BioCity’s SC0062 secures second breakthrough therapy designation in China for diabetic kidney disease

Shanghai-based clinical-stage biotech developer BioCity Biopharma has received a second Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA) for its investigational ETA-selective antagonist SC0062. The designation applies to the treatment of diabetic kidney disease (DKD) with albuminuria, expanding upon its prior BTD award for IgA nephropathy (IgAN) with proteinuria. This latest recognition further affirms SC0062’s emerging role as a next-generation renal therapy capable of addressing multiple chronic kidney disease (CKD) pathologies. The update follows robust data from the DKD cohort of the Phase 2 2-SUCCEED clinical trial, which demonstrated statistically and clinically significant albuminuria reduction and a favorable safety profile.

BioCity Biopharma, founded in 2017, has been actively positioning SC0062 as a selective ETA antagonist with potential best-in-class benefits in renal care, and the latest BTD represents another major regulatory milestone in its China-first development pathway.

Why did China’s regulatory agency grant SC0062 breakthrough designation for diabetic kidney disease in 2025?

The Center for Drug Evaluation (CDE), under China’s NMPA, conferred the Breakthrough Therapy Designation to BioCity Biopharma’s SC0062 based on new clinical data from its Phase 2 2-SUCCEED trial involving DKD patients. In this cohort, patients receiving a 20 mg dose of SC0062 experienced marked reductions in albuminuria compared to placebo, meeting both statistical and clinical thresholds. The BTD status is reserved for investigational drugs showing substantial improvement over existing therapies in serious conditions, and the designation is expected to accelerate SC0062’s development timeline within the regulatory framework.

SC0062 had previously received BTD for IgA nephropathy in 2024. The dual BTDs position the molecule as a leading candidate among a new wave of highly selective endothelin receptor antagonists with improved tolerability. Analysts view the move by China’s regulator as a timely signal that advances BioCity Biopharma’s credibility in kidney disease innovation, especially in a domestic market where chronic kidney diseases are rising sharply due to metabolic syndromes.

How did the SC0062 Phase 2 trial results influence regulatory confidence in BioCity’s renal drug platform?

The SC0062 Phase 2 program, branded as 2-SUCCEED, evaluated the molecule in two separate indications: IgA nephropathy and diabetic kidney disease. Across both arms, SC0062 met its efficacy and safety endpoints at 12 and 24 weeks. The DKD-specific results, which supported the latest BTD, included statistically significant reduction in urinary albumin levels and absence of fluid retention—an adverse effect often seen with non-selective endothelin antagonists.

Moreover, the treatment exhibited strong safety both as monotherapy and in combination with widely prescribed standard-of-care medications such as SGLT2 inhibitors, RAAS blockers, GLP-1 receptor agonists, insulin, and Finerenone. Over 70% of enrolled patients were on GLP-1 agonists and/or insulin, and nearly one-third were also receiving Finerenone, reflecting real-world treatment complexity.

Institutional sentiment suggests that the trial’s background-therapy diversity, coupled with SC0062’s selectivity for ETA receptors, offers a differentiated benefit profile. Analysts believe this feature could help BioCity Biopharma secure strong market positioning should the molecule receive full regulatory approval.

What is the clinical burden of diabetic kidney disease in China and how does SC0062 address this unmet need?

As of 2021, approximately 20.9 million individuals in China were affected by diabetic kidney disease, a leading cause of end-stage renal disease (ESRD) in the region. Without novel interventions, the age-standardized incidence rate (ASIR) of CKD is projected to increase by over 25% by 2036. Despite the growing use of SGLT2 inhibitors and MRAs like Finerenone, progression to ESRD remains a common outcome, particularly among high-risk populations.

SC0062 introduces a mechanistically distinct therapeutic option. As a highly selective ETA antagonist, the molecule targets endothelin pathways linked to proteinuria, glomerular inflammation, and fibrosis—biological processes central to CKD pathogenesis. Unlike non-selective endothelin blockers that interact with ETB receptors and often produce side effects such as fluid retention, SC0062 aims to mitigate disease progression with a better safety margin.

Medical institutions and nephrology professionals in China have welcomed the potential of ETA-selective agents, particularly in combination with GLP-1 receptor agonists and SGLT2 inhibitors. BioCity Biopharma’s compound is viewed as part of a broader trend toward combinatorial renal therapies with complementary mechanisms.

