Keyi Pharmaceuticals Initiates Phase 1/2 Clinical Trial of KY-0301, a First-in-Class EGFR/cMET Bispecific Nanobody ADC

▎Armstrong

On April 15, 2025, Novatim registered the Phase 1/2 clinical trial of KY-0301 on the Clinicaltrials.gov website.

This Phase 1/2 clinical trial plans to enroll 212 patients with advanced solid tumors and is expected to be completed by the end of 2027.

KY-0301 is a dual-target ADC targeting EGFR and cMET, and also the first dual-target ADC new drug developed by Novatim.

According to official information from Novatim, KY-0301 is a nanobody-based dual-target ADC that delivers more effectively to tumor tissues, with a DAR value of 4.

Payload focuses on two directions: topoisomerase inhibitors and tubulin inhibitors.

Summary

In the dual-target ADC track, Chinese companies have become the absolute protagonists, with the efficiency of differentiated design and the speed of clinical advancement leaving foreign competitors far behind.