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
3D Systems Achieves Full-Scope EU MDR Certification, Accelerating European Launch of NextDent® Jetted Denture Solution Targeted for Summer 202625.3.2026 18:20:00 EET | Press release
3D Systems (NYSE: DDD) today announced it has received full-scope certification under the European Union Medical Device Regulation (EU MDR) 2017/745. The certification was attained on Monday, March 16, 2026. This milestone confirms that the Company’s quality system, technical documentation, and clinical evidence meet the most rigorous regulatory requirements in the medical device sector. With the MDR certificate in hand, 3D Systems will now introduce MDR-compliant product versions through a carefully coordinated, phased rollout across its dental product families and European markets. This approach ensures a smooth transition while maintaining uninterrupted product availability for customers and healthcare providers. The EU MDR certification immediately enables the introduction of innovative new materials and is a pivotal step for one of 3D Systems’ largest potential new product launches: the NextDent® Jetted Denture Solution. This solution forms the cornerstone of the Company’s ‘replac
Visa to Bring Privacy-Preserving Payments to Canton Network25.3.2026 18:00:00 EET | Press release
Visa (NYSE:V), a global leader in digital payments, today announced it will join the Canton Network as the first major global payments company to serve as a Super Validator, to help extend privacy‑preserving blockchain infrastructure to banks and financial institutions around the world. Visa will be one of 40 Super Validators on Canton. That move goes straight to a core challenge for financial institutions: the same transparency that gives blockchains their appeal can clash with privacy expectations financial institutions operate under. Canton Network, a blockchain built for regulated finance, has privacy built in from the beginning, so organizations can use shared infrastructure without exposing sensitive information. As a Super Validator, Visa will help clients who choose to run and secure operations on the Canton Network, applying the same trusted and reliable standards it uses to operate critical payment systems today. Institutions can experiment with and scale stablecoin payments,
Andersen Consulting Adds Collaborating Firm Stratis Consulting in Ireland25.3.2026 15:30:00 EET | Press release
Andersen Consulting enters into a Collaboration Agreement with Stratis Consulting, a Dublin-based firm specializing in strategic employment relations, people strategy, and workplace policy. Founded in 2017, Stratis Consulting is an advisory firm recognized for its deep expertise in employment relations and leadership strategy. The firm works closely with senior executives, boards, and HR leaders as a trusted advisor to design practical, people-centered solutions that improve engagement, strengthen leadership effectiveness, and align workforce strategy with long-term business objectives. Stratis Consulting supports organizations navigating M&A activities and major changes in the company to ensure effective practice and implementation of workforce strategies. “At Stratis, we believe that people strategy enabled by successful employment relations is business strategy,” said Brendan McGinty, managing partner of Stratis Consulting. “Our goal is to help organizations recognize the value of s
ECU Worldwide Unveils XLERATE 2.0 Expansion to Bypass Asia–Europe Supply Chain Disruptions25.3.2026 15:30:00 EET | Press release
ECU Worldwide, Allcargo Globals’ wholly-owned global subsidiary, has announced a strategic expansion of its transformative logistics solution, XLERATE 2.0, to provide a high-speed and resilient alternative to Asia-to-Europe trade lanes facing transit disruptions. Under this alternative routing, cargo is transported across the Pacific to the US West Coast, using Los Angeles (LAX) as a temporary hub. The solution leverages XLERATE 2.0’s premium, time-definite ocean services, ensuring greater transit agility and continuity. XLERATE 2.0 offers two distinct shipping solutions from China and Vietnam, providing shippers with flexibility as traditional trade arteries remain impacted by shifts in global logistics. These changes have led to reduced overall capacity and the disruption of standard sea–air services via conventional transit points. Commenting on the rollout, Simon Bajada, Regional CEO, Europe, ECU Worldwide, said “With the expansion of XLERATE 2.0, we are offering our customers a de
Incyte Announces Executive Leadership Appointments25.3.2026 15:00:00 EET | Press release
Incyte (NASDAQ:INCY) today announced appointments among its executive leadership team to support the Company’s strategic focus and long-term growth plans. Pablo J. Cagnoni, M.D., has been appointed President, Incyte and Global Head of Research and Development. In this role, Dr. Cagnoni will retain responsibility for Research and Development, while also supporting enterprise-wide strategic planning and operational execution. Under Dr. Cagnoni’s scientific leadership, Incyte’s R&D progress has been notable, including advancing our mutCALR antibody, povorcitinib, CDK2, KRASG12D and TGFßR2xPD1 programs. Dr. Cagnoni has also continued to strengthen the way Incyte conducts R&D, introducing a new structure, processes and new technologies to improve productivity and keep Incyte competitive. Steven Stein, M.D., has been appointed Executive Vice President, Chief Medical Officer and Head of Late-stage Development. In this role, Dr. Stein will continue to oversee Incyte’s extensive and growing lat
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