Tai'ai (telitacicept) / Rongchang Pharma 
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  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Journal:  Telitacicept as a BLyS/APRIL dual inhibitor for autoimmune disease. (Pubmed Central) -  Feb 24, 2022   
    in China and is approved to treat systemic lupus erythematosus in China. We review the rationale, clinical evidence, and future perspectives of telitacicept for the treatment of autoimmune disease.HighlightThe B lymphocyte stimulator BLyS (also known as B-cell-activating factor, BAFF) and APRIL (a proliferation-inducing ligand), members of tumor necrosis factor (TNF) family, and which are critical factors in the maintenance of the B-cell pool and humoral immunity.BAFF and APRIL are implicated in the pathogenesis of several human autoimmune diseases with autoreactive B-cell involvement, and targeting both is beneficial for the treatment of autoimmune diseases.Telitacicept is a novel recombinant fusion protein of both the ligand-binding domain of the TACI receptor and the Fc component of human IgG, as a BLyS/APRIL dual inhibitor and which has been approved by National Medical Products Administration (MNPA) for the treatment of patients with SLE in China.With more clinical trials underway, telitacicept may also be approved for the treatment of other autoimmune diseases in the future.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion date, Trial primary completion date:  A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy (clinicaltrials.gov) -  Feb 24, 2022   
    P2,  N=30, Recruiting, 
    We review the rationale, clinical evidence, and future perspectives of telitacicept for the treatment of autoimmune disease.HighlightThe B lymphocyte stimulator BLyS (also known as B-cell-activating factor, BAFF) and APRIL (a proliferation-inducing ligand), members of tumor necrosis factor (TNF) family, and which are critical factors in the maintenance of the B-cell pool and humoral immunity.BAFF and APRIL are implicated in the pathogenesis of several human autoimmune diseases with autoreactive B-cell involvement, and targeting both is beneficial for the treatment of autoimmune diseases.Telitacicept is a novel recombinant fusion protein of both the ligand-binding domain of the TACI receptor and the Fc component of human IgG, as a BLyS/APRIL dual inhibitor and which has been approved by National Medical Products Administration (MNPA) for the treatment of patients with SLE in China.With more clinical trials underway, telitacicept may also be approved for the treatment of other autoimmune diseases in the future. Trial completion date: Jun 2022 --> Sep 2022 | Trial primary completion date: Mar 2022 --> Aug 2022
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Review, Journal:  Telitacicept: First Approval. (Pubmed Central) -  Jan 27, 2022   
    Clinical studies of telitacicept in several other indications, including IgA nephropathy, MS, myasthenia gravis, neuromyelitis optica spectrum disorders, RA and Sjögren's syndrome are underway in China. This article summarizes the milestones in the development of telitacicept leading to this first approval for SLE.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion date, Trial primary completion date:  RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) -  Jan 11, 2022   
    P2,  N=18, Recruiting, 
    Recruiting --> Active, not recruiting | N=20 --> 29 | Trial completion date: Dec 2021 --> Jul 2022 | Trial primary completion date: Oct 2021 --> Feb 2022 Trial completion date: Feb 2022 --> Nov 2022 | Trial primary completion date: Dec 2021 --> Apr 2022
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Journal:  Oligotyping and metagenomics reveal distinct Candidatus Accumulibacter communities in side-stream versus conventional full-scale enhanced biological phosphorus removal (EBPR) systems. (Pubmed Central) -  Nov 16, 2021   
    Furthermore, genome-resolved metagenomics enabled extraction of three metagenome-assembled genomes (MAGs) belonging to CAP clades IIB (RCAB4-2), IIC (RC14) and II (RC18), from full-scale EBPR sludge for the first time, including a distinct Ca...The results also revealed the temporally increasing predominance of RC14, which belonged to Clade IIC, during the implementation of the S2EBPR configuration. Finally, we also show the existence of previously uncharacterized diversity of clades of CAP, namely the clades IIB and as yet unidentified clade of type II, in full-scale EBPR communities, highlighting the unknown diversity of CAP communities in full-scale EBPR systems.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    New P2 trial:  Telitacicept in Primary APS Patients (clinicaltrials.gov) -  Oct 14, 2021   
    P2,  N=20, Recruiting, 
  • ||||||||||  Orencia (abatacept) / BMS, Actemra IV (tocilizumab) / Roche, JW Pharma
    Review, Journal:  Sjögren's syndrome: Old and new therapeutic targets. (Pubmed Central) -  Aug 7, 2021   
    Abatacept and belimumab, already licensed for the treatment of RA and lupus respectively, as well combination regimens of both rituximab and belimumab hold some promise in alleviation of SS-specific complaints, but data from large controlled trials are awaited...While targeting of cathepsin-S (Petesicatib), inducible costimulator of T cells ligand (prezalumab), and lymphotoxin beta receptor (baminercept) failed to fulfil the primary outcome measures, preliminary results from two randomized placebo controlled trials on CD40 blockade (Iscalimab) and B-cell activating factor receptor (Ianalumab) inhibition resulted in significant reduction of SS disease activity, with a favorable so far safety profile. Results from administration of other kinase inhibitors, a transmembrane activator and calcium-modulator and cytophilin ligand interactor TACI fusion protein (RC18), as well as low dose recombinant interleukin-2 to expand T-regulatory cells are currently awaited.
