Innovent Biologics has filed a China NDA for arcotatug tavatecan (IBI343; TAK‑921) after the Phase 3 G‑HOPE‑001 trial met its primary endpoint in CLDN18.2‑positive gastric cancer. The ADC showed strong efficacy with manageable safety and is under priority review by the NMPA.
Written By: Dr. Preethi Putti, PharmD
Reviewed By: Pharmacally Editorial Team
Innovent Biologics has submitted a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) for arcotatug tavatecan (IBI343; Takeda code: TAK-921). The filing follows positive results from the Phase 3 G-HOPE-001 study, which achieved its predefined primary endpoint of progression-free survival (PFS) in patients with CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who had received at least two prior systemic therapies.
The NDA has been accepted under the NMPA’s priority review pathway, reflecting the potential clinical importance of the therapy.
Addressing a High-Need Population
Patients with advanced gastric cancer who progress after standard therapies face poor outcomes, with median survival in later-line settings remaining around six months. No CLDN18.2-targeted antibody-drug conjugates (ADCs) are currently approved, underscoring the potential first-in-class positioning of arcotatug tavatecan.
The ADC delivers the potent topoisomerase I inhibitor exatecan through a cleavable linker and incorporates Fc silencing technology to help reduce off-target toxicity. CLDN18.2 is expressed in approximately 70% to 80% of gastric cancers while showing limited distribution in normal tissues, making it an attractive therapeutic target for precision oncology.
G-HOPE-001 Trial Details
The randomized, open-label Phase 3 G-HOPE-001 trial (NCT06238843) enrolled patients in China and Japan with CLDN18.2-positive, locally advanced unresectable or metastatic G/GEJA who had received at least two prior systemic treatments. Arcotatug tavatecan monotherapy was compared with investigator-selected treatment.
The protocol-specified first interim analysis met the primary endpoint of progression-free survival. Overall survival remains a co-primary endpoint and will continue to be evaluated as the study matures. Investigators reported a manageable safety profile and a low incidence of gastrointestinal toxicities, a key consideration for therapies targeting CLDN18.2.
The company did not disclose detailed efficacy metrics from the interim analysis, and full clinical results are expected to be presented at future scientific meetings and published in peer-reviewed journals.
Clinical Implications and Strategic Importance
Professor Lin Shen, Director of the Department of Gastrointestinal Oncology at Beijing Cancer Hospital, commented: “We are delighted to see that the pivotal Phase 3 clinical trial of arcotatug tavatecan has been successfully conducted in China and Japan, and achieved its primary endpoint at the first interim analysis. This represents an important advance for patients with refractory gastric cancer.”
Dr. Michael Yu, Founder, Chairman and CEO of Innovent Biologics, stated: “The NDA acceptance under priority review is a major milestone for Innovent and for patients with CLDN18.2‑positive gastric cancer. Arcotatug tavatecan has demonstrated encouraging efficacy and tolerability, and we are committed to working closely with regulators to bring this innovative therapy to patients as quickly as possible.”
Global Development Path
Beyond gastric cancer, arcotatug tavatecan is being evaluated in a Phase 3 study for CLDN18.2-positive pancreatic cancer and in earlier-stage trials across additional treatment settings.
The program gained momentum in 2025 when Innovent and Takeda entered a global partnership granting Takeda exclusive rights to the therapy outside Greater China. The China filing could provide the first regulatory validation of a CLDN18.2-targeted ADC and support broader global development efforts under the collaboration, potentially expanding treatment options for patients with CLDN18.2-expressing cancers.
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About the Writer
Dr.Preethi Putti, PharmD (LinkedIn) is a pharmaceutical researcher with experience in healthcare and pharmaceutical market research and competitive intelligence. She specializes in analyzing drug pipelines, clinical data, and industry trends and translating complex scientific data into clear and structured medical content. Strong foundation in clinical research, data interpretation, and evidence-based healthcare analysis. Committed to advancing a global career in clinical research and healthcare innovation.