On September 27, 2026 Innovent Biologics, Inc. (HKEX Stock Code: 01801), a biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative drugs for major diseases including oncology, autoimmune, metabolic, and ophthalmic diseases, reported expansion of the global Phase 3 MarsLight-11 (NCT07217301) trial, which is evaluating IBI363 (Takeda R&D code: TAK-928) in patients with squamous non-small cell lung cancer (NSCLC) whose disease has progressed on or after chemotherapy and immunotherapy, to include patients with non-squamous NSCLC. This expansion marks another important milestone in the development of this investigational innovative immunotherapy. IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being jointly developed by Innovent and Takeda globally.
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The evaluation of IBI363/TAK-928 in non-squamous NSCLC will be conducted as a new substudy of MarsLight-11, a global, multicenter, randomized, controlled Phase 3 study. MarsLight-11 will therefore be comprised of two independent substudies—one in squamous NSCLC and the other in non-squamous NSCLC. Each substudy will evaluate the efficacy and safety of IBI363 monotherapy versus docetaxel in patients with unresectable, locally advanced or metastatic NSCLC whose disease has progressed during or after treatment with platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.
About IBI363 /TAK-928 (alpha-biased IL-2/PD-1 Bispecific Fusion Protein)
IBI363/TAK-928 is a potential first-in-class alpha-biased IL-2/PD-1 bispecific fusion protein being co-developed by Innovent and Takeda. It functions by both blocking the PD-1/PD-L1 pathway and selectively activating the IL-2 pathway. The IL-2 arm of IBI363/TAK-928 is designed to maintain its affinity for IL-2Rα while reducing binding to IL-2Rβ and IL-2Rγ, with the aim of minimizing toxicity. The PD-1 binding arm not only blocks PD-1 but also selectively delivers IL-2 to the tumor.
IBI363/TAK-928 is being evaluated in a series of clinical trials globally, including
a pivotal Phase II study in China in previously untreated acral and mucosal melanoma
a global multi-center Phase III trial in immunotherapy-resistant squamous and non-squamous NSCLC
a pivotal Phase III study in China in advanced CRC refractory or intolerant to standard therapy.
In parallel, multiple Phase Ib/II trials are evaluating IBI363/TAK-928 in NSCLC and CRC including the first-line and later line settings, and in additional tumor types.
IBI363/TAK-928 has received two Fast Track Designations (FTD) from the U.S. FDA and three Breakthrough Therapy Designations (BTD) from China NMPA so far.
In October 2025, Innovent entered into a license and collaboration agreement with Takeda, under which Innovent and Takeda will co-develop IBI363 (Takeda R&D code: TAK-928) globally and co-commercialize IBI363/TAK-928 in the U.S., and Takeda will exclusively commercialize IBI363/TAK-928 worldwide other than the U.S. and greater China.
(Press release, Innovent Biologics, SEP 27, 2026, View Source [SID1234671105])