Zydus’ new drug discovery, ‘Desidustat’ licensed to China Medical System Holdings receives approval from NMPA of China

Zydus’ new drug discovery, ‘Desidustat’ licensed to China Medical System Holdings receives approval from NMPA of China  Desidustat tablets, discovered and developed by Zydus, are a novel oral HIF-PHI approved for treating anaemia in non-dialysis adult CKD patients. The drug is administered orally, is therefore expected to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia. It is estimated that there are more than 120 million CKD patients in China.  China Medical System Holdings Limited (Hong Kong Stock Code:867, Singapore Stock Code:8A8,“CMS”) through its subsidiary obtained an exclusive license for the Desidustat from Zydus. Desidustat is now approved by National Medical Products Administration of China (NMPA) for renal anaemia in China.  China Phase III clinical trial of the Product had demonstrated positive results. The study met its primary efficacy endpoint. Extension study results demonstrated that the Product could maintain Hb level within the target range over the long term with acceptable safety, while significantly reducing hepcidin levels and ameliorating iron metabolism disorders. Ahmedabad, India, 14 March, 2026 Zydus Lifesciences Limited (“Zydus”), an innovation-led global lifesciences company, announced that its innovative drug Desidustat tablets, licensed to the subsidiary of China Medical System Holdings Limited (Hong Kong Stock Code:867, Singapore Stock Code:8A8,“CMS”), has been approved for renal anaemia in China by the National Medical Products Administration of China (NMPA). CMS International Development and Management Limited, a wholly-owned subsidiary of CMS had obtained an exclusive license for the drug from Zydus in 2020. Desidustat tablets are administered orally and represent a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of kidney function and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production, also known as erythropoiesis. When kidneys are impaired in patients with Chronic Kidney Disease, EPO production is reduced, leading to the development of anaemia. HIF-PHI promotes erythropoiesis by increasing endogenous erythropoietin, reducing hepcidin thereby improving iron availability. Speaking on the development, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel said, “We are encouraged by the NMPA’s approval for marketing the drug in China. Our life-changing discoveries are driven by a commitment to improving patient outcomes and enabling healthier, more fulfilled lives, globally. We are happy to partner with CMS and are confident that this will expand access to patients suffering from Chronic Kidney Disease across Greater China.” Desidustat is discovered, developed and marketed by Zydus in India under the brand name Oxemia™. More than 1 lac CKD patients in India have been successfully treated with Oxemia™ since its launch in 2022. 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, and its incidence increases progressively with disease progression. A survey in China showed that the prevalence of anaemia in patients at CKD stage 1 to 5 was 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively[2]. The target achievement rate (the Hb level reaching the target value of 110~120 g/L) for haemodialysis CKD patients with anaemia has increased to 51.5% [3], but is still only 8.2% for anaemia patients in non-dialysis CKD [4].The Product is administered orally, and is thus expected to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia. About Zydus Lifesciences Ltd. Zydus Lifesciences Ltd., with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 29,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for addressing unmet healthcare needs with vaccines, therapeutics, biologicals, and New Chemical Entities. For more details, visit www.zyduslife.com. 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 ###

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