On December 30, 2024, BioRay Biopharmaceutical Co., Ltd (BioRay) announced that the application for the clinical trial of its proprietary BRY812 for injection, has been approved by the U.S. Food and Drug Administration (FDA).

BRY812 is a LIV-1 targeting novel antibody-drug conjugate (ADC) developed on BioRay’s CysLink™ technology platform, which consists of a humanized IgG1 antibody coupled with MonoMethyl auristatin E (MMAE). LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity as a member of the ZIP superfamily of zinc transporters. Its involvement in the homeostatic metabolism of zinc in cells and its role in promoting the transport of zinc ions from the extracellular or intracellular organelle to the cytoplasm make it a key factor in cell growth and the epithelial-mesenchymal transformation (EMT) process. LIV-1, highly expressed in a variety of solid tumors, plays an important role in tumor metastasis.

Based on the interim clinical data from the ongoing Phase 1a dose-escalation study in China (CTR20232761), the FDA has approved BRY812 for a dose-escalation bridging study and a Phase 1b study focused on dose optimization and efficacy exploration in the target indications for solid tumors in the United States. The data from the Phase 1a study in China demonstrated that BRY812 was well tolerated and showed encouraging clinical efficacy in some patients with relapsed and metastatic solid tumors who have undergone multiple lines of treatment. BioRay will continue to advance the clinical development of BRY812 for solid tumors.

Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay’s BRY812 is currently the first LIV-1 ADC drug that reaches the clinical study stage in China, and the second LIV-1 ADC drug that reaches the clinical study stage in the world after Seagen's Ladiratuzumab Vedotin, marking the BioRay’s leading position in this field.

Dr. Zhu Wei, Chief Medical Officer of BioRay, said, “The proprietary BRY812 for injection is a novel antibody-drug conjugate (ADC). The approval of the clinical trial application of BRY812 for injection in the United States is a testament to BioRay's R&D capabilities and innovative spirit, and it is also strong evidence of our favorable position in the global drug development competition. With no approved drugs targeting the same antigen globally, we look forward to BRY812 overcoming the limitations of existing treatment methods and providing new therapeutic options for patients worldwide.”