Clinical Trials

Boan Biotech enrols first patient for Nivolumab phase 3 trial in China

Boan Biotech has announced that the first patient has been enrolled in its phase 3 trial of its Nivolumab injection (BA1104) in China. The drug is the first biosimilar to Opdivo to be part of a phase 3 clinical study in China.
The drug is a monoclonal antibody intended to enhance the immune response of T-cells against tumours by preventing the programmed cell death (PD-1) receptor from binding to its ligands PD-L1 and PD-L2.
Dr Dou Changlin, president of R&D and chief operating officer at Boan Biotech, commented: “As fundamental anti-cancer drugs, PD-1 inhibitors have a wide range of indications and the potential for use in combination with other drugs, holding promise for treating multiple types of cancer and meeting the needs of patients. We are at the forefront of developing Nivolumab as a biosimilar in China thanks to our strong CMC and R&D management capabilities. We will accelerate its clinical development and explore its potential to combine with other innovative antibodies in our pipeline such as
BA1106 (a novel immune checkpoint inhibitor), BA1301 (an antibody-drug conjugate) and BA1202 (a CD3/CEA bispecific antibody). This will make our pipeline even stronger.”
Nivolumab has already been approved for multiple anti-cancer indications both in China and elsewhere. These indications include uses as a neoadjuvant, an adjuvant, first-line or later-line therapies for advanced cancers, both as a stand-alone treatment, in combination with chemotherapy or with novel immune checkpoint inhibitors.
Preclinical studies have demonstrated the BA1104 is highly similar to Opdivo in pharmaceutical and non-clinical activities.