By Fineline Cube 
China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its investigational drug IBI363. The designation is for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma in patients who have not received prior systemic treatment.
Drug Mechanism and Results
IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody (BsAb) fusion protein, demonstrated a 61.5% objective response rate (ORR) and an 84.6% disease control rate (DCR) in melanoma patients previously untreated with immunotherapy. These results were observed in both Phase I (NCT05460767) and Phase II (NCT06081920) studies, indicating sustained remission and potential long-term benefits.
Pivotal Regulatory Study
Innovent Biologics has recently initiated a pivotal regulatory study to evaluate the efficacy and safety of IBI363 compared to Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.
Global Recognition
The drug has previously been awarded fast-track statuses in the US for the treatment of squamous non-small cell lung cancer and melanoma, highlighting its potential to address significant unmet medical needs.-Fineline Info & Tech