Chinese biopharmaceutical company BioCity Biopharma announced on Wednesday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its highly selective endothelin receptor type A (ETA) antagonist SC0062 for the treatment of diabetic kidney disease (DKD) with albuminuria.

This marks the second BTD for SC0062, following its initial designation for IgA nephropathy (IgAN) with proteinuria.

The new designation is supported by data from the DKD cohort of the Phase 2 2-SUCCEED study, where SC0062 demonstrated: statistically and clinically significant albuminuria reduction at the 20 mg dose versus placebo; a favourable safety profile with no increase in the risk of fluid retention observed in the SC0062 group; and good safety both as monotherapy and in combination with standard-of-care therapies including SGLT2 inhibitors, RAAS inhibitors, GLP-1 receptor agonists, insulin, and Finerenone (MRA).