VIFOR-PHARMA-GROUP
30.4.2021 07:02:13 CEST | 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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20210429005950/en/
Link:
About Business Wire
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
Wolters Kluwer launches Libra Academy across Europe to help legal professionals realize the full value of legal AI8.9.2026 09:01:00 CEST | Press release
Developed by lawyers for lawyers, Libra Academy brings together learning resources, use cases and a European user community to accelerate AI adoption and customer success Wolters KluwerLegal & Regulatory today announced the launch of Libra Academy, a new learning and enablement platform around the company’s legal AI workspace Libra by Wolters Kluwer, designed to help legal professionals confidently integrate AI into their daily work. As legal teams increasingly look to move beyond experimentation and achieve measurable productivity gains, they face a new challenge: keeping pace with an AI landscape that evolves faster than traditional training can follow. New features, models, and use cases emerge continuously, making it difficult for busy legal professionals to stay current while managing the demands of their daily work. Libra Academy was created to close this gap. Built directly into the Libra experience, it provides continuous learning that evolves alongside the platform, helping cu
James von Moltke Joins Warburg Pincus8.9.2026 09:00:00 CEST | Press release
Former President and Chief Financial Officer, Deutsche Bank AG, Joins Warburg Pincus in Europe as a senior advisor and Executive-in-Residence Warburg Pincus, the pioneer of private equity global growth investing, today announced the appointment of James von Moltke as a senior advisor and Executive-in-Residence. Mr. von Moltke, who takes up the role with immediate effect, will bring his extensive industry expertise to support the firm’s European activities with particular focus on the financial and technology sectors, where he will support the identification and evaluation of new potential investment opportunities. He will also play an active role in value creation across the firm’s existing portfolio in Europe. Mr. von Moltke brings significant industry experience to the firm, having served as President of Deutsche Bank AG since 2022 and as Chief Financial Officer and Member of the Management Board of the Group for nine years. During this time, he played a key role in driving the bank’
AGCO Power: Forestry Machines Need Purpose-Built Off-Road Engines – Not Compromises8.9.2026 08:00:00 CEST | Press release
Modern forestry machines work in some of the most demanding conditions in the off-road world. Harvesters and forwarders operate far from workshops, under rapidly changing loads and in environments where uptime, fuel efficiency and serviceability have a direct impact on productivity. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907908774/en/ Forestry applications place very different demands on an engine than on-road applications do,” says Juha Tervala, Managing Director at AGCO Power. Juha Tervala and Andreas Eurs, Product Manager at long-standing partner Logset, are pictured presenting Logset’s new 8H GTE 4.0 Hybrid harvester, powered by an AGCO Power engine. For AGCO Power, the starting point is clear: a forestry machine needs an engine designed for demanding off-road applications. “Forestry applications place very different demands on an engine than on-road applications do. The engine must respond instantly to changi
DCO Concludes LEAP 2026 with Partnerships and Digital Cooperation Milestones7.9.2026 21:48:00 CEST | Press release
The Digital Cooperation Organization (DCO) concluded its participation at LEAP 2026, during which the State of Palestine signed the DCO Charter, becoming a Signatory Member, and unveiled the Digital Prosperity Plan 2026–2028, co-developed with DCO to advance digital infrastructure and AI readiness, digital government, skills, startups, and SMEs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907201316/en/ DCO Concludes LEAP 2026 with Partnerships and Digital Cooperation Milestones (Photo: AETOSWire) The signing followed the DCO Council’s earlier approval of eight candidate countries. Upon completion of accession procedures, DCO will expand from 16 to 24 Member States, representing approximately 980 million people and paving the way for a billion-strong voice for digital cooperation. Tajikistan is also on track to join the organization as an Associate Member, opening new opportunities to strengthen digital cooperation, acc
LR Health & Beauty Strengthens Its Management Team With Martin Lipp as New Chief Financial Officer (CFO)7.9.2026 15:36:00 CEST | Press release
The LR Health & Beauty GmbH, Europe’s leading social commerce company for high-quality nutritional supplements and beauty products, is strengthening its management team: effective 7 September 2026, Martin Lipp takes over as Chief Financial Officer (CFO) and joins the Executive Management Team. In his new role, Martin Lipp will be responsible for Global Controlling & Finance, Legal, IT and Operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260907262360/en/ Martin Lipp, new CFO of the LR Group “With Martin Lipp, we are gaining a highly experienced international finance executive with extensive expertise in managing and transforming businesses. During the current transition phase, he will enrich the senior management in particular with his strong transformation expertise and excellent know-how in the areas of finance, operations and IT. Together, we will consistently drive forward the implementation of our strategy with
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