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.
