Ardelyx's tenapanor receives approval in China for controlling phosphorus levels in dialysis patients, triggering a $5 million milestone payment.
Quiver AI Summary
Ardelyx, Inc. has received approval from China's National Medical Products Administration for its drug tenapanor, designed to manage serum phosphorus levels in dialysis patients suffering from chronic kidney disease who cannot adequately respond to or tolerate standard phosphorus binders. This approval activates a $5 million milestone payment to Ardelyx as part of its licensing agreement with Fosun Pharma, its partner in China. Ardelyx could earn up to $100 million more in milestone payments and royalties on net sales. Tenapanor, to be marketed as Wan Ti Le, is notable for its unique mechanism that inhibits phosphate absorption in the gut. The need for such treatment is significant, given that a substantial percentage of dialysis patients in China have hyperphosphatemia, with many failing to achieve target phosphate levels.
Potential Positives
- Ardelyx received approval for tenapanor from China's Center for Drug Evaluation, expanding its market presence in a significant region.
- This approval triggers a $5 million milestone payment from collaboration partner Fosun Pharma, enhancing the company's financial position.
- Ardelyx could potentially earn up to $100 million in additional milestones and tiered royalty payments, indicating a strong revenue growth opportunity.
- The approval addresses a critical medical need for over one million dialysis patients in China suffering from hyperphosphatemia, aligning with Ardelyx's mission to meet significant unmet medical needs.
Potential Negatives
- The approval of tenapanor in China underlines the company's reliance on partnerships for market penetration, limiting its direct control over commercialization in key regions.
- The significant side effect of diarrhea reported in clinical trials raises concerns regarding patient adherence to treatment and overall market acceptance of tenapanor in China.
- There are substantial risks and uncertainties associated with the regulatory process and commercialization of drugs, which may hinder Ardelyx's future performance and milestones despite the current approval.
FAQ
What is tenapanor used for in dialysis patients?
Tenapanor is used to control serum phosphorus levels in dialysis patients with chronic kidney disease who do not respond to phosphorus binders.
Who developed tenapanor?
Tenapanor was discovered and developed by Ardelyx, Inc., a biopharmaceutical company focused on innovative medicines.
What is the significance of the NDA approval in China?
The NDA approval for tenapanor in China supports Ardelyx's goal of addressing significant unmet medical needs in patients with chronic kidney disease.
What are the potential financial benefits of the approval?
The approval triggers a $5 million milestone payment to Ardelyx and potential additional milestones up to $100 million and tiered royalties.
How will tenapanor be marketed in China?
Tenapanor will be marketed in China under the trade name Wan Ti Le by Fosun Pharma, who has exclusive marketing rights.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
WALTHAM, Mass., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced the approval of a New Drug Application (NDA) by China’s Center for Drug Evaluation of the National Medical Products Administration for tenapanor to control serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders.
This approval triggers a $5 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). Under the terms of its agreement, Ardelyx is eligible to receive additional developmental and commercialization milestones of up to $100 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent.
“The approval of tenapanor for hyperphosphatemia in China marks another important milestone in Ardelyx’s commitment to bringing our novel therapies to patients with unmet medical needs globally,” said Mike Raab, president and chief executive officer of Ardelyx. “I thank our partners at Fosun Pharma for their continued efforts to support this approval. Fosun Pharma is a leading healthcare company in China with a strong focus and track record of successfully marketing cardiorenal medicines in China and shares our commitment to improving the lives of patients. We look forward to further collaboration as Fosun Pharma brings this treatment to patients.”
Data indicate that at the end of 2023, there were more than one million patients on maintenance hemodialysis in China, with an annual growth rate of approximately 12%. Among these patients, 76% have hyperphosphatemia, and the rate of achieving target phosphate levels is only 39%
1
(according to China’s hemodialysis quality control standards: serum phosphate 1.13–1.78 mmol/L). If the target range for serum phosphate is set at 0.87–1.45 mmol/L, as stipulated by the Chinese guidelines for the diagnosis and treatment of Chronic Kidney Disease Mineral and Bone Disorder, the achievement rate decreases to 26.7%
2
.
The NDA in China was supported by data from two studies undertaken by Fosun Pharma, a single pharmacokinetic study and a single pivotal trial in patients with CKD on dialysis, in addition to Ardelyx clinical studies.
Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau. Tenapanor will be marketed with the Chinese trade name Wan Ti Le.
About XPHOZAH
®
(tenapanor)
XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3, thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full
Prescribing Information
.
About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA
®
(tenapanor) and XPHOZAH
®
(tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL
®
(tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit
https://ardelyx.com/
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.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including, Ardelyx’s current expectation regarding the receipt of a $5 million milestone payment from Fosun Pharma and the potential to receive additional development and commercialization milestones under its agreement with Fosun Pharma, the potential for XPHOZAH to provide a meaningful benefit for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis in China, and the growth rate of the population of patients on maintenance hemodialysis in China. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 20, 2025, and its future current and periodic reports to be filed with the Securities and Exchange Commission.
Investor and Media Contacts:
Caitlin Lowie
clowie@ardelyx.com
1. Data from the Chinese National Renal Data System (CNRDS 2023)
2. Ya Zhan, et al. Sci Rep. 2022 Oct 6;12(1):16694.
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