Shanghai, April 17th, 2026 — WinHealth Pharma today announced that Kapruvia® (difelikefalin acetate injection) has been approved by China’s National Medical Products Administration (NMPA) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis【1】. This approval provides a new treatment option for patients in China living with moderate-to-severe chronic kidney disease-associated pruritus. Kapruvia® is already approved in major markets including the United States, the European Union and Japan, and is recommended by multiple authoritative guidelines as a first-line therapy for moderate-to-severe chronic kidney disease-associated pruritus.【2】. Clinical data have shown that Kapruvia® provides rapid【3】, clinically meaningful, and sustained relief from pruritus【4】.
Chronic kidney disease-associated pruritus (CKD-aP) is characterized by generalized, persistent itching. In China, an estimated 39% of patients undergoing hemodialysis experience moderate-to-severe CKD-aP【5】【6】. Findings from the Dialysis Outcomes and Practice Patterns Study (DOPPS) indicate that CKD-aP not only significantly impacts patients’ quality of life, including a 10% higher risk of poor sleep, a 13% higher risk of depression and a 16% higher risk of dizziness, but is also associated with a 29% higher risk of all-cause mortality, a 48% higher risk of cardiovascular events and a 17% higher risk of hospitalization, imposing a substantial burden on patients, healthcare systems and society【7】. CKD-aP is a multifactorial condition, and growing attention has been directed toward underlying mechanisms such as opioid receptor imbalance and immune dysregulation【8】. In China, current treatment options for moderate-to-severe CKD-aP remain insufficient to fully address clinical needs, and many patients continue to suffer from persistent itch.
Kapruvia® is a peripherally acting kappa opioid receptor (KOR) agonist that targets a key underlying mechanism of CKD-aP【9】【10】【11】. By correcting the imbalance between mu- and kappa-opioid receptor activity, it significantly reduces 10 inflammatory biomarkers associated with itch intensity and helps improve the pro-inflammatory state, and is associated with clinically meaningful and sustained improvements in pruritus and quality of life in patients with moderate to severe CKD aP. The hydrophilic peptide structure of difelikefalin limits its penetration into the central nervous system (CNS) and prevents it from crossing the blood-brain barrier. Unlike many opioid therapies, it is not associated with addiction potential or centrally mediated adverse events such as insomnia and constipation, and it is not classified as a controlled substance. Administered as an intravenous bolus into the venous line of the dialysis circuit at the end of hemodialysis, Kapruvia® also helps address long-term adherence challenges associated with a high oral pill burden in this patient population, with one-year treatment adherence exceeding 98%【12】.
Multiple global Phase III studies of Kapruvia® have demonstrated that:
- Kapruvia® significantly improved pruritus as early as Week 1 after treatment initiation【4】. By Week 12, 74% of patients achieved a marked improvement in itch symptoms【13】, with sustained benefits observed through 64 weeks of continued treatment【4】.
- In patients with moderate-to-severe CKD-aP who had previously received nalfurafine, treatment with Kapruvia® for 4 weeks led to further significant improvement in itch symptoms, with the WI-NRS score decreasing by an additional 1.49 points from baseline【14】.
- Kapruvia® led to a clinically meaningful improvement in itch-related quality of life. At Week 12, 66% of patients experienced a significant improvement in sleep quality, while 63% achieved significant improvement in mood, social functioning and scratching behavior【13】.
Difelikefalin injection is currently recommended for the treatment of moderate-to-severe CKD-aP in more than 10 authoritative guidelines and expert consensus statements in China and globally. According to the 2025 clinical pathway for the diagnosis and management of pruritus associated with chronic kidney disease in patients undergoing hemodialysis, difelikefalin injection is recommended as a first-line treatment for moderate-to-severe CKD-aP【2】.
Jack Wang, Chairman of WinHealth Pharma, said, “The approval of Kapruvia® in China brings a new treatment option to patients with moderate-to-severe CKD-aP and represents another important milestone for WinHealth Pharma in kidney disease. As an integrated pharmaceutical company guided by our purpose, Patients First, and with a long-standing commitment to kidney disease, we remain dedicated to accelerating access to innovative therapies with proven clinical value for patients in China. Moving forward, we will continue to leverage our global partnerships and local commercial capabilities to expand access to innovation, support improvements in clinical care, and help deliver better long-term outcomes for patients.”
About Chronic Kidney Disease-Associated Pruritus (CKD-aP)
Chronic kidney disease-associated pruritus (CKD-aP) is a common complication in patients with chronic kidney disease（CKD）and is particularly prevalent among those undergoing hemodialysis. Longitudinal, multinational pooled analyses estimate a weighted prevalence of approximately 40% among patients with end-stage renal disease (ESRD), with around 25% of patients reporting severe pruritus. The majority of patients undergoing hemodialysis (approximately 60% to 70%) report experiencing pruritus, including 30% to 40% who report moderate or severe symptoms【15】【16】【17】. Recent data from the ITCH national registry study showed that, among patients with pruritus, approximately 59% experienced symptoms every day or nearly every day for more than one year. Given its association with CKD/ESRD, symptoms in most affected patients persist for months or even years, and currently used antipruritic treatments, such as antihistamines and corticosteroids, do not provide sustained and adequate relief. Moderate-to-severe chronic pruritus significantly impairs quality of life and is associated with depression【18】. CKD-aP is also an independent predictor of mortality in patients undergoing hemodialysis.
About Kapruvia® (difelikefalin acetate injection)
Kapruvia® (difelikefalin acetate injection), developed by Cara Therapeutics, Inc., and acquired by Vifor Fresenius Medical Care Renal Pharma since April 2025, is the first and currently the only therapy approved in 41 countries, including the United States, the European Union (including Iceland, Norway and Liechtenstein), the United Kingdom, Canada, Switzerland, Singapore, Australia and Japan, for the treatment of CKD-aP in adult patients undergoing hemodialysis. It is marketed globally under the brand names KORSUVA® and Kapruvia®.
Difelikefalin, the active ingredient in Kapruvia®, is a kappa opioid receptor agonist that binds to receptors on neurons and immune cells involved in the control of pruritus and inflammation. By binding to these receptors, known as kappa opioid receptors, difelikefalin activates them and inhibits signals that directly lead to the sensation of itch【19】【20】【21】. The hydrophilic peptide structure of difelikefalin limits its entry into the central nervous system (CNS)【22】, distinguishing it from centrally acting kappa opioid receptor agonists. Unlike most opioid therapies, difelikefalin is not a controlled substance and does not cause respiratory depression, among other adverse effects.
In December 2022, WinHealth Pharma entered into a long-term exclusive licensing agreement with Vifor Fresenius Medical Care Renal Pharma (a joint company between CSL Vifor and Fresenius Medical Care) for the development and commercialization of Kapruvia® in PRC. Under the agreement, WinHealth Pharma holds exclusive rights to develop and commercialize the product in PRC.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes within its group of companies, the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 29,000+ people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, CSL.com.
About WinHealth Pharma
WinHealth Pharma is a China-based integrated pharmaceutical company with a core focus on kidney diseases and strategic expansion into hematology and other major therapeutic areas. It possesses comprehensive capabilities across the entire pharmaceutical value chain from research and development to manufacturing and commercialization. Guided by its “Patients-First” philosophy and the mission of “Advancing Health, Empowering Lives,” the company is dedicated to improving patients' quality of life through innovative therapies. By leveraging a multi-strategy-driven business model, WinHealth Pharma connects with global innovations to continuously build a diverse, differentiated, and highly competitive product portfolio. Anchoring a strong presence in China, the company is actively expanding into other Asian markets and key international regions, including Switzerland and Japan. WinHealth Pharma is committed to fostering an open and collaborative healthcare ecosystem, driving industry innovation to meet the evolving needs of patients worldwide. For more information, please visit www.winhealth.hk.
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