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Lundbeck Seeks Asian Market Approval for Vyepti Migraine Prevention Therapy

Monoclonal Antibody
  • Lundbeck has filed marketing authorization applications for Vyepti (eptinezumab) in Japan, China, and South Korea, marking the company's first regulatory submissions for this migraine prevention therapy in Asia.
  • The applications are supported by Phase 3 SUNRISE trial data demonstrating eptinezumab's efficacy in predominantly Asian patients with chronic migraine, addressing a significant unmet medical need in the region.
  • If approved, this would represent Lundbeck's first marketing authorization in Japan and the first biologic launch by the company in China and South Korea, expanding access to CGRP-targeted migraine prevention.

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

NCT04921384CompletedPhase 3
H. Lundbeck A/S
Posted 5/29/2021

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

NCT05064371CompletedPhase 3
H. Lundbeck A/S
Posted 9/21/2021

ImageneBio Advances Anti-OX40 Antibody IMG-007 with Protocol Amendment for Phase 2b Atopic Dermatitis Trial

Monoclonal Antibody
  • ImageneBio announced a protocol amendment for its ongoing Phase 2b ADAPTIVE study of IMG-007 in atopic dermatitis to optimize study design and expand dosing regimens based on the drug's unique molecular attributes.
  • The company will present novel alopecia areata data at the Inflammatory Skin Disease Summit, showing dose-related hair regrowth and biomarker suppression in Phase 1b/2a trials.
  • IMG-007 demonstrated a 77% mean reduction in EASI score at week 16 in atopic dermatitis patients, with 54% achieving EASI-75 response and 31% reaching EASI-90 response.
  • The company strengthened its cash position to $142.6 million following completion of a reverse merger and $75 million private placement financing.

FDA Approves First Interchangeable Biosimilar to Pertuzumab for HER2-Positive Breast Cancer

Drug ApprovalMonoclonal Antibody
  • The FDA has approved pertuzumab-dpzb (Poherdy) as the first interchangeable biosimilar to pertuzumab (Perjeta), providing a new treatment option for HER2-positive breast cancer patients.
  • The biosimilar is approved for the same indications as the reference product, including metastatic and early-stage breast cancer treatment in combination with trastuzumab and chemotherapy.
  • As an interchangeable biosimilar, pertuzumab-dpzb may be substituted for the reference product without prescriber consultation, potentially enhancing therapeutic accessibility and reducing drug costs.
  • The approval was supported by comprehensive analytical, pharmacokinetic, immunogenicity, and clinical data demonstrating no clinically meaningful differences in safety, purity, and potency compared to pertuzumab.

A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer

NCT05346224Active, Not RecruitingPhase 3
Shanghai Henlius Biotech
Posted 4/25/2022

Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

NCT04411550CompletedPhase 1
Shanghai Henlius Biotech
Posted 7/1/2020

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

NCT01358877CompletedNot Applicable
Hoffmann-La Roche
Posted 11/8/2011

A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer

NCT00567190CompletedPhase 3
Genentech, Inc.
Posted 2/12/2008

NHS Approves Glofitamab for Earlier Treatment of Aggressive Blood Cancer

Monoclonal AntibodyDrug Approval
  • The NHS has approved glofitamab (Columvi) for around 300 patients annually with relapsed or refractory diffuse large B-cell lymphoma after just one previous treatment, expanding access from the previous requirement of two failed treatments.
  • Clinical trial data shows nearly 60% of patients achieved complete remission with glofitamab plus chemotherapy, with 54% survival at two years compared to 34% with standard treatment.
  • The drug will be available immediately through the NHS Cancer Drugs Fund, representing a significant advancement for patients with this aggressive form of non-Hodgkin lymphoma that affects approximately 5,500 people annually in England.

Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT03399799Active, Not RecruitingPhase 1
Janssen Research & Development, LLC
Posted 12/16/2017

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

NCT04634552RecruitingPhase 2
Janssen Research & Development, LLC
Posted 2/1/2021

Vietnam Approves Russian Pembrolizumab Biosimilar for Cancer Treatment

Monoclonal AntibodyDrug Approval
  • Vietnam's Ministry of Health has approved Pembroria, a Russian-produced pembrolizumab biosimilar, for treating over 14 types of cancer including melanoma, lung, breast, and colorectal cancers.
  • The drug, manufactured by Russia's Limited Liability "PK-137" and containing 100 mg pembrolizumab per 4 ml vial, expands access to advanced immunotherapy treatments for Vietnamese patients.
  • Each treatment cycle costs approximately $1,400 (VND36 million for two vials) and is not yet covered by Vietnam's health insurance system.
  • The approval follows Vietnam-Russia health cooperation discussions in September, with both countries agreeing to strengthen collaboration in cancer vaccine research and technology transfer.

EirGenix Secures $152M Licensing Deal with Sandoz for HER2-Positive Breast Cancer Biosimilar

Monoclonal Antibody
  • EirGenix signed a global exclusive licensing agreement with Sandoz for EG1206A, a pertuzumab biosimilar targeting HER2-positive breast cancer, worth up to $152 million in upfront and milestone payments.
  • The biosimilar has completed pharmacokinetic studies and received positive regulatory feedback from FDA and EMA, qualifying for an abbreviated development pathway that waives Phase III efficacy trials.
  • EG1206A targets the significant market opportunity in HER2-positive breast cancer, which affects approximately 20% of the 2.3 million global breast cancer patients.
  • This partnership builds on the companies' existing collaboration for EG12014 trastuzumab biosimilar, which has already received European approval and is under FDA review.

ABL Bio Secures $2.6 Billion Deal and $180 Million Strategic Investment from Eli Lilly for Grabbody Platform

Monoclonal Antibody
  • ABL Bio signed a $2.6 billion technology transfer and joint development agreement with Eli Lilