Peptide News Digest

#Multiple-Myeloma

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Industry · View digest

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.

Regulatory · View digest

Oncopeptides Files EMA Type II Variation to Expand Pepaxti (Melflufen) Peptide-Drug Conjugate Label to Third-Line Multiple Myeloma

Oncopeptides AB announced May 11-12 it intends to submit a Type II variation application to the European Medicines Agency to expand the Pepaxti (melflufen) label to include third-line treatment of relapsed/refractory multiple myeloma. Pepaxti is one of two FDA-approved peptide-drug conjugates currently on market (the other being Novartis's 177Lu-dotatate Lutathera) and acts as a melphalan-flufenamide alkylating peptide that exploits aminopeptidase enzymes overexpressed in myeloma plasma cells to selectively release the cytotoxic payload inside tumor cells. The Pepaxti EMA label currently covers heavily pre-treated (≥4 prior lines) RRMM; the new third-line expansion submission would meaningfully extend the eligible population. The filing positions the PDC modality for a broader regulatory footprint as the broader peptide-drug-conjugate field heads into ASCO 2026.

Clinical Trials · View digest

Oncopeptides SPiKE Platform: Affibody-Derived NK-Cell Engager Preclinical Data for Multiple Myeloma at AACR 2026

Oncopeptides AB (Nasdaq Stockholm: ONCO) will present preclinical data on its SPiKE platform at AACR 2026, showing synergistic effects when combining an affibody-derived bispecific engager with expanded adaptive NK cells (ADAPT-NK) in a humanized multiple myeloma mouse model. The approach leverages peptide-scaffold targeting to direct NK-cell cytotoxicity at malignant plasma cells in difficult-to-treat cancers.