MedPath

Tagged News

Chinese Biotech Firms Surge in Global Oncology Licensing Deals, Commanding $30 Billion in 2024

Monoclonal AntibodyOncology
  • Chinese biopharmaceutical companies secured $30 billion in oncology licensing deals in 2024, with monoclonal antibodies and antibody-drug conjugates accounting for 89% of all molecule types.
  • The total deal value from Chinese biopharma was three times that of similar deals licensed from the US, reflecting growing global confidence in China's innovative capabilities.
  • Antibody-drug conjugates dominated the licensing activity, constituting 56% of total deal value at $19 billion, with over half involving bispecific ADCs.
  • Chinese biotech firms completed 33 overseas licensing deals worth $36.2 billion in the first quarter of 2025, up from 28 deals in the same period last year.

Real-World Studies Confirm Bevacizumab Biosimilars Deliver Cost Savings and Equivalent Clinical Outcomes in Metastatic Colorectal Cancer

Monoclonal AntibodyReal World EvidenceOncology
  • A Canadian population-based study found bevacizumab biosimilars Mvasi and Zirabev provided $6,379 CAD in annual cost savings per patient compared to originator Avastin while maintaining equivalent survival outcomes in metastatic colorectal cancer.
  • An Indian real-world analysis of 944 patients demonstrated comparable progression-free survival and overall survival between bevacizumab biosimilars and the reference product in first-line and second-line treatment settings.
  • Both studies support the cost-effectiveness and clinical equivalence of bevacizumab biosimilars, providing evidence for healthcare policy decisions and building confidence among oncologists treating metastatic colorectal cancer.

Fremanezumab Demonstrates Long-Term Efficacy in Migraine Prevention Across Multiple Real-World Studies

Monoclonal AntibodyReal World Evidence
  • The phase 4 PEARL study involving 1,140 patients confirmed fremanezumab's long-term effectiveness, with 66% of episodic migraine patients and 51.6% of chronic migraine patients achieving at least 50% reduction in monthly migraine days over 24 months.
  • A phase 2b/3 trial in Japan and Korea showed fremanezumab significantly reduced acute medication use by approximately 2.8 days per month and decreased migraine-associated symptoms including nausea, vomiting, and light sensitivity.
  • Real-world evidence demonstrates high treatment adherence with over 75% of patients completing the 2-year study duration, while 25.9% of patients were able to discontinue treatment due to sustained improvement.
  • Teva Pharmaceuticals is seeking FDA approval to expand fremanezumab's indication to pediatric patients aged 6-17 years, supported by positive results from the phase 3 SPACE study.

Fremanezumab Compassionate Use Program for Pediatric Patients

NCT03539393available
Teva Branded Pharmaceutical Products R&D, Inc.

Uplizna Shows Remarkable Efficacy in Reducing Flares and Glucocorticoid Dependence in IgG4-Related Disease

Monoclonal Antibody
  • Phase III MITIGATE trial demonstrates Uplizna (inebilizumab) significantly reduces flare risk in IgG4-related disease, with only 10% of treated patients experiencing flares compared to 60% in the placebo group.
  • The CD19-targeting monoclonal antibody proved particularly effective for patients with pancreatic and biliary manifestations of IgG4-RD, showing even greater benefits than in the overall study population.
  • Uplizna treatment led to higher rates of glucocorticoid-free complete remission, potentially establishing a new second-line standard of care following initial glucocorticoid therapy.

Open Label Two-Arm Study to Evaluate Rilzabrutinib in IgG4-Related Disease Participants

NCT04520451CompletedPhase 2
Principia Biopharma, a Sanofi Company
Posted 8/22/2020

A Study of Inebilizumab Efficacy and Safety in IgG4- Related Disease

NCT04540497Active, Not RecruitingPhase 3
Amgen
Posted 12/4/2020

Alvotech's Xolair Biosimilar AVT23 Achieves Positive Phase III Results and UK Regulatory Acceptance

Monoclonal Antibody
  • Alvotech, Kashiv Biosciences, and Advanz Pharma announced positive topline results from a confirmatory efficacy study of AVT23, a proposed biosimilar to Xolair (omalizumab), demonstrating therapeutic equivalence and comparable safety in chronic spontaneous urticaria patients.
  • The randomized, double-blind study enrolled 600 patients and met its primary endpoint of change from baseline in weekly Itch Severity Score at Week 12, with 400 patients receiving the confirmatory 300 mg dose evaluated for efficacy and safety.
  • The UK Medicines and Healthcare Products Regulatory Agency has accepted the marketing authorization application for AVT23, targeting a market where Xolair generated approximately $4.4 billion in global sales in 2024.
  • An application to the European Medicines Agency is expected before year-end, as the companies advance their biosimilar candidate for severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy indications.

