Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced receiving another breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC) YL201. The designation is for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), following the first BTD granted in October of last year for recurrent small cell lung cancer (SCLC).
YL201: Development and Platform
YL201 is a B7H3-targeted ADC developed on MediLink’s Tumor Microenvironment Activable LINker (TMALIN) platform. This innovative platform enables the ADC to be activated specifically within the tumor microenvironment, enhancing its therapeutic efficacy while minimizing systemic side effects. YL201 is currently being tested in exploratory studies across multiple solid tumors globally.
Clinical Progress and Future Studies
YL201 is undergoing pivotal Phase III studies in China for both SCLC and NPC, highlighting its potential as a targeted therapy in these challenging indications. Additionally, the ADC is being explored in multiple solid tumor studies in front-line settings, often in combination with other therapies. The latest BTD underscores the promise of YL201 in addressing significant unmet medical needs in oncology.-Fineline Info & Tech
Leave a Reply