China Medical System: New Drug Application of Desidustat Tablets Accepted in China
April 23 2024 - 9:46AM
- Desidustat Tablets are novel, oral HIF-PHI for treating anaemia
in non-dialysis adult chronic kidney disease patients. 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, including both dialysis and non-dialysis
patients.
- China Phase III trial of the Product has demonstrated positive
results. The primary endpoint has indicated that Desidustat is more
effective than placebo in increasing Hb level.
- Currently, 4 innovative drugs of CMS have entered into
commercialization stage. Meanwhile, continuous advance of products’
clinical development and registration process such as Desidustat
Tablets is expected to enrich the Group’s marketed innovative
product portfolio, and generate new driving force to the Group’s
sustainable and healthy development.
China Medical System Holdings Limited (“CMS” or
the “Group”) is pleased to announce that on 22 April 2024, the New
Drug Application (NDA) of Desidustat Tablets (“Desidustat
Tablets” or the “Product”) has been accepted by the National
Medical Products Administration of China (NMPA). The Product is a
novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor
(HIF-PHI) for treating anaemia in non-dialysis adult, Chronic
Kidney Disease (CKD) patients.
CKD involves the gradual loss of functioning of
kidneys and eventually leads to kidney failure. If kidneys are
healthy, they will naturally secrete beneficial levels of a hormone
called Erythropoietin (EPO), which encourages red blood cell
production. If the kidneys are impaired, they will produce reduced
levels or tire of EPO production completely, leading to anaemia.
HIF-PHI promotes erythropoiesis through increasing endogenous
erythropoietin, improving iron availability and reducing
hepcidin.
It is estimated that more than 120 million
people are living with CKD in China[1]. Anaemia is one of the
frequent complications of CKD. A survey in China showed that the
prevalence 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 haemoglobin (Hb) level reaching the
target value (110~120g / L)) was only 8.2% for anaemia patients in
non-dialysis CKD and 35.2% for haemodialysis CKD, showing a large
unmet healthcare need[3].
China Phase III trial of the Product has
demonstrated positive results. The primary endpoint of the Hb mean
change from baseline to the period of Week 7-9 has indicated that,
Desidustat is more effective than placebo in increasing Hb level.
The least squares mean and 95% CI of Hb change from baseline to the
period of Week 7-9, using covariance model analysis, has shown an
increase of 16.38 g/l [95%CI: 14.50, 18.26] in the Desidustat group
and a decrease of 1.13 g/l [95%CI: -3.68, 1.41] in the placebo
group, for a between-group difference of 17.52 g/l [95%CI:14.353,
20.681], with the lower limit of 95% CI above 0.
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,
including both dialysis and non-dialysis patients. 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) on 20 January
2020.
Reference:
- 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
- Chinese expert consensus on diagnosis and therapy of renal
anaemia (the 2014 revised edition), Chinese Journal of Nephrology,
2014;30:712-716
- Chinese expert consensus on diagnosis and therapy of renal
anaemia (the 2018 revised edition), Chinese Journal of Nephrology,
2018, 34(11): 860-866
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Source: China Medical System
Holdings Ltd.