By Fineline Cube 
China‑based pharmaceutical company RemeGen (HKG: 9995) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted its new indication application for telitacicept (brand name: Tacicept) in the treatment of Sjögren’s syndrome. This marks the first time a biologic drug has been approved for this rare autoimmune disorder in the world.
About Telitacicept
- Mechanism – A recombinant fusion protein that simultaneously targets B‑lymphocyte stimulator (BLyS) and proliferating‑inducing ligand (APRIL), effectively dampening pathogenic B‑cell activity.
- Prior Approvals – Already authorized in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG).
- Clinical Evidence – The Phase 3, multicenter, randomized, double‑blind, placebo‑controlled study in Sjögren’s syndrome met all primary endpoints, showing sustained symptom improvement and a favorable safety profile.
Implications for the Autoimmune Market
- First‑Mover Advantage – By becoming the first biologic approved for Sjögren’s syndrome, RemeGen positions itself at the forefront of a niche yet growing therapeutic area.
- Global Expansion – The CDE clearance paves the way for parallel submissions in the EU, U.S., and other key markets, potentially unlocking multi‑billion‑dollar revenue streams.
- Competitive Landscape – Current treatment options for Sjögren’s are limited to symptomatic care; telitacicept offers a targeted, disease‑modifying approach that could redefine standard of care.
Next Steps
- Regulatory Filings – RemeGen will prepare dossiers for the U.S. FDA, EMA, and other jurisdictions in the coming year.
- Commercial Roll‑out – Pricing and reimbursement strategies will be tailored to each market, leveraging the drug’s unique mechanism and robust data.
- Post‑Marketing Studies – Ongoing safety surveillance and real‑world evidence collection will be critical to sustain payer confidence and market uptake.-Fineline Info & Tech