Drug intelligence / Profile preview

SKB535

Development stage
Phase 1
Lead developer
Sichuan Colombotai Biomedical
Modality
Peptide-Drug Conjugates → Peptide Conjugates → Peptides, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

SKB535 is an innovative antibody-drug conjugate (ADC) developed by Sichuan Kelun-Biotech Biopharmaceutical in collaboration with Merck & Co. It is designed for the treatment of advanced solid tumors and is currently in Phase 1 clinical trials in China. The drug was developed using Kelun-Biotech’s OptiDC platform and has demonstrated promising efficacy and safety profiles in preclinical studies. The precise mechanism of action and molecular target have not been publicly disclosed as of June 2025[1][2][3][4][5]. Clinical development focuses on patients with advanced or metastatic solid tumors who have failed standard treatments, including colorectal cancer, gastric carcinoma/gastroesophageal junction adenocarcinoma, esophageal carcinoma, pancreatic cancer, non-small cell lung cancer (NSCLC), cervical carcinoma, and head and neck squamous cell carcinoma[7].

Other names
CDH17/CEACAM5 bispecific antibody-drug conjugateCDH17/CEACAM5 targeted bispecific ADC
02

Targets

CEACAM5 (Carcinoembryonic antigen related cell adhesion molecule 5)TOP1 (DNA Topoisomerase I)CDH17 (Cadherin-17)

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