Innovent Biologics：IBI343 has been formally accepted for review.

On June 4, according to the latest announcement on the official website of the CDE, the New Drug Application (NDA) for IBI343, a Class 1 novel drug independently developed by Innovent Biologics, has been formally accepted. The proposed indication is for the treatment of locally advanced unresectable or metastatic CLDN18.2-positive gastric/gastroesophageal junction adenocarcinoma in patients who have received at least two prior systemic treatment regimens.

IBI343 is a recombinant humanized anti-CLDN18.2 antibody-drug conjugate (ADC) that achieves potent antitumor efficacy through its precise targeting mechanism. The drug specifically binds to CLDN18.2-expressing tumor cells, and upon internalization, releases a payload toxin that induces DNA damage and subsequent apoptosis of the tumor cells.

This drug has outstanding therapeutic segment value as the world’s first CLDN18.2 ADC to be submitted for marketing approval. Currently, no ADC targeting this same epitope has been approved for marketing globally, positioning it to fill a clinical treatment gap. Additionally, this indication has received dual policy support: it was granted Breakthrough Therapy designation in May 2024, and further granted Priority Review in May 2026, significantly accelerating the path to market.

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