(RTTNews) - Innovent Biologics, Inc. (1801.HK), a biopharmaceutical company focused on developing therapies across oncology and other major diseases, announced the expansion of the global Phase 3 MarsLight-11 study of IBI363/TAK-928 to include patients with non-squamous non-small cell lung cancer (NSCLC).

MarsLight-11 is a global, multicenter, randomised Phase 3 study evaluating IBI363/TAK-928 in patients with unresectable locally advanced or metastatic NSCLC whose disease has progressed during or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

With the expansion, the study will include two independent sub-trials evaluating squamous and non-squamous NSCLC. Each sub-trial will compare IBI363 immunotherapy with docetaxel for efficacy and safety.

IBI363 is an investigational alpha-based IL-2/PD-1 bispecific fusion protein jointly developed by Innovent and Takeda. The drug candidate is designed to block the PD-1/PD-L1 pathway while activating the IL-2 pathway to selectively target and activate tumor-specific T-cell subsets.

IBI363 is being evaluated in multiple clinical studies, including Phase 2 development in mucosal and acral melanoma and Phase 3 studies in immunotherapy-resistant NSCLC and advanced colorectal cancer. IBI363 is also being studied in combination and monotherapy settings across several tumor types.

IBI363 has received two FDA Fast Track designations and three Breakthrough Therapy designations from China's NMPA.

Innovent and Takeda entered into a strategic partnership in October 2025 to jointly develop IBI363 globally and co-commercialize the drug in the U.S. Under the agreement, Innovent granted Takeda commercialization rights outside Greater China and the U.S. Innovent shares are trading down 4.16% at HK$95.55 on the Hong Kong Stock Exchange.