinical
development and commercialization of tenapanor in the regions including
Mainland China, Hong Kong SAR and Macau SAR. Tenapanor, a chemical
drug developed for the treatment of irritable bowel syndrome
with constipation, was approved by the US Food and Drug Administration (“US
FDA”) in September 2019, and the NDA for the New Drug as a medicine for the
treatment of irritable bowel syndrome with constipation was also submitted in
Hong Kong SAR in March 2023. As of the date, the phase I clinical trial of the
New Drug for the indication of irritable bowel syndrome with constipation was
completed in China (excluding Hong Kong, Macau and Taiwan regions), and the NDA for the New Drug used for the control of serum phosphorus in adult patients
with CKD on dialysis is currently under US FDA regulatory review.
Tenapanor can reduce intestinal
sodium ion absorption, increase the water in the intestinal lumen, promote
intestinal peristalsis and the frequency of normal bowel movements.Several phase II and III studies in the United States and Japan have
shown that tenapanor significantly reduces elevated serum phosphorus (sP)
levels in hemodialysis patients, and also shown its therapeutic tolerability in
the study of treatment duration up to 52 weeks. Without new safety
signals identified1,2,3,the results of phase III study of
tenapanor conducted in China are consistent with previously published research
findings and support tenapanor
as the medicine for the treatment of hyperphosphatemia in end-stage renal
disease on hemodialysis (ESRD-HD) patients.On
June 16, 2023, at the 68th Annual Meeting of the Japanese Society for Dialysis
Therapy, Fosun Pharma orally presented the China Phase III results of
tenapanor.
***
References:
1. Block GA, Rosenbaum DP,
Yan A, Chertow GM. Efficacy and Safety of Tenapanor in Patients with
Hyperphosphatemia Receiving Maintenance Hemodialysis: A Randomized Phase 3
Trial. J Am Soc Nephrol 2019; 30: 641–52.
2. Inaba M, Une Y, Ikejiri
K, Kanda H, Fukagawa M, Akizawa T. Dose-Response of Tenapanor in Patients With
Hyperphosphatemia Undergoing Hemodialysis in Japan-A Phase 2 Randomized Trial.
Kidney Int Rep 2021; 7: 177–88.
3. Block GA, Bleyer AJ,
Silva AL, et al. Safety and Efficacy of Tenapanor for Long-term Serum Phosphate
Control in Maintenance Dialysis: A 52-Week Randomized Phase 3 Trial (PHREEDOM).
Kidney360 2021; 2: 1600–10.
About Fosun Pharma
Founded in 1994,Shanghai Fosun Pharmaceutical (Group) Co.,
Ltd.*("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a
global innovation-driven pharmaceutical and healthcare industry group. Fosun
Pharma directly operates businesses including pharmaceuticals, medical devices,
medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co.,
Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and
retail business.
Fosun Pharma is patient-centered and clinical needs-oriented. The
company continuously enriches its innovative product pipeline through
independent research and development, cooperative development, license-in, and
in-depth incubation. Fosun Pharma improves the research and clinical
development capabilities of FIC (First-in-class) and BIC (Best-in-class) new
drugs as well as accelerates the R&D and launch of innovative technologies
and products.
Guided by the 4IN strategy (Innovation, Internationalization,
Intelligentization, and Integration), Fosun Pharma will uphold the development
model of “Innovation Transformation, Integrated Operation and Steady
Growth", with the mission of creating shareholder values through
strengthening its independent R&D and external cooperation and enriching
its product pipelines, as well as promoting the global networks and enhancing
operational efficiency. Fosun Pharma will actively promote the digital and
physical business layout in the pharmaceutical and healthcare industry and is
committed to becoming a first-class enterprise in the global pharmaceutical and
healthcare markets.
For more information, please visit our official website:www.fxcprm.com
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