MediLink announces YL201 granted Breakthrough Therapy Designation by FDA

CAR-T Digest - August 2020

24 June 2025: MediLink announces YL201 granted Breakthrough Therapy Designation by FDA

The U.S. FDA has granted Breakthrough Therapy Designation to YL201, a B7H3-targeted ADC developed by MediLink Therapeutics, for the treatment of small cell lung cancer (SCLC)
YL201 is built on MediLink’s proprietary TMALIN® technology platform and is under Phase 3 clinical trials in China for SCLC and Nasopharyngeal Carcinoma
YL201 targets B7H3, a protein abundantly expressed in tumor cells but limited in normal tissues, making it a promising ADC target, and is being evaluated both as a mono and in combo for various solid tumors
MediLink’s TMALIN® platform enables the development of homogeneous ADCs with a high DAR and an improved safety profile, with 12 ADCs already in clinical development in China and the U.S.