BioCity's ETA-Selective Antagonist SC0062 Granted Breakthrough Therapy Designation in China for Diabetic Kidney Disease with Albuminuria

• Second BTD Recognition Highlights Compound's Potential as Next-Generation Broad-Spectrum Renal Therapy

SHANGHAI, June 26, 2025 /PRNewswire/ -- BioCity Biopharma ("BioCity") announced today 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, which is conducting in Phase III, underscoring the compound's transformative potential across multiple chronic kidney disease (CKD) indications.

The designation is supported by compelling data from the DKD cohort of the Phase 2 2-SUCCEED study, where SC0062 demonstrated:

1)  Statistically and clinically significant albuminuria reduction at the 20 mg dose versus placebo.

2)  Favorable safety profile with no increase in the risk of fluid retention observed in the SC0062 group.

3)  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).Most participants in the trial received SGLT2 (sodium-glucose co-transporter-2) inhibitors and RAAS (renin-angiotensin-aldosterone system) inhibitors as background therapies, over 70% received GLP-1 (Glucagon-like peptide-1) receptor agonists and/or insulin, and approximately one-third were on Finerenone (a mineralocorticoid receptor antagonist, MRA).

"With over 700 million people affected globally, kidney disease represents one of our greatest unmet medical challenges," said Dr. Ivy Wang, BioCity Co-founder and Executive President. "This dual BTD recognition validates SC0062's potential to redefine treatment paradigms across renal diseases. We're accelerating development to deliver this promising therapy to patients worldwide."

Clinical and Commercial Context

The completed Phase 2 2-SUCCEED program met all efficacy and safety endpoints in both IgAN and DKD cohorts at 12- and 24-week timepoints. Full DKD results will be presented at an upcoming international congress.

DKD, affecting ~20.9 million patients in China (2021), drives the nation's CKD epidemic. Without innovation, age-standardized incidence rates（ASIR）are projected to rise 25% by 2036. Current therapies provide limited protection against progression to end-stage renal disease (ESRD).

As an ET_A antagonist showing optimized effect for CKD, SC0062 represents a mechanistically distinct approach that:

• Modulates renal hemodynamics
• Reduces proteinuria/albuminuria
• Counters inflammation and fibrosis

With its demonstrated clinical benefits and superior selectivity profile, SC0062 is positioned to potentially become a best-in-class renal therapeutic. BioCity remains committed to advancing this promising candidate through late-stage development for multiple kidney disease indications.

About SC0062

SC0062 is a novel and unique ET_A  antagonist characterized by its high selectivity for ET_A compared to the endothelin receptor B (ET_B). Its strong selectivity for ET_A suggests that it has greater potential than non-selective endothelin receptor antagonists for slowing the progression of CKD while avoiding the side effects associated with non-selective medications in the same class used to treat IgAN and DKD and other types of CKD.

Preclinical studies showed that SC0062 significantly improved pathological scores in acute and chronic kidney disease models. Completed Phase 1 studies demonstrated good safety, tolerability, and pharmacokinetics, with no signs of fluid retention. SC0062 has completed enrollment in both cohorts (IgAN and DKD) of the Phase 2 2-SUCCEED study. The IgAN cohort has met primary and secondary endpoints, with results published in JASN. The DKD cohort has now also met its primary and secondary endpoints. SC0062 has now received BTD twice from the CDE – first for IgAN with proteinuria and now for DKD with albuminuria.

BioCity is conducting initiate two Phase 3 trials: SUCCESS-01 (IgAN) and SUCCESS-02 (CKD). SUCCESS-01 has been launched at Guangdong Provincial People's Hospital, led by Professor Xueqing Yu, President of the hospital and President of the Asia-Pacific Society of Nephrology.

About BioCity Biopharma

Founded in December 2017, BioCity is a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders including CKD. BioCity has established a pipeline of more than 10 innovative drug candidates, including small molecules, monoclonal and bispecific antibodies, and antibody-drug conjugates (ADC).

Currently, SC0062 a highly selective ET_A antagonist owned by BioCity, is in development for CKD. A Phase 3 confirmatory trial for IgAN has been initiated in China and a Phase 3 multi-regional clinical trial (MRCT) is being planned. In addition, BioCity has five core novel oncology assets in clinical development, including first-in-class CDH3- and GPC3-targeting antibody drug conjugates (ADCs), WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3.

For more information, please visit: www.biocitypharma.com
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