VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China
Regulatory News:
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced positive results from a phase-III study in China (PA-CL-CHINA-01), evaluating the efficacy of Velphoro® (PA21) compared to sevelamer carbonate in lowering and maintaining serum phosphorus in adult Chinese patients with chronic kidney disease (CKD) on dialysis after 12 weeks of treatment. The study met its primary endpoint demonstrating non-inferiority versus sevelamer carbonate in the change from baseline in serum phosphorus levels at week 12.
Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group commented, “We are delighted by the positive results from the PA-CL-CHINA-01 study, which confirm previous data generated in the US and Europe, and reinforce the potential of Velphoro® as an important new treatment option for dialysis patients with hyperphosphatemia in China where there is a high prevalence of CKD1. This is another important step in our geographic expansion and will further strengthen the position of Velphoro® as a global leader in the calcium-free phosphate binder market2.”
Importantly, patients who received Velphoro® experienced additional benefits compared to those in the sevelamer control group: Serum phosphorus levels in patients treated with Velphoro® declined faster than in the sevelamer group and the average number of tablets taken daily (3.23) was significantly lower than with sevelamer carbonate (6.31). Safety results were consistent with the known safety profile of Velphoro® with no new safety signal observed in Chinese CKD patients with hyperphosphataemia.
VFMCRP intends to submit the Chinese New Drug Application to the National Medical Products Administration’s CDE at the end of 2021.
About the PA-CL-CHINA-01 study
This phase-III study was designed to demonstrate non-inferiority of the change from baseline at week 12 in serum phosphorus between PA21 (Velphoro®) and sevelamer carbonate, and support market expansion of Velphoro® to China. PA-CL-CHINA-01 was an open-label, active-controlled, parallel group, multicenter study with a total of 286 patients randomized: 142 in the Velphoro® arm and 144 in the sevelamer arm. No major protocol deviation related to COVID-19 were reported and no patients were excluded from the Per Protocol Set (PPS) due to COVID-19.
About Velphoro®
Velphoro® is a non-calcium, iron-based, chewable phosphate binder approved for the control of phosphate levels in the blood of adults with CKD on dialysis. Velphoro® has been launched in over 30 countries, with more than 100,000 patients estimated to use the drug on a yearly basis. In 2020, Velphoro® became a global leader by value in the calcium-free phosphate binder market2.
References:
1 Zhang et al. Lancet. 2012 Mar 3;379(9818):815-22; Guo et al. Int J Environ Res Public Health 2016; 13: E770; Guo et al. Curr Cardiol Rev. 2013 May; 9(2): 112–122.
2 Monthly IQVIA MIDAS panel, INSIGHT Health & DN, GERS, DLI, Farminform | 03.2020.
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210429005950/en/
Contact information
Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com
Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
OAG Appoints ex-Skyscanner Executive Filip Filipov as New Chief Executive Officer16.12.2025 18:00:00 EET | Press release
OAG announces today the appointment of Filip Filipov, ex-Skyscanner executive, as new Chief Executive Officer. Filip Filipov currently serves as the company’s Chief Operating Officer and takes over from Phil Callow who has chosen to step down having completed thirteen transformational years at the helm of OAG to pursue his many other interests. Since joining in 2024, Filipovhas played a leading role in the company’s ambitious next phase of growth and ongoing acceleration. He will now lead OAG into a new era defined by advanced data products and AI-driven intelligence. Before joining OAG, Filipov held senior roles in travel technology and big-data consulting, including on Skyscanner’s executive team. Filip Filipov said: “It’s a privilege to step into this role and lead a company with such a strong heritage and reputation. I’m excited for what’s ahead and committed to serving our customers with the reliability, service, and innovation they depend on.” Chairman of OAG, Gehan Talwatte, com
Xsolla Integrates SPENN in Rwanda and Zambia Giving Developers Access to a Strong Consumer-Merchant Ecosystem16.12.2025 17:49:00 EET | Press release
Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announced that it has added SPENN to its payments solution portfolio in Rwanda and Zambia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216303338/en/ Xsolla Integrates SPENN In Rwanda And Zambia Giving Developers Access To A Strong Consumer-Merchant Ecosystem Both Rwanda and Zambia are mobile-first, wallet-led economies where mobile money drives financial inclusion and rapid growth in digital transactions. Reports found that approximately 86% of Rwandan adults own or have used mobile money. As of mid-2024, mobile money transaction volumes in Zambia increased by 44% to 1.4 billion transactions from mid-2023. By adding SPENN as a payment method to its portfolio, Xsolla enables players to continue paying seamlessly in a way they are already familiar with. Key benefits of the SPENN integration include: Streamline
New Survey of Nearly 4,300 C-suite Leaders Reveals Intensifying Demand for Faster Innovation, Higher ROI and Stronger Business Resilience16.12.2025 16:00:00 EET | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, managed services and Agentic AI ERP innovation solutions, and the leading third-party support provider for Oracle, SAP and VMware software, today announced the findings of its new global survey, “C-suite Imperatives: Accelerating Innovation in a Shifting Landscape.” The research was conducted in partnership with Censuswide surveying nearly 4,300 CFOs, CIOs, CEOs and CISOs across the globe, examining the pressures influencing executive-level technology decisions and the priorities shaping their investment strategies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251216456670/en/ New Survey of Nearly 4,300 C-suite Leaders Reveals Intensifying Demand for Faster Innovation, Higher ROI and Stronger Business Resilience The analysis shows executives are recalibrating their strategies around AI, automation and resilience as boards push
Enersense Selects Sitetracker as the Platform of Choice for 5G and Fiber Expansion Initiatives16.12.2025 16:00:00 EET | Press release
Sitetracker, the global leader in complete Asset Lifecycle Management, announced that Enersense, a leading lifecycle partner for customers operating in energy transmission and production, industrial energy transition and telecommunications services across Finland and the Baltics, has selected Sitetracker to digitize and scale its operations. The implementation enabled Enersense to replace legacy systems, standardize workflows, and support their ability to deliver services with short lead times and high process precision. The first phase of implementation is already supporting Finland’s 5G and rapidly expanding fiber-to-the-home (FTTH) initiatives. Before Sitetracker, Enersense relied on spreadsheets and email to manage project execution, resulting in limited visibility into project milestones, asset tracking, and field performance. As 5G and FTTH deployment accelerated, these manual processes created operational bottlenecks, slowed invoicing, and hindered communication with customers a
Sutherland and ComplyAdvantage Launch AI-Native "Unified FinCrime Compliance" Solution to Combat Sophisticated, Next Generation Financial Crime16.12.2025 16:00:00 EET | Press release
Sutherland, a global leader in business and digital transformation, today announced a strategic partnership with ComplyAdvantage, a leading AI-driven risk intelligence platform. The collaboration introduces a comprehensive, AI-driven financial crime (FinCrime) management solution designed to help banks and Fintechs respond to the rapid rise of AI-designed fraud, complex AML risks, fast-evolving financial crime threats, and complex compliance requirements. Today, financial crime requires sophisticated, AI-intelligence-based solutions, as traditional risk and compliance controls cannot keep up. The Sutherland-ComplyAdvantage solution transforms FinCrime management by delivering a single AI-native intelligence layer that continuously enhances screening, transaction monitoring, fraud prevention, case investigations, and regulatory reporting. This solution delivers consistent compliance, which is scalable and balances compliance and customer experience. “Financial crime today behaves like a
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom