Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Wednesday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a second Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2 alpha-bias bispecific antibody fusion protein, IBI363, for the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immunotherapy and platinum-based chemotherapy.

To date, IBI363 has received BTDs from China's NMPA CDE and Fast Track Designations (FTDs) from the US FDA for two indications: sqNSCLC and melanoma. The company says that the latest BTD further advances IBI363's potential in addressing immunotherapy resistance and cold tumor challenges.

The latest data from the Phase 1 clinical study of IBI363 in subjects with sqNSCLC who previously received immunotherapy were reported in an oral presentation at the 2025 ASCO Annual Meeting. Manageable safety, encouraging efficacy, and long-term survival benefits were observed in both immunotherapy-resistant squamous non-small cell lung cancer and wild-type lung adenocarcinoma. At this year's ASCO conference, IBI363 presented breakthrough clinical findings in three immunotherapy-resistant and cold tumour types: non-small cell lung cancer, colorectal cancer, and melanoma.