IBI363

Innovent Biologics will showcase seven oral presentations at ASCO 2025, featuring breakthrough clinical data for its novel PD-1/IL-2α-bias bispecific antibody IBI363 in melanoma, colorectal cancer, and non-small cell lung cancer.

Innovent's IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody, received FDA Fast Track Designation for treating advanced squamous non-small cell lung cancer after immunotherapy and chemotherapy failure.

Innovent's IBI343, an anti-CLDN18.2 ADC, has been granted Breakthrough Therapy Designation (BTD) by China's NMPA for advanced pancreatic cancer.

Lifileucel (Amtagvi), a tumor-derived autologous T-cell immunotherapy, received FDA accelerated approval for unresectable or metastatic melanoma after PD-1 inhibitor treatment.

The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.