Company: GLPG
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001558370-25-003806
Chunk: 18

Company: GALAPAGOS NV
Filing Date: 2025-03-27
Form: 20-F
Item: Item 3
Chunk 18
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19 CAR T) and Abecma® (BCMA CAR T) and Autolus’ Aucatzyl® (CD19 CAR-T).
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In the field of systemic lupus erythematosus (SLE), corticosteroids, antimalarials and immunosuppressants are commonly used to control lupus disease activity. Only two products are currently approved to treat SLE, both as add-on to standard therapy: Belimumab (Benlysta®) (anti-BAFF) from GSK and recently anifrolumab (Saphnelo®) (anti-IFN) from AstraZeneca. There are currently over 10 products in Phase 3 clinical development for SLE, of which the minority are oral therapies – including deucravacitinib (SotyktuTM) (TYK2) from BMS, upadacitinib (JAK) from Abbvieand cenerimod (S1P1) from Idorsia/Viatris. 
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In the field of dermatomyositis (DM), physical therapy, exercise and medication including corticosteroids, immunosuppressants or recently immunoglobulin treatment, are typically used to treat DM. 

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Treatment of this disease has relied for many years on off-label medication - in 2021 the FDA approved immunoglobulin treatment Octagam®, based on the Phase 3 ProDerm trial of Octapharma.
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In the cell therapy manufacturing space, many of our competitors are also working to simplify and expedite the manufacture of next-generation CAR-T and other cell therapies. Innovation in the manufacturing space broadly falls into two separate concepts: (i) novel manufacturing hardware (e.g. Miltentyi’s CliniMACS Prodigy, Cellares’ Cell Shuttle etc.) and (ii) novel manufacturing processes (e.g. Novartis’ T-Charge, AstraZeneca/Gracell’s FasTCAR, or BMS’ NEX-T). Again, as a consequence, we are operating in a highly competitive arena, with potential major market disruption possible in the mid-to long term.
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Many of our competitors have significantly greater financial, technical, and human resources than we have. Mergers and acquisitions in the pharmaceutical, medical device and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Our commercial opportunity could