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
NIKE, Inc. Announces Senior Leadership Changes to Accelerate “Win Now” Actions2.12.2025 23:59:00 EET | Press release
NIKE, Inc. (NYSE:NKE) today shared the following note with employees regarding changes to its Senior Leadership Team. // Team, I’d like to share some important changes to our Senior Leadership Team (SLT) that further remove layers and continue to bring us closer to athletes* and the marketplace. We’re establishing the role of EVP, Chief Operating Officer (COO), reporting to me, to better connect our operations and integrate technology more seamlessly into our sport offense. Venkatesh Alagirisamy (“Venky”), currently Chief Supply Chain Officer and a nearly 20-year Nike veteran, will take on this role effective December 8. Venky will lead Technology, in addition to his existing responsibilities leading Supply Chain, Planning, Operations, Manufacturing and Sustainability. He and his team will now be able to look end-to-end to ensure technology is fully integrated across the company and into how we create, plan, make, deliver and sell our world-class innovations across our three iconic bra
NetApp Collaborates with AWS to bring Enterprise Data to AWS AI Services2.12.2025 20:30:00 EET | Press release
NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced a new capability that enables enterprises to make their workflows simpler and more efficient by connecting Amazon Web Services (AWS) AI and Analytics services directly with their NetApp data both in the cloud and on-premises. Amazon S3 Access Points for Amazon FSx for NetApp ONTAP® enable customers to accelerate AI and analytics projects by allowing FSx for ONTAP-resident file data to be accessed via the S3 API by AWS's extensive portfolio of AI/ML and analytics services—all while the data remains in place and is fully accessible for read / write via file protocols. “By connecting FSx for ONTAP data natively to AWS's wide range of AI, ML, and analytics services, the new integration with Amazon S3 Access Points unleashes the potential to connect to more than 100 exabytes of enterprise data stored on NetApp systems for transformative use cases like generative AI and analytics uses cases built on AWS,” sa
SLB Announces Dates for Fourth-Quarter and Full-Year 2025 Results Conference Call2.12.2025 20:00:00 EET | Press release
SLB (NYSE: SLB) will hold a conference call on January 23, 2026, to discuss the results for the fourth quarter and full year ending December 31, 2025. The conference call is scheduled to begin at 9:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (833) 470-1428 within North America or +1 (646) 844-6383 outside of North America approximately 10 minutes prior to the start of the call and the access code is 122785. A webcast of the conference call will be broadcast simultaneously at https://events.q4inc.com/attendee/391273915 on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until January 30, 2026, and can be accessed by dialing +1 (866) 813-9403 within North
Daikin Leverages DataXstream’s OMS+ to Take Customer Experience to New Heights2.12.2025 17:03:00 EET | Press release
DataXstream LLC, an SAP® Endorsed App partner developing intelligent solutions for SAP sales and distribution, announced today that Daikin Comfort Technologies North America, Inc. (Daikin), a subsidiary of Daikin Industries Ltd. and leading HVAC manufacturer, has selected its OMS+ platform to deliver real-time point-of-sales capabilities, along with an intuitive, streamlined order management to transform Daikin’s in-store and online customer experience. Leveraging SAP solutions, Daikin and DataXstream are elevating the way customers engage with Daikin’s stores and brand by delivering unparalleled, consistent point-of-sale capabilities, along with real-time visibility of orders and inventory across all sales channels. “Customers want a consistent and responsive experience, regardless of where they place their order,“ said Tim Yates, CEO, DataXstream. “But no channel exists in a vacuum. To provide that level of consistency you need a platform that can view and aggregate data in real-time
Halo Infinite and Elysium Senior Concept Designer Ben Mauro Launches HUXLEY: The Oracle - Sci-Fi Prequel Debuts as #1 Amazon New Release2.12.2025 17:00:00 EET | Press release
Ben Mauro, the acclaimed concept artist and worldbuilder behind Halo Infinite, Call of Duty, Elysium, and The Predator, today announced the US release of HUXLEY: The Oracle. The book, serving as the narrative prequel to Mauro’s expanding HUXLEY universe, has already reached #1 in Amazon’s New Releases for Conceptual Art based on pre-orders alone. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251202609807/en/ HUXLEY: The Oracle Cover illustration HUXLEY: The Oracle departs from the graphic novel format in the first book, adopting an immersive narrative art book format that pairs cinematic, full-page illustrations alongside storytelling. Using a format familiar to readers of Simon Stålenhag’s Tales from the Loop, the book places world-building at the forefront, delivering a large-scale, atmospheric introduction to the world of HUXLEY that is fitting to the new story. HUXLEY: The Oracle unites a "dream team" of industry heavyw
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