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
Calix CEO Michael Weening To Keynote at MWC26 Barcelona: How Agentic AI Enables an ‘Experience of One’ for Every Subscriber5.2.2026 21:30:00 EET | Press release
Calix, Inc. (NYSE: CALX) today announced that President and Chief Executive Officer Michael Weening will deliver a keynote in the Tuesday morning, March 3, “Architects of the AI Age” session at MWC26 Barcelona. Calix’s presence at MWC, the world’s largest and most influential connectivity event, extends the momentum following the recent launch of the company’s AI‑native platform. Weening will take the MWC Main Stage on Tuesday morning to reveal a transformative vision for telecommunications: how agentic AI enables service providers to deliver an “experience of one” to millions of subscribers simultaneously—personalizing every interaction in real time, unlocking new revenue streams, and fundamentally redefining what it means to grow in the connected world. He will be joined onstage by leading AI researcher and author Kate Crawford, a globally recognized voice in AI ethics, to explore how this transformation goes beyond automation. They will address how responsible agentic AI can amplify
Verimatrix: Sale of Extended Threat Defense Assets (Mobile Application Protection) to Guardsquare5.2.2026 18:45:00 EET | Press release
Regulatory News: Verimatrix, (Euronext Paris: VMX), a leading provider of security solutions for a safer connected world, today announced that it has completed the sale of 100% of its Extended Threat Defense (XTD) assets to Guardsquare, a Belgian company and leader in mobile application security. This transaction follows the signing of an agreement announced in a press release on December 8, 2025, as well as regulatory approval. It is part of Verimatrix's overall strategy to refocus on its core business, reflecting the group's strategic decision to concentrate on the key growth segments of the video protection market. Commenting on the announcement, Laurent Dechaux, CEO of Verimatrix, said: “Verimatrix has a strong technological foundation that enables our teams to pursue new business opportunities. Our priorities are to identify key growth drivers, address our clients’ needs effectively, and optimize resource allocation. I look forward to presenting these strategic initiatives to the
Andersen Consulting Enters Into Collaboration Agreement With Alfa Group5.2.2026 16:30:00 EET | Press release
Andersen Consulting adds depth to its cybersecurity offering with collaborating firm Alfa Group, a leading technology firm with nearly three decades of experience helping organizations safeguard and optimize their operations. Founded in 1996 and headquartered in Rome, Alfa Group delivers advanced solutions in cybersecurity, fraud detection and prevention, incident response, and vulnerability management, as well as select business process management services. Its proprietary technology, N.O.V.A., is an end-to-end managed service that integrates Alfa Group’s innovations with third-party systems to safeguard digital infrastructures, mitigate risk, and enhance operational efficiency. The firm serves clients across industries including finance and insurance, defense and aerospace, telecom, manufacturing, energy, and pharmaceutical. "Our collaboration with Andersen Consulting allows us to extend our reach and deliver greater value to clients navigating the complexities of digital transformat
Duna, Built by Stripe Veterans, Raises €30 Million CapitalG-led Series A to Solve Business Identity For The Internet5.2.2026 16:00:00 EET | Press release
Duna, the identity fintech founded by two Stripe alumni, today announced a €30 million Series A funding round led by CapitalG, Alphabet’s independent growth fund. Existing investors Index Ventures, Puzzle Ventures and Snowflake Chairman Frank Slootman also participated in the round. The company, based in Germany and the Netherlands, was launched in 2023 by Duco van Lanschot, who was head of Benelux and DACH at Stripe for three years, and David Schreiber, who spent six years at Stripe where he ran the company’s largest global business unit, including the core card payment platform. In May 2025, the company announced a €10.7 million seed round led by Index Ventures. The latest fundraise brings Duna’s total funding to more than €40 million. Duna’s mission is to build global trust infrastructure by providing a digital passport for every business. Over time, this will evolve into a network for shareable identity and one-click onboarding. Today Duna’s AI-native business identity platform ser
AI-Powered Experian Assistant for Model Risk Management Wins 2026 BIG Innovation Award5.2.2026 16:00:00 EET | Press release
Experian today announced that its recently launched, AI‑powered Experian Assistant for Model Risk Management has been awarded the 2026 BIG Innovation Award in the Innovative Products category. Recognizing trailblazers across industries since 2014, this global award celebrates exceptional innovation and the value it brings to a recipient’s clients, stakeholders and community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260205042051/en/ Experian's recently launched, AI-powered Experian Assistant for Model Risk Management has been awarded the 2026 BIG Innovation Award in the Innovative Products category. Fully integrated into the Experian Ascend Platform™ and powered by ValidMind technology, Experian Assistant for Model Risk Management helps accelerate model validation, improve auditability and reduce regulatory risk. By offering standardized templates, centralized documentation and streamlined workflow approvals, the soluti
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