Calliditas Therapeutics AB is a commercial-stage biopharma company focused on identifying, developing, and commercializing novel treatments in orphan indications, initially focusing on renal and hepatic diseases with unmet medical needs. The company's pipeline candidate is TARPEYO medication to reduce proteinuria in IgA nephropathy.
相关临床试验
28
17 进行中
药物批准
2
批准总数
监管机构
1
监管机构数
成立时间
1991
进行中（未招募）
17
60.7%
已完成
10
35.7%
招募中
1
3.6%
- Vera Therapeutics reported that Trutakna met all prespecified endpoints in the final ORIGIN 3 analysis of 428 adults with primary IgA nephropathy at risk of progression. - Annualized eGFR slope through 104 weeks was -0.6 mL/min/1.73m2/year with Trutakna versus -5.6 with placebo, a 5.0 mL/min/1.73m2/year treatment effect (p<0.0001). - Composite kidney disease progression events occurred in 11 Trutakna patients versus 38 on placebo, a 76% risk reduction (hazard ratio 0.24; 95% CI 0.12, 0.48). - Vera plans to submit a supplemental BLA in Q4 2026 for full approval, with more than 350 patient start forms generated in the first ten weeks of launch.
- VR-205 achieved a 33.75% reduction in geometric mean urine protein-to-creatinine ratio at 9 months compared to baseline [95% CI: -45.27 to -19.80; p < 0.001], meeting the primary endpoint. - The targeted-release budesonide formulation was well tolerated in Japanese patients, with a safety profile consistent with global Phase 3 studies. - No study participants progressed to dialysis, kidney transplant, or severe renal impairment by the end of the 9-month treatment period. - Viatris plans to submit a New Drug Application in Japan by the end of 2026, where IgAN incidence is the highest globally at 39–45 cases per million per year.
- Calliditas Therapeutics will present seven abstracts at the 2026 World Congress of Nephrology, including new secondary analyses from the Phase 3 NefIgArd study evaluating Nefecon's effects on gut-associated lymphoid tissue biomarkers in IgA nephropathy patients. - The presentations will highlight mechanistic data demonstrating Nefecon's immunomodulatory effects in Peyer's patches, reinforcing its disease-modifying role in reducing pathogenic galactose-deficient IgA1 levels. - Additional data will include proteinuria response analyses and preliminary efficacy findings from a Phase 2a trial of setanaxib in Alport syndrome patients. - The company will also sponsor an educational symposium titled "The Evolving IgAN Treatment Paradigm: Why Target the Gut?" featuring international nephrology experts.
- Seven new real-world evidence studies from leading Chinese hospitals will be presented at the 18th International IgA Nephropathy Symposium, demonstrating NEFECON's efficacy and safety across diverse patient populations including pediatric cases and those with renal insufficiency. - The studies validate NEFECON's position as the world's first etiological treatment for IgA nephropathy, showing significant proteinuria reduction and renal function preservation with extended treatment beyond 9 months. - NEFECON has achieved regulatory approval from major agencies including FDA, EMA, and NMPA, and was included in China's National Reimbursement Drug List in November 2024, reinforcing its role as first-line cornerstone therapy for IgAN patients.
- Hansa Biopharma has appointed Dr. Richard Philipson as Chief Medical Officer effective July 14, bringing over 25 years of industry experience to the commercial-stage biopharmaceutical company. - Dr. Philipson's track record includes clinical leadership resulting in four product approvals, including rare disease and gene therapy treatments, with expertise spanning first-in-human to Phase 3 studies. - The appointment positions Hansa to advance its proprietary IgG-cleaving enzyme technology platform, including imlifidase for kidney transplantation and HNSA-5487 for autoimmune diseases. - Dr. Philipson will support upcoming regulatory submissions and help build strategic development plans for future indications across rare diseases, inflammation, and oncology.
- DelveInsight's 2025 pipeline analysis reveals over 30 companies developing 30+ liver cirrhosis therapies, with promising candidates like Rezdiffra, efruxifermin, and belapectin showing significant clinical progress. - Madrigal Pharmaceuticals' Rezdiffra demonstrated reduced liver scarring in compensated cirrhosis patients in Phase 3 MAESTRO-NAFLD-1 trial data, while Akero Therapeutics reported preliminary results from its Phase IIb SYMMETRY study of efruxifermin. - The liver cirrhosis treatment market is experiencing robust growth driven by rising global prevalence of liver diseases, particularly NAFLD, fueled by lifestyle factors including obesity and metabolic syndrome. - Key pipeline therapies span diverse mechanisms including sodium-bile acid cotransporter inhibitors, regulatory T-lymphocyte stimulants, and Wnt signaling pathway inhibitors across oral, intravenous, and subcutaneous administration routes.
• Renée Aguiar-Lucander has been appointed as the new CEO of Hansa Biopharma AB, effective immediately, replacing Søren Tulstrup who steps down after seven years with the company. • Aguiar-Lucander brings significant experience from her seven-year tenure as CEO of Calliditas Therapeutics, where she led a successful dual NASDAQ listing and launched the first approved drug for IgA nephropathy in the U.S. • The leadership change signals Hansa Biopharma's transition into a new growth phase, with the Board expressing confidence in Aguiar-Lucander's ability to advance the company's strategic positioning.
- Biogen's anti-CD38 antibody felzartamab demonstrated substantial reductions in proteinuria and stabilized kidney function in a 54-patient phase 2 study for IgA nephropathy. - The IGNAZ study showed 50% reduction in proteinuria levels after two years of follow-up, with maintained estimated glomerular filtration rate levels. - Felzartamab works by depleting CD38-expressing antibody-secreting cells that contribute to kidney inflammation and function loss in this autoimmune disease. - The encouraging results support Biogen's $1.8 billion acquisition of Human Immunology Biosciences and the company's plan to advance felzartamab into phase 3 trials.
• Calliditas Therapeutics' Nefecon demonstrated significant efficacy in Phase 3 trial, showing 31% reduction in proteinuria compared to 5% in placebo for IgA nephropathy treatment. • The drug showed favorable safety profile consistent with budesonide, with key secondary endpoint demonstrating 7% treatment benefit in estimated glomerular filtration rate versus placebo. • Company plans FDA filing for accelerated approval in Q1 2021, followed by EMA submission in H2, targeting 130,000-150,000 potential patients in US market.
- The Taiwan Food and Drug Administration (TFDA) has approved NEFECON® for treating primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. - NEFECON®, already approved by the U.S. FDA, is the first IgAN etiological treatment drug to receive full approval, now expanding to more IgAN patients. - Clinical trials demonstrated NEFECON®'s ability to reduce proteinuria, microscopic hematuria, and significantly improve estimated glomerular filtration rate (eGFR) compared to placebo (p<0.0001). - NEFECON® is expected to be included in Chinese IgAN guidelines as a first-line treatment for patients at risk of disease progression.
