Innovent Biologics’ CLDN18.2 ADC IBI343 Receives Breakthrough Designation in China

Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company based in China, has announced that its antibody-drug conjugate (ADC), IBI343, targeting CLDN18.2, has been granted breakthrough therapy designation (BTD) status in China. This designation highlights the potential of IBI343 as a third-line treatment option for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) that express CLDN18.2.

In June 2021, Innovent entered into a licensing agreement with Synaffix B.V., a US-based subsidiary of Lonza (SIX:LONN), to utilize Synaffix’s ADC technology platforms on a non-exclusive basis for the development of IBI343. The drug is designed to bind to tumor cells expressing CLDN18.2, internalize the ADC, and release toxin drugs that cause DNA damage, leading to tumor cell apoptosis. Additionally, the free toxin drugs can diffuse through the plasma membrane, affecting and killing adjacent tumor cells, a phenomenon known as the bystander effect. Phase I clinical trials conducted in China and Australia have demonstrated promising efficacy and a favorable tolerability profile in patients with advanced GC/GEJC.- Flcube.com

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