Harbour BioMed has received US Food and Drug Administration (FDA) approval to conduct a Phase II clinical trial of HBM9167 to treat nasopharyngeal cancer (NPC).

HBM9167 is a humanised IgG1 monoclonal antibody designed to target programmed death-ligand 1 (PD-L1). The drug candidate prevents the interactions of PD-L1 with programmed cell death protein 1 (PD-1).

The mechanism restores the cytotoxic immune function of T-cells and boosts anti-tumour immunity.

Monoclonal antibodies targeting PD-1 or PD-L1 are said to possess the capacity to block their binding and maintain effector T-cells’ ability to prevent cancer cells from avoiding immune surveillance.

Harbour BioMed obtained the right to develop and commercialise HBM9167 from Kelun-Biotech.

In a separate development, the FDA awarded orphan drug designation (ODD) for the use of the drug candidate to treat NPC.

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.

Harbour BioMed founder, chairman and CEO Jingsong Wang said: “Nasopharyngeal cancer is a tumour type for which patients remain in need of effective treatment options.

“The orphan drug designation for HBM9167 will provide an accelerated development path for HBM9167. In addition, we were also able to work with the FDA to enable a direct entry into a Phase II clinical study in patients with metastatic or recurrent disease.”

Kelun-Biotech assessed the drug candidate in more than 300 patients in clinical trials across China.

These trials include Phase I and ongoing Phase II trials in various cancer types, including NPC and classical Hodgkin’s Lymphoma. Preliminary data from the studies demonstrated a tolerable safety profile.