How is BioCity Biopharma structuring its Phase 3 development strategy for SC0062 across renal indications?

BioCity Biopharma has already launched its confirmatory Phase 3 clinical trial, SUCCESS-01, for SC0062 in IgA nephropathy. The study is being conducted at Guangdong Provincial People’s Hospital and is led by Professor Xueqing Yu, a recognized nephrologist and President of the Asia-Pacific Society of Nephrology. A multi-regional clinical trial (MRCT) for broader CKD indications, including DKD, is also being planned under the title SUCCESS-02.

These Phase 3 programs are structured to validate SC0062’s efficacy across ethnic and treatment-variable cohorts, as well as to prepare the asset for eventual commercialization beyond China. Institutional investors have noted BioCity’s pace in progressing SC0062 through late-stage trials, with some projecting regulatory submissions within two years contingent on Phase 3 outcomes.

The dual-track approach in IgAN and DKD not only reduces development risk but also positions SC0062 as a platform therapy for proteinuric kidney diseases. Analysts expect that future filings in the U.S. or Europe may follow, pending supportive global data and licensing partnerships.

How does SC0062 compare with existing endothelin receptor antagonists for chronic kidney disease?

SC0062 differentiates itself from other agents in the endothelin class through its high selectivity for the ETA receptor subtype. This design minimizes unintended activation or blockade of the ETB receptor, which plays a protective role in renal vasodilation and natriuresis. Traditional non-selective agents have shown efficacy but are often limited by side effects such as fluid overload and electrolyte imbalance.

Preclinical models demonstrated that SC0062 improved renal pathology scores in both acute and chronic injury settings. Phase 1 clinical trials confirmed tolerability and absence of fluid retention, a consistent finding that has now been reproduced in the DKD Phase 2 data. Analysts believe this selectivity advantage could allow SC0062 to move forward not only as a stand-alone therapy but also as part of multi-drug regimens aimed at slowing CKD progression.

Given that most current therapies target metabolic or hormonal pathways—such as glucose transport (SGLT2), mineralocorticoid signaling (MRAs), or incretin pathways (GLP-1)—SC0062’s mechanism could play a unique role in addressing glomerular and endothelial dysfunctions directly.

What is BioCity Biopharma’s broader strategy and how does SC0062 fit into its pipeline?

BioCity Biopharma, established in 2017, is focused on developing highly differentiated therapeutics across oncology, autoimmune disorders, and renal diseases. The Chinese biotech firm has built a clinical pipeline with more than 10 novel drug candidates, spanning small molecules, monoclonal antibodies, bispecifics, and antibody-drug conjugates (ADCs).

SC0062 is currently the lead renal asset in the portfolio. In parallel, BioCity is advancing five core oncology assets, including first-in-class ADCs targeting CDH3 and GPC3, as well as DNA damage response inhibitors such as WEE1 and ATR compounds. A monoclonal antibody targeting TIM-3 is also in clinical development for immune-oncology applications.

The dual BTD recognition for SC0062 not only accelerates its development but also demonstrates BioCity Biopharma’s capability to navigate China’s regulatory framework for complex chronic diseases. Investors are watching closely as the firm transitions from mid-stage development to potential registration pathways across its portfolio.

What is the market and regulatory outlook for SC0062 as a potential best-in-class therapy?

With the Phase 2 2-SUCCEED program achieving positive results and two Breakthrough Therapy Designations in hand, BioCity Biopharma has positioned SC0062 for accelerated development. Institutional sentiment suggests that the drug has strong potential to become a best-in-class treatment for both DKD and IgAN, particularly in the Asia-Pacific region.

Regulatory filings for SC0062 are expected to progress in China through 2026, with potential expansion into other key markets thereafter. Future clinical data from SUCCESS-01 and SUCCESS-02 will be critical in determining the commercial trajectory. If the results confirm Phase 2 trends, SC0062 could set a new benchmark in selective endothelin receptor antagonism.

While competition in the CKD therapeutic space is intensifying, SC0062’s unique mechanism, clean safety data, and dual BTDs are seen as significant assets by institutional investors. Analysts expect the asset to attract strategic partnership interest, particularly as the program moves toward multi-regional trials and eventual global registration.