Innovent Announces Expansion of Global Phase 3 MarsLight-11 Study of IBI363/TAK-928 (Alpha-biased IL-2/PD-1 Bispecific Fusion Protein) in Immunotherapy-Resistant NSCLC to Include Patients with Non-Squamous NSCLC
PR Newswire
SAN FRANCISCO and SUZHOU, China, Sept. 27, 2026
SAN FRANCISCO and SUZHOU, China, Sept. 27, 2026 /PRNewswire/ -- 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, announces 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.
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.
About Innovent
Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NMPA review, 5 assets in phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage.
Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the highquality outbound internationalization of China's innovative drug industry.
Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.
For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Statement: (1)Innovent does not recommend the use of any unapproved drug (s)/indication (s).
(2) Ramucirumab Injection (Cyramza®), Selpercatinib Capsules (Retsevmo®), Pirtobrutinib Tablets (Jaypirca®) and abemaciclib (Verzenios®) are products discovered and developed by Eli Lilly.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.
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