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
Pierre Le Manh to Step Down as PMI President and CEO21.9.2026 15:45:00 EEST | Press release
Project Management Institute (PMI), the leading authority in project management, today announced that Pierre Le Manh has decided to step down as President and Chief Executive Officer, effective September 30, 2026. Johannes Heinlein, Chief Growth Officer, has been appointed Interim President & Chief Executive Officer of PMI, also effective September 30, 2026. Pierre Le Manh joined PMI in September 2022. During his four-year tenure, he led the development and execution of PMI’s current strategy, strengthened its leadership team, expanded its capabilities through acquisitions and partnerships, and positioned PMI for a profession being rapidly transformed by artificial intelligence and a greater focus on project success. “On behalf of the Board, I want to thank Pierre Le Manh for his leadership and his commitment to PMI,” said Ike Nwankwo, Chair of the PMI Board of Directors. “PMI has a clear strategy, a strong leadership team and significant momentum. Pierre leaves the organization well p
Lenovo and Schneider Electric Partner to Bring Decarbonization Tools and Expertise to IT Channel Partners21.9.2026 15:10:00 EEST | Press release
Lenovo today announced that Schneider Electric, a global energy technology leader, will join Lenovo 360 Circle as a strategic ally to bring decarbonization expertise and management tools directly to IT channel partners. Lenovo 360 Circle is Lenovo’s global sustainability community, bringing together channel partners worldwide to collaborate on shared challenges, accelerate sustainability transformation, and turn sustainability ambitions into business opportunities. Through its Allyship program, Lenovo 360 Circle connects partners with leading technology and industry organizations to enable collaboration and provide access to specialized expertise that helps partners accelerate their sustainability goals. As its newest strategic ally, Schneider Electric will bring its Decarbonization Champion initiative to the community, giving eligible members access to carbon management tools and hands-on support from Schneider Electric Advisory Services specialists to measure their emissions, identif
Serbian Biotech Startup Takes Its Journey from Belgrade to Cambridge with Documentary on Longevity Science21.9.2026 14:02:00 EEST | Press release
BioEridan, a Serbian biotechnology startup backed by Telekom Srbija Group’s TS Ventures Fund, has premiered a new documentary showcasing its development of underwater Aquafarms and its ambition to contribute to the next generation of longevity science. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921345879/en/ BioEridan Documentary Premiere BioEridan: Science Beneath the Surface premiered in Belgrade on September 15 before being screened the following day at a UK-Serbia Health, Digital Transformation & Innovation roundtable held at Christ’s College, University of Cambridge, as part of Cambridge Tech Week 2026. The roundtable brought together prominent representatives from the UK and Serbia across science, healthcare, technology, academia and business to discuss opportunities for collaboration, innovation and the commercialisation of scientific research. The documentary follows BioEridan’s development from an early scien
LabVantage Named a Visionary Leader in Life Sciences and Industrial LIMS by Frost & Sullivan21.9.2026 11:30:00 EEST | Press release
LabVantage Solutions, Inc., a leading global provider of laboratory informatics solutions and services, has been named a Visionary Leader in two 2026 Frost Radar™ reports by Frost & Sullivan: Frost Radar™: Life Sciences Laboratory Information Management Systems, 2026 and Frost Radar™: Laboratory Information Management Systems in Industrial Applications, 2026. Announced at LabVantage’s Customer Training and Education Conference (CTEC) Europe 2026 in Paris, the dual recognition marks LabVantage’s fourth consecutive year of Frost Radar leadership. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260921487430/en/ The Frost Radar is an independent benchmarking analysis that evaluates companies on a Growth Index and an Innovation Index. The Growth Index measures a company’s growth performance, track record, and ability to execute its growth strategy, while the Innovation Index assesses its ability to develop globally applicable solu
Bending Spoons opens office in Warsaw as Polish applications reach 50,000 in 202621.9.2026 10:15:00 EEST | Press release
Bending Spoons has opened an office in Warsaw, adding to its Milan headquarters and locations in London and Madrid. The technology company, whose portfolio includes Eventbrite and WeTransfer, has seen a sharp rise in applications from Poland and will use the new base to recruit locally for roles across key projects. “We’ve received around 50,000 applications from Poland so far this year, more than twice as many as the whole of 2025. What stands out isn’t just the volume. Many Polish candidates are among the strongest we see in our selection process, and the student talent has been particularly impressive. More than half of our recent hires from Poland were still studying when they applied,” says Andrea Maiorana, Talent data lead. Located in Śródmieście, Warsaw’s city center, the office is within walking distance of the Presidential Palace and the University of Warsaw. Bending Spoons encourages all new hires to spend their first few months in Milan, with travel and accommodation costs f
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