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
ADNEC Group Kickstarts November with Two of the World’s Largest Events in the Energy and Tourism Sectors31.10.2026 05:53:00 EET | Press release
ADNEC Group, a Modon company, begins November by hosting two of the world’s most significant international events in the same week. ADIPEC 2026, the world’s largest energy event, takes place at ADNEC Centre Abu Dhabi from 2 to 5 November. Meanwhile, World Travel Market (WTM) London, one of the global travel industry’s leading gatherings, takes place at the Group’s Excel London venue from 3 to 5 November. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030918463/en/ ADNEC Centre Abu Dhabi (Photo: AETOSWire) The two events, held simultaneously at the Group’s largest venues in the UAE and the UK, reflect ADNEC Group’s capability to deliver large-scale international events across multiple markets. ADIPEC has grown alongside the venue since it was first held at the ADNEC Centre Abu Dhabi in 2006. This year’s edition is set to be the largest in the event’s history, occupying the venue’s entire 153,000 square metres of exhibition
SES and Air Astana Introduce Multi-orbit Inflight Connectivity on A321LR Fleet30.10.2026 19:35:00 EET | Press release
SES was selected by Air Astana, the award-winning flag carrier of Kazakhstan, to introduce next-generation inflight connectivity services across its Airbus A321LR fleet. The first connected aircraft entered commercial service on 29 October 2026. Fleet-wide deployment will continue across the remaining A321LR fleet. Equipped with SES’s new electronically steered array (ESA) antenna, the aircraft delivers reliable connectivity over the SES multi-orbit network. SES will provide a fully managed inflight connectivity service across the fleet, enabling Air Astana passengers to enjoy a seamless online experience throughout their journey. “Airlines are increasingly looking for connectivity solutions that deliver a seamless passenger experience while providing the flexibility to evolve with changing customer expectations,” said Blane Boynton, Senior Vice President, Aviation at SES. “SES's multi-orbit solution will enable Air Astana to offer a consistent, high-quality online experience across it
CIRCOR to Expand Industrial Portfolio with Acquisition of Green Silence Group S.p.A.30.10.2026 18:06:00 EET | Press release
CIRCOR, a KKR portfolio company and global manufacturer of flow control products for industrial and naval markets, today announced that it has signed a definitive agreement to acquire Green Silence Group S.p.A., an Italian provider of hydraulic pumps, electric motors and advanced engineering solutions. The acquisition will bring together the complementary capabilities of Settima, Motive and Spin expanding CIRCOR’s Industrial portfolio with three-screw and ultra-low-noise hydraulic pumps, Motive electric motors, high-efficiency rare-earth-free motor technologies, power electronics and advanced engineering capabilities. Together, these technologies will broaden CIRCOR’s ability to deliver integrated solutions that improve system efficiency, reduce energy consumption and critical raw materials dependency, and address evolving customer needs across industrial and mobile applications. The combination will also provide Green Silence Group access to CIRCOR’s global commercial and operational
Quectel Sues Telit, Alleging False Statements, Cybersquatting and Unfair Competition30.10.2026 17:41:00 EET | Press release
Quectel Wireless Solutions, a global end-to-end IoT solutions provider, today announced that it has filed legal action in the United States District Court for the Southern District of Florida against Telit IoT Solutions Inc. The lawsuit seeks to bring an end to Telit’s campaign of false and misleading claims about Quectel and its products. Quectel alleges that, rather than competing on the strength of its products and technology, Telit engaged in a coordinated campaign to undermine Quectel’s reputation by exploiting geopolitical concerns surrounding Chinese technology companies. According to the complaint, Telit funded, promoted, and amplified false and misleading claims about Quectel’s products while positioning itself to customers as a safer “Western” alternative. The lawsuit further alleges that Telit engaged in cybersquatting involving Quectel’s U.S. domain name to advance its campaign. Quectel maintains that these alleged actions have caused substantial harm to its sales, customer
TestMu AI Launches Kane CLI Exploration, an AI Agent That Maps an Entire Web App From a Single URL and Turns It Into Tests30.10.2026 16:00:00 EET | Press release
TestMu AI, the Full Stack Agentic AI Quality Engineering platform, announced Kane CLI Exploration, an autonomous agent that learns a web application before anyone writes a test. Given a single URL, it walks the entire app on its own, flags problems along the way and gives Kane CLI the context it needs to generate and run tests, even when no requirements, user stories or acceptance criteria exist. Every test plan starts from something written down, and many apps never had it. Legacy products lose their specs when the people who wrote them move on, and apps a coding agent built in a week often have no record of intended behavior beyond the prompt history. With nothing to test against, a testing agent ends up grading the app against itself. Starting from the URL a developer provides, the exploration agent moves through every page, junction and flow it can reach, the way a new QA engineer clicks through a product in their first week. For each page it records the controls, the flows in and
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