The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) for Innovent Biologics’ IBI343 monotherapy.

The designation is for the treatment of claudin18.2-positive advanced gastric/gastro-oesophageal junction adenocarcinoma (GC) in patients whose disease advanced following a minimum of two lines of systematic treatments.

The BTD for IBI343 is based on promising data from an ongoing Phase I clinical trial.

The trial has shown that the monotherapy has favourable safety and tolerability profiles, along with significant antitumour activity in patients with advanced GC.

Innovent is preparing to initiate a registrational, multi-regional Phase III G-HOPE-001 clinical trial of IBI343, targeting patients with claudin18.2-positive, HER2-negative GC.

IBI343 is an antibody-drug conjugate that combines an anti-claudin18.2 antibody with the cytotoxic drug exatecan, a topoisomerase I inhibitor.

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BTD status is designed to expedite the development and review of drugs intended to treat serious diseases or conditions when preliminary clinical evidence suggests a substantial improvement over existing therapies.

This development will enable IBI343 to receive a rapid review by the CDE and aid Innovent in obtaining timely advice and communication, accelerating the drug’s approval and launch.

Innovent senior vice-president Dr Hui Zhou stated: “We are glad to see the NMPA granted BTD for IBI343 monotherapy based on the PoC clinical results in GC, and we will continue to validate its efficacy and safety in the registrational MRCT trial.

“Innovent has a comprehensive and robust oncology pipeline, and, particularly in GC, we have PD-1 inhibitor (TYVYT) for first-line GC treatment and anti-angiogenic drug (CYRAMZA) for second-line GC treatment. We will further explore IBI343’s potential in combination therapy, as well as in other solid tumours such as pancreatic cancer.”

Last month, the China NMPA granted priority review for Innovent and Hutchmed’s new drug application for the combination of sintilimab and fruquintinib for advanced endometrial cancer.