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
First Guests Arrive at Four Seasons Resort and Residences Red Sea at Shura Island from 20 May, as Red Sea Global Launches First JV Resort18.5.2026 21:06:00 EEST | Press release
Red Sea Global (RSG), the regenerative tourism developer, has reached a major milestone as Four Seasons Resort and Residences Red Sea at Shura Island welcomes first guests from 20 May, marking the first joint venture-developed resort within its portfolio to enter the market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518349628/en/ An aerial view of Four Seasons Resort and Residences at Shura Island, set along the shoreline with clear views of the Red Sea. Developed in partnership with Kingdom Holding Company (KHC), the launch represents a shared milestone for both organizations and marks a new phase in RSG’s development model, highlighting the growing role of institutional and private sector partnerships in scaling Saudi Arabia’s luxury tourism sector. “With Four Seasons preparing to welcome guests, we are significantly scaling the capacity and offering of The Red Sea destination in time for one of the busiest travel
Belkin Advances Towards Carbon Neutrality in Scope 3 Emissions18.5.2026 19:10:00 EEST | Press release
Belkin, a leading consumer electronics brand for 40 years, published its 2025 Impact Report, highlighting key achievements and reaffirming its commitment to corporate responsibility. Having achieved carbon neutrality in scope 1 and scope 2 emissions in 2025, the company continues to advance toward scope 3 carbon neutrality through enhanced life cycle assessment capabilities and improved supplier and logistics data collection. In 2025, Belkin calculated 131 product carbon footprints across its portfolio, surpassed 21.6 million PCR products sold, and has achieved a 95% reduction in single-use plastic packaging since 2019, reflecting continued progress in carbon reduction and responsible product design. “As we continue to make progress against our sustainability goals, we are taking deliberate steps to reduce our impact,” said Steven Malony, CEO of Belkin. “Over the past year, we expanded the use of post-consumer recycled materials, further reduced single-use plastic packaging, and streng
Infobip Named a Leader in the 2026 Gartner® Magic Quadrant™ for Communications Platform as a Service18.5.2026 17:25:00 EEST | Press release
Infobip is excited to share that global AI-first cloud communications platform Infobip has been recognized as a Leader in the 2026 Gartner Magic Quadrant for Communications Platform as a Service. Check back for a complimentary copy of the full report soon! In Infobip’s view, this recognition reflects what the company has spent 20 years building: a communications platform that stays focused on what customers actually need and evolves as markets change. Infobip believes that recognition in a fast-moving market comes not from chasing trends, but from disciplined execution and a clear long-term vision. As Infobip marks its 20th year of operations, the company thinks the shift to agentic AI represents the most significant transformation in customer communications in our history. Infobip believes enterprises need a partner that empowers them to move from campaigns and rigid workflows to autonomous, goal-driven interactions, while retaining the openness and flexibility to adapt as the technol
Seoul Design Foundation Announces ‘Seoul Design AI Film Festival’ Call for Entries18.5.2026 17:00:00 EEST | Press release
The Seoul Design Foundation (CEO Cha Kang Heui) is inviting visionaries worldwide to the Seoul Design AI Film Festival (SDAFF). This global competition aims to redefine the Dongdaemun Design Plaza (DDP)—the world’s largest atypical architecture—as a premier destination for AI-driven media art. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518044745/en/ An official poster for Seoul Design AI Film Festival (Image: Seoul Design Foundation) The DDP’s 222-meter curved exterior wall, a Guinness World Record holder for the "World's Largest 3D Mapping on an Atypical Building," will serve as the digital canvas for the winners. ‘Seoul Light DDP’ has already achieved global acclaim by winning the world’s top three design awards: iF, Red Dot, and IDEA. Bridging AI Technology and K-Culture The festival seeks high-quality video works that blend artistic inspiration with cutting-edge AI technology. The competition features two main cat
SERI Lugano Launches International Scientific Outreach Initiative on Light-Based Neuroscience and Pineal Gland Research18.5.2026 16:38:00 EEST | Press release
As scientific interest in light-based stimulation, neuroendocrine regulation, and integrative medicine continues to grow internationally, the Switzerland Eye Research Institute (SERI Lugano) has launched a new international scientific outreach initiative focused on public engagement and interdisciplinary research communication in neuroscience and cellular modulation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515840289/en/ Ophthalmologist Roberto Pinelli explains, in an engaging personal narrative style, his unique methods for using a combination of light, sound, and nutraceuticals to non-invasively activate the pineal gland to promote cellular rejuvenation, decrease aging, and improve overall well-being. Supported by case studies and peer-reviewed research, Pinelli’s method centers on using photons to convey vibrational energy through the eyes to target areas of the body with the sinergic use of sound vibrations 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