HANGZHOU, China – April 7, 2025 – TJ Biopharma (“TJ Bio” or “Company”), a fully integrated biotech company in China focusing on discovery, development, manufacturing and commercialization of innovative biologics in the areas of autoimmune diseases, oncology and metabolic disorders, today announced alignment with Biogen to support development of felzartamab in China in two pivotal Phase 3 studies of felzartamab in IgA nepropathy (IgAN) and primary membranous nephropathy (PMN). TJ Bio owns the exclusive rights for development and commercialization of felzartamab for all indications in Greater China, which encompasses Mainland China, Hong Kong, Macao, and Taiwan.

Consistent with the terms of the existing agreement and with the aim of accelerating the global development and registration of felzartamab, Biogen and TJ Bio have formalized their business arrangements associated with trial operations and regulatory interactions in China. Biogen will sponsor and operationalize the Phase 3 felzartamab studies for IgAN and PMN in China. TJ Bio will facilitate regulatory interactions in China for the registration of felzartamab in China for both IgAN and PMN upon successful study completion.

In December 2024, TJ Bio submitted a biologics license application (BLA) for felzartamab in the treatment of multiple myeloma to China’s National Medical Products Administration (NMPA). The BLA has been accepted and is currently under review. Additionally, in August 2024, TJ Bio received Production License A for manufacturing felzartamab at its own GMP facility in Hangzhou. 

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About Felzartamab

Felzartamab is an investigational therapeutic human monoclonal antibody directed against CD38, a protein expressed on mature plasma cells. Felzartamab is a potential first-in-class therapeutic candidate with promise as a pipeline-in-a-product across a range of immune-mediated diseases. Felzartamab has been shown in clinical studies to selectively deplete CD38+ plasma cells, which may allow applications that ultimately improve clinical outcomes in a broad range of diseases driven by pathogenic antibodies. Felzartamab was originally developed by MorphoSys AG (now MorphoSys GmbH, a Novartis company). Human Immunology Biosciences (HI-Bio) exclusively licensed the rights to develop and commercialize felzartamab across all indications in all countries and territories excluding China (including Macau and Hong Kong and Taiwan). Biogen acquired HI-Bio in July 2024.

Felzartamab is an investigational therapeutic candidate that has not yet been approved by any regulatory authority and its safety and effectiveness have not been established.

About TJ Biopharma

TJ Biopharma is a fully integrated biotech company at the forefront of pioneering cutting-edge therapies for autoimmune diseases, immuno-oncology and metabolic disorders. Through its R&D and manufacturing establishments in China, including comprehensive R&D centers in Shanghai and Beijing and a state-of-the-art GMP manufacturing facility in Hangzhou, TJ Biopharma has developed a differentiated and advanced pipeline of innovative clinical and pre-clinical assets, with its first series of advanced clinical assets now progressing toward market approval. Over the years, the Company has established a series of development and commercialization partnerships with Jumpcan, CSPC, Sanofi, and others to commercialize its pipeline products. TJ Biopharma is committed to driving excellence in drug innovation and development through a diverse and sustainable revenue model comprising global asset transactions, contract manufacturing services and future sales revenues. For more information, please visit: TJBio.com.