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
Kingswood Capital Management Raises $4 Billion Across Two Oversubscribed Middle-Market Funds30.7.2026 18:00:00 EEST | Press release
Kingswood Capital Management, L.P. (together with its affiliates, “Kingswood”), a Los Angeles-based investment firm focused on the middle-market, today announced the final closing of Kingswood Capital Opportunities Fund IV, L.P. (together with its parallel fund, “Fund IV”), with total capital commitments of $3.1 billion, as well as Kingswood Capital Opportunities Small Cap Fund I, L.P. (together with its parallel fund, “Small Cap Fund I”), with total capital commitments of $900 million. These funds more than double Kingswood’s total assets under management (“AUM”) to over $7 billion. Fund IV represents the fourth institutional fundraise in five years for Kingswood and is more than double the size of Fund III. Both Fund IV and the inaugural Small Cap Fund I were significantly oversubscribed in just five weeks. Fund IV exceeded its initial target of $2.25 billion, while Small Cap Fund I exceeded its initial target of $550 million and both closed at their hard caps. The successful fundrai
CyrusOne Names John Hatem Chief Executive Officer to Accelerate its Global Digital Infrastructure Strategy30.7.2026 16:30:00 EEST | Press release
CyrusOne (the “Company”), a leading global data center owner, developer and operator, today announced the appointment of John Hatem as Chief Executive Officer and a member of the Company’s Board, effective immediately. As part of the Company’s long-term succession planning, Eric Schwartz, who successfully led CyrusOne through a period of significant expansion, is stepping down as CEO and will work together with Hatem to ensure a smooth transition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730005910/en/ John Hatem Hatem joined CyrusOne in 2011 and has held a series of increasingly senior roles across the business. He most recently served as President, responsible for global sales, global procurement, and design, engineering, and construction in the United States. His deep experience in data center design, development, and operations has helped transform CyrusOne into one of the world’s leading digital infrastructure p
Mary Kay Releases 2026 Sustainability Report Highlighting Transformative Progress Across Social, Economic, and Environmental Impact Globally30.7.2026 15:03:00 EEST | Press release
Mary Kay Inc., a leading global beauty company committed to sustainability and women’s empowerment, today released its 2026 Sustainability Report, outlining progress toward its 2030 goals and celebrating the 2025 and latest achievements that continue to drive positive change globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730240667/en/ Mary Kay's annual 2026 Sustainability Report highlights the company's decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in Mary Kay's mission of “enriching women’s lives” around the world. (Image Credit: Mary Kay Inc.) The annual report highlights Mary Kay’s decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in the company’s mission of “enriching women’s lives”
Veracode Launches “Veracode Marketplace”: A Curated Ecosystem of Elite Security Integrations Built for the AI-Powered Software Development Era30.7.2026 15:00:00 EEST | Press release
Veracode, the global leader in application risk management, today announced the launch of the Veracode Marketplace, a curated ecosystem that gives customers a single, trusted destination to discover, evaluate, and deploy third-party security integrations as an extension of the Veracode platform. The marketplace debuts with DryRun Security as its inaugural partner, delivering AI-native contextual analysis and verification to Veracode customers on day one. A New Standard for the AppSec Ecosystem The Veracode Marketplace enables security and engineering teams to extend their existing Veracode investment with validated, best-in-class integrations. Every partner is vetted for technical depth, product quality, and workflow fit. Integrations are anchored to Veracode findings for a unified audit trail, and every purchase goes through a single procurement path on a single contract, with a personalized support experience. “Application security has entered a new era, and no single vendor will sol
INNIO Awarded EcoVadis Platinum Medal for Fifth Consecutive Year30.7.2026 15:00:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) has been awarded the EcoVadis Platinum Medal, the highest recognition granted by the globally trusted provider of business sustainability ratings. This marks the fifth consecutive year that INNIO has achieved Platinum status since 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730309718/en/ INNIO N.V. Awarded EcoVadis Platinum Medal for Fifth Consecutive Year In the latest assessment cycle, INNIO further improved its overall EcoVadis score compared to the previous year by introducing additional policies and further strengthening its sustainability management system. “This recognition is a strong validation of our sustainability strategy,” said Marcin Kawa, Vice President Sustainability at INNIO. “Achieving EcoVadis Platinum status for the fifth consecutive year shows that we have consistently delivered on our sustainability commitments and embedded responsible business practices throughout
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