MHB036C: A Comprehensive Clinical and Scientific Profile of a Novel TROP2-Targeted Antibody-Drug Conjugate

1.0 Executive Summary

MHB036C is a novel, investigational antibody-drug conjugate (ADC) developed by Minghui Pharmaceutical as a potential therapy for advanced solid tumors. It is engineered to target Trophoblast cell-surface protein 2 (TROP2), a well-validated tumor-associated antigen overexpressed in a multitude of malignancies. The molecular architecture of MHB036C is derived from Minghui's proprietary SuperTopoi™ ADC platform, which combines three distinct components: a humanized anti-TROP2 monoclonal antibody, a highly potent proprietary DNA topoisomerase I (TopoI) inhibitor payload, and a stable, cleavable linker. Preclinical evidence established a strong foundation for clinical development, demonstrating antitumor potency 3 to 10 times greater than deruxtecan (DXd) counterparts and a favorable safety profile notable for the absence of severe pulmonary toxicities.

The clinical development program for MHB036C is comprehensive, encompassing Phase I/II dose-escalation and expansion studies across multiple jurisdictions. Early clinical data have demonstrated a manageable safety profile and compelling antitumor activity in heavily pre-treated patient populations. The most common treatment-related adverse events include stomatitis and myelosuppression, with Grade 3 stomatitis identified as the dose-limiting toxicity. Critically, no cases of interstitial lung disease (ILD) have been reported, a significant point of differentiation from other ADC platforms.