Telitacicept for Sjögren’s syndrome: which patients may benefit from a specialist assessment in China
If you have been diagnosed with Sjögren’s syndrome and still have active inflammation after conventional treatment, you can ask a rheumatology specialist to check whether you meet the approved indication for telitacicept in China. The approval in China covers adults receiving conventional treatment who have an ESSDAI disease activity score of at least 5 points. The severity of dry mouth and dry eyes alone does not allow a doctor to determine eligibility.
Key points
- Organize information about affected organs and recent test results by date.
- When requesting a quote, specify “telitacicept for injection” and ask where you can obtain prescriptions after returning home.
Why the score needs to be checked again
A doctor assesses ESSDAI based on organ involvement and test results. Tell your doctor whether you have gland swelling, joint swelling and pain, a rash, or lung, kidney, or nervous system problems, and list when symptoms first appeared and when they most recently worsened. Bring the evidence supporting your original diagnosis, antibody and complement results, a complete blood count, and any existing imaging or biopsy reports. You can submit your medical records even without a scoring form; you do not need to estimate your own score.
Where approval in China and overseas research stand
RemeGen and its overseas partner announced approval for this use in China on June 8, 2026. Telitacicept targets both BAFF and APRIL, two signals related to B cells. In a randomized phase III trial in China, by week 24, 49.6% of patients in the 160 mg group had reached low disease activity (an ESSDAI score below 5 points), compared with 10.9% in the placebo group. This score measures systemic organ disease activity; to understand how much dry eyes, dry mouth, or fatigue have improved, review changes in these symptoms separately with your rheumatologist. A separate international phase III study is underway in the United States and other locations, with study sites checking eligibility against the protocol.
What to arrange for the first visit and the following months
Give your rheumatologist a list of medicines you currently take or have stopped taking, including doses, duration of use, improvement, and reasons for stopping. Ask which conventional medicines to continue, how to screen for infection before starting, and when to repeat your complete blood count and immune marker tests. Agree with your doctor on which organ manifestations to track, and record dry eyes, dry mouth, and fatigue separately; even after disease activity decreases, these problems may still need care from an ophthalmologist or a dental specialist.
How the cost per vial translates into ongoing treatment costs
For telitacicept for injection 80 mg, the reference medicine cost in China is CNY 689.15 per vial. If the prescribed dose is 160 mg each time, two vials cost CNY 1,378.30, and four doses cost CNY 5,513.20. Follow-up visits, laboratory tests, and injection services are charged separately. The prefilled injectable formulation used for kidney disease requires a separate price quote for that dosage form. Before returning home, make sure you have your prescription, injection records, and arrangements for your next follow-up tests.
Frequently asked questions
Can I have an initial consultation without a kidney or lung biopsy?
You can send the reports you already have first. The specialist will decide which documents are sufficient and whether further tests are needed based on the specific manifestations of organ involvement.
If my only finding is a positive anti-SSA test, can I start treatment directly?
Antibody results are one part of the diagnostic information. The doctor also needs to confirm the diagnosis, the level of disease activity, and your history of conventional treatment.
If dry mouth remains pronounced after starting injections, does that mean treatment has failed?
Start by recording dry mouth and organ disease activity separately. At follow-up, ask your doctor to assess the effectiveness of systemic treatment and whether measures to relieve dry mouth and dry eyes need adjustment separately.
I currently have a fever. Should my next injection go ahead as usual?
Contact your treatment team promptly with your temperature, accompanying symptoms, and the time of your last injection so they can assess possible infection and decide on the dosing schedule.
Can an overseas doctor continue treatment directly using a Chinese prescription?
Before traveling, send the generic name, dosage form, and treatment plan to your local rheumatologist to confirm whether prescribing, medicine supply, and follow-up testing can be arranged legally, then decide whether to start treatment in China.
Sources and references
- RemeGen: registration announcement for the Sjögren’s syndrome indication
- ClinicalTrials.gov: international phase III trial of telitacicept for active primary Sjögren’s disease
- RemeGen and Vor Bio: approval for Sjögren’s syndrome in China
- RemeGen interim report: results of the phase III study in Sjögren’s disease in China