The therapy proved safe and tolerable in advanced PDAC subjects. Credit: sasirin pamai/Shutterstock.

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted breakthrough therapy designation (BTD) to Innovent Biologics’ IBI343as a monotherapy treatment for CLDN18.2-positive pancreatic ductal adenocarcinoma (PDAC).

The designation includes subjects who have experienced progression after a minimum of one previous systemic treatment.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

It is supported by the data from an ongoing Phase I trial carried out across the US, Australia and China. The therapy was shown to be safe and tolerable as a single agent, with significant antitumour activity in advanced PDAC subjects.

43 subjects with this condition were treated with the therapy. The treatment resulted in a confirmed overall objective response rate (ORR) of 23.3%. Median progression-free survival was recorded at 5.3 months.

Innovent Biologics senior vice-president Dr Hui Zhou stated: “As the world’s first CLDN18.2 ADC to receive BTD in this difficult-to-treat cancer, IBI343 monotherapy has shown encouraging efficacy and tolerable safety in late-line treatment of patients with advanced pancreatic cancer.

“Subject to PoC data readout, we plan to initiate pivotal MRCT studies to further confirm its efficacy and safety in this indication. Additionally, we will also explore the potential of IBI343 in combination therapy for pancreatic cancer and other solid tumours, including gastric cancer.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Pancreatic cancer, known for its low five-year survival rate of around 10%, is a particularly aggressive form of the disease.

In May 2024, the therapy was granted its first BTD by CDE for treating individuals with CLDN18.2-positive advanced junction gastric/gastro-oesophageal adenocarcinoma (GC).

In June, the US Food and Drug Administration granted the therapy fast track status for advanced PDAC treatment.