CSPC Pharmaceutical Group: New drug Desidustat for renal anemia approved for marketing in China
China Medical System Holdings Limited (867.HK/8A8.SG) ("China Medical System") is pleased to announce that the Marketing Authorization Application (MAA) for the new drug Desidustat Tablets (formerly: Daprodustat Tablets) ("the Product") for the treatment of renal anemia has been approved by the National Medical Products Administration (NMPA) of China on March 13, 2026. The Product is an innovative oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), indicated for the treatment of anemia in adult patients with non-dialysis chronic kidney disease (CKD).
The approval of Desidustat Tablets will further strengthen China Medical System's overall strategic layout in the nephrology specialty field and create synergistic effects with the innovative drug Vifor (sucroferric oxyhydroxide chewable tablets, for hyperphosphatemia in CKD), which is already in the commercialization stage. Through the efficient linkage of nephrology expert resources and channel networks, China Medical System is expected to rapidly promote the large-scale clinical application of Desidustat Tablets, providing differentiated treatment options for Chinese CKD patients with renal anemia and making positive contributions to the Group's performance.
More Information on Desidustat Tablets and Renal Anemia
As an innovative oral HIF-PHI, the Product's mechanism of action is to promote erythropoiesis by increasing endogenous erythropoietin production, improving iron utilization, and reducing hepcidin levels. Its Phase III clinical trial in China achieved positive results. The results for the primary endpoint, hemoglobin (Hb) level (change from baseline in the mean Hb level during weeks 7-9), showed that the treatment group was superior to the placebo group. Extension study results indicated that the Product can maintain Hb levels at target levels over the long term with a favorable safety profile. Furthermore, the Product can significantly reduce hepcidin levels and correct iron metabolism disorders.
There remains a significant unmet need in the field of CKD anemia treatment in China. It is estimated that there are over 120 million CKD patients in China [1]. Anemia, as one of its common complications, shows an increasing incidence as the disease progresses. A domestic survey revealed that the prevalence of anemia among CKD patients in stages 1 to 5 is 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively [2]. The treatment target achievement rate (Hb level reaching the target range (110～120 g/L)) for hemodialysis CKD anemia patients has increased to 51.5% [3], but it remains only 8.2% for non-dialysis CKD anemia patients [4]. The Product's oral administration route is expected to improve patient compliance and address the unmet treatment needs in the field of CKD anemia.
The Product has already been approved for marketing in India.
China Medical System's wholly-owned subsidiary, CMS International Development Management Limited, obtained the exclusive license rights for the Product from Zydus Lifesciences Limited (formerly Cadila Healthcare Limited) through a License Agreement effective January 20, 2020.
Adhering to its core strategy of "Innovation-Driven," China Medical System has established a well-structured and sufficiently stocked innovative product matrix with seamless echelons: 7 new drugs approved for marketing, 6 under marketing review, and nearly 20 projects about to commence or currently undergoing clinical trials. Through the dual-engine innovation model of "Co-development + Independent R&D," China Medical System continues to enrich its innovative pipeline centered on First-in-Class (FIC) and Best-in-Class (BIC) products, efficiently advancing clinical development and commercialization. In the future, China Medical System will continue to be guided by clinical needs, provide more high-quality pharmaceutical solutions, and steadfastly progress towards becoming a specialty-focused, innovative, and excellent international pharmaceutical enterprise.
About China Medical System
China Medical System is an open platform enterprise that connects pharmaceutical innovation with commercialization, managing the entire product lifecycle. It is committed to providing competitive products and services to meet unmet medical needs.
China Medical System focuses on First-in-Class (FIC) and Best-in-Class (BIC) innovative products, efficiently advancing their clinical research, development, and commercialization processes, empowering the continuous translation of scientific achievements into clinical practice for the benefit of patients.
China Medical System concentrates on specialty fields, possessing proven commercialization capabilities, extensive channel coverage, and expert resources across multiple disease areas. Its core marketed products have achieved leading academic and market positions. China Medical System continues to deepen its development around its advantageous specialty fields to consolidate competitiveness in cardio-renal-metabolic/digestive/ophthalmology/skin health businesses, bringing about scale efficiency in specialties. Among them, the skin health business (Dermagene) has become a leading enterprise in its segment and plans to list independently on the Stock Exchange. Simultaneously, China Medical System continues to promote the operational development of the entire R&D, production, and sales industrial chain in Southeast Asia and the Middle East to capture incremental growth in emerging markets, supporting the Group's achievement of high-quality and sustainable development.
References/Materials
1. ZhangL, WangF, WangL, et al. Prevalence of chronic kidney disease in China: a cross-sectional survey[J]. Lancet, 2012, 379(9818):815-822. DOI: 10.1016/S0140-6736(12) 60033-6
2. Chinese expert consensus on diagnosis and treatment of renal anemia (2014 revised edition)[J]. Chinese Journal of Nephrology, 2014, 30(9): 712-716. DOI: 10.3760/cma.j.issn.1001-7097.2014.09.015
3. The 19th Congress of Critical Nephrology and Blood Purification, Chinese Society of Nephrology, Chinese Medical Association (July 2-5, 2025)
4. Chinese expert consensus on diagnosis and treatment of renal anemia (2018 revised edition)[J]. Chinese Journal of Nephrology, 2018, 34(11): 860-866. DOI: 10.3760/cma.j.issn.1001-7097.2018.11.012
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