VFMCRP announces positive results of phase-III clinical trial of Velphoro® in China
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
Suzano Reports Increased Operational Efficiency With Lower Cash Cost in the Third Quarter of 20257.11.2025 00:58:00 EET | Press release
Suzano, the world’s largest pulp producer, announces its results for the third quarter of 2025 (3Q25), reporting sales of 3.6 million tonnes of pulp and paper combined, a 20% increase on the same quarter last year (3Q24). The positive result is driven by the operations of the Ribas do Rio Pardo pulp mill, inaugurated in 2024, and by the integration of paper production from assets acquired in the United States in October 2024. The cash cost of pulp production (excluding downtime) was R$801 per tonne, a 7% reduction compared to 3Q24, another positive highlight of the quarter. The results reflect the continuation of the downward trend in production costs and the ongoing improvement in structural competitiveness. Net revenue for the quarter totalled R$12.2 billion, broadly flat on the comparable period last year. Adjusted EBITDA totalled R$5.2 billion and operating cash generation was positive at R$3.4 billion. The movement is mainly influenced by lower pulp prices and a weaker exchange ra
Vedanta Resources Launches CopperTech Metals to Bolster U.S. Copper Security and Advance Technology and Infrastructure Transformation6.11.2025 18:45:00 EET | Press release
Vedanta Resources Limited ("Vedanta") today announced the launch of CopperTech Metals Inc. ("CopperTech" or the "Company"), a U.S.-domiciled company with a mission to 'Power the Copper Century' and to bolster America's copper security needs while capitalizing on surging copper demand driven by artificial intelligence, data center expansion, grid modernization, defense technologies and industrial onshoring requirements. CopperTech will1 own and operate the Konkola Copper Mines in Zambia, one of the highest-grade copper producing assets in the world with proven cobalt reserves. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106537189/en/ CopperTech intends to build on the existing $3 billion investment made by Vedanta Resources Limited in the Konkola Copper Mines – which included construction of a deep mine shaft, a smelter and a concentrator, and engaging in general mine development – and intends to invest an additional $1
NJ Bio Bridges the Translation Research Gap with the Asset Purchase and Integration of L2P ® Services6.11.2025 18:11:00 EET | Press release
NJ Bio, Inc., a premier contract research and clinical manufacturing service provider in Princeton, New Jersey has announced the asset purchase and full integration of the research services of L2P Research Labs® (“Lab to Pharmacy”), further expanding its service portfolio, and bridging the translational research gap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251106703527/en/ NJ Bio, Inc. now offers translational research services after completing asset purchase and full integration of the services of L2P® Research Labs, enhancing the discovery-to-development pipeline Currently, the attrition rate of biological molecules moving past phase 1 clinical trials is very high and the way to overcome this challenge is through translational research. NJ Bio specializes in preclinical and early-phase clinical research and development, with a primary focus on ADCs, bioconjugation, custom synthesis, oligonucleotides, and mRNAs. Howe
DevvStream Reports Fiscal Year 2025 Results and Advances Digital-Asset and Tokenization Strategy6.11.2025 18:01:00 EET | Press release
DevvStream Corp. (Nasdaq: DEVS) (“DevvStream” or the “Company”), a leading carbon management and environmental-asset monetization firm, today announced financial results for its fiscal year ended July 31, 2025, and provided an update on strategic initiatives designed to enhance liquidity, expand technology capabilities, and position the Company for scalable, acquisition-driven growth. Fiscal 2025 Highlights Completed Nasdaq listing and de-SPAC transaction, establishing DevvStream as one of the few publicly traded pure plays in carbon and renewable-energy asset monetization. Closed initial $10 million tranche under the Helena $300 million convertible-note facility, providing liquidity to launch the Company’s digital-asset treasury. Reported initial revenue as the Company begins monetizing its environmental-asset pipeline. Successfully completed strategic investments and partnerships that expand DevvStream’s reach across carbon, renewable-energy, and environmental-credit markets. Strengt
BST Global Launches 2026 AI + Data Impact Survey for the AEC Industry6.11.2025 17:41:00 EET | Press release
BST Global, the leading provider of AI-powered project intelligence™ solutions for the AEC industry, has launched its second annual global AI + Data Survey. Seeking insights from technology and data leaders of architecture, engineering and environmental consultancies around the world, the survey will be available until 11:59 p.m. ET, December 31, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105615222/en/ BST Global, the leading provider of AI-powered project intelligence™ solutions for the AEC industry, has launched its second annual global AI + Data Survey. Seeking insights from technology and data leaders of architecture, engineering and environmental consultancies around the world, the survey will be available until 11:59 p.m. ET, December 31, 2025. Conducted in partnership with BST Global’s AI + Data Consortium and the American Council of Engineering Companies' (ACEC) Technology Committee, the survey focuses s
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