#China #Suzhou #Innovent Biologics #IBI363 #melanoma

Innovent's IBI363 Receives Breakthrough Therapy Designation

Introduction
Innovent Biologics, Inc. has achieved a significant milestone in the field of oncology with the recent Breakthrough Therapy Designation (BTD) granted by the National Medical Products Administration (NMPA) in China for its innovative drug, IBI363. This first-in-class bispecific antibody fusion protein targets PD-1 and IL-2α-bias and is designed to treat patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not previously undergone systemic therapy.

Background on IBI363
IBI363 represents a new therapeutic approach in the treatment of melanoma, a type of skin cancer known for its aggressiveness and high mortality rate. This bispecific antibody is engineered to boost the immune response against tumors while minimizing potential side effects. The ability to specifically inhibit the PD-1/PD-L1 pathway and simultaneously activate the IL-2 pathway provides IBI363 with a unique mechanism of action that differentiates it from existing treatments.

Clinical Efficacy
Recent clinical trials have indicated promising efficacy for IBI363. In a pivotal study comparing IBI363 to pembrolizumab (Keytruda®), initial results showed an overall objective response rate (ORR) of 61.5% and a disease control rate (DCR) of 84.6% among participants with advanced melanoma. These results significantly surpass the current immunotherapy benchmarks. Moreover, sustained follow-ups revealed long-term benefits, indicating that IBI363 could offer a superior alternative to standard treatment options.

Regulatory Recognition and Future Directions
The BTD from the NMPA not only expedites the development and review processes for drugs that show promise but also facilitates faster access to those who need them most. IBI363 has also received two fast track designations from the FDA for the treatment of squamous non-small cell lung cancer and melanoma, further highlighting its clinical potential and the urgency of addressing unmet medical needs in oncology.

Innovent's Commitment
Dr. Hui Zhou, Senior Vice President of Innovent, emphasized the importance of their Fight against melanoma, particularly for subtypes that show resistance to traditional immunotherapy. Innovent is accelerating the global development of IBI363, with the aim of broadening its impact across various types of cancers and enhancing treatment options for melanoma patients worldwide.

Conclusion
The promising results associated with IBI363 highlight Innovent Biologics' dedication to innovative cancer therapies and its role in advancing the treatment landscape for melanoma. As the company progresses with pivotal studies and expands its reach, the hope is that IBI363 can revolutionize how this aggressive form of cancer is treated, ultimately improving patient outcomes.