Product Description
Telitacicept (Tai'ai®) is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept is being developed by Yantai Rongchang Pharmaceutical through its subsidiary RemeGen for the treatment of B cell-mediated autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and multiple sclerosis (MS). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34463932/)
Mechanisms of Action: BLyS Inhibitor,APRIL Inhibitor
Novel Mechanism: Yes
Modality: Fusion Protein
Route of Administration: Subcutaneous
FDA Designation:
Fast Track - Erythema|Lupus Erythematosus|Lupus Erythematosus, Systemic
Fast Track - Sjogren's Syndrome
Orphan Drug - Myasthenia Gravis|Asthenia *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: RemeGen
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description

Countries in Clinic: Argentina, Australia, Belgium, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, Germany, Greece, Guatemala, Hungary, Italy, Mauritius, Mexico, Philippines, Poland, Puerto Rico, Romania, Spain, United States
Active Clinical Trial Count: 22
Highest Development Phases
Phase 3: Glomerulonephritis|IgA Nephropathy|Kidney Diseases|Lupus Erythematosus, Systemic|Muscle Weakness|Myasthenia Gravis|Neuromyelitis Optica|Sjogren's Syndrome
Phase 2: Lupus Nephritis|Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
18C022 | P3 |
Active, not recruiting |
Sjogren's Syndrome |
2027-12-01 |
|
RC18G002 | P3 |
Unknown Status |
Lupus Erythematosus, Systemic |
2027-08-10 |
|
RC18G006 | P3 |
Recruiting |
Myasthenia Gravis |
2027-05-14 |
|
REMESLE-2 | P3 |
Recruiting |
Lupus Erythematosus, Systemic |
2027-04-01 |