18 Dec 2024: MediLink announces YL201 granted orphan-drug designation by the US FDA
MediLink Therapeutics announced that the FDA has granted Orphan-Drug Designation to YL201 for the treatment of small cell lung cancer (SCLC)
YL201 is an investigational B7H3-targeted antibody-drug conjugate (ADC) developed using MediLink’s proprietary TMALIN® technology platform
YL201 is being developed globally in multiple exploratory clinical trials for various solid tumors, including two pivotal Phase III studies in China for SCLC and Nasopharyngeal Carcinoma
The ongoing pivotal studies for SCLC and Nasopharyngeal Carcinoma are in the active enrollment stage and several combination studies are also underway to explore the potential of YL201 in earlier treatment lines for multiple solid tumors
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