Early Rituximab Treatment Shows Significant Benefits for Advanced-Stage, Low Tumor Burden Follicular Lymphoma

Monoclonal AntibodyOncology
  • Recent phase III JCOG1411/FLORA trial demonstrates that early rituximab administration significantly delays disease progression to high tumor burden follicular lymphoma and postpones the need for cytotoxic chemotherapy compared to watchful waiting.
  • Long-term 15-year follow-up data from a separate phase III trial confirms the durability of rituximab's benefits, with 65% of patients in the rituximab maintenance group avoiding new treatments compared to just 34% in the watchful waiting group.
  • Despite clear benefits in delaying disease progression, both studies found no significant differences in overall survival between early rituximab treatment and watchful waiting approaches, prompting ongoing debate about optimal timing of intervention.

Rituximab in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

NCT00112931CompletedPhase 3
University College, London
Posted 9/1/2004

WHO Prequalifies First Maternal RSV Vaccine and Issues Global Immunization Recommendations

Monoclonal Antibody
  • The World Health Organization has prequalified Pfizer's Abrysvo as the first maternal RSV vaccine, enabling procurement by international agencies for low- and lower-middle-income countries.
  • WHO published its first position paper recommending two RSV immunization products: maternal vaccine RSVpreF and monoclonal antibody nirsevimab to protect infants from severe disease.
  • RSV causes an estimated 100,000 deaths and over 3.6 million hospitalizations annually in children under five, with 97% of fatalities occurring in low- and middle-income countries.
  • The maternal vaccine is recommended from 28 weeks of gestation onwards, while nirsevimab is administered as a single dose to infants at birth or before hospital discharge.

Benralizumab Shows Superior Long-Term Outcomes in Eosinophilic Granulomatosis with Polyangiitis

Monoclonal AntibodyRare Disease
  • The MANDARA study extension demonstrates that benralizumab maintains remission in 62.1% of EGPA patients through 104 weeks, with 43.9% achieving complete oral glucocorticosteroid withdrawal.
  • Benralizumab's superior eosinophil depletion mechanism, targeting IL-5 receptors rather than IL-5 directly, provides more complete and rapid eosinophil suppression compared to mepolizumab.
  • Real-world evidence confirms that IL-5 pathway inhibitors significantly reduce disease burden, with mepolizumab showing 18% reduction in daily oral corticosteroid use and 49% decrease in EGPA-related hospitalizations.
  • The convenience advantage of benralizumab's monthly dosing versus mepolizumab's requirement for three monthly injections may improve patient compliance and treatment outcomes.

Biogen's Felzartamab Shows Promising Results in IgA Nephropathy Phase 2 Trial

Monoclonal AntibodyRare Disease
  • 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.

Roche's PiaSky Becomes First Subcutaneous PNH Therapy Approved in EU

Drug ApprovalMonoclonal AntibodyRare Disease
  • Roche's PiaSky (crovalimab) has received European Commission approval as the first subcutaneous therapy for paroxysmal nocturnal haemoglobinuria (PNH) that can be self-administered monthly at home.
  • The approval is based on COMMODORE 2 trial data showing PiaSky was equivalent to AstraZeneca's Soliris in controlling red blood cell destruction while reducing blood transfusion needs.
  • PiaSky now has regulatory clearance in the top four global pharmaceutical markets including China, Japan, the US, and EU, positioning it to compete with established intravenous therapies.
  • The drug faces emerging competition from oral therapies including Novartis' recently approved Fabhalta, which analysts predict could reach $3.6 billion in peak annual sales.

A Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors

NCT04434092Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 10/8/2020

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.