China Medical System 109 0 Kommentare New Drug Application of Desidustat Tablets Accepted in China - Seite 2

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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