CMS (867.HK/8A8.SG) : New Drug for Renal Anaemia Desidustat Tablets Approved in China

SHENZHEN, CHINA - China Medical System Holdings Limited (“CMS”, or the “Group”) is pleased to announce that on 13 March 2026, new drug for renal anaemia Desidustat Tablets (the “Product”) has been approved for marketing in China by the National Medical Products Administration of the People’s Republic of China (NMPA). The Product is a novel, oral HypoxiaInducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in non-dialysis adult, Chronic Kidney Disease (CKD) patients.

The approval of Desidustat Tablets will further strengthen the Group’s overall layout in the field of nephrology, and synergize with the marketed innovative drug Velphoro (Sucroferric Oxyhydroxide Chewable Tablets, indicated for CKD hyperphosphatemia). Through the efficient linkage of nephrology expert resources and channel networks, the Group is expected to rapidly promote the large-scale clinical application of Desidustat Tablets, providing differentiated treatment options for Chinese CKD patients with renal anaemia and making a positive contribution to the Group’s performance.

More information about Desidustat Tablets and Renal Anaemia

As a novel oral HIF-PHI, the Product’s mechanism of action promotes erythropoiesis through increasing endogenous erythropoietin, improving iron availability and reducing hepcidin. Its China Phase III clinical trial has demonstrated positive results. The primary endpoint of the haemoglobin (Hb) mean change from baseline to Week 7-9 has indicated that, Desidustat is more effective than placebo in increasing Hb level. Results from the extension study demonstrate that the Product can maintain Hb level within the target range over the long term with acceptable safety. In addition, the Product significantly reduces hepcidin levels and ameliorates iron metabolism disorders.

There is still a large unmet need in the treatment of anaemia in CKD patients in China. It is estimated that there are more than 120 million CKD patients in China^[1]. Anaemia is one of the frequent complications of CKD, which exhibits a progressively increasing incidence with disease progression. A survey in China showed that the prevalences of anaemia in patients at CKD stage 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively^[2]. The target-achieving rate (the Hb level reaching the target value (110~120g / L)) has increased to 51.5% for haemodialysis CKD patients with anaemia^[3], but is still only 8.2% for anaemia patients in non-dialysis CKD^[4]. The Product is administrated orally, thus expecting to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia.

Desidustat Tablets have been approved for marketing in India.

CMS INTERNATIONAL DEVELOPMENT AND MANAGEMENT LIMITED, a wholly-owned subsidiary of the Group, obtained an exclusive license for the Product from Zydus Lifesciences Limited (earlier known as Cadila Healthcare Limited) pursuant to a License Agreement with an effective date of 20 January 2020.

The Group adheres to its core strategy of “innovation-driven”, having established a tiered and multi-dimensional innovation product portfolio with abundant reserves: 7 new drugs have been approved for marketing, 6 are currently under marketing review, and nearly 20 projects are about to initiate or are progressing through clinical trials. Through a dual-engine innovation approach combining collaborative development and in-house R&D, the Group continuously enriches its innovative pipeline centered on first-in-class (FIC) and best-in-class (BIC) products, efficiently advancing clinical development and commercialization. Moving forward, CMS will remain clinical needs-driven to deliver more quality pharmaceutical solutions, steadfastly advancing toward the goal of becoming a specialty-focused, innovation-excellent multinational pharmaceutical enterprise.

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

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 the 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. 19th CSN Critical Care & Blood Purification Congress, Chinese Medical Association (July 2-5, 2025)

4. Chinese Expert Consensus on the 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

CMS Disclaimer and Forward-Looking Statements

This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.

This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.

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