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
Vantor, UK Ministry of Defence and Industry Partners Establish Defence Intelligence Innovation Cluster – Project FAIRFAX16.9.2026 11:00:00 EEST | Press release
Vantor, the leader in unified spatial intelligence, announced today it has joined the UK Ministry of Defence and industry partners to launch the UK Defence Intelligence Innovation Cluster, a new collaboration designed to accelerate the development and deployment of next-generation defence and intelligence capabilities and strengthen the UK’s sovereign defence industrial base. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916244808/en/ Vantor's Mike Buckley with RAF Wyton officials, council and industry partners at the FAIRFAX Collaboration Hub opening. The cluster is being established through Project FAIRFAX, a joint initiative between the UK Ministry of Defence, Huntingdonshire District Council, Vantor, CGI UK and MAIAR. Together, the founding partners are creating a permanent hub at RAF Wyton where the UK government, industry and academia can work together on operational challenges, evaluate emerging technologies and a
More than Half of Consumers are Comfortable with AI Agents Applying for Credit, Experian Research Finds16.9.2026 11:00:00 EEST | Press release
Consumers are ready to take the next step in their relationship with artificial intelligence (AI), according to AI in Risk: The Rise of Agentic Commerce, new research from data and technology company, Experian, conducted by Forrester Consulting. The study of 6,247 credit-active consumers across 13 EMEA and Asia Pacific markets, found that more than half (54%) of respondents are comfortable with AI agents applying for credit on their behalf. The findings point to the next stage in the evolution of financial services, where consumers are becoming comfortable allowing AI to move beyond providing information to supporting parts of the lending journey, including comparing lenders, checking eligibility, completing applications and securely submitting authorised documents. "Consumers are already changing the way they engage with financial services," said Mariana Pinheiro, Chief Executive Officer, Experian EMEA & Asia Pacific. "They are not just experimenting with AI anymore; they are beginnin
Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes16.9.2026 10:00:00 EEST | Press release
Aqara, a global leader and pioneer in IoT, today announced the release of the Spatial Multi-Sensor FP400. The FP400 is designed to bring precise, spatial intelligence to homes without sacrificing the privacy typically compromised by smart cameras. Rather than simply detecting motion or presence, the FP400 enables homes to better understand occupancy, movement, and context for more granular and personalized automations and insight. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916958372/en/ Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes The Spatial Multi-Sensor FP400 redefines how smart homes perceive and interact with living spaces by combining high-precision spatial sensing with AI-powered environmental understanding. Powered by a next-generation high-precision 60GHz mmWave radar, the FP400 delivers industry-leading multi-person sensing, precise
Cambridge Associates Opens Italian Office and Expands European Leadership16.9.2026 10:00:00 EEST | Press release
Global investment firm Cambridge Associates (CA) today announced the opening of a new office in Milan and the appointment of two senior hires in Europe. The move reflects the firm’s ongoing commitment to providing bespoke services to current and future institutional and family office investors across the region. Raphael Heynold has joined the Client Solutions team as Head of EMEA and APAC and will serve on the firm’s EMEA Operating Committee. Based in London, Raphael is a key member of the Global Client Solutions Leadership team, responsible for driving growth and market expansion and overseeing client engagement efforts across Europe, the Middle East, and Asia Pacific regions. Heynold brings more than 30 years of experience across client strategy, investment banking and investment management, and has worked with many sophisticated families and institutions around the world. Riccardo Pianeti has joined Cambridge Associates to lead the Italian office. He will serve as Head of the Milan
International Expansion Far Outweighs M&A as a Legal and Compliance Execution Burden, CSC Research Finds16.9.2026 09:49:00 EEST | Press release
International expansion is creating a far heavier legal and compliance execution burden than M&A itself, with nearly three quarters (74%) of senior cross-border professionals citing market entry or international expansion as a leading burden, compared with just 28% for M&A transactions, according to new research from CSC, the leading provider of global business administration and compliance solutions. The challenge extends well beyond deal execution. Ongoing entity governance and compliance is cited by 71% of respondents, highlighting the operational burden of establishing and maintaining a presence across multiple jurisdictions. CSC’s new report, The Cross-Border Readiness Gap: Navigating the Legal and Compliance Burden of International Expansion, draws on the views of 200 senior professionals globally with direct experience of cross-border transactions, expansion, restructuring, and entity or compliance work. Fragmented entity and ownership information is a major source of that compl
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