China Medical System’s Collaborative Partner Zydus Announced its Submission of the New Drug Application to the Drug Controller General of India for Desidustat Tablets

Company News

On November 23, Cadila Healthcare Limited (“Zydus”), a collaborative partner of China Medical System, announced that it has submitted the New Drug Application (NDA) to the Drug Controller General of India for Desidustat tablets, which is based on positive data from the two Phase III trials, DREAM-D and DREAM-ND.

The DREAM-D trial of 392 Chronic Kidney Disease (CKD) patients on dialysis compared Desidustat tablets versus Epoetin alfa injection, while the DREAM-ND trial of 588 CKD patients not-on-dialysis compared Desidustat tablets versus Darbepoietin alpha injection. In the Desidustat group of both trials, mean hemoglobin (Hb) increased and reached the predefined target of 10.0–12.0 g/dl in patients and was maintained within the target range for 24 weeks. Both studies demonstrated the noninferiority of Desidustat tablets compared to positive control drug in the treatment of anemia in patients on dialysis and not on dialysis, and met their primary efficacy endpoints.

Desidustat Tablets is a novel oral hypoxia-inducible factor-prolyl hydroxylase inhibitors (HIF-PHI), intended for the treatment of anemia in CKD patients  on dialysis and not on Dialysis. In China, China Medical System has completed the localized manufacturing of the product preparations used for clinical trials through technology transfer, and obtained the approval for drug clinical trial in China as Category 1 New Drug in January 2021. Currently, the Group has completed the Phase I pharmacokinetic (PK) trial of the product and is working on the Phase IIItrials.

Further information can be found in the Zydus’ PressRelease: