VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China
30.4.2021 08:00:00 EEST | Business Wire | Press release
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
Radial Selects Riskified to Power Payment Fraud and Refund/Return Protection for Merchant Client Portfolio9.3.2026 16:00:00 EET | Press release
Riskified (NYSE: RSKD), a leader in ecommerce fraud and risk intelligence, today announced a strategic partnership with Radial, a leading 3PL set to become Paxon later this year. Radial will integrate with Riskified’s AI-powered platform to help its merchants approve more legitimate orders and reduce losses from payment fraud, including many merchants that use Shopify as their ecommerce platform. Radial supports many of the world’s most recognized retail brands with a global ecommerce fulfillment network of more than 20 centers across North America, helping merchants deliver orders quickly and cost effectively. By bringing Riskified’s AI-powered fraud decisioning into its commerce ecosystem, Radial gives merchants the surgical ability to calibrate the checkout experience according to risk—without slowing fulfillment. This also supports brands seeking to expand into new markets. Riskified empowers Radial's customers with accurate, real-time fraud decisions at checkout, approving or decl
Andersen to Announce Fourth-Quarter and Full-Year 2025 Financial Results9.3.2026 16:00:00 EET | Press release
Andersen Group Inc. (NYSE: ANDG) (“Andersen”), a leading provider of independent tax, valuation and financial advisory services to individuals and family offices, businesses and funds in the United States, will announce its financial results for the full year and fourth quarter 2025 after the market closes on Tuesday, March 17, 2026. Andersen CEO and Chairman, Mark L. Vorsatz, and Andersen Chief Financial Officer, Neal Livingston, will host a conference call to discuss Andersen’s financial results on Tuesday, March 17, 2026 at 5PM ET. Participants can join the webcast at https://event.choruscall.com/mediaframe/webcast.html?webcastid=J3Hvslre. The webcast replay link will be archived on Andersen’s Investor Relations website at investor.andersen.com within a few hours of the event and will remain on the website for six months. About Andersen Andersen is a leading provider of independent tax, valuation and financial advisory services to individuals, family offices, businesses and alternat
Safe Software Announces the Peak of Data and AI 2027, a Premier Global Conference, in London, UK9.3.2026 15:00:00 EET | Press release
Safe Software (Safe) officially announced today the return of its global user conference, the Peak of Data and AI, taking place March 9–11, 2027, at the QEII Centre in London, UK. A Partner Summit will kick off the event on March 8, 2027, bringing together Safe’s global partner community ahead of the main conference. Hosted every two years, the Peak of Data and AI has evolved from Safe Software’s long-running user conference into a premier global event for data and AI professionals. The conference alternates between North America and international locations, with previous events held in Bonn, Germany (2023) and Seattle, Washington (2025). “At the Peak of Data and AI, we bring together the people who are shaping how organizations use data to drive real-world outcomes,” said Don Murray, CEO of Safe Software. “With London as our host city in 2027, we’re excited to connect with the global community to learn, listen, and share what’s next for data and AI.” The three-day conference will feat
Boomi Activates Data for the Enterprise9.3.2026 15:00:00 EET | Press release
Boomi™, the data activation company, today announced new capabilities within the Boomi Enterprise Platform. Data activation brings data to life across systems and processes, delivering it with the right context and timing to power everything from AI to BI. The Boomi Enterprise Platform, the foundation that puts data in motion, now adds new semantic context to help AI agents operate on grounded business realities, expands governed SAP data movement with change data capture, enhances transparency and oversight across agentic workflows, and introduces a dedicated European platform instance for localized data control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260309682526/en/ Boomi Activates Data for the Enterprise “Last year, Boomi helped enterprises move from experimentation to execution. What we’re seeing now is clear: AI only delivers value when data is properly activated, trusted and governed first,” said Steve Lucas,
Thredd Accelerates in 2026 with its Global Platform and Delivering Enterprise-Scale Outcomes9.3.2026 15:00:00 EET | Press release
Thredd, the AI-first issuer processing platform, today announced a major acceleration phase for 2026, marked by the appointment of Marilyn McDonald as Chief Technology Officer and the promotion of Ryan Dew to Chief Product Officer. Thredd has never been in a stronger position. A fully cloud-native version of its global platform is live in the United States, with end-to-end credit capabilities launching in the coming months alongside a state-of-the-art debit platform and modern unified ledger. Marilyn McDonald joins as CTO to lead the next phase of enterprise-scale execution. She succeeds Edwin Poot, who helped lead the modernisation of Thredd’s architecture and technology stack, laying the foundation for cloud-native and agentic growth. Marilyn brings global transformation experience from senior roles at Citigroup, Mastercard, Expedia Group and StubHub. Her focus is on strengthening operational readiness, bank-grade delivery, enterprise execution and continuous resilience as Thredd sca
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