China Medical System Holdings Limited (“CMS” or the “Group”) is pleased to announce that, the Group through its wholly-owned subsidiary entered into an exclusive commercialization and supply agreement (the “Agreement”) with Pharmacosmos A/S for Iron Isomaltoside Injection (“Monofer®”) and Iron Dextran Injection (“Cosmofer®”) recently. In accordance with the Agreement, the Group has obtained an exclusive right to commercialize the products in the People’s Republic of China (for the purpose of this Agreement, excluding the Hong Kong Special Administrative Region, the Macau Special Administrative Region and Taiwan region). Pharmacosmos A/S will continue to manufacture and supply the products. The cooperation term shall be fifteen years from the effective date stipulated in the Agreement, which may be extended upon mutual agreement between the parties prior to expiry.The two intravenous iron therapies under this cooperation are both originator products that have been approved for marketing in China and included in the China’s National Reimbursement Drug List (NRDL). Among them, Monofer® is an exclusive drug and the first third-generation intravenous iron therapy approved for marketing in China. It features an innovative and more stable matrix-like nanostructure and provides a superior safety profile[1]. Its single-dose full iron replenishment significantly reduces the number of infusions, enables faster improvement in hemoglobin levels and enhances clinical convenience. Another product, Cosmofer®, is currently the only intravenous iron therapy included in Category A of the NRDL and also the only one included in the National Essential Medicines List (NEML). With many years of accumulated clinical use, its efficacy and safety have been supported by accumulated clinical experience and published data.
The above two products will form a comprehensive intravenous iron product portfolio covering all channels and treatment scenarios, which can support meeting the clinical needs of different levels of healthcare institutions and different types of iron deficiency anemia (IDA) patients, providing more diversified, safe and effective treatment options for patients. Patients with iron deficiency (ID) and IDA are widely distributed across multiple clinical departments, including gastroenterology, cardiology, nephrology, obstetrics and gynecology, and orthopedics, which are all key specialty areas of the Group. The addition of the two products will generate efficient synergies with the Group’s existing marketed products in expert resources and academic promotion network, further strengthening the Group’s overall competitiveness in the field of anemia treatment, and is expected to have a positive impact on the Group’s performance.
More information about Monofer®
Monofer® was approved on 30 January 2021 for the treatment of iron deficiency in patients where oral iron preparations are ineffective, cannot be used, or where there is a clinical need for rapid iron supplementation. In 2023, Monofer® was included in the NRDL as a Category B reimbursable drug. Monofer® consists of nanoparticles with a stable, matrix-like structure composed of interchanging layers of iron atoms and short, linear isomaltose carbohydrates. This structure enables controlled iron release with low levels of labile iron, contributing to a favourable safety profile, including a low risk of hypersensitivity reactions and hypophosphatemia.
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