VIFOR-PHARMA-GROUP
27.9.2021 08:04:09 CEST | Business Wire | Press release
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Kissei Pharmaceutical Co., Ltd., marketing authorization approval for TAVNEOS® for the treatment of patients with granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main types of ANCA-associated vasculitis, a rare and severe autoimmune renal disease with high unmet medical need.
“We are delighted that TAVNEOS® has been approved in Japan, the first market worldwide, and congratulate our partner Kissei for this significant milestone,” said Abbas Hussain, CEO of Vifor Pharma Group. “ANCA-associated vasculitis is officially designated an intractable disease in Japan, indicating a rare disease without any effective treatment but for which long-term treatment is required. There is significant unmet medical need of over 10,000 patients in Japan, and we believe in the potential of TAVNEOS® for treating it. We are confident that Kissei will fully focus on bringing this breakthrough treatment to this patient population, helping them lead better, healthier lives.”
The approval is based on the marketing authorization application filing by Kissei which was supported by positive clinical data from the pivotal phase-III trial ADVOCATE in a total of 331 patients with MPA and GPA in 18 countries and regions, including Japan. TAVNEOS® demonstrated superiority over standard of care at week 52 based on Birmingham Vasculitis Activity Score (BVAS).
VFMCRP holds the rights to commercialize TAVNEOS® outside the U.S.. In June 2017, VFMCRP granted Kissei the exclusive right to develop and commercialize TAVNEOS® in Japan. Kissei expects to begin to market TAVNEOS® as soon as possible following NHI price listing. Outside Japan, TAVNEOS is currently in regulatory review with various agencies, including the U.S. Food and Drug Administration and the European Medicines Agency.
About Vifor Pharma Group
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 .
About Kissei Pharmaceutical Co., Ltd.
Kissei Pharmaceutical Co., Ltd. is a Japanese pharmaceutical company with approximately 70 years of history. Based on its management philosophy, “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees”, Kissei is concentrating on providing innovative pharmaceuticals to patients worldwide as a strongly R&D-oriented corporation. Kissei is engaged in R&D and licensing activities in the field of nephrology/dialysis, urology, and unmet medical needs in other disease areas. Kissei has an established collaboration with VFMCRP for sucroferric oxyhydroxide which Kissei fully developed in Japan as P-TOL® (known as Velphoro® in Europe/US) for the treatment of hyperphosphatemia. Since the launch in 2015, the market share of P-TOL® has been steadily expanding in Japan. For more information about Kissei Pharmaceutical, please visit www.kissei.co.jp .
About ChemoCentryx Inc.
ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. Besides ChemoCentryx’s lead drug candidate, avacopan, ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.
About ANCA-associated vasculitis
ANCA-associated vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated. Currently, treatment for ANCA-associated vasculitis consists of courses of non-specific immuno-suppressants (cyclophosphamide or rituximab), combined with the administration of daily glucocorticoids (steroids) for prolonged periods of time, which can be associated with significant clinical risk including death from infection.
About TAVNEOS® (avacopan)
Avacopan is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor C5aR1. By precisely blocking the receptor (the C5aR) for the pro-inflammatory complement system fragment, C5a on destructive inflammatory cells such as blood neutrophils, avacopan arrests the ability of those cells to do damage in response to C5a activation, which is known to be the driver of inflammation. Moreover, avacopan’s selective inhibition of only the C5aR1 leaves the beneficial C5a l pathway through the C5L2 receptor functioning normally.
ChemoCentryx is also developing avacopan for the treatment of patients with C3 Glomerulopathy (C3G) and hidradenitis suppurativa (HS). The U.S. Food and Drug Administration has granted avacopan orphan-drug designation for ANCA-associated vasculitis, C3G and atypical hemolytic uremic syndrome. The European Commission has granted orphan medicinal product designation for avacopan for the treatment of two forms of ANCA vasculitis: microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis), as well as for C3G. In October 2020, European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for avacopan for the treatment of patients with ANCA-associated vasculitis (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)).
View source version on businesswire.com: https://www.businesswire.com/news/home/20210926005078/en/
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
SES and Air Astana Introduce Multi-orbit Inflight Connectivity on A321LR Fleet30.10.2026 18:35:00 CET | Press release
First aircraft is now delivering a new generation of onboard Wi-Fi experiences for business and leisure travelers 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.
CIRCOR to Expand Industrial Portfolio with Acquisition of Green Silence Group S.p.A.30.10.2026 17:06:00 CET | Press release
Acquisition adds complementary pump, electric motor and control technologies to strengthen CIRCOR's industrial solutions portfolio 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 a
QuectelSues Telit, Alleging False Statements, Cybersquatting and Unfair Competition30.10.2026 16:41:00 CET | 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 15:00:00 CET | Press release
The exploration agent walks every page and flow of a web app on its own, flags UX, security and accessibility issues, and builds the map Kane CLI uses to write, run and ship tests to CI, even when no requirements exist 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
The Estée Lauder Companies and Microsoft Announce a New Strategic Partnership to Power Enterprise Efficiency and Consumer-Centric Growth30.10.2026 14:22:00 CET | Press release
The new collaboration will strengthen the company’s cloud, data, and AI capabilities to accelerate innovation and enhance productivity The Estée Lauder Companies Inc. (NYSE: EL) today announced a new strategic partnership with Microsoft Corp. to advance its cloud and data foundation and support the responsible adoption of AI-enabled capabilities across the enterprise. The collaboration will help connect data and intelligent tools to support faster innovation, more efficient operations, and more relevant consumer experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030616823/en/ This new partnership is a critical part of The Estée Lauder Companies’ One Operating Ecosystem, which brings together shared platforms, connected data, and best-in-class partners to enable consistent, scalable, and effective execution across the enterprise. A key initiative of this expanded partnership is harnessing the Microsoft platform to
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