Biogen (NASDAQ: BIIB) and Chinese Partner TJ Biopharma Announced Monday August 17, 2026 That Felzartamab for Injection (Branded Jingfei in China) an Anti-CD38 Monoclonal Antibody Has Been Approved by China's National Medical Products Administration (NMPA) for Use With Lenalidomide and Dexamethasone in Adults With Multiple Myeloma Who Have Received at Least One Prior Line of Therapy; Felzartamab Represents an Alternative Anti-CD38 Mechanism to Sanofi's SARCLISA (Isatuximab) and J&J's DARZALEX (Daratumumab) That Have Anchored the Anti-CD38 Multiple Myeloma Commercial Segment; The China Approval Marks TJ Biopharma's First Regional Commercial Launch for Felzartamab and Extends the Biogen-China Partnership Approach for Both Ex-China Drug Development and In-China Commercial Positioning
Biogen (NASDAQ: BIIB) and Chinese partner TJ Biopharma announced Monday August 17, 2026 that felzartamab for injection (branded Jingfei in China), an anti-CD38 monoclonal antibody, has been approved by China's National Medical Products Administration (NMPA) for use with lenalidomide and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy. Anti-CD38 mechanism context: CD38 is a transmembrane glycoprotein highly expressed on multiple myeloma plasma cells and less on normal cells, making it a validated target for monoclonal antibody therapy. Felzartamab represents an alternative anti-CD38 mechanism to Sanofi's SARCLISA (isatuximab) and Johnson & Johnson's DARZALEX (daratumumab), the two commercial anti-CD38 monoclonal antibodies that have anchored the anti-CD38 multiple myeloma commercial segment since first approvals in 2015 (daratumumab) and 2020 (isatuximab). Felzartamab's specific differentiation lies in a distinct epitope-binding domain on CD38 that may translate to different infusion-reaction profiles and combination-therapy potential. The China NMPA approval marks TJ Biopharma's first regional commercial launch for felzartamab and extends the Biogen-China partnership approach for both ex-China drug development and in-China commercial positioning. Beyond multiple myeloma, felzartamab is being studied for anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis), IgA nephropathy, and antibody-mediated kidney transplant rejection in ex-China trials that Biogen leads.