INNOVENT BIO (01801) reported that the National Medical Products Administration of China has accepted—and granted priority review status to—the New Drug Application for arcotatug tavatecan (IBI343) in previously treated, locally advanced unresectable or metastatic CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma.

The filing is supported by the first interim analysis from the G-HOPE-001 phase 3 study (NCT06238843), an international, multi-center, randomized, open-label trial conducted in China and Japan. The analysis reached the co-primary endpoints of progression-free survival and overall survival, demonstrating what the company describes as “excellent efficacy” alongside a tolerable safety profile. Specific data will be disclosed in forthcoming scientific forums.

If approved, arcotatug tavatecan would become the first antibody–drug conjugate (ADC) targeting CLDN18.2 to enter the commercial market worldwide, addressing a patient population that currently faces median overall survival of roughly six months after two prior systemic therapies.

Arcotatug tavatecan is a recombinant human anti-CLDN18.2 monoclonal ADC. Upon binding to CLDN18.2-expressing tumor cells, the conjugate is internalized and releases a cytotoxic payload that induces DNA damage, apoptosis and a “bystander effect” on neighboring cells.

Beyond the current gastric cancer indication, the molecule is: • in a phase 3 study for CLDN18.2-positive advanced pancreatic cancer in China; • in phase 1 exploration for first-line gastric cancer and for pancreatic cancer; • licensed to Takeda Pharmaceutical outside Greater China (R&D code TAK-921) under a 2025 global partnership.

Management highlighted the milestone as a key step toward introducing targeted precision therapy to gastrointestinal tumors with high CLDN18.2 expression, aiming to extend survival and improve quality of life for late-stage patients.