VIFOR-PHARMA-GROUP
30.4.2021 07:02:13 CEST | 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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20210429005950/en/
Link:
About Business Wire
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
Filippo Fagnani from Quanta System Receives the EAU Award for Significant Contribution to Endourology at ICE 202610.10.2026 18:09:00 CEST | Press release
Filippo Fagnani, Marketing & Scientific Director of Quanta System’s Surgical Division, has been honoured with the Award for Significant Contribution to Endourology at ICE26, the International Conference on Endourology organised by the EAU Endourology Section. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261010101303/en/ Filippo Fagnani receiving the prize with Olivier Traxer and Professor Bhaskar Somani. The recognition celebrates more than two decades of professional commitment to laser technology and a career built around a clear ambition: to translate the needs of urologists into increasingly precise, flexible and useful technologies, with the ultimate goal of supporting patient safety and better surgical outcomes. “I have always believed that technology should make the surgeon’s work more precise, more flexible and, most importantly, safer for the patient. My goal has never been to develop technology for its own sake,
Emdoor Information Marks 18 Years of Rugged Computing Excellence with Vertically Integrated Capabilities10.10.2026 12:30:00 CEST | Press release
As industrial automation, smart manufacturing, and field operations increasingly depend on mission-critical mobile computing, global demand for reliable rugged tablets, rugged laptops, and rugged handhelds continues to accelerate. Emdoor Information, a publicly listed company on China’s A-share main board since 2023 and an 18-year veteran in rugged computing, has established itself as a rugged computing solutions provider for industrial customers worldwide. Founded in 2008, the company delivers sustained growth, world-class manufacturing, resilient supply chains, full-stack R&D, and comprehensive lifecycle services. Its rugged computing products and industrial customers now span North America, Latin America, Europe, and Asia-Pacific, serving sectors such as public utilities, intelligent manufacturing, warehouse management, transportation, energy industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261010564561/en/ Rugged
Vertex to Present New Data on ALYFTREK® at the North American Cystic Fibrosis Conference9.10.2026 19:15:00 CEST | Press release
- Data on ALYFTREK in children ages 2 to 5 years demonstrate recovery of pancreatic function in some children –- Additional abstracts on clinical and real-world evidence on CFTR modulators also presented - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new interim data from the ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor) 2 to 5 years old open-label extension study, highlighting recovery of exocrine pancreatic function in some children in that age group, allowing those children to discontinue pancreatic enzyme replacement therapy (PERT). Pancreatic exocrine insufficiency in children with cystic fibrosis (CF) was previously believed to be irreversible. These data were presented at the North American Cystic Fibrosis Conference (NACFC). “The data presented at NACFC underscore the safety and efficacy of our CF medicines in the real world and in clinical trials in younger age groups. The data from the Phase 3 open-label study in 2 to 5 year olds evaluating exocrine p
Andersen Consulting udvider med TalentSmartEQ for at fremme lederskab og virksomhedstransformation9.10.2026 18:48:00 CEST | Pressemeddelelse
Andersen Consulting styrker sine kompetencer inden for humankapital gennem en samarbejdsaftale med TalentSmartEQ, en San Diego-baseret virksomhed, der har fokus på at skabe praktiske, engagerende og handlingsorienterede læringsoplevelser med udgangspunkt i emotionel intelligens (EQ) og lederudvikling. I mere end to årtier har TalentSmartEQ arbejdet sammen med organisationer verden over med henblik på at udvikle ledelseskompetencer ved hjælp af emotionel intelligens og dermed styrke medarbejderengagement, teamwork og de samlede resultater. Virksomheden kombinerer forskningsbaserede metoder med praktiske læringsforløb, vurderinger, coaching og skræddersyede programmer, der skal omsætte opbygningen af emotionel intelligens til vedvarende ændringer i adfærden på arbejdspladsen. Som førende aktør i branchen samarbejder TalentSmartEQ med organisationer lige fra Fortune 500-virksomheder til offentlige myndigheder og privatejede virksomheder. "Organisationer stiller stadig større krav til dere
Verdant Rock Receives A (low) Financial Strength Rating from Morningstar DBRS, Adding a Second International Investment-Grade Assessment9.10.2026 16:00:00 CEST | Press release
Verdant Rock now holds Financial Strength Ratings from both Fitch Ratings and Morningstar DBRS, providing counterparties with dual-agency confirmation and reinforcing the security architecture behind each financial guarantee Verdant Rock Limited, a Bermuda Monetary Authority-regulated Class 3B insurance company, has received an A (low) Financial Strength Rating from Morningstar DBRS. The rating reflects Verdant Rock’s financial strength and its capacity to meet policyholder obligations as an investment-grade financial guarantor for Emerging Markets credit. Morningstar DBRS is a global credit rating agency with coverage across North America, Europe, Asia, and Latin America. Its assessment of Verdant Rock reflects the company’s strong projected earnings ability, robust risk profile, sound liquidity, and good capitalization. Morningstar DBRS also assigned an A (low) Issuer Rating to Verdant Rock. The rating follows Verdant Rock’s BBB+ Long-Term Insurer Financial Strength Rating with a Sta
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