Innovent Biologics’ IBI363 Receives Breakthrough Therapy Designation from China’s NMPA
On March 30, 2025, Innovent Biologics, Inc. (Innovent), a leading biopharmaceutical company, announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy for the treatment of unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy.
What is IBI363?
IBI363 is a bispecific antibody fusion protein that targets both PD-1 and IL-2α. PD-1 is a protein found on the surface of immune cells that helps to regulate the immune response. IL-2α is a cytokine that plays a crucial role in activating and expanding T cells, which are a type of immune cell. By targeting both PD-1 and IL-2α, IBI363 is designed to enhance the immune response against cancer cells.
Clinical Trials for IBI363
Following the BTD designation, Innovent initiated and dosed the first patient for IBI363 in its first pivotal study. This study aims to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab (Keytruda®) monotherapy in patients with unresectable, locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. This trial will provide valuable data on the effectiveness and safety of IBI363 as a potential treatment for this type of melanoma.
Impact on Patients
For patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy, the BTD designation for IBI363 represents a significant step forward in the development of new treatment options. These patients currently have limited therapeutic options, and the granting of BTD designation indicates that IBI363 has the potential to provide meaningful clinical benefits.
Impact on the World
The BTD designation for IBI363 is not only a milestone for Innovent but also for the global biopharmaceutical industry. It demonstrates China’s commitment to advancing the development of innovative therapies and strengthening its position as a key player in the global healthcare market. Moreover, it highlights the potential of bispecific antibody fusion proteins as a new class of therapeutics for the treatment of various types of cancer.
Conclusion
The granting of Breakthrough Therapy Designation for IBI363 by China’s NMPA marks an important milestone in the development of this first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein as a potential treatment for unresectable locally advanced or metastatic mucosal or acral melanoma. The initiation of the first pivotal study to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab will provide valuable data on the potential benefits of this novel therapeutic approach. For patients and the global healthcare community, this represents a significant step forward in the quest to develop new and effective treatments for various types of cancer.
- Innovent Biologics announces BTD designation for IBI363
- IBI363 is a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein
- Initiation of first pivotal study to evaluate IBI363 monotherapy versus pembrolizumab
- Significant step forward for patients with unresectable locally advanced or metastatic mucosal or acral melanoma
- Demonstrates China’s commitment to advancing innovative therapies
