TaiAi® is the commercial brand name of Telitacicept for Injection, a recombinant fusion protein developed by Rongchang Biotech. It simultaneously binds to BAFF and APRIL, inhibiting the activation and maturation of B lymphocytes and reducing autoantibody production to modulate abnormal autoimmune responses.
Main Indications
Treatment of adult patients with active systemic lupus erythematosus (SLE) who have inadequate response to standard therapy.
Clinical Research
The pivotal Phase II/III Chinese clinical trial demonstrated that telitacicept significantly improves SLE responder index, reduces disease activity and autoantibody levels compared with placebo;
Dose-ranging studies showed a favorable dose-response relationship and acceptable safety profile;
Long-term extension studies indicated sustained disease control and no new unexpected safety signals.
Common Side Effects
Severe but important risks: Serious infections, infusion or injection-related hypersensitivity reactions, decreased immunoglobulin levels;
Common mild adverse reactions: Upper respiratory tract infection, diarrhea, nausea, injection site reactions and leukopenia.
Approval Status in China
Original drug TaiAi® (Telitacicept for Injection, specification:80mg per vial) was officially approved for marketing in China in 2021. It is currently a prescription biologic agent.
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