China IND Application of CMS (00867)¡¯s Innovative Drug Desidustat Tablet was Accepted
2020-11-17 22:42

On November 17, the IND application of CMS¡¯s innovative drug Desidustat Tablet was accepted by the Center for Drug Evaluation, NMPA. Desidustat Tablet is a novel oral Hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) for treating anemia in chronic kidney disease (CKD) patients.

Desidustat Tablet was developed by the Group¡¯s collaborative partner Cadila Healthcare Limited (¡°Zydus¡±) , and the Group has exclusive licensed rights of the product in Mainland China, Hong Kong, Macao and Taiwan (¡°related territory¡±). As a new molecular entity, Desidustat has been granted a material patent in related territory. In order to accelerate its clinical development and registration progress in China, the manufacturing of the tablet will be localized by the Group in China with technology transfer from Zydus.

More than 120 million people are estimated to be living with CKD in China. Anemia is one of the frequent complications of CKD. A survey in China showed that the prevalence of anemia in patients at CKD stage 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively. The target-achieving rate (the hemoglobin (Hb) level reaching the target value (110~120g/L)) was only 8.2% for anemia patients in non-dialysis CKD and 35.2% for hemodialysis CKD, showing large unmet healthcare need.