By Fineline Cube 
China-based TJ Biopharma has entered into an agreement with US-based Biogen Inc. (NASDAQ: BIIB) to collaborate on two regulatory Phase III studies for felzartamab in China. This partnership aims to advance the global development and regulatory filings of the CD38 antibody in the treatment of IgA nephropathy (IgAN) and primary membranous nephropathy (PMN).
Collaboration Details
Under the agreement, Biogen will sponsor and operationalize the Phase III studies for felzartamab in IgAN and PMN in China. TJ Biopharma holds exclusive rights for the development and commercialization of felzartamab for all indications in Greater China, including mainland China, Hong Kong, Macao, and Taiwan.
Regulatory and Commercialization Support
TJ Biopharma will facilitate regulatory interactions in China to support the registration of felzartamab for both IgAN and PMN upon successful completion of the studies. This collaboration underscores the commitment of both companies to bringing innovative treatments to patients in China.
Drug Background
Felzartamab, a CD38-targeting antibody, is currently awaiting regulatory decisions in China for the treatment of multiple myeloma. This new indication expansion into IgAN and PMN highlights the potential of the drug to address significant unmet medical needs in nephrology.-Fineline Info & Tech