MedPath

Clinical Trial News

Samsung Bioepis Secures Korean Approval for Denosumab Biosimilar XBRYK, Completing Global Regulatory Trifecta

Drug ApprovalOncology
  • Samsung Bioepis received Korean regulatory approval for XBRYK, a biosimilar to Amgen's bone cancer drug XGEVA, used to prevent fractures in patients with bone metastases and treat rare bone tumors.
  • The approval follows earlier Korean approval of OVODENS, a biosimilar to Amgen's PROLIA for osteoporosis treatment, giving Samsung access to a combined global market worth $6.599 billion annually.
  • Samsung has now secured regulatory approval for both denosumab biosimilars across all three major markets including the United States and Europe.
  • The Korean prescription market for denosumab-based products is valued at approximately 187 billion won, with Samsung's biosimilars expected to provide more cost-effective treatment options for bone disease patients.

Yuhan Corporation Receives $15 Million Milestone from Janssen Following Japan Launch of Lazertinib-Amivantamab Combination for EGFR-Mutated NSCLC

Drug Approval
  • Yuhan Corporation will receive a $15 million milestone payment from Janssen Biotech following the commercialization of the Lazertinib-Amivantamab combination therapy in Japan for EGFR-mutated non-small cell lung cancer.
  • The combination therapy demonstrated superior efficacy in the Phase 3 MARIPOSA trial, reducing disease progression risk by 30% compared to Osimertinib monotherapy with median progression-free survival of 23.7 months versus 16.6 months.
  • Japan's Ministry of Health, Labour and Welfare approved the combination as first-line treatment in March 2024, with market projections indicating 6,400 patients will receive treatment over 10 years.
  • The approval represents the third major regulatory milestone for the combination therapy, following previous approvals in the United States and Europe that generated $90 million in milestone payments.

China Approves Zanidatamab as First Dual HER2-Targeted Bispecific Antibody for Biliary Tract Cancer

Drug ApprovalOncology
  • China's National Medical Products Administration granted conditional approval to zanidatamab for previously treated, unresectable or metastatic HER2-positive biliary tract cancer, marking the first dual HER2-targeted bispecific antibody approved for this indication in China.
  • The approval triggers a $20 million milestone payment to Zymeworks from partner BeOne Medicines, with potential for up to $144 million in additional development and commercial milestones plus tiered royalties up to 19.5%.
  • Zanidatamab represents a significant advancement for HER2-positive biliary tract cancer patients, a population with historically high unmet medical need and poor prognoses, affecting approximately 11%-25.2% of biliary tract cancer patients.
  • The conditional approval follows previous regulatory successes, including FDA approval in November 2024 and a positive opinion from the European Medicines Agency in April 2025.

A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers

NCT04466891CompletedPhase 2
Jazz Pharmaceuticals
Posted 10/1/2020

Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer

NCT06282575RecruitingPhase 3
Jazz Pharmaceuticals
Posted 7/19/2024

Marksans Pharma Subsidiary Receives UK Marketing Authorization for Metformin Oral Solution

Drug Approval
  • Marksans Pharma's subsidiary Relonchem Ltd received UK Medicines and Healthcare Products Regulatory Agency (UKMHRA) marketing authorization for Metformin Hydrochloride oral solution in 500 mg/5 ml strength.
  • The approval represents a significant milestone for expanding the company's presence in the anti-diabetic therapeutic segment within the UK market.
  • Metformin Hydrochloride oral solution is used to treat type 2 diabetes and serves as an essential medication for patients requiring oral liquid dosage forms.
  • Marksans Pharma shares gained up to 1.78% following the regulatory approval announcement, reflecting positive market response to the company's expanding portfolio.

Advanced Renal Cell Carcinoma Pipeline Shows Strong Growth with 60+ Therapies in Development

Drug Approval
  • DelveInsight's assessment reveals over 50 companies are actively developing 60+ advanced renal cell carcinoma therapies across various clinical phases.
  • Recent regulatory milestones include Innovent Biologics and HUTCHMED seeking approval for their sintilimab-fruquintinib combination following successful Phase II/III trial results.
  • Emerging therapies span multiple mechanisms including checkpoint inhibitors, antibody-drug conjugates, and targeted small molecules, with notable candidates like OATD-02, DS-6000a, and NKT2152 advancing through clinical development.
  • The pipeline demonstrates significant diversity in therapeutic approaches, with treatments categorized across oral, parenteral, and intravenous routes of administration.

