Drug intelligence / Profile preview

QHL-1618

Development stage
Phase 2
Lead developer
Affinity Biopharmaceutical
Modality
Prodrugs/Conditional Activator Small Molecules → Small Molecules
Administration
Intravenous
01

Overview

QHL-1618 is a tumor microenvironment-activated small molecule drug conjugate (TMEA-SMDC) being developed by Affinity Biopharmaceutical for the treatment of solid tumors. It utilizes the proprietary TMEA (Tumor MicroEnvironment Activated) platform, which features a unique linker system designed for conditional activation specifically within the tumor microenvironment. This mechanism allows for the targeted release of its cytotoxic payload—identified as a Dxd (exatecan derivative) payload—directly at the tumor site, thereby enhancing anti-tumor efficacy while reducing systemic off-target toxicity. In February 2024, Zhejiang Anglikang Pharmaceutical licensed the rights to develop and commercialize QHL-1618 (referred to as ALK-N001 in the partnership) in Greater China. The drug has demonstrated anti-tumor activity in preclinical xenograft models and is currently in the preclinical stage of development.

02

Targets

TOP1 (DNA Topoisomerase I)

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