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
The Smarter E Europe Sends a Strong Message: the Energy Future Is Renewable17.6.2026 17:09:00 EEST | Press release
Europe is once again facing an energy crisis, another reminder of just how vulnerable our fossil fuel-based energy system is. Yet the current crisis is also accelerating the energy transition and the adoption of electromobility. The objective is to reduce dependence on imports of fossil-based raw materials and thereby increase resilience. This year, The smarter E Europe, Europe’s largest alliance of exhibitions for the energy industry, is sending a strong and clear message with its new special exhibit Renewables 24/7: Renewable energies ensure a secure, reliable and affordable energy supply every day, around the clock. This message is scientifically supported by a new study from the Fraunhofer Institute for Solar Energy Systems ISE, which will be presented on June 23. From June 23–25, around 2,800 exhibitors will present groundbreaking, market-ready and cross-system technologies for a 24/7 renewable energy supply at Messe München. More than 100,000 visitors are expected. This press rel
Xsolla Sponsors Game Camp France, Reinforcing Commitment to France’s Dynamic Games Ecosystem17.6.2026 16:47:00 EEST | Press release
Xsolla, a global video game commerce company that helps developers launch, grow, and monetize their games, today announced its sponsorship of Game Camp France this 18-19 June 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617351463/en/ Graphic: Xsolla The French video game industry is widely recognized as one of the most vibrant in Europe, with revenue reaching approximately €5.8 billion in 2025. Rather than a centralized market, it is a patchwork of regional scenes, each with its own communities, creative identity, and business dynamics. Game Camp France plays a key role in bringing these diverse voices together, creating a centralized space for collaboration, exchange, and growth. By sponsoring Game Camp France, Xsolla is investing directly in the local ecosystem and the developers who power it. Xsolla will be on-site to engage with studios, share insights, showcase its product offerings, and better understand the
The Estée Lauder Companies and Jo Malone London Launch Experience That Turns Visual Taste into a Personalized Fragrance Wardrobe, exclusively on Pinterest17.6.2026 16:26:00 EEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) and Jo Malone London today announced the launch of Scent Scanner, a first-of-its-kind experience available exclusively on Pinterest and rolling out in the US and France. The experience translates the visual preferences people have expressed across their Pinterest boards into personalized Jo Malone London fragrance recommendations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617962807/en/ Building on the success of Jo Malone London's AI Scent Advisor, introduced in 2025, Scent Scanner offers a new way for consumers to find their personalized scent, shifting the starting point from words to images. While the AI Scent Advisor invited consumers to describe the scent they were seeking, Scent Scanner reads visual inspiration – imagery, color palettes, textures, destinations, rituals and aesthetics – to suggest fragrances suited to each individual. The custom Pinterest experience bri
Azul Addresses the Java Runtime Security Blind Spot Autonomous AI Can Now Exploit17.6.2026 16:00:00 EEST | Press release
Azul, the trusted leader in enterprise Java for today’s AI and cloud-first world, today launched a free JVM vulnerability risk assessment to address the blind spot that autonomous AI exploitation tools are increasingly able to find. With mean time to exploit (MTTE) collapsing from months to days or hours, the unmanaged Java estate has become an urgent enterprise security vulnerability. Azul’s assessment gives DevOps and SecOps teams complete visibility into the hidden risks embedded in the runtime of their Java estate before threat actors get there first, and is designed to complement the broader security, licensing and compliance solutions and services delivered by Azul’s trusted partners. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617352753/en/ Azul's JVM Vulnerability Risk Assessment dashboard. The Threat Landscape Has Transformed For most of Java’s enterprise history, a sophisticated exploit required a sophisticat
Hologic’s New Sustainability Report Marks 40 Years of Impact17.6.2026 16:00:00 EEST | Press release
Hologic, Inc., a global leader in women’s health, today released its 2025 Sustainability Report. The new report coincides with Hologic’s 40th anniversary and underscores how the company’s longstanding purpose — to enable healthier lives for women everywhere, every day — continues to drive progress for patients, communities and the planet. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260617160174/en/ Hologic 2025 Sustainability Report “We have always firmly believed that our success as a company is fundamentally tied to our ability and commitment to help women worldwide live healthier lives,” said Sharon Vidal, Chief Sustainability Officer at Hologic. “Together with our customers and partners, we’re taking measurable steps to increase global access to innovative medical technologies while pursuing a more sustainable and equitable future for all.” Hologic’s Sustainability Report details progress on environmental sustainabili
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