#China #Suzhou #Cancer Treatment #Innovent Biologics #IBI363

Innovent's IBI363 Achieves Second Breakthrough Designation

Innovent Biologics, a renowned biopharmaceutical firm, has made headlines with its acquisition of a second Breakthrough Therapy Designation (BTD) from the National Medical Products Administration (NMPA) in China for IBI363. This bispecific antibody fusion protein is making waves in the oncology field, particularly for treating unresectable squamous non-small cell lung cancer (sqNSCLC) that resists traditional therapies.

The Significance of the Breakthrough Therapy Designation

The BTD designation is a status awarded by the NMPA that aims to expedite the drug development process for serious conditions, indicating that IBI363 exhibits promising potential to significantly improve treatment efficacy over existing therapies. IBI363 has already demonstrated considerable progress, having previously secured Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for both sqNSCLC and melanoma.

Promising Clinical Studies

During the recent 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, findings from Phase 1 trials of IBI363 were presented, showing manageable safety profiles paired with encouraging efficacy. This research highlighted long-term survival benefits for patients who previously had immunotherapy-resistant sqNSCLC and wild-type lung adenocarcinoma, igniting optimism for future treatments in immunotherapy-resistant patients.

Dr. Hui Zhou, Senior Vice President at Innovent, expressed confidence in IBI363's capabilities to serve as a next-generation immunooncology agent. By employing a dual-action mechanism that combines PD-1 blockade with IL-2-driven T-cell expansion, IBI363 has the potential to not only reshape the tumor microenvironment but also bring forth innovative therapies poised to meet existing clinical demands for multiple tumor types.

A Closer Look at IBI363

IBI363 stands out by being the first PD-1/IL-2α-bias bispecific antibody fusion protein developed by Innovent. Its unique design allows it to block the PD-1/PD-L1 pathway while promoting the IL-2 pathway, maintaining strong binding to IL-2Rα while minimizing attachment to IL-2Rβ and IL-2Rγ, thus reducing potential toxicity.

The protein specifically activates T-cells expressing both PD-1 and IL-2α, ensuring more directed therapeutic actions against tumors and enhancing the overall effectiveness of the treatment protocol. The robust antitumor activity of IBI363 has been recorded across diverse pharmacological models, particularly excelling in instances of PD-1 resistance and tumor metastasis.

Ongoing and Future Studies

Responding to the urgent and unmet clinical needs present today, Innovent is actively conducting studies across China, the United States, and Australia. These trials are exploring IBI363’s efficacy in a range of indications, including immune-resistant and cold tumors. The first pivotal trial commenced earlier this year for patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not undergone systemic therapies prior.

As it stands, IBI363 has gained two fast-track designations from the FDA and is now recognized with two breakthrough designations from the NMPA, solidifying its significance in advancing treatment options for squamous non-small cell lung cancer and melanoma.

Conclusion

Innovent aims to remain at the forefront of medical innovation, committed to ensuring that their groundbreaking treatments become accessible to patients on a global scale. With the encouraging advancements seen in IBI363, there is a hopeful outlook for the future of immunotherapy in addressing long-standing challenges in the treatment of lung cancer and beyond.

For more information about Innovent and its pioneering therapies, visit Innovent Biologics.