June 23, 2025 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to YL201 for the treatment of small cell lung cancer (SCLC). YL201 is an investigational B7H3-targeted antibody drug conjugate (ADC) developed based on MediLink’s proprietary TMALIN® (Tumor Microenvironment Activable LINker) technology platform.

YL201 is being evaluated in multiple clinical trials around the globe, including two pivotal Phase III studies for the treatment of SCLC and Nasopharyngeal Carcinoma in China. In addition, trials are ongoing to explore YL201 as a monotherapy or in combination with other treatments in multiple solid tumors. 

About YL201

YL201 is an innovative ADC that specifically targets B7H3. The B7H3 protein is overexpressed on malignant cells and cancer-initiating cells of various tumor types, but has a restricted expression in normal tissue, indicating its potential as an ADC drug target. YL201 was developed utilizing MediLink's Tumor Microenvironment Activable LINker-payload (TMALIN®) conjugated with a highly specific B7H3 antibody. Currently, YL201 is being investigated in a variety of solid tumors and has entered into pivotal stage in Small Cell Lung Cancer and Nasopharyngeal Carcinoma in China.

About MediLink

MediLink Therapeutics, founded in 2020, is a clinical stage biotech company dedicated to developing conjugated drugs for cancer patients around the globe. MediLink has developed proprietary linker-payload technologies, among which the TMALIN® (Tumor Microenvironment Activable LINker-payload) platform enables the generation of homogeneous ADC with high drug-antibody ratio and improved therapeutic window for the treatment of solid tumors. Based on the TMALIN® platform, twelve ADCs have entered into the clinical development stage in China and the US. MediLink aims to provide improved treatment options to address unmet medical needs of patients around the globe. The company is headquartered in Suzhou, China and has established R&D sites in Shanghai, China and Boston, US.