Core Viewpoint - TCE's efficacy and commercialization capabilities in hematological malignancies have been fully validated, but several challenges remain for its widespread application in solid tumors [1] Group 1: Current Status of TCE - A total of 12 TCE therapies have been approved globally, with 10 in the US and 6 in China; 9 are for hematological malignancies and only 3 for solid tumors [1] - The application of TCE in solid tumors faces challenges such as targeting tumor-associated antigens (TAA) without harming healthy tissues, enhancing T cell infiltration in the tumor microenvironment, and overcoming immunosuppressive cells and cytokines that lead to T cell exhaustion [1] Group 2: Design Innovations Enhancing TCE Applicability - Non-full-length bispecific antibodies and 2+1 format designs have shown promise; Amgen's DLL3/CD3 bispecific antibody has been approved for SCLC, and MSD's Gocatamig has demonstrated high tumor response rates in later-line SCLC patients [2] - The "2+1" format design allows for precise control of CD3 affinity, with Xencor's XmAb platform advancing its pipeline to Phase III clinical trials [2] - TCR therapy, exemplified by Immunocore's KIMMTRAK, targets intracellular protein antigens and has received FDA approval for uveal melanoma, with potential for expansion into other indications [2] Group 3: Strategies to Mitigate Toxicity and Enhance Efficacy - Prodrug designs are being explored to reduce off-target toxicity; Janux has validated its TCE in clinical settings, and Vir's VIR-5818 shows promising initial data in HER2-positive breast cancer [3] - Co-stimulatory signals from CD28, 4-1BB, and CD2 are expected to enhance TCE responses; Regeneron's CD28 bispecific antibody strategy has shown effectiveness but raised safety concerns [3] - Selective T cell activation targets are being developed to avoid broad T cell activation risks; AstraZeneca and LavaTherapeutics are working on TCEs that selectively target CD8+ T cells and Vγ9Vδ2 T cells [4] Group 4: Domestic Companies and Pipeline Development - Domestic companies are advancing TCE research with diverse technical paths, including CD28 co-stimulatory bispecific antibodies and TCR therapies, forming a robust pipeline [5] - Companies to watch include Zai Lab, Wuxi Biologics, Heng Rui Medicine, Bai Li Tianheng, and others, indicating a rich landscape for TCE development in solid tumors [5]

WCLC 2025 Highlights DAIICHI SANKYO CO., LTD. September 17th (US)/ 18th (JP), 2025 Forward-Looking Statements Management strategies and plans, financial forecasts, future projections and policies, and R&D information that Daiichi Sankyo discloses in this material are all classified as Daiichi Sankyo's future prospects. These forward looking statements were determined by Daiichi Sankyo based on information obtained as of today with certain assumptions, premises and future forecasts, and thus, there are vario ...