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Innovent Biologics Achieves FDA Approval for IBI363 in Phase III Clinical Trial for Squamous Non-Small Cell Lung Cancer
2025-08-25 /
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Author：小编
Innovent Biologics has secured approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for IBI363, a self-developed PD-1/IL-2α-biased bispecific antibody fusion protein. This approval paves the way for the initiation of the first global Phase III clinical study (MarsLight-11), focused on treating patients with immune-resistant squamous non-small cell lung cancer. Furthermore, a pivotal registration study in China is currently underway, comparing the efficacy of IBI363 with pembrolizumab in the treatment of melanoma. This significant progress underscores Innovent Biologics' groundbreaking strides in the realm of dual immunotherapy.
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