San Francisco, California, U.S., and Suzhou, China, September 23, 2026

Innovent Biologics has announced that multiple clinical datasets from its next-generation immuno-oncology (IO) and antibody-drug conjugate (ADC) pipeline will be presented at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting, taking place from October 23 to 27 in Madrid, Spain. The company’s planned presentations span IBI363/TAK-928, IBI343/TAK-921, IBI3001, IBI354 and sintilimab (TYVYT®) across several cancer types and stages of clinical development. A major highlight is IBI343/TAK-921 (arcotatug tavatecan), a CLDN18.2-targeted ADC, with results from the registrational Phase 3 G-HOPE-001 study selected as a Late-Breaking Abstract (LBA) for a proffered oral presentation. The announcement highlights Innovent’s expanding oncology portfolio and its strategy of developing targeted ADCs and next-generation immunotherapies for difficult-to-treat solid tumors.

IBI343 Phase 3 Data Highlight Gastric Cancer Program

The most prominent presentation will focus on IBI343/TAK-921 (arcotatug tavatecan) in previously treated, advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA). The randomized, open-label Phase 3 G-HOPE-001 trial is evaluating IBI343 against treatment of physician’s choice in patients with CLDN18.2-positive advanced gastric or gastroesophageal junction cancer who have received at least two prior systemic therapies. The first interim analysis has been selected as LBA77 and will be presented during the proffered paper session at ESMO 2026. Innovent previously reported that the study reached its primary endpoint of progression-free survival (PFS), while the upcoming ESMO presentation is expected to provide detailed clinical findings from the interim analysis. IBI343 is an investigational CLDN18.2-targeted antibody-drug conjugate designed to selectively deliver a cytotoxic payload to tumor cells expressing the CLDN18.2 protein. The program has also advanced into regulatory review in China, highlighting its late-stage development status.

IBI363 and Next-Generation Immunotherapy Data

Innovent will also present new clinical data for IBI363/TAK-928, a PD-1/IL-2α-biased bispecific antibody fusion protein being developed as a next-generation immuno-oncology therapy. The ESMO program includes updated Phase 1b data for IBI363 combined with chemotherapy as a first-line treatment for advanced non-small cell lung cancer (NSCLC). Additional presentations will evaluate IBI363 with XELOX chemotherapy in first-line gastric or gastroesophageal junction adenocarcinoma and IBI363 combined with bevacizumab in patients with immunotherapy-resistant lung adenocarcinoma. These studies are designed to investigate whether the investigational immunotherapy can provide clinical activity across different tumor types and treatment settings. Innovent has reported that IBI363 is advancing through multiple registrational and proof-of-concept studies, including programs in NSCLC, colorectal cancer and melanoma, while the candidate has received regulatory designations supporting its continued development.

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New ADC Programs Expand Innovent’s Oncology Pipeline

The ESMO 2026 program will also feature clinical data from two additional antibody-drug conjugate programs, expanding Innovent’s next-generation targeted oncology portfolio. IBI3001, an investigational EGFR/B7H3 bispecific ADC, will have its global multicenter Phase 1 findings presented in a proffered paper session. The study is evaluating the safety and efficacy of IBI3001 in patients with advanced solid tumors. Meanwhile, IBI354, a HER2-targeted ADC, will be presented in a Phase 2 study evaluating its combination with pertuzumab as first-line treatment for patients with HER2-positive, unresectable locally advanced or metastatic breast cancer. Innovent will additionally present multiple studies involving sintilimab, its PD-1 inhibitor, across several cancer settings. Collectively, the presentations demonstrate the company’s focus on immuno-oncology, ADC technology, bispecific therapies and combination treatment strategies. Most of these programs remain investigational, and further clinical and regulatory evaluation will be required to establish their safety, efficacy and potential approvals.

The upcoming ESMO presentations represent a significant clinical update for Innovent’s oncology development portfolio. In particular, the Phase 3 IBI343 G-HOPE-001 data could provide additional evidence from a late-stage program targeting CLDN18.2-positive gastric and gastroesophageal junction cancer, while the IBI363, IBI3001 and IBI354 presentations will add clinical information from earlier-stage immunotherapy and ADC programs. Innovent continues to develop medicines across oncology, autoimmune diseases, cardiovascular and metabolic disorders, and ophthalmology, with multiple assets progressing through late-stage and early clinical development. The company’s collaboration with Takeda also supports international development of selected programs, including IBI363 and IBI343/TAK-921. As the company prepares for ESMO 2026, the new clinical data will provide researchers and clinicians with a broader view of Innovent’s approach to developing next-generation cancer therapies.

Source: Innovent Biologics press release