Suzhou-based Medilink Therapeutics announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its YL201, an antibody drug conjugate (ADC) targeting B7H3, for the treatment of small-cell lung cancer (SCLC).
Drug Profile
YL201 is developed via Medilink’s TMALIN technology platform and is designed to deliver cytotoxic agents specifically to cancer cells expressing B7H3, a protein frequently overexpressed in various solid tumors.
Clinical Development
The drug is currently undergoing multiple clinical trials globally and has entered Phase III studies in China for SCLC and nasopharyngeal carcinoma. Both indications have been awarded BTD in China, underscoring the significant unmet medical need and the potential of YL201 to address these conditions effectively.-Fineline Info & Tech
