YL-201: A Novel B7-H3-Targeting Antibody-Drug Conjugate for Solid Tumor Therapy

I. Executive Summary

YL-201 is an investigational antibody-drug conjugate (ADC) engineered by MediLink Therapeutics, targeting B7-homologue 3 (B7-H3), a protein frequently overexpressed on various cancer cells. The therapeutic is built upon MediLink's proprietary Tumor Microenvironment Activable LINker (TMALIN®) technology platform, which facilitates the site-specific conjugation of a potent topoisomerase I inhibitor payload. This innovative platform is designed to enhance the therapeutic window by ensuring payload stability in circulation and promoting targeted release within the tumor microenvironment and cancer cells.

Clinical investigations have demonstrated notable anti-tumor activity for YL-201, particularly in heavily pre-treated patient populations with Small Cell Lung Cancer (SCLC) and Nasopharyngeal Carcinoma (NPC). Data presented from Phase I/II studies have shown substantial overall response rates and encouraging progression-free survival in these challenging indications.[1] The safety profile of YL-201 appears manageable, characterized primarily by hematological toxicities, with a notably low incidence of severe non-hematological adverse events such as interstitial lung disease (ILD).[1]