Efficacy and Safety of Fruquintinib in Combination With Sintilimab in Advanced Renal Cell Carcinoma (FRUSICA-2)

NCT05522231Active, Not RecruitingPhase 2
Hutchmed
Posted 10/27/2022

Phase 1 Study of Oral TP-1454

NCT04328740CompletedPhase 1
Sumitomo Pharma America, Inc.
Posted 7/8/2020

Outcomes4Me Raises $21M to Expand AI-Driven Cancer Care Platform Globally

AIOncology
  • Outcomes4Me secured $21 million in funding led by Salica Investments to accelerate its AI-driven cancer care platform that serves over 280,000 patients.
  • The Boston-based company's platform integrates clinical guidelines, genomics, trial matching, and symptom tracking to help cancer patients navigate their care journey.
  • Seven of the top 10 global cancer pharmaceutical companies are already customers, demonstrating strong market adoption since commercial launch in 2022.
  • The funding will support international expansion, enhanced AI capabilities, and scaling partnerships with health systems and life sciences companies worldwide.

Cardiosense Launches SEISMIC-HF II Study to Validate AI Algorithm for Heart Failure Management

AI
  • Cardiosense has launched SEISMIC-HF II, a nationwide multi-center study to validate its machine learning algorithm for non-invasively assessing intracardiac filling pressure in heart failure patients.
  • The study builds on successful SEISMIC-HF I results that demonstrated accuracy comparable to FDA-approved implantable sensors for estimating pulmonary capillary wedge pressure.
  • Heart failure affects 6.7 million U.S. adults with over $30 billion in annual healthcare costs and nearly 50% readmission rates within six months.
  • The prospective, blinded trial will compare the AI algorithm's non-invasive estimates against invasive right heart catheterization measurements to support regulatory filings.

Itepekimab Shows Mixed Results in Phase 3 COPD Trials, Meeting Primary Endpoint in One of Two Studies

Monoclonal Antibody
  • The AERIFY-1 phase 3 trial met its primary endpoint, demonstrating a statistically significant 27% reduction in moderate or severe COPD exacerbations at week 52 in former smokers treated with itepekimab compared to placebo.
  • The AERIFY-2 phase 3 trial failed to meet the same primary endpoint despite showing early benefits, with only a 2% reduction in exacerbations at week 52 for the every-two-week dosing regimen.
  • Itepekimab demonstrated a favorable safety profile across both trials, with adverse event rates comparable to placebo and consistent with previous clinical studies.
  • Sanofi and Regeneron are reviewing the data and plan to discuss next steps with regulatory authorities to evaluate the path forward for this IL-33 targeting monoclonal antibody.

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

NCT04751487CompletedPhase 3
Sanofi
Posted 2/12/2021

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)

NCT04701983CompletedPhase 3
Sanofi
Posted 12/16/2020

QV Bioelectronics Secures £1.26 Million to Advance GRACE Brain Tumor Device Toward Clinical Trials

  • QV Bioelectronics has secured £1.26 million from Innovate UK's Biomedical Catalyst programme to prepare for the first in-human trial of its GRACE device.
  • GRACE is a surgically implanted device designed to deliver electric field therapy directly to glioma tumor margins to disrupt cancer cell division while preserving healthy tissue.
  • The funding follows QV's participation in the Brain Tumour Research Novel Therapeutics Accelerator programme, where they received expert guidance on manufacturing, funding, and clinical trial design.
  • The development represents progress in bridging the 'Valley of Death' in brain tumor research, moving innovative therapeutics closer to patient treatment.

Illumina Launches PromoterAI Tool to Detect Disease-Causing Mutations in Previously Overlooked Genomic Regions

AIRare DiseasePrecision Medicine
  • Illumina has introduced PromoterAI, an AI tool that detects disease-causing mutations in noncoding promoter regions of the genome, areas typically overlooked in clinical diagnostics.
  • The breakthrough technology, featured in Science, could explain up to 6% of undiagnosed rare disease cases and potentially double diagnostic success when combined with existing AI tools.
  • PromoterAI analyzes promoter sequences using deep learning and is freely available for academic research through Illumina Connected Software, offering precomputed scores to prioritize harmful mutations.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.