VIFOR-PHARMA-GROUP
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
LambdaTest and SVAM International Inc. Announce Partnership to Transform Quality Engineering for Businesses26.11.2025 18:00:00 CET | Press release
The alliance empowers enterprises with accelerated SDLC cycles, reduced testing effort, and modern AI-driven digital transformation capabilities LambdaTest, a Gen-AI native quality engineering platform, announced a partnership with SVAM International, Inc., a global leader in digital transformation services. This strategic alliance marks a significant step forward in their mission to transform quality engineering for businesses worldwide. The partnership allows LambdaTest to extend its AI-native quality engineering capabilities into SVAM’s extensive digital transformation ecosystem. By integrating with SVAM’s experience in large-scale application development, testing, and delivery across major New York State and City agencies, as well as their platform expertise across Salesforce, ServiceNow, and Dynamics365, LambdaTest will empower more enterprises to modernize their software delivery pipelines. With LambdaTest’s intelligent test orchestration and execution engine at the core, teams c
GLORY Acquires Remaining Equity Shares in Acrelec Group26.11.2025 16:11:00 CET | Press release
Acrelec becomes a wholly owned subsidiary of Glory Glory Global Solutions (International) Ltd, a wholly-owned subsidiary of GLORY Ltd. [TYO:6457], has announced the acquisition of the remaining equity shares in Acrelec Group SAS. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126039437/en/ Acrelec is a global technology company focused on reinventing the customer experience for restaurant and retail brands. Leveraging decades of software, hardware and service expertise, the company develops and integrates new platforms that increase customer engagement, optimize efficiency and improve operations. With over 120,000 installations across more than 70 countries, Acrelec counts many of the world’s best-known restaurant mega-brands among its customers. We announce that Jalel Souissi has left the Acrelec Group following the completion of the recent share acquisition. Jalel Souissi has played a pivotal role in the development and
Andersen Global styrker sin platform i Tyrkiet med tilføjelsen af medlemsvirksomhed26.11.2025 14:49:00 CET | Pressemeddelelse
Andersen Global udvider sin tilstedeværelse i Tyrkiet, efter at Celen Corporate Property Valuation & Counseling Inc. bliver til Andersen i Tyrkiet, hvilket udvider de kompetencer, der tilbydes under Andersen-brandet i landet. Det Istanbul-baserede firma blev stiftet i 1995 og ledes af Managing Partner Guniz Celen med en bred vifte af ydelser til både nationale og internationale kunder. Med ekspertise inden for finansiering af fast ejendom, værdiansættelse af materielle og immaterielle aktiver samt formueforvaltning leverer den tyrkiske afdeling af Andersen løsninger, der understøtter komplekse finansielle beslutninger for kunder i mere end 18 lande. “Vores mission har altid været at levere løsninger på de mest komplekse udfordringer inden for ejendoms- og investeringssektoren,” sagde Guniz. “At blive en del af Andersen-brandet styrker vores kompetencer som en betroet rådgiver og giver os adgang til globale ressourcer, hvilket gør os i stand til at skabe endnu større langsigtet værdi fo
Cegid Acquires Shine to Accelerate the Path of Becoming Europe's Leading Financial Copilot for SMBs and Accountants26.11.2025 14:00:00 CET | Press release
Transformative combination creates a powerhouse for SMBs and accountants, empowering businesses across Europe by integrating leading suites of e-invoicing, digital accounting, business accounts and payments, and HR solutions into a unified platform. Cegid, a European leader in cloud software for finance, accounting, HR, and retail software, and Shine, a fast-growing European fintech unicorn providing digital business accounts and payments, e-invoicing, accounting, and payroll software to small businesses across Europe, announced today that the companies have entered a definitive agreement to join forces to form a European champion and become a leading provider of software for businesses and their accountants. This transformational combination will create the first fully integrated, cloud-native and AI-driven financial hub for SMBs and accounting professionals in Europe – bringing together market-leading capabilities in e-invoicing, accounting, digital business accounts and payments, ta
U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma26.11.2025 12:00:00 CET | Press release
If approved, sonrotoclax will become the first BCL2 inhibitor for R/R MCL in the U.S., addressing a high unmet need in an aggressive cancerSonrotoclax previously received Breakthrough Therapy Designation based on clinically meaningful, rapid responses in R/R MCLBeOne Medicines will present the data supporting the NDA and Priority Review for the first time at ASH 2025 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. “Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai Wang, Ph.D., Global Head of R&D at BeOne.
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