SC-0062

SHANGHAI, March 13, 2025 /PRNewswire/ -- BioCity Biopharmaceutics Co., Ltd., a clinical-stage biopharmaceutical company, today announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate the combination of BioCity's BC3195 and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in a global phase 1/2 trial in patients with locally advanced or metastatic solid tumors. Under the terms of the agreement, BioCity will conduct a phase 1/2 clinical trial to evaluate the safety and efficacy of BC3195 in combination with KEYTRUDA. BioCity and MSD each retain all commercial rights to their respective compounds. The recruitment in the clinical study is expected in Q4 2025. "We are encouraged by the clinical data we have seen thus far for BC3195 as monotherapy, which have demonstrated improved anti-tumour activity in patients with certain non-small cell lung and breast cancers. We now look forward to exploring the potential of BC3195 in combination with KEYTRUDA through this collaboration, as we continue to advance our clinical program and seek to further validate our differentiated drug discovery and development approach." Said by Ivy Wang, Co-founder and Executive President of BioCity. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About BC3195 BC3195 is currently the only ADC targeting CDH3 (P-Cadherin) in clinical development globally. In preclinical studies, BC3195 binds to membrane CDH3 with strong affinity and is efficiently internalized. BC3195 is designed with a clinically validated, cleavable linker and payload (vc-MMAE) allowing for the destruction of targeted cancer cells, as well as surrounding cells, which is known as the bystander effect. In animal models, BC3195 demonstrated a favorable safety profile and robust antitumor activity with tumor growth inhibition ≥100% in some animals bearing well established cancers. BC3195 is currently undergoing concurrent Phase I dose optimization and dose expansion in China and in US. BC3195 demonstrated a manageable safety profile and favorable PK characteristics, significant antitumor activity with confirmed PRs observed across multiple tumor types. About BioCity 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 chronic kidney diseases. 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, BioCity has five core oncology assets in Phase 1/2 clinical development, including first-in-class CDH3-targeting ADC and GPC3-targeting ADCs, WEE1 and ATR inhibitors targeting the DNA damage response (DDR) pathway, and a monoclonal antibody targeting TIM-3 in collaboration with AstraZeneca. In addition, BioCity's SC0062, a highly selective ETA antagonist, is in phase 3 clinical development for IgA nephropathy and a global phase 3 registration trial is being planned. For more information, please visit Or LinkedIn BioCity Biopharma Contact: [email protected] [email protected] SOURCE BioCity Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BioCity Biopharma has since launched a phase 3 trial of SC0062 in Chinese patients with immunoglobulin A nephropathy.\n BioCity Biopharma’s selective endothelin receptor type A (ETA) antagonist has reduced excess proteins in the urine of patients with diabetic kidney disease (DKD), hitting a primary endpoint of a phase 2 trial in China.The therapy, dubbed SC0062, was shown to “significantly reduce” proteinuria among patients who received the highest dose at 20 mg when compared to a placebo cohort at 12 weeks, BioCity said in a press release published Feb. 25.The Chinese biotech didn’t share any detailed data, only disclosing that the “effect of SC0062 on proteinuria was both clinically meaningful and statistically significant.” A full readout of data at 24 weeks is being saved for an “upcoming scientific conference,” BioCity said.Most patients received sodium-glucose co-transporter-2 inhibitors and renin-angiotensin-aldosterone system inhibitors as background therapy. SC0062 showed a favorable safety profile in subjects, with no elevated risk of sodium retention compared to the placebo group, the Shanghai-based biotech said.The 2-SUCCEED trial has a separate cohort of patients with another kidney condition called immunoglobulin A nephropathy (IgAN). This cohort hit its primary endpoint last year of showing a “clinically meaningful and statistically significant” reduction in proteinuria. Specifically, the 5-mg, 10-mg and 20-mg dose cohorts saw geometric mean reductions in 24-hour urine protein-to-creatinine ratio of 39.2%, 33.7% and 48.3%, respectively, compared to 16.5% in the placebo cohort. BioCity has since launched a phase 3 trial of SC0062 in Chinese patients with IgAN, while a late-stage multiregional study is also in the works.“SC0062 is a best-in-class, highly selective, small molecule ETA antagonist that has demonstrated efficacy and safety in pre-clinical studies, which have translated into highly favorable therapeutic index in subjects with both IgAN and DKD in a randomized, placebo-controlled clinical study,” BioCity’s co-founder and executive president Ivy Wang, M.D., Ph.D., said in the release.“We are pleased that SC0062 demonstrated a significant reduction in proteinuria, as well as a favorable safety profile in subjects with DKD and IgAN, which greatly strengthens our commitment to develop SC0062 in CKD,” Wang added.Novartis is hoping to get its own ETA receptor antagonist approved for IgAN this year. The Swiss pharma secured the therapy, called atrasentan, as part of its $3.2 billion acquisition of Chinook Therapeutics. The FDA has already approved Travere Therapeutics’ Filspari, a dual antagonist of endothelin and angiotensin receptors, for IgAN.