Innovent Biologics Receives Breakthrough Therapy Designation for Novel Lung Cancer Treatment
Innovent Biologics has been granted a second Breakthrough Therapy Designation by the Centre for Drug Evaluation (CDE), part of China’s National Medical Products Administration.
This designation applies to its innovative drug candidate, IBI363, for the treatment of patients with unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (NSCLC) who have progressed after receiving both anti-PD-(L)1 immunotherapy and platinum-based chemotherapy.
IBI363 is an innovative bispecific antibody fusion protein designed to simultaneously target PD-1 and IL-2α. The most recent designation underscores the drug’s promise in overcoming resistance to immunotherapy and addressing tumors that are typically hard to treat.
IBI363 works through a dual mechanism: it blocks the PD-1 immune checkpoint pathway while selectively activating the IL-2 pathway, aiming to enhance immune responses against cancer cells.
This design helps activate specific T cells that are important for attacking cancer, while aiming to reduce side effects.
Preclinical models have shown that IBI363 is effective in tumours that have become resistant to PD-1 inhibitors and in cases of metastasis.
The NMPA’s Breakthrough Therapy Designation aims to speed up the development and review of promising treatments for serious conditions.
It is granted when early evidence suggests a drug may significantly improve current treatment options. This designation allows closer communication between the drug developer and the regulator, helping to bring new therapies to patients more quickly.
IBI363 has received two Fast Track Designations from the U.S. FDA and two Breakthrough Therapy Designations from China's NMPA for the treatment of sqNSCLC and melanoma.
Innovent continues to engage with regulatory agencies to expand the drug’s development into other cancers such as lung and colorectal cancer.
