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
Unleashing GEN4: a New Era of High-performance, Sustainable Electric Racing Begins21.4.2026 18:54:00 EEST | Press release
The Fédération Internationale de l'Automobile (FIA) and Formula E have unleashed the GEN4 car on track in its debut run in the South of France, signalling the beginning of a new era for electric motor sport. This all-new car will be raced in the 2026/27 Season of the ABB FIA Formula E World Championship. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421618886/en/ Unleashing GEN4: A new era of high-performance, sustainable electric racing begins Capable of speeds over 335kph (208mph), 0-100kph in approximately 1.8s, and 0-200kph in just 4.4s - 1.5s faster than its predecessor. GEN4 produces up to 600kW of power, a 71% increase in base output over GEN3 Evo, and is also the only single-seater with permanent all-wheel drive, promising to deliver the fastest-ever lap times by a Formula E car. As the only all-electric FIA World Championship, GEN4 is both at the pinnacle of motor sport innovation and a testbed for future mobili
Unleashing GEN4: a New Era of High-performance, Sustainable Electric Racing Begins21.4.2026 18:54:00 EEST | Press release
The Fédération Internationale de l'Automobile (FIA) and Formula E have unleashed the GEN4 car on track in its debut run in the South of France, signalling the beginning of a new era for electric motor sport. This all-new car will be raced in the 2026/27 Season of the ABB FIA Formula E World Championship. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260421618886/en/ Unleashing GEN4: A new era of high-performance, sustainable electric racing begins Capable of speeds over 335kph (208mph), 0-100kph in approximately 1.8s, and 0-200kph in just 4.4s - 1.5s faster than its predecessor. GEN4 produces up to 600kW of power, a 71% increase in base output over GEN3 Evo, and is also the only single-seater with permanent all-wheel drive, promising to deliver the fastest-ever lap times by a Formula E car. As the only all-electric FIA World Championship, GEN4 is both at the pinnacle of motor sport innovation and a testbed for future mobili
Resale on the Rise: Klarna's Resell Feature Grows 75% as Consumers Put Real Money Back in Their Pockets21.4.2026 18:00:00 EEST | Press release
New data from Klarna,the global digital bank and flexible payments provider, reveals that its in-app resell feature is gaining significant momentum:listings created through the app grew by up to 75% over the past 13 months*, as consumers increasingly turn to resale as a way to earn real money from items they already own. The data points to a broader shift in financial behaviour: consumers are increasingly treating the things they own not as fixed costs, but as assets with ongoing value. Reselling is becoming routine, not a one-off First launched in Sweden in 2022, Klarna's resell feature is now available across 15 markets, letting users list items for resale directly from their purchase history via leading resale marketplaces such as eBay, Poshmark and Tradera. No need to remember what they paid, find the receipt, or switch to another app. Klarna pre-fills key listing details, making the process as frictionless as possible. It is a convenience that is clearly resonating: returning user
Resale on the Rise: Klarna's Resell Feature Grows 75% as Consumers Put Real Money Back in Their Pockets21.4.2026 18:00:00 EEST | Press release
New data from Klarna,the global digital bank and flexible payments provider, reveals that its in-app resell feature is gaining significant momentum:listings created through the app grew by up to 75% over the past 13 months*, as consumers increasingly turn to resale as a way to earn real money from items they already own. The data points to a broader shift in financial behaviour: consumers are increasingly treating the things they own not as fixed costs, but as assets with ongoing value. Reselling is becoming routine, not a one-off First launched in Sweden in 2022, Klarna's resell feature is now available across 15 markets, letting users list items for resale directly from their purchase history via leading resale marketplaces such as eBay, Poshmark and Tradera. No need to remember what they paid, find the receipt, or switch to another app. Klarna pre-fills key listing details, making the process as frictionless as possible. It is a convenience that is clearly resonating: returning user
Frasca Pilatus PC-12 PRO Flight Training Device Receives FOCA Qualification21.4.2026 17:05:00 EEST | Press release
Frasca International, Inc., a FlightSafety International company and global leader in flight simulation, today announced that its Pilatus PC-12 PRO Flight Simulation Training Device (FSTD) received Level 2 Flight Training Device (FTD2) and Flight and Navigation Procedures Trainer (FNPT II) qualification from Switzerland’s Federal Office of Civil Aviation (FOCA). Frasca is the first to develop a PC-12 PRO training device. The device equipped with Garmin’s G3000 PRIME Avionics suite is installed at Pilatus Aircraft Ltd headquarters in Stans, Switzerland, where it will support training for the next generation of PC-12 pilots. The qualification enables pilots to complete a wide range of instruments, procedural and advanced systems training in a highly immersive environment that mirrors the capabilities of the aircraft. “The PC-12 PRO leads the way with advanced features, and we’re proud to produce a state-of-the-art simulator that allows pilots to seamlessly transition from the FTD to the
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