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.