On June 4, 2025, the Phase I clinical study (ESG406-101) of the ADC drug ESG406, independently developed by Shanghai Escugen Biotechnology Co., Ltd. (hereinafter referred to as "Escugen"), successfully administered the first dose to a participant. ESG406 received approval from the National Medical Products Administration on April 21, 2025, to conduct clinical research. The initiation of the ESG406-101 project marks the comprehensive iteration and upgrade of Escugen 's ADC technology. Moving forward, the company will focus on the pipeline development of the new generation of ADC technologies.
Product Introduction
ESG406 is developed based on Escugen 's EZWi-Fit® platform technology. EZWi-Fit® is a new-generation ADC platform technology with independent intellectual property rights established by Escugen. This technology surpasses previous technologies and international benchmarks in multiple dimensions. ESG406 exhibits broad-spectrum antitumor activity and significant resistance to drug resistance. Preclinical research results show that ESG406 has significant activity in multiple PDX models of various tissue origins that are unresponsive to other ADCs targeting the same antigen. It also demonstrates significant antitumor activity in CDX and PDX models with primary and secondary resistance to various approved and investigational ADC drugs. In the GLP safety evaluation of repeated dosing in non-human primates (NHP), ESG406 was well-tolerated, with an HNSTD (Highest No Toxicity Dose) of 60 mg/kg.
Project Introduction
The ESG406-101 study is an open-label, dose-escalation, and cohort-expansion Phase I trial, aimed at evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of ESG406. The study will determine the maximum tolerated dose of ESG406, the recommended Phase II clinical trial dose, and the dosing regimen. The ESG406-101 study includes a dose-escalation phase (Phase Ia) and a cohort-expansion phase (Phase Ib), and will be conducted in patients with locally advanced or metastatic solid tumors. The study is led by Professor Qiu Fuming from the Second Affiliated Hospital of Zhejiang University School of Medicine and is planned to be carried out in multiple centers nationwide, with an estimated enrollment of approximately 556 patients.
About Escugen
Escugen is a clinical-stage biotechnology company located in Shanghai, China, focusing on the development of innovative ADC drugs. Currently, Escugen's lead Trop-2 ADC pipeline, ESG401, has entered Phase III clinical trials. Escugen's next-generation linker-payload technology platform, EZWi-Fit®, offers significant competitive advantages in terms of safety, efficacy, anti-multiple drug resistance, and pharmacokinetic characteristics. Leveraging this platform technology, Escugen is rapidly expanding its ADC pipeline targeting new or validated target. The first ADC product baring the EZWi-Fit® technology has successfully launched its FIH clinical campaign. In addition, Escugen has licensed this platform technology to several domestic and international biotechnology companies to empower their innovative ADC projects.
