Telitacicept is under clinical development by RemeGen and currently in Phase II for IgA Nephropathy (Berger’s Disease). According to GlobalData, Phase II drugs for IgA Nephropathy (Berger’s Disease) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Telitacicept’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Telitacicept overview

Telitacicept (Tai' ai) is a potential new TACI-Fc fusion protein, acts as an immunosuppressant and immunomodulating agent. It is formulated as injectable solution for subcutaneous route of administration. Tai' ai is indicated for the treatment of systemic lupus erythematosus.

Telitacicept is under development for the treatment of relapsing remitting multiple sclerosis, rheumatoid arthritis, IgG4 related diseases, lupus nephritis, neuromyelitis optica spectrum disorders, primary sjogren's syndrome, multiple sclerosis, IgA nephropathy (Berger's Disease), myasthenia gravis, antineutrophil cytoplasmic antibody-associated vasculitis and systemic lupus erythematosus. It is administered through subcutaneous route. RCT-18 is a recombinant human B lymphocyte stimulating factor receptor, TACI-antibody fusion protein, acts by inhibiting B-lymphocyte stimulator and proliferation inducing ligand.

RemeGen overview

RemeGen, a subsidiary of Yantai Rongchang Pharmaceutical Co Ltd, is a biopharmaceutical company that focused on discovery, development and commercialization of therapeutic antibody drugs such as antibody drug conjugates (ADCs), antibody fusion proteins, monoclonal antibodies and bispecific antibodies for the treatment of cancer, autoimmune and eye diseases. RemeGen investigating its lead product candidate RC18, a novel BLyS/APRIL induced fusion protein against rheumatoid arthritis, multiple scierosis, neuromyelitis optica spectrum disorder (NMOSD) and other autoimmune diseases. It also evaluating RC48, a HER2 directed antibody drug conjugate targeting gastric, urothelial, breast, lung and bile duct cancer; and RC28 molecule to treat WAMD (wet age-related macular degeneration) and multiple solid cancers. It operates research facilities and offices in China and the US. RemeGen is headquartered in Yantai, Shangdong, China.

For a complete picture of Telitacicept’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.