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
Wolters Kluwer integrates Libra AI workflows into monKEY for Belgian tax professionals24.9.2026 10:00:00 EEST | Press release
Wolters Kluwer Legal & Regulatory today announced the integration of Libra AI workflows in monKEY, its research platform for tax professionals in Belgium. The add-in of Libra by Wolters Kluwer enables customers to directly access Libra’s AI capabilities from the trusted research environment in monKEY, combining generative AI with tax research based on long-trusted expert content. “By integrating Libra into monKEY, we are taking another important step towards connected, AI-powered workflows for our customers,” said Rimco Spanjer, Vice President & Managing Director, Wolters Kluwer Legal & Regulatory Benelux. “We are bringing together the power of AI and the trusted, up-to-date tax content professionals rely on every day. This helps them reach relevant insights faster while staying connected to the underlying domain expertise.” The integration also marks an important milestone in the expansion of Libra by Wolters Kluwer beyond legal workflows, bringing trusted AI capabilities to tax profe
SES Advances Satellite Manufacturing Facility in Luxembourg24.9.2026 09:50:00 EEST | Press release
SES, a space solutions company, has commenced construction of a new satellite manufacturing facility in Kockelscheuer, Luxembourg, marking a major milestone in the company’s vertical integration and business model evolution. The facility will enhance SES’ ability to design, develop and manufacture critical satellite technologies, accelerating the deployment of next-generation satellite networks and secure communications solutions. It will also help create a hub for innovation and enable SES partners and ecosystem with opportunities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923560183/en/ SES Advances Satellite Manufacturing Facility in Luxembourg The new facility in Kockelscheuer is at the center of Luxembourg’s effort to build and scale a dedicated Space Campus to stimulate New Space companies and industrial collaboration, and serve as a center for engineering, testing, manufacturing and assembly, accelerating devel
NTT DOCOMO BUSINESS Launches “Pro”, a New docomo business SIGN ® Offering for Large-Scale Global Connected Products24.9.2026 05:00:00 EEST | Press release
NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation) announced today the launch of "Pro," a new offering in the docomo business SIGN®1 lineup, an IoT-focused Network as a Service (NaaS) with built-in security features. Designed to support the large-scale and global deployment of connected products, “Pro” helps customers manage and operate tens of thousands of IoT connections. The service will be available from March 2027. This new offering addresses the challenges of achieving more advanced operational management through the centralized management of domestic and international IoT connectivity, operational automation, and system integration, while also enhancing security. It will reduce the operational burden on customers while supporting the continued delivery of value through connected products and services. 1. Background In recent years, against the backdrop of labor shortages resulting from Japan’s declining birthrate and aging population, various industries, such as
HeadFirst Global Becomes Vertage, Uniting 11 Businesses in a Single Work Orchestration Platform24.9.2026 02:01:00 EEST | Press release
HeadFirst Global, a leader in work orchestration, today announced it will become Vertage, as it builds a global technology platform that dynamically curates the right mix of expert talent and AI agents to deliver the work outcomes enterprises need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260923823506/en/ Edzard Overbeek, Group CEO at Vertage The €10 billion group is bringing its 11 operating businesses together under the Vertage name, platform, and operating model. Vertage starts with a foundation few can match: 1.5 million specialists, more than €10 billion in gross invoice value from multi-sector enterprise customers and governments, and delivery across 80 countries. The capabilities come from the 2024 integration of HeadFirst Group and Impellam Group, which combined technology and data with leadership in global managed services and specialist talent communities, and from the group's subsequent expansion into India.
Grid Dynamics Co-Hosts Physical AI Summit Alongside NVIDIA, EAIGG, and BGV to Accelerate Manufacturing Automation23.9.2026 23:05:00 EEST | Press release
Grid Dynamics Holdings, Inc. (Nasdaq: GDYN) (“Grid Dynamics”), a premier AI transformation partner for the Fortune 1000, announced today that it is co-hosting the Physical AI Summit alongside NVIDIA, EAIGG, and BGV. The invite-only working forum will bring together participants from enterprises, Physical AI startups, and investors on September 24, 2026, at the Wells Fargo Innovation Center in Menlo Park, CA. Centered on the theme "From World Models to Real-World Control," the summit will focus on the practical challenges of deploying, scaling, and operating Physical AI systems in production. Grid Dynamics' participation builds on its strategic partnerships with NVIDIA and Doosan Robotics, expanding its Physical AI capabilities to advance enterprise robotics applications. Ilya Katsov, CTO, Americas at Grid Dynamics, will lead a session titled "Operationalizing Physical AI: Lessons From the Field." The session will draw on Grid Dynamics' experience deploying Physical AI, including humano
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