Policy & Regulation
BioRay Pharmaceutical's Investigational New Drug Application for BRY812 clinical trial accepted by Chinese regulator
25 May 2023 -

BioRay Pharmaceutical Co., Ltd. (BioRay), a China-based biopharmaceutical company focusing on immune-mediated diseases, announced on Wednesday that the China National Medical Products Administration (NMPA) (Acceptance No. CXSL2300366) has accepted the Investigational New Drug (IND) application for the clinical trial of its proprietary BRY812, a novel antibody-drug conjugate (ADC) targeting human LIV-1 for the treatment of advanced malignant tumours.

The product, a LIV-1 targeting ADC, has been developed based on the company's CysLink technology platform, where highly stable conjugation is created via irreversible chemistry. During pre-clinical pharmacological studies, the product indicated significant antitumor activity in various tumour models. The company said that it has higher stability in circulation by eliminating payload exchange, delivering toxins more selectively to tumour tissue, which resulted in a superior safety profile in pre-clinical toxicology studies compared to other ADCs targeting the same pathway. BRY812 is expected to be the second LIV-1 ADC that reaches clinical stage.

Dr Haibin Wang, BioRay CEO, said, 'Since this January, we have obtained the IND approval of two innovative antibody drug candidates, BR108 and BRY805. We are committed to finding better therapeutic options for patients living with cancers and immune-mediated diseases. We will continue the research in exploring innovative targets, technologies and therapeutic modalities, including ADCs.'



Related Headlines