On July 31, 2026, Medilink Therapeutics announced that its proprietary YL413 has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA). This marks the 15th antibody-drug conjugate (ADC) in Medilink Therapeutics' clinical-stage pipeline and the company's first dual-payload ADC developed on its proprietary technology platform.

About YL413
YL413 concurrently delivers a topoisomerase I inhibitor and a microtubule inhibitor. It is designed to leverage synergistic dual mechanisms to address potential resistance to single-agent therapies and to further expand the therapeutic window through optimized payload ratios. In vitro studies demonstrate that YL413 exhibits favorable binding and internalization characteristics in HER2-positive cells, with superior cytotoxicity compared to single-payload ADCs. In vivo, it also shows enhanced anti-tumor activity in both CDX models and Enhertu-resistant models. Furthermore, cynomolgus monkey studies further support its favorable in vivo stability and tolerability, characterized by low levels of circulating free payloads and ideal pharmacokinetic profiles. Overall, by combining the proven efficacy of topoisomerase I inhibitors with the complementary mechanism of microtubule inhibitors, YL413 demonstrates significant anti-tumor efficacy in both in vitro and in vivo settings, highlighting its potential to be advanced into earlier lines of therapy.

About Medilink Therapeutics

Founded in 2020, MediLink Therapeutics is a biotechnology company focused on innovative conjugated drugs, with its headquarters in Suzhou and R&D centers in Shanghai, Boston, and Singapore. Through proactive and visionary planning, the company has strategically established a full-chain ADC capability. Anchored on the core concept of "tumor microenvironment + lysosomal dual-cleavage mechanism", MediLink has pioneered a next-generation conjugation technology platform, including its first proprietary Tumor Microenvironment Activable LINker (TMALIN) platform, which has been consistently validated in multiple clinical studies across the world. To date, MediLink has advanced 15 ADC assets into clinical development, addressing large unmet medical needs. Guided by an entrepreneurial spirit, the company drives integrated innovation across concept, technology, pipeline, clinical studies, global partnerships, and intelligent manufacturing, staying true to its mission of "Innovative Medicines for Global Patients," and striving to bring better treatment options to patients around the world.

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