Policy & Regulation
China's administrator approves Harbour BioMed's Investigational New Drug application for HBM4003
26 February 2021 -

China's National Medical Products Administration (NMPA) has approved Hong Kong-based Harbour BioMed's Investigational New Drug (IND) application for HBM4003, the next generation anti-CTLA-4 antibody in combination with PD-1 antibody/chemotherapy intended for the treatment of patients with advanced NSCLC and solid tumours, it was reported on Thursday.

The study is to assess the safety, tolerability, PK/PD, and anti-tumour activity of the product in combination with PD-1 antibody, with or without chemotherapy, in subjects with advanced NSCLC and other solid tumours.

The product is the fully human anti-CTLA-4 monoclonal heavy chain only antibody generated from Harbour Mice. It has already received US FDA and China NMPA IND approvals of the mono therapy and another combination therapy in China. It has completed patient dosing in several patients in its ongoing phase I study in Australia.

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