Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 2
- 1 min read
28/05/2026
Zenas BioPharma announced submission of BLA to US FDA for Obexelimab in IgG4-RD (Ref)
Zenas BioPharma announced the submission of its Biologics License Application (BLA) to the US FDA for obexelimab (CD19 and FcγRIIb) in Immunoglobulin G4-Related Disease (IgG4-RD).
The BLA submission was supported by results from the Phase 3, INDIGO trial of obexelimab for the treatment of IgG4-RD.
Data from the INDIGO trial were scheduled to be presented during an oral session at the EULAR 2026 Congress on June 4, 2026.
Innocare announced the acceptance of the NDA for Orelabrutinib in Primary ITP in China (Ref)
InnoCare Pharma announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) had accepted the New Drug Application (NDA) for orelabrutinib (a BTK inhinitor) for the treatment of patients with primary immune thrombocytopenia (ITP) in China.
This was the first NDA acceptance for orelabrutinib in an autoimmune indication; the molecule demonstrated favorable efficacy and safety in autoimmune diseases.
