Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Sunday that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted a third Breakthrough Therapy Designation (BTD) to its first-in-class PD-1/IL-2 alpha-bias bispecific fusion protein, IBI363, in combination with bevacizumab, for the treatment of patients with advanced microsatellite stable or proficient mismatch repair (MSS/pMMR) colorectal cancer (CRC) who have failed at least two prior lines of standard therapy.

A Phase III clinical trial in China for this indication is set to commence soon.

Previously, IBI363 has received two BTDs from China's NMPA CDE and two Fast Track Designations (FTDs) from the US FDA, covering indications in non-small cell lung cancer (NSCLC) and melanoma. The early-stage clinical data of IBI363 in advanced MSS/pMMR colorectal cancer were reported at 2025 ASCO conference, in which IBI363, in combination with bevacizumab, demonstrated promising efficacy in patients who have failed multiple prior lines of standard therapy.

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of investigational drugs for serious diseases or conditions when preliminary clinical evidence indicates substantial improvement over current therapies. BTD qualifies a drug candidate for accelerated review by the CDE and provides the sponsor with advice and communication to expedite the approval process, helping to address the unmet clinical needs of patients more swiftly.

IBI363 is being evaluated in a series of clinical trials globally, led by a pivotal Phase II study in China in previously untreated acral and mucosal melanoma and a global multi-regional Phase III trial in immunotherapy-resistant squamous NSCLC.