Tenapanor Approved in China for Hyperphosphatemia
Ardelyx (ARDX) has received approval from China's Center for Drug Evaluation for tenapanor, a treatment to control serum phosphorus levels in dialysis patients with chronic kidney disease who have inadequate response or intolerance to phosphorus binders. The approval triggers a $5 million milestone payment from their Chinese partner Fosun Pharma.
Under the agreement, Ardelyx is eligible for additional milestones up to $100 million and tiered royalties of mid-teens to 20% on net sales. The drug will be marketed in China as 'Wan Ti Le'. The approval is particularly significant given that China has over one million maintenance hemodialysis patients, growing at 12% annually, with 76% experiencing hyperphosphatemia. Currently, only 39% of patients achieve target phosphate levels under China's hemodialysis standards.
Ardelyx (ARDX) ha ricevuto l'approvazione dal Centro per la Valutazione dei Farmaci della Cina per tenapanor, un trattamento per controllare i livelli di fosforo sierico nei pazienti in dialisi con malattia renale cronica che hanno una risposta inadeguata o intolleranza ai leganti del fosforo. L'approvazione attiva un pagamento di milestone di 5 milioni di dollari dal loro partner cinese Fosun Pharma.
Secondo l'accordo, Ardelyx è idonea a ulteriori milestone fino a 100 milioni di dollari e royalties scalari che vanno dal 15% al 20% sulle vendite nette. Il farmaco sarà commercializzato in Cina con il nome 'Wan Ti Le'. L'approvazione è particolarmente significativa considerando che in Cina ci sono oltre un milione di pazienti in emodialisi di mantenimento, in crescita del 12% all'anno, con il 76% che presenta iperfosfatemia. Attualmente, solo il 39% dei pazienti raggiunge i livelli target di fosfato secondo gli standard di emodialisi della Cina.
Ardelyx (ARDX) ha recibido la aprobación del Centro de Evaluación de Medicamentos de China para tenapanor, un tratamiento para controlar los niveles de fósforo sérico en pacientes de diálisis con enfermedad renal crónica que tienen una respuesta inadecuada o intolerancia a los quelantes de fósforo. La aprobación activa un pago de hito de 5 millones de dólares de su socio chino Fosun Pharma.
Según el acuerdo, Ardelyx es elegible para hitos adicionales de hasta 100 millones de dólares y regalías escalonadas del 15% al 20% sobre las ventas netas. El medicamento se comercializará en China como 'Wan Ti Le'. La aprobación es particularmente significativa dado que China tiene más de un millón de pacientes en hemodiálisis de mantenimiento, creciendo a un 12% anualmente, con el 76% experimentando hiperfosfatemia. Actualmente, solo el 39% de los pacientes alcanza los niveles de fosfato objetivo según los estándares de hemodiálisis de China.
Ardelyx (ARDX)는 중국 약물 평가 센터로부터 테나파노르에 대한 승인을 받았습니다. 이는 만성 신장 질환으로 인한 투석 환자의 혈청 인산염 수치를 조절하는 치료제입니다. 인산염 결합제에 대한 반응이 불충분하거나 내성이 있는 환자에게 적합합니다. 이 승인으로 인해 중국 파트너인 Fosun Pharma로부터 500만 달러의 마일스톤 지급이 발생합니다.
계약에 따라 Ardelyx는 최대 1억 달러의 추가 마일스톤과 순매출의 중간 15%에서 20%까지의 단계적 로열티를 받을 수 있습니다. 이 약물은 중국에서 '완 티 레'라는 이름으로 판매될 예정입니다. 이 승인은 중국에 100만 명 이상의 유지 혈액투석 환자가 있으며, 매년 12%씩 증가하고 있고, 그 중 76%가 고인산혈증을 경험하고 있다는 점에서 특히 중요합니다. 현재, 환자의 39%만이 중국의 혈액투석 기준에 따른 목표 인산염 수치를 달성하고 있습니다.
Ardelyx (ARDX) a reçu l'approbation du Centre chinois d'évaluation des médicaments pour tenapanor, un traitement visant à contrôler les niveaux de phosphore sérique chez les patients sous dialyse atteints de maladie rénale chronique ayant une réponse inadéquate ou une intolérance aux liants de phosphore. Cette approbation déclenche un paiement de jalon de 5 millions de dollars de son partenaire chinois Fosun Pharma.
Selon l'accord, Ardelyx est éligible à des jalons supplémentaires pouvant atteindre 100 millions de dollars et à des redevances échelonnées de 15% à 20% sur les ventes nettes. Le médicament sera commercialisé en Chine sous le nom de 'Wan Ti Le'. Cette approbation est particulièrement significative étant donné qu'il y a plus de un million de patients sous hémodialyse de maintien en Chine, en augmentation de 12% par an, dont 76% souffrent d'hyperphosphatémie. Actuellement, seulement 39% des patients atteignent les niveaux cibles de phosphate selon les normes d'hémodialyse de la Chine.
Ardelyx (ARDX) hat die Genehmigung des chinesischen Zentrums für Arzneimittelbewertung für Tenapanor erhalten, eine Behandlung zur Kontrolle der Serumphosphatwerte bei Dialysepatienten mit chronischer Nierenerkrankung, die unzureichend auf Phosphatbinder reagieren oder intolerant sind. Die Genehmigung löst eine Milestone-Zahlung von 5 Millionen Dollar von ihrem chinesischen Partner Fosun Pharma aus.
Im Rahmen der Vereinbarung ist Ardelyx für zusätzliche Milestones von bis zu 100 Millionen Dollar und gestaffelte Lizenzgebühren von 15% bis 20% auf Nettoumsätze berechtigt. Das Medikament wird in China unter dem Namen 'Wan Ti Le' vermarktet. Die Genehmigung ist besonders bedeutend, da es in China über eine Million Patienten in der Erhaltungs-Hämodialyse gibt, die jährlich um 12% wachsen, wobei 76% an Hyperphosphatämie leiden. Derzeit erreichen nur 39% der Patienten die Zielwerte für Phosphat gemäß den Hämodialystandards in China.
- Received regulatory approval in China for tenapanor
- Immediate $5M milestone payment
- Potential for up to $100M in additional milestone payments
- Royalties of mid-teens to 20% on net sales
- Large addressable market: 1M+ dialysis patients with 12% annual growth
- 76% of patients have hyperphosphatemia, indicating strong market need
- None.
Insights
The approval of tenapanor in China represents a meaningful commercial expansion for Ardelyx's hyperphosphatemia treatment. The immediate
The market opportunity is substantial and well-defined: China has over 1 million hemodialysis patients growing at
Fosun Pharma brings valuable commercial expertise in cardiorenal medicines within China's complex healthcare system, which should help navigate potential reimbursement hurdles. While the timeline to meaningful royalty revenue isn't specified, Fosun's established presence should facilitate relatively efficient commercialization.
This approval strengthens Ardelyx's global strategy for tenapanor, diversifying revenue streams beyond the US market where XPHOZAH® (tenapanor) launched in 2023. The China approval validates the drug's clinical profile and may positively influence ongoing commercialization efforts in other territories, creating a more robust global revenue framework for what remains a first-in-class phosphate absorption inhibitor with a unique mechanism of action.
Ardelyx to receive
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
“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
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/ and connect with us on X (formerly known as Twitter), LinkedIn and Facebook.
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
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.
FAQ
What milestone payment will ARDX receive for tenapanor's approval in China?
What are the potential additional revenues for ARDX from the Fosun Pharma agreement?
What is the market size for tenapanor in China?
What territories are covered under ARDX's agreement with Fosun Pharma for tenapanor?
