January 20, 2025 — MediLink Therapeutics (“MediLink”), a clinical-stage biotechnology company, announced that the Center for Drug Evaluation (CDE) granted Breakthrough Therapy Designation to YL201, for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC). Previously, the Breakthrough Therapy Designation was also granted for YL201 by the CDE for the treatment of recurrent small cell lung cancer.

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 series of exploratory clinical trials for the treatment of multiple solid tumors, among which two pivotal trials have started enrollment in China for the treatment of Small Cell Lung Cancer and Nasopharyngeal Carcinoma, respectively. Further, combination studies are ongoing to explore the potential of YL201 in multiple solid tumors in earlier treatment lines.

About NPC

Nasopharyngeal carcinoma (NPC) is an epithelial carcinoma originating from the nasopharyngeal mucosa, with tumors often observed in the nasopharyngeal recess. According to GLOBOCAN, there were over 120 thousand new cases of NPC worldwide in 2022, including 50 thousand in China. Patients with recurrent or metastatic (R/M) NPC have extremely poor survival outcomes. Currently, systemic chemotherapy combined with PD-1 inhibitors is the primary treatment option for R/M NPC. However, for patients who fail platinum-based therapies, there are limited treatment options and suboptimal outcomes for second- or third-line therapies targeting R/M NPC.

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.