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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

FDA Regulatory Framework Provides Multiple Pathways for Cancer Drug Access Beyond Traditional Approval

Drug ApprovalOncology
  • The FDA maintains several regulatory pathways including Emergency Use Authorization (EUA) and Expanded Access programs to provide cancer patients access to investigational treatments when standard therapies are inadequate.
  • Emergency Use Authorization allows the FDA to authorize unapproved medical products during declared public health emergencies when no adequate approved alternatives exist.
  • Expanded Access programs offer potential treatment pathways for patients with serious or life-threatening conditions to access investigational drugs outside of clinical trials.
  • These regulatory mechanisms serve as critical safety nets for cancer patients, particularly those with bladder cancer and breast cancer, when conventional treatment options are insufficient.

AI Test Identifies Prostate Cancer Patients Who Benefit Most from Life-Saving Drug Abiraterone

AIPrecision MedicineOncologyDrug Approval
  • Researchers developed an AI test that can predict which men with high-risk prostate cancer will benefit most from abiraterone treatment by analyzing tumor images.
  • The AI identified that 25% of men with a specific biomarker saw their five-year death risk cut from 17% to 9% when taking abiraterone alongside standard therapy.
  • Men without the biomarker showed no statistically significant benefit from abiraterone, allowing doctors to spare them unnecessary treatment and side effects.
  • The breakthrough could enable NHS England to reconsider funding abiraterone for newly diagnosed high-risk prostate cancer that hasn't spread, potentially helping 2,100 men annually.

RemeGen's Telitacicept Receives Approval in China for Generalized Myasthenia Gravis Treatment

Drug ApprovalRare Disease
  • RemeGen announced that Telitacicept has officially been approved for marketing in China by the National Medical Products Administration for treating generalized myasthenia gravis.
  • The approval represents a significant milestone for patients with this rare autoimmune neuromuscular disorder in China.
  • This regulatory decision expands the therapeutic options available for generalized myasthenia gravis patients in the Chinese market.

SKYTROFA Receives Australian Approval as First Once-Weekly Growth Hormone Therapy for Children

Rare DiseaseDrug Approval
  • The Therapeutic Goods Administration has approved SKYTROFA (lonapegsomatropin) as a once-weekly injectable treatment for pediatric growth hormone deficiency in children aged 3-18 years.
  • The therapy addresses a rare condition affecting approximately 2,000 Australian children, offering a significant improvement over daily injection regimens previously required.
  • SKYTROFA utilizes Ascendis Pharma's TransCon technology platform to provide sustained release of unmodified growth hormone over one week.
  • The approval was based on three pivotal Phase 3 clinical trials that collectively treated over 300 pediatric patients with growth hormone deficiency.

A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency

NCT04615273CompletedPhase 3
Ascendis Pharma Endocrinology Division A/S
Posted 12/3/2020

KYZATREX Oral Testosterone Therapy Achieves 96% Efficacy Rate in Phase 3 Trials for Hypogonadism Treatment

Drug Approval
  • KYZATREX, developed by Marius Pharmaceuticals, received FDA approval in 2022 as the first oral testosterone replacement therapy utilizing phytosterols for lymphatic absorption.
  • Clinical trials demonstrated up to 96% of patients achieved normal testosterone levels by Day 90, with improvements in quality of life, energy, and erectile function.
  • The therapy addresses a significant unmet need, with approximately 40% of men over 45 and 30-50% of men with obesity or diabetes suffering from hypogonadism.
  • The global testosterone replacement therapy market is projected to grow from $1.9 billion in 2022 to $2.9 billion by 2032, with oral formulations expected to register high growth rates.

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