Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its antibody drug conjugate (ADC) YL201 for the treatment of small-cell lung cancer (SCLC). This designation highlights the potential impact of YL201 in addressing a significant unmet medical need.
YL201: A B7H3-Targeted ADC Developed on the TMALIN Platform
YL201 is a B7H3-targeted ADC product that utilizes MediLink’s innovative Tumor Microenvironment Activable LINKer (TMALIN) platform. The drug is currently being tested in exploratory studies for multiple solid tumors globally. The TMALIN platform is designed to enhance the selectivity and efficacy of ADCs, targeting tumor-specific antigens while minimizing damage to healthy tissues.
Prior Orphan Drug Designation for Esophageal Cancer
In November of the previous year, YL201 was awarded ODD status in the US for the treatment of esophageal cancer (EC). This latest designation for SCLC further expands the potential therapeutic applications of YL201 and underscores MediLink Therapeutics’ commitment to developing targeted therapies for oncology.-Fineline Info & Tech
