December 18, 2024 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, today announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation to YL201, for the treatment of small cell lung cancer (SCLC). YL201 is an investigational B7H3-targeted ADC, developed based on MediLink’s proprietary TMALIN® (Tumor Microenvironment Activable LINker) technology platform.

YL201 is being developed globally in a number of exploratory clinical trials for the treatment of multiple solid tumors, among which two pivotal Phase III studies have started and are in active enrollment stage in China for the treatment of Small Cell Lung Cancer and Nasopharyngeal Carcinoma. In addition, there are several combination studies ongoing to explore the treatment potential of YL201 in multiple solid tumors in earlier treatment lines.

About SCLC

SCLC is an aggressive high-grade neuroendocrine carcinoma with extremely poor outcomes. SCLC comprises roughly 15% (~0.36 million new cases) of the 2.4 million new lung cancer cases worldwide each year. Approximately two-thirds of patients with SCLC present with extensive-stage (ES) disease at diagnosis, featuring tumors with distant metastasis or exceeding an area that can be treated within a single radiation field. Patients with ES-SCLC, compared with patients with limited-stage (LS-SCLC), manifested with worse prognosis as the median expected overall survival is ~12 months following initial therapy and a 5-year overall survival rate of 3%

About YL201

YL201 is an innovative ADC that specifically targets B7-H3. B7-H3 is overexpressed on different 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 has been developed by utilizing MediLink's Tumor Microenvironment Activable LINker-payload (TMALIN®) conjugated with a highly specific B7-H3 antibody. Currently, YL201 is being investigated in a variety of solid tumors, and has entered into pivotal clinical development 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 innovative conjugated drugs for global patients. MediLink has established its proprietary TMALIN® ADC technology platform, enabling stabilized conjugation of highly homogeneous high-DAR (drug-antibody ratio) ADC so as to augment therapeutic window for the treatment of solid tumors. Our goal is to provide better treatment options for global patients and address unmet medical needs. The company is located in Suzhou and Boston, with subsidiaries in Shanghai and Singapore.