Medilink Therapeutics’ YL201 Earns Orphan Drug Designation for Esophageal Cancer

Suzhou-based Medilink Therapeutics has announced that it has obtained orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its antibody-drug conjugate (ADC) YL201, which is being developed to treat esophageal cancer (EC). YL201, a B7H3-targeted ADC product, is based on Medilink’s Tumor Microenviroment Activable LINker (TMALIN) platform. Pre-clinical and clinical trials have demonstrated that YL201 can effectively kill esophageal cancer tumor cells by combining the tumor microenvironment-penetrating capabilities of the TMALIN technology platform with traditional lysosome extracellular and intracellular dual lysis mechanisms.

Esophageal Cancer Burden in China and the US

In China, esophageal cancer has a significant impact, with the incidence rate and mortality ranking sixth and fourth among malignant tumors, respectively. The country sees 323,000 new cases and 301,000 deaths each year. China accounts for more than 50% of the global incidence and mortality of esophageal cancer. In contrast, esophageal cancer is less prevalent in the United States, with 18,000 new cases and 16,000 deaths reported in 2020.- Flcube.com

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