Ferinject® approved in Chinafor the treatment of iron deficiency in adult patients
28.11.2022 09:00:00 EET | Business Wire | Press release
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221127005020/en/
CSL Vifor and Fresenius Kabi today announced that China’s National Medical Products Administration (NMPA) has approved Ferinject®, a preparation for intravenous iron therapy for the treatment of iron deficiency in adult patients for whom oral iron preparations are ineffective, oral iron preparations cannot be used or for whom there is a clinical need to deliver iron rapidly. Ferinject® has now received marketing authorization in 85 countries worldwide.
“We are thrilled about the marketing authorization of Ferinject®, which is a milestone for Chinese patients living with iron deficiency or iron deficiency anemia”, said Hervé Gisserot, General Manager of CSL Vifor. “There is a high unmet need in China, which has the world’s largest iron deficiency population, and we are confident that Ferinject® can make a meaningful difference in the treatment of these patients. At the same time, this is another important step in our goal to globalizing and maximizing the performance of our iron franchise as we look forward to bring this treatment to market as soon as possible.”
“Marketing authorization of Ferinject® will strengthen our commitment of bringing innovative medicines for patients in China. We are guided by our corporate philosophy of caring for life and invested to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face”, said Yang Weiping, President of Fresenius Kabi China.
The approval of Ferinject® may also enable a more effective implementation of PBM in Chinese hospitals, where an estimated 3-4 million patients undergo elective surgery each year. In China, PBM encompasses multiple in-hospital procedures across therapeutic areas. The China National Health Commission (NHC) has announced guidelines for perioperative PBM as a health standard across China, effective as per 1 June 2022.
Marketing authorization in China is based on positive clinical results from the phase-III trial VIT-IRON-2011-004. This open label, randomized multicenter study showed that Ferinject® is an effective and well-tolerated alternative to iron sucrose for the treatment of iron deficiency anemia that can provide an improved hemoglobin response and correction of iron deficiency in Chinese patients.
CSL Vifor and Fresenius Kabi currently expect to begin to market Ferinject® in the first half of 2023, with National Reimbursement Drug List (NRDL) listing anticipated in January 2024.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com.
About Fresenius Kabi
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. Fresenius Kabi’s product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the devices for administering these products. In the field of biosimilars, Fresenius Kabi focuses on autoimmune diseases and oncology. In 2019, the first biosimilar product by Fresenius Kabi was launched. Within transfusion medicine and cell therapies, Fresenius Kabi offers products for collection of blood components and extracorporeal therapies.
With its corporate mission of "caring for life", the company is committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face. For more information, please visit www.fresenius-kabi.com.
About Ferinject®
Ferinject®/Injectafer® (ferric carboxymaltose) is an i.v. iron therapy with market authorization in 85 countries by November 2022. More than 19 million patient years of experience have helped to establish Ferinject®/ Injectafer® as a trusted brand, with clinical benefits demonstrated by its efficacy and safety data2. Ferinject’s® quality relies on a consistent and firmly-controlled manufacturing process based on decades of experience.
About iron deficiency
Iron Deficiency affects about half of the patients with chronic kidney disease3 and chronic heart failure and is associated with reduced quality of life4, an increased risk of hospitalization5 and cardiovascular death6. Despite the serious consequences and high prevalence, of iron deficiency, the condition remains under-recognized7.
Iron plays a vital role in many bodily processes, including the production of red blood cells, effective heart and brain function, and the prevention of infection and illness. Without enough iron, the body is unable to function properly. Common symptoms include fatigue, dizziness, and shortness of breath. Iron deficiency and iron deficiency anemia is estimated to affect one in three people worldwide8, yet despite the serious consequences and high prevalence9, it remains an under-recognized condition.
Although iron deficiency can affect anyone, it is most prevalent in premenopausal women, pregnant woman and children under five10. Left untreated, it can develop into iron deficiency anemia. The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being11. Even without anemia, iron deficiency can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality12. Common symptoms include fatigue11, 13, 14 pale skin13, brittle nails13, 15, craving non-food items such as dirt, clay and ice16, and an inability to concentrate11, 17. In children, iron deficiency can significantly impair cognitive and motor development18.
About Patient Blood Management (PBM)
PBM is designed to improve surgical and medical patient outcomes by optimally managing and preserving patients’ blood. Proactive identification and treatment of iron deficiency anemia in patients scheduled for elective surgery has been associated with a reduced need for blood transfusion19 , reduced length of hospital stay19, improved patient’s outcomes20, and overall healthcare expenditure reduction21.
References:
1. Ni W, Yuan X, Sun Y, et al. Anaemia and associated factors among older adults in an urban district in China: a large-scale crosssectional study. BMJ Open 2022;12:e056100. doi:10.1136/ bmjopen-2021-056100.
2. Scott Drugs. 2018 Mar;78(4):479–493. doi: 10.1007/ s40265-018-0885-7.
3. Wong MMY et al. Clin Kid J 2019:1–12; Rocha BML, et al. J Am Coll Cardiol. 2018;71(7):782–793.
4. Guedes M NDT 2021. doi: 10.1093/ndt/gfab050; Enjuanes C, et al. Int J Cardiol. 2014;174(2):268–275.
5. Guedes et al. J Am Soc Nephrol. 2021 Aug;32(8):2020-2030, Martens P, et al. Acta Cardiol. 2018;73(2):115–123.
6. Guedes et al. J Am Soc Nephrol. 2021 Aug;32(8):2020-2030; Klip IT, et al. Am Heart J. 2013;165:575–82.e3.
7. Eur J Heart Fail. 2021 Sep 3. doi: 10.1002/ejhf.2338.
8. Peyrin-Biroulet L, et al. Guidelines on the diagnosis and treatment of iron deficiency across indications: a systematic review. Am J Clin Nutr. 2015;102(6):1585-94.
9. World Health Organization. Worldwide prevalence of anaemia 1993-2005. 2008. Available at URL: http://apps.who.int/iris/bitstream/handle/10665/43894/9789241596657_eng.pdf;jsessionid=9C613E2F4D481EDEB9DE07986AFCE0C7?sequence=1. Last accessed: June 2018.
10. Hercberg S, et al. Iron deficiency in Europe. Public Health Nutr. 2007;4(2b).
11. Fernando B, et al. A guide to diagnosis of iron deficiency and iron deficiency anemia in digestive diseases. World J Gastroenterol. 2009 Oct 7; 15(37): 4638-4643.
12. Cappellini MD et al. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068-1078.
13. Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016;91(1):31-38.
14. Favrat, B., et al. (2014). Evaluation of a single dose of ferric carboxymaltose in fatigued, iron-deficient women--PREFER a randomized, placebo-controlled study. PLoS One 9(4): e94217. eCollection 2014.
15. Cashman MW, Sloan SB. Nutrition and nail disease. Clin Dermatol. 2010;28(4):420-5.
16. Barton JC, et al. Pica associated with iron deficiency or depletion: clinical and laboratory correlates in 262 non-pregnant adult outpatients. BMC Blood Disord. 2010;10:9. doi:10.1186/1471-2326-10-9.
17. Patterson A et al. Iron deficiency, general health and fatigue: Results from the Australian Longitudinal Study on Women’s Health. Qual Life Res. 2000;9:491-497.
18. World Health Organization. Nutritional anaemias: tools for effective prevention and control. 2017. Available at URL: http://www.who.int/nutrition/publications/micronutrients/anaemias-tools-prevention-control/en/. Last accessed: June 2018.
