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
Special Olympics Airlift Takes Flight Nationwide; Dove 1 Arrives at St. Paul Downtown Airport19.6.2026 18:09:00 EEST | Press release
The 2026 Special Olympics Airlift officially took flight today as all participating Cessna, Beechcraft and Hawker aircraft, known as Doves, departed from airports across the country. Dove 1 for arrival day, a Cessna Citation Latitude generously operated by Prent Corporation, landed at St. Paul Downtown Airport (STP) carrying Special Olympic athletes and delegation members, signaling the start of Airlift arrivals for the Special Olympics USA Games. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619085293/en/ Special Olympics Airlift takes flight nationwide; Dove 1 arrives at St. Paul Downtown Airport (Photo credit: Textron Aviation). The arrival signals the start of the world’s largest cumulative peacetime airlift spanning more than 40 years, a coordinated aviation effort organized by Textron Aviation, a Textron Inc. (NYSE: TXT) company, that transports hundreds of Special Olympics athletes and coaches from multiple states
Record Currency Management Participates in Innovative European Bank for Reconstruction and Development (EBRD) -Backed Mongolian Tugrik Transaction19.6.2026 17:53:00 EEST | Press release
Record Currency Management Ltd (RCM), subsidiary of London-listed Record plc (Record Financial Group), is pleased to announce its participation in an innovative local currency bond transaction issued by the European Bank for Reconstruction and Development (EBRD), supporting the development of Mongolia's capital markets while providing institutional investors with access to attractive frontier market opportunities. RCM is the UK currency management arm of Record Financial Group, the London-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. Headquartered in London, Record has offices in Hamburg, Zurich, Zug, New York, and Hong Kong. The investment forms part of Record Financial Group's broad
Plasma One Launches to Herald a New Era of Stablecoin Banking19.6.2026 15:29:00 EEST | Press release
Plasma has today announced the launch of Plasma One, its flagship financial product designed to make digital dollars usable for everyday spending, sending and earning. Plasma One is designed to make stablecoins feel like money, only better - more accessible, reliable and efficient. For years, stablecoin adoption has been held back by a fragmented system and poor user experience. We have seen wallets in one place, exchanges in another, and costly off-ramps standing between digital dollars and daily life. Plasma One brings that experience together in a single app, giving users a simple way to spend, send and earn with stablecoins from one account with zero fees. Headquartered in London, the city that gave rise to Revolut, Wise and Monzo, Plasma is making a bigger bet, that the next generation of consumer banking will be built on stablecoin rails, not legacy banking infrastructure. Underneath Plasma One is the Plasma Network, Plasma’s own blockchain, purpose-built to move stablecoins inst
IQM Appoints Craig Ciesla, Former Illumina VP, as CTO; Inés de Vega Becomes Chief Scientist19.6.2026 10:00:00 EEST | Press release
IQM Quantum Computers, the global leader in superconducting quantum computers, today announced the appointments of Dr. Craig Ciesla as Chief Technology Officer (CTO) and Dr. Inés de Vega as Chief Scientist, as she transitions from her role as Vice President of Quantum Solutions, deepening IQM´s leadership as the company prepares for its planned Nasdaq listing through a merger with Real Asset Acquisition Corp. (Nasdaq: RAAQ). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260619693929/en/ From left to right: Dr. Inés de Vega, Chief Scientist, and Dr. Craig Ciesla, Chief Technology Officer. Ciesla, an experienced deep tech executive with more than 25 years delivering products across multiple industries from startups to Fortune 500 companies, will advance IQM's technology strategy and drive its implementation into systems and products. De Vega, meanwhile, will be responsible for ensuring scientific feasibility and system-level
Teijin Receives Approval for Additional Indications of XEOMIN ® for Cervical Dystonia and Blepharospasm in Japan19.6.2026 10:00:00 EEST | Press release
Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, and Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, jointly announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. This approval represents the fourth and fifth indications for XEOMIN® authorized in Japan, alongside its existing approvals for the treatment of upper limb spasticity, lower limb spasticity and chronic sialorrhea. Cervical dystonia is a focal dystonia characterized by involuntary contractions of the neck muscles, resulting in abnormal or repetitive movements and postures.1 Blepharospasm is also a focal dystonia, characterized by excessive involuntary contractions of the muscles surrounding the eye.2 Both conditions significantly impact patients’ quality of life. The approval by MHLW is based on Phase III clinic
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