  • ||||||||||  hydroxychloroquine / Generic mfg., cyclosporine / Generic mfg.
    Clinical, Journal:  An Update on the Management of Childhood-Onset Systemic Lupus Erythematosus. (Pubmed Central) -  Jul 22, 2021   
    Anti-interferon therapies (sifalimumab and anifrolumab) have shown beneficial results in phase II randomized control trials in adult SLE patients, as have some Janus kinase inhibitors, and these could be alternative treatments for pediatric patients with severe interferon-mediated inflammatory disease in the future. In addition, strict control of proteinuria and blood pressure is required in cSLE, especially with angiotensin-converting enzyme inhibitor and angiotensin receptor blocker use.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy (clinicaltrials.gov) -  Jul 19, 2021   
    P2,  N=44, Completed, 
    In addition, strict control of proteinuria and blood pressure is required in cSLE, especially with angiotensin-converting enzyme inhibitor and angiotensin receptor blocker use. Active, not recruiting --> Completed | N=30 --> 44 | Trial completion date: Dec 2021 --> May 2021 | Trial primary completion date: Oct 2021 --> May 2021
  • ||||||||||  telitacicept (RC18) / Rongchang Pharma
    Preclinical, Journal:  In vitro digestibility and structural control of rice starch-unsaturated fatty acid complexes by high-pressure homogenization. (Pubmed Central) -  May 21, 2021   
    t12 was too mobile to form single helix, leading to the formation of loose matrix; t18 fitted better within the cavity of starch than c18, and formed structural domain with higher compactness and thermal stability; Rloa had lower complex index but higher degree of short-range order, and tended to form alternating amorphous and crystalline structure. The digestibility was higher in the order of Rloa, Rt18, Rc18 and Rt12.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion date, Trial primary completion date:  A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sj (clinicaltrials.gov) -  Apr 26, 2021   
    P2,  N=30, Recruiting, 
    Trial completion date: Dec 2020 --> Mar 2023 | Trial primary completion date: Dec 2020 --> Dec 2022 Trial completion date: Dec 2020 --> Oct 2021 | Trial primary completion date: Oct 2020 --> Jul 2021
  • ||||||||||  Soliris (eculizumab) / Alexion Pharma, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    Journal:  Emerging drugs for the treatment of neuromyelitis optica. (Pubmed Central) -  Feb 4, 2021   
    For the first time in this disease, class I treatment evidence is available, but long-term data will be necessary to confirm the overall promising study results of the compounds close to approval. While drug development still centers around AQP4 antibody seropositive patients, current and future research requires consideration of possible diverging treatment demands for the smaller group of seronegative patients and patients with presence of MOG antibodies.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial initiation date:  RC18 in Patients With Relapsing Remitting Multiple Sclerosis?a Phase II Trial (clinicaltrials.gov) -  Feb 2, 2021   
    P2,  N=18, Not yet recruiting, 
    While drug development still centers around AQP4 antibody seropositive patients, current and future research requires consideration of possible diverging treatment demands for the smaller group of seronegative patients and patients with presence of MOG antibodies. Initiation date: Dec 2020 --> Mar 2021
  • ||||||||||  telitacicept (RC18) / Rongchang
    I’m short RC18 (Twitter) -  Oct 27, 2020   
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion, Trial completion date, Trial primary completion date:  Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) -  Mar 4, 2020   
    P2b,  N=249, Completed, 
    Trial completion date: Dec 2019 --> Dec 2020 | Trial primary completion date: Dec 2019 --> Dec 2020 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Dec 2019 --> Jun 2019
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Enrollment closed, Enrollment change:  Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) (clinicaltrials.gov) -  Jul 18, 2019   
    P2b,  N=249, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Jul 2019 | Trial primary completion date: Dec 2019 --> Jun 2019 Recruiting --> Active, not recruiting | N=160 --> 249