19. Froessler B. et al., Ann Surg 2016
20. Kotzé A. et al., British Journal of Anaesthesia 2012
21. Basora M. et al., Blood Transfus 2018
# # #
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/20221127005020/en/
Contact information
CSL Vifor Media Contact
Thomas Hutter
Mobile: +41 79 957 96 73
Email: media@viforpharma.com
CSL Investor Contact
Steve McKeon
Associate Director, Investor Relations
CSL Limited
Mobile +61 402 231 696
Email: stephen.mckeon@csl.com.au
Fresenius Kabi contacts:
China Corporate Communications
+86 010 – 59096999
cn.communications@fresenius-kabi.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
OKX Launches X-Perps on the Magnificent 7 Stocks, Gold, Silver and Oil for European Traders9.6.2026 14:06:00 EEST | Press release
OKX, a leading global fintech company and crypto trading platform, today launched 13 new X-Perp markets for traders across Europe, giving retail users direct access to futures on the "Magnificent 7" tech stocks, four major commodities and the world's biggest* indices. From today, OKX customers in Europe can trade futures on Apple, Amazon, Alphabet, Meta, Microsoft, Nvidia and Tesla, alongside Gold, Silver, WTI Crude Oil and Brent Crude Oil. SPY and QQQ X-Perps are also available, allowing Europeans to build wealth by offering price exposure to the 500 largest US companies and the 100 largest non-financial Nasdaq companies respectively. On Friday June 12, following its IPO, X-Perps on SpaceX will also become available. All markets are available 24/7, with up to 10x leverage. Previously, acting on a Fed decision at midnight or a commodity spike over the weekend meant either waiting for markets to open or managing a separate brokerage account. X-Perps remove that constraint. Capital stays
Promega Receives SBTi Validation for Near-Term Science-Based Emissions Reduction Targets9.6.2026 14:01:00 EEST | Press release
Promega Corporation has received approval from the Science Based Targets initiative for its near-term emissions reduction targets, developed to reflect the current status of climate science. SBTi is a corporate climate organization that develops standards, tools and guidance for setting greenhouse gas emissions reductions targets in line with what is needed to avoid the worst impacts of climate change. “These goals aren’t just a commitment, they represent a verified plan with third-party accountability built in,” says Corey Meek, Corporate Responsibility Program Manager at Promega. “Our SBTi-validated targets reflect a comprehensive understanding of our greenhouse gas emissions across our entire value chain and set a clear, science-aligned standard for what we aim to achieve by 2030.” The Science Based Targets initiative has approved the following near-term targets: Scope 1 and 2: Reduce absolute Scope 1 and 2 emissions by 47% by 2030, from a 2023 baseline. Scope 3 (absolute reduction)
IFF’s 2025 Do More Good Report Highlights Progress in Nature-Based Innovation9.6.2026 14:00:00 EEST | Press release
IFF (NYSE: IFF) — a global leader in flavors, fragrances, food ingredients and health & biosciences — released its 2025 Do More Good Report, highlighting the company’s commitment to creating better products and experiences for people and the planet. IFF’s increasingly nature-based portfolio underscores the central role of sustainability and positions its innovation at the intersection of biology and chemistry. Through continued investment in R&D, expanded global innovation partnerships and measurable impact across the value chain, the report demonstrates how IFF is reducing environmental impact while delivering differentiated performance and long-term value for customers and consumers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260608586967/en/ Cover image for IFF’s 2025 Do More Good report. “IFF’s 2025 Do More Good Report shows clear progress in advancing nature-based solutions and strengthening our portfolio,” said Eri
Icon Solutions Showcases How Banks Can Accelerate Digital Asset Innovation with IPF9.6.2026 12:30:00 EEST | Press release
Icon Solutions – the UK fintech enabling banks to design and implement state-of-the-art payment systems – has released a reference implementation showing how banks can use the Icon Payments Framework (IPF) to accelerate support for payments processing using distributed ledger technology (DLT)-based digital assets. As IPF is agnostic to both the type of digital asset and the DLT network on which they are issued, the risk of fragmentation is reduced as adoption scales. There is growing momentum for digital assets such as stablecoins, tokenised deposits, deposit tokens and central bank digital currencies (CBDCs) to enable faster, cheaper and smarter payments. Yet the emergence of different digital asset types and DLT networks – which must also work with existing financial infrastructure – creates fragmentation and operational complexity for banks. This is compounded by legacy vendor solutions that limit choice and lock banks in, making it slow, costly and risky to make the changes require
monday.com Appoints Ben Barnett General Manager of EMEA to Drive Next Phase of Regional Growth9.6.2026 11:00:00 EEST | Press release
monday.com (Nasdaq: MNDY), the AI work platform that turns strategy into execution at scale, today announced Ben Barnett’s appointment to General Manager (GM) of Europe, the Middle East and Africa, marking a major milestone in the company’s global expansion. Ben, who has been with monday.com for five years, brings a decade of experience in senior B2B sales roles at software companies and has overseen significant, sustained growth at monday.com in the UK and Ireland since joining in 2021. In his new position, Ben’s priorities include delivering the monday.com’s EMEA go-to-market strategy, fostering key partnerships, and bolstering its newly announced AI work platform. He is based in London. Ben’s promotion comes as monday.com builds on a period of rapid regional success, with EMEA revenue up 26% year-on-year in 2025. Last year, monday.com expanded its regional EMEA headquarters in Fitzrovia, London, now occupying 80,000 sq ft across three floors where more than 370 employees are based,
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