Rongchang Pharma 
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  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial termination:  A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy (clinicaltrials.gov) -  Dec 6, 2023   
    P2,  N=15, Terminated, 
    Further studies are ongoing to confirm the safety and efficacy of anti-APRIL approaches as an effective therapeutic strategy in IgAN. Active, not recruiting --> Terminated; Decision that continuing with the study would not generate useful data
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Trial completion, Trial completion date, Trial primary completion date:  Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov) -  Dec 5, 2023   
    P1,  N=92, Completed, 
    Active, not recruiting --> Terminated; Decision that continuing with the study would not generate useful data Recruiting --> Completed
  • ||||||||||  Benlysta (belimumab) / GSK, Tai'ai (telitacicept) / Rongchang Pharma
    Biomarker, Review, Journal:  Biomarkers Associated with Drugs for the Treatment of Lupus Nephritis. (Pubmed Central) -  Nov 29, 2023   
    If simple, non-invasive and effective biomarkers can be found, drug intervention and prognosis can be better monitored and targeted. In this review, we focus on LN and explore biomarkers related to LN therapeutics, providing clinicians with more possibilities to track the therapeutic effect of drugs, improve treatment options and assess patient outcomes.
  • ||||||||||  Aidixi (disitamab vedotin) / Pfizer
    Enrollment open, Combination therapy, Metastases:  A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer (clinicaltrials.gov) -  Nov 29, 2023   
    P2/3,  N=60, Recruiting, 
    In this review, we focus on LN and explore biomarkers related to LN therapeutics, providing clinicians with more possibilities to track the therapeutic effect of drugs, improve treatment options and assess patient outcomes. Not yet recruiting --> Recruiting
  • ||||||||||  Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
    Enrollment closed, Phase classification, Trial completion date, Trial primary completion date, Metastases:  A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (clinicaltrials.gov) -  Nov 27, 2023   
    P2/3,  N=301, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: Dec 2022 --> Jun 2023 Recruiting --> Active, not recruiting | Phase classification: P3 --> P2/3 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Aidixi (disitamab vedotin) / Pfizer
    Enrollment closed, Trial primary completion date, Metastases:  A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer (clinicaltrials.gov) -  Nov 27, 2023   
    P2,  N=57, Active, not recruiting, 
    Recruiting --> Active, not recruiting | Phase classification: P3 --> P2/3 | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023 Recruiting --> Active, not recruiting | Trial primary completion date: Aug 2023 --> Nov 2023
  • ||||||||||  RC98 / Rongchang Pharma
    Enrollment closed, Enrollment change, Trial primary completion date, Metastases:  A Study of RC98 in Subjects With Advanced Malignant Solid Tumors (clinicaltrials.gov) -  Nov 27, 2023   
    P1,  N=63, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=25 --> 63 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  Aidixi (disitamab vedotin) / Rongchang Pharma, Pfizer
    Enrollment open, Real-world evidence, Real-world:  RC48-ADC in Breast Cancer (clinicaltrials.gov) -  Nov 21, 2023   
    P=N/A,  N=45, Recruiting, 
    DV demonstrated a promising efficacy with a manageable safety profile in patients with HER2-positive locally advanced or metastatic UC who had progressed on at least one line of systemic chemotherapy. Not yet recruiting --> Recruiting
  • ||||||||||  Review, Journal:  A narrative review of potential drug treatments for nephritis in children with IgA vasculitis (HSP). (Pubmed Central) -  Nov 13, 2023   
    RC48-ADC shows promising efficacy and manageable safety in HER2-expressing advanced or metastatic solid tumor patients. Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab.
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Journal:  Efficacy and safety of Telitacicept in patients with IgA nephropathy. (Pubmed Central) -  Nov 8, 2023   
    Novel drugs that may be considered for use in early nephritis include TRF-budesonide; B-cell inhibiting agents including belimumab, telitacicept, blisibimod, VIS649, and BION-1301; B-cell depleting agents such as rituximab, ofatumumab, and bortezomib; sparsentan; angiotensin converting enzyme inhibitors (ACE-Is); and complement pathway inhibitors including avacopan, iptacopan, and narsoplimab. No abstract available
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Extracellular potassium increases in unmyelinated and myelinated regions and cortical hyperexcitability (WCC Halls A-C) -  Nov 3, 2023 - Abstract #Neuroscience2023NEUROSCIENCE_5793;    
    Supported By Italian Ministry of Health (RRC), Progetto 5PerMille Ictomyelin RC18...In PC layer I a large and fast increase of extracellular potassium concentration ([K+]o) at the onset of seizure-like event induced by the K+ channel blocker 4-aminopyridine (4AP) was recorded in the guinea pig brain in vitro (Uva 2017 doi: 10...111/epi. 16824), pathological K+ changes could support hyperexcitability.
  • ||||||||||  Avastin (bevacizumab) / Roche, Aidixi (disitamab vedotin) / Pfizer
    Enrollment open, Trial initiation date, Metastases:  RC48-ADC Combined With Bevacizumab in HER2-positive Advanced Colorectal Cancer (clinicaltrials.gov) -  Oct 30, 2023   
    P2,  N=30, Recruiting, 
    16824), pathological K+ changes could support hyperexcitability. Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Aug 2023
  • ||||||||||  Tai'ai (telitacicept) / Rongchang Pharma
    Enrollment open:  Study of Telitacicept in Generalized Myasthenia Gravis (clinicaltrials.gov) -  Oct 12, 2023   
    P3,  N=100, Recruiting, 
    ACR20 Response Rate Through Week 24 (NRI, FAS).#P<0.001 vs. Placebo. Not yet recruiting --> Recruiting