Bioray, TOT BIOPHARM's CDMO partner, announced that its application for clinical trials of BRY812 injection, a class 1 innovative biological product independently developed by itself, has been accepted by NMPA. BRY812 is a novel antibody-drug conjugate (ADC) targeting human LIV-1 (zinc transporter) and is the first LIV-1 ADC in China. TOT BIOPHARM hereby extends its congratulations!
LIV-1, also known as SLC39A6 or ZIP6, is a multi-pass transmembrane protein with zinc transporter and metalloproteinase activity. LIV-1 is directly involved in the homeostatic metabolism of intracellular zinc ions and can promote the transport of zinc ions from extracellular or intracellular organelles to the cytoplasm, therefore playing a role in cell growth. Globally, no LIV-1 targeting ADC has received marketing approval yet, and BioRay's BRY812 is anticipated to be the second LIV-1 ADC that reaches the clinical stage.
TOT BIOPHARM has recently entered into a comprehensive CDMO strategic cooperation with Bioray. As a professional and reliable CDMO service provider, TOT BIOPHARM has provided ADC coupling and formulation production services for BRY812, and will continue to provide one-stop CDMO solutions for multiple ADC development projects with an integrated, end-to-end service platform, helping BioRay to develop antibody-drug conjugate(ADC) pipeline from R&D and IND to future clinical approval and commercial production.
TOT BIOPHARM is one of the few companies that have several complete commercial production lines of antibodies and ADC, and also one of the leading one-stop ADC CDMO service companies in the world that integrates antibody intermediate, ADC DS and ADC DP which has accumulated comprehensive experience in drug process development, clinical research, new drug application and commercialization. It currently has marketed drugs in commercial production and its quality system is continuously regulated by national regulations.
BioRay is a leader in the research and development of popular tumor immune targets and autoimmunity, and has a full range of R&D expertise and innovation capabilities, with a number of drugs already on the market. It is believed that with the cooperation of both parties, we will promote the rapid development of ADC industry and benefit more patients.