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
TestMu AI Announces Day-Zero Support for macOS Golden Gate and iOS 27 Beta Following WWDC 202610.6.2026 22:52:00 EEST | Press release
TestMu AI (formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced day-zero support for Apple's newly unveiled operating systems, macOS Golden Gate and iOS 27 Beta, across its cloud testing platform. Announced at Apple's Worldwide Developers Conference (WWDC) 2026, macOS Golden Gate and iOS 27 introduce significant platform updates that will impact application compatibility, user experience, and performance. Both operating systems are now available for testing on TestMu AI, the same day Apple released its beta versions, allowing engineering teams to identify issues months before the stable rollout reaches millions of users worldwide. macOS Golden Gate is available through the TestMu AI Real Time Testing platform, while iOS 27 Beta is available on TestMu AI Real Device Cloud across the latest iPhones and iPads. "WWDC marks the start of a critical testing window for every team that ships on Apple platforms," said Mudit Singh, Co-Founder
Pure Lithium Corporation Named World Economic Forum Technology Pioneer10.6.2026 21:10:00 EEST | Press release
Pure Lithium Corporation, a disruptive lithium metal battery technology company, is pleased to announce that the company has been selected as a 2026 Technology Pioneer by the World Economic Forum. Launched in 2000, the Technology Pioneers is a leading community for companies from around the world that are shaping the future through breakthrough technologies and innovations. These companies are selected for their potential to have a significant impact on business and society and are invited to engage with public and private sector leaders through the World Economic Forum’s global platform. “We are delighted to be selected as a World Economic Forum Technology Pioneer. I would like to express my gratitude to the World Economic Forum for this honor,” said Pure Lithium Founder, Chairman and CEO, Emilie Bodoin. “Pure Lithium’s selection is a testament to our breakthrough lithium metal battery technology. We are constantly reminded of the urgent need for a battery that is more energy efficien
Visa Partners with OpenAI to Power the Next Generation of AI Commerce10.6.2026 21:00:00 EEST | Press release
Visa (NYSE: V) today announced a strategic collaboration with OpenAI to enable secure Visa payments within agentic commerce, enabling seamless and trusted payments across OpenAI. The companies made the announcement at the Visa Payments Forum in San Francisco. Through the partnership, Visa will provide its global network, credentialing capabilities and security infrastructure to support agentic commerce experiences, helping consumers and businesses interact and transact with confidence. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610422687/en/ The collaboration is part of the broader Visa Intelligent Commerce initiative, which is focused on extending secure payment capabilities into new digital environments. Together, Visa and OpenAI will also explore a range of enterprise applications, including developer-focused experiences powered by Codex, as well as more automated and conversational workflows, as AI continues to ev
Visa Announces New AI, Stablecoin and Token Innovations to Power Intelligent, Programmable Commerce at Visa Payments Forum10.6.2026 21:00:00 EEST | Press release
At Visa Payments Forum 2026, Visa (NYSE: V) today announced new AI, stablecoin and token capabilities designed to help clients unlock the next generation of commerce. These innovations reflect a simple objective: ensuring trust, security and control evolve alongside increasingly fast, automated and intelligent commerce experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610464331/en/ In a keynote presentation, Jack Forestell, Chief Product & Strategy Officer at Visa, outlined how two foundational shifts—artificial intelligence and stablecoins—are transforming both the front end and back end of money movement, and how Visa is enabling clients to participate. “AI is transforming the front end of commerce. Stablecoins are reshaping the back end,” said Forestell. “Visa’s role is to enable it to work securely, reliably and at global scale, for every participant in the ecosystem.” Powering the Front End of Commerce—and
NEURA Robotics Announces Record Series C of up to $1.4 Billion to Accelerate the World’s Leading Physical AI Platform10.6.2026 18:26:00 EEST | Press release
NEURA Robotics (“NEURA”), the pioneer in cognitive robotics and creator of the Neuraverse, today announced a landmark Series C financing with a total round size of up to $1.4 billion to accelerate its mission of building the world’s leading Physical AI platform. The financing brings together global leaders across AI, robotics, compute, manufacturing and industrial infrastructure, including Tether, Qualcomm Technologies, Inc., Amazon, NVIDIA, imec.xpand, Bosch, Schaeffler, European Investment Bank, Lingotto Horizon, InterAlpen Partners and others. NEURA is building a new category of AI infrastructure where cognitive robots continuously learn, collaborate and operate across real world environments through a shared intelligence ecosystem called the Neuraverse. Unlike traditional robotics companies focused on isolated machines or narrow industrial automation, NEURA combines robotics, AI, sensors, edge compute and large scale learning infrastructure into one unified platform architecture de
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