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
Rising Global Bullion Market Risks Are Forcing European Investors to Rethink Physical Gold Access3.2.2026 11:35:00 EET | Press release
As volatility reshapes global financial markets, European institutional investors are turning to safe-haven assets. While physical gold remains one of the world's most resilient and attractive store-of-value assets, secure and verifiable access to bullion has become increasingly difficult. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203826775/en/ Illustrative image of physical gold bullion bars. (Photo: AETOSWire) Recent industry developments have placed structural pressure on the gold market. Elevated price levels have heightened concerns around counterfeit bars, fragmented supply chains, and the complexity of cross-border custody. For European institutions operating under strict regulatory oversight, the challenge is no longer whether to allocate to gold — but how to do so safely, transparently, and within established compliance frameworks. To this end, Golden Ark Reserve, operated by Golden Ark General Trading (FZC)
Hyper-Personalization at Scale: Why Brands Must Shift to an Agentic AI Strategy3.2.2026 11:00:00 EET | Press release
Global AI-first cloud communications platform Infobip, celebrating two decades of innovation, predicts an imminent and seismic shift in brand-consumer engagement. Moving away from the current application-to-person (A2P) messaging, Infobip forecasts a widespread shift to an agent-to-person model, eventually leading to a fully autonomous agent-to-agent future by 2030. The Evolution of Engagement Swift AI adoption is driving enterprises toward agentic AI communication models, which drive autonomous customer communications across all touchpoints. This technology enables hyper-personalization across multiple channels, creating highly engaging content tailored to individual needs. Silvio Kutić, Infobip CEO, comments: “How we communicate with brands is constantly evolving. In this new agentic AI world, brands must seize the opportunity to take a holistic approach to communication. They must capitalize on the hyper-personalization made available through agentic AI and rich communication channe
Generali Deutschland AG Selects Clearwater Analytics to Modernize and Scale Investment Operations Unit-Linked Fund Business3.2.2026 10:00:00 EET | Press release
Clearwater Analytics (NYSE: CWAN), the most comprehensive technology platform for investment management, announced today that Generali Deutschland AG has selected CWAN’s investment management platform for its €40 billion unit-linked fund (ULF) life insurance business, unifying processes across four subsidiaries and preparing the group for accelerated growth in one of Europe’s fastest-expanding sectors. The partnership reflects a strategic move ahead of unprecedented market expansion. The global unit-linked insurance market reached $906.9 billion in 2023 and is projected to grow at 10.9% annually through 2032, reaching $2.3 trillion, according to Allied Market Research. This growth trajectory is creating competitive separation between insurers capable of scaling operations and those constrained by fragmented systems across multiple European jurisdictions. Under a multi-year agreement, Generali Deutschland will consolidate portfolio management, order execution, and reconciliation on CWAN
Corona Cero Unveils Global Roster of Athlete Ambassadors to Champion TIME CERO at Milano Cortina 20263.2.2026 10:00:00 EET | Press release
Corona Cero today unveiled its global roster of brand ambassadors who will champion TIME CERO, the brand’s new initiative created in partnership with the IOC and Athlete365, throughout the Olympic Winter Games. Together, Team Corona Cero will bring the brand’s “For Every Golden Moment” global platform to life, reminding people that meaningful golden moments can happen anytime, anywhere, or in any season. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203205858/en/ Team Corona Cero Central to Corona Cero’s commitment as a Worldwide Olympic Partner, TIME CERO is designed to celebrate Olympians and help them relax, stay present, and embrace balance amid the intensity of competition. Activated across a range of Olympic Games locations, all Winter Olympians at Milano Cortina 2026 will be able to embrace TIME CERO through nature-inspired spaces and post-competition retreats. “'For Every Golden Moment’ is more than medals or mil
Ares Completes Acquisition of BlueCove to Launch Systematic Credit Strategy3.2.2026 10:00:00 EET | Press release
Ares Management Corporation (NYSE: ARES) (“Ares”), a leading global alternative investment manager, announced today that it has completed its acquisition of all outstanding shares of BlueCove Limited (“BlueCove”), a London-based systematic fixed-income manager. The integrated BlueCove business will operate as Ares Systematic Credit, the latest strategy within the Ares Credit Group. Ares Systematic Credit offers systematic fixed-income strategies that harness the power of data and technology to deliver differentiated solutions to investors. The strategy leverages proprietary technology to support an evidence-based and data-driven investment process across high-yield, investment grade corporates, convertible bonds, and other liquid credit instruments in a variety of portfolio constructions. These methods seek to systematically access, select, analyze and deploy information to capitalize on market inefficiencies and generate high-quality alpha. Led by Alex Khein, most recently CEO of Blue
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