Pharmaceutical Company Kangzhe: New drug Daxidustat tablets for renal anemia approved for marketing in China

- Daxidustat tablets are an innovative oral HIF-PHI, approved for the treatment of anemia in adult CKD patients not on dialysis; the product is administered orally, which is expected to improve patient compliance with treatment and meet unmet therapeutic needs in the CKD anemia space

- The Phase III clinical trial of the product in China achieved positive results: the study met its primary efficacy endpoint; extension phase results showed that the product can maintain long-term Hb levels within target range, with good safety, while significantly reducing hepcidin levels and correcting iron metabolism disorders

- The product will strengthen the group's presence in the nephrology field and create synergies with Vifor (sucroferric oxyhydroxide chewable tablets, used for CKD hyperphosphatemia), an already marketed innovative drug, through shared expert resources and channel networks

China Medical System Holdings Limited ("CMS" or "the Group") is pleased to announce that the marketing authorization application for Desidustat Tablets (formerly known as Daprodustat Tablets) ("the Product"), a new drug for renal anemia, was 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) designed for the treatment of anemia in adult patients with non-dialysis-dependent chronic kidney disease (CKD).

The approval and launch of Desidustat Tablets will further strengthen the Group's overall strategic position in the nephrology sector and create synergies with Vifor (sucroferric oxyhydroxide chewable tablets, used for CKD hyperphosphatemia), which is already in commercialization. Leveraging its network of nephrology experts and efficient channel resources, the Group aims to rapidly promote the large-scale clinical adoption of Desidustat Tablets, offering differentiated treatment options to Chinese CKD patients with renal anemia and contributing positively to the Group’s performance.

More Information on Desidustat Tablets and Renal Anemia

As an innovative oral HIF-PHI, the product works by increasing endogenous erythropoietin production, improving iron utilization, and reducing hepcidin levels to stimulate red blood cell production. Its Phase III clinical trial in China yielded positive results. The primary endpoint, hemoglobin (Hb) level (mean change in Hb from baseline during weeks 7-9), showed that the treatment group outperformed the placebo group. Extension study results demonstrated that the product can maintain Hb levels within target ranges over the long term with a favorable safety profile. Additionally, the product significantly reduces hepcidin levels, correcting iron metabolism disorders.

There remains a significant unmet need in the treatment of anemia associated with CKD in China. It is estimated that there are over 120 million CKD patients in China [1], and anemia, as one of the common complications, shows an increasing prevalence rate as the disease progresses. A domestic survey indicated that the prevalence rates of anemia among CKD stages 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively [2]. The treatment goal achievement rate (Hb levels reaching target values of 110-120 g/L) for dialysis-dependent CKD anemia patients has improved to 51.5% [3], but for non-dialysis-dependent CKD anemia patients, it remains as low as 8.2% [4]. With its oral administration, the product is expected to enhance patient compliance and address unmet treatment needs in CKD anemia.

The product has been approved for marketing in India.

The Group’s wholly-owned subsidiary, CMS International Development Management Limited, obtained exclusive licensing rights to the product through a License Agreement effective January 20, 2020, from Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited).

Adhering to its core strategy of 'Innovation-Driven Growth,' the Group has established a robust and diversified portfolio of innovative products: seven new drugs have received marketing approval, six are currently under regulatory review, and nearly 20 projects are either about to commence or are advancing through clinical trials. Through a dual-driven innovation model combining co-development and in-house R&D, the Group continues to enrich its pipeline with first-in-class (FIC) and best-in-class (BIC) products while efficiently advancing clinical development and commercialization. Moving forward, CMS will remain committed to addressing clinical needs, providing high-quality pharmaceutical solutions, and steadfastly progressing toward becoming a specialized, innovative, and globally competitive pharmaceutical enterprise.

References/Resources

1. Zhang L, Wang F, Wang L, 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 on Critical Care Nephrology and Blood Purification of the 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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