SHENZHEN, CHINA – 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. Monofer® can be administered as a high-dose infusion of 1,000 mg or more in a single visit, whereas older therapies such as iron sucrose typically require repeated administrations of 100 to 200 mg. This enables full iron repletion in one treatment, reducing the need for multiple infusions, lowering the burden on patients and healthcare systems, and increasing infusion capacity. At the same time, the low risk of hypophosphatemia helps avoid complications such as fractures and supports recovery from fatigue, a key symptom of iron deficiency anaemia.
More information about Cosmofer®
Cosmofer® is a second-generation low-molecular-weight iron dextran injection. It was approved for marketing in Mainland China in 2003 and is indicated for patients with iron deficiency who cannot take oral iron preparations (such as those who are intolerant to oral iron or have unsatisfactory therapeutic outcomes). Cosmofer® also allows single-dose high-dose iron repletion. With many years of accumulated clinical use, its efficacy and safety have been supported by accumulated clinical experience and published data. Its dual status as a Category A NRDL-listed product and NEML supports its core role in iron supplementation in primary healthcare settings.
About Iron Deficiency and Iron Deficiency Anemia
ID and IDA are global health issues that commonly affect children, premenopausal women (particularly pregnant women) and the elderly. These conditions may impair the function of multiple organ systems, leading to a series of health problems such as growth retardation, behavioral disorders, cognitive impairment, reduced physical capacity, and peri-natal and peri-operative complications. They also significantly affect the prognosis of chronic diseases such as gastrointestinal diseases, chronic kidney disease, heart failure and tumors[2]. More than 1 billion people live with iron deficiency anaemia[3], making it one of the leading contributors to the global burden of disease[4]. Data from the Fourth National Nutrition Survey in China indicate that the prevalence of IDA among Chinese residents is 20.1%[5]. However, both patients and healthcare professionals have insufficient awareness of the disease. Less than 20% of patients with mild anemia receive diagnosis and treatment, while only about 50% of patients with severe anemia receive appropriate diagnosis and treatment[2]. This indicates significant underdiagnosis and undertreatment of ID/IDA. Iron supplementation is the standard treatment for ID/IDA and includes oral iron therapy and intravenous iron therapy. Intravenous iron therapy is an important option for patients who cannot tolerate oral iron, have inadequate response to oral therapy, require rapid iron repletion, or prefer full iron supplementation within one to two administrations[1,2,6]. However, due to insufficient awareness of IDA, patient adherence issues, hospitalization constraints, infusion convenience, and safety concerns regarding intravenous iron therapies, the clinical use of intravenous iron in China remains relatively conservative. A Chinese real-world study shows that the average total dose of iron sucrose used in IDA patients was approximately 511 mg, which was significantly lower than the target dose of 1,000 mg[2]. There is therefore a significant clinical need for intravenous iron therapies that offer high safety, strong demonstrated efficacy and single-dose full iron repletion. Monofer® and Cosmofer® together establish a comprehensive intravenous iron product portfolio covering multiple treatment scenarios, providing tiered treatment options for patients with iron deficiency anemia.
About Pharmacosmos A/S
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anemia. Leveraging its deep expertise in carbohydrate chemistry and cell cycle biology, the company is committed to developing innovative therapies to address unmet patient needs, with a particular focus on iron metabolism and hematology-related diseases. Pharmacosmos A/S was founded in 1965 and is headquartered in Denmark, and employs more than 700 specialists from the United Kingdom, Ireland, the Nordic countries, Germany, the United States, Canada and China. With excellent product quality and strong clinical value, its core iron therapy products have been approved and widely used in multiple countries and regions worldwide, establishing strong technological capabilities and a solid market reputation.
About CMS
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.
CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.
CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development in its advantageous specialty fields, strengthening the competitiveness of the cardiovascular-kidney-metabolic/gastroenterology/ophthalmology/skin health businesses, bringing economies of scale in specialty fields. Among them, the skin health business (Dermavon) has become a leading enterprise in its field, and is proposed to be listed independently on the SEHK. Meanwhile, CMS continuously promotes the operation and development of its integrated R&D, manufacturing and commercialization chain in Southeast Asia and the Middle East, capturing growth opportunities in emerging markets to support the high-quality and sustainable development of the Group.
Reference:
- Chinese Pharmacological Society Professional Committee of Drug‑induced Diseases, Guangdong Pharmaceutical Association. Expert consensus of clinical application and pharmaceutical care for intravenous iron agents (2024) [J]. Adverse Drug Reactions Journal, 2025, 27(3): 129-141. DOI: 10.3760/cma.j.cn114015⁃20240929⁃00070
- Liao Minjing, Zhang Liansheng. Standardized diagnosis and treatment of iron deficiency and iron‑deficiency anemia [J]. Chinese Journal of Internal Medicine, 2023, 62(6): 722-727. DOI: 10.3760/cma.j.cn112138-20230210-00074.
- Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019 (GBD 2019) Results. Seattle, United States: Institute for Health Metrics and Evaluation (IHME); 2020. Available from http://ghdx.healthdata.org/gbd-results-tool.
- Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248.
- Li Lijuan, Zhang Liansheng. Considerations on the standardized diagnosis and treatment of iron‑deficiency anemia [J]. National Medical Journal of China, 2021, 101(40): 3266-3270. DOI: 10.3760/cma.j.cn112137-20210609-01319.
- Red Blood Cell Disease (Anemia) Group, Chinese Society of Hematology, Chinese Medical Association. Multidisciplinary expert consensus on the diagnosis, treatment and prevention of iron deficiency and iron deficiency anemia (2022 edition) [J]. National Medical Journal of China, 2022, 102(41): 3246-3256. DOI: 10.3760/cma. j.cn112137-20220621-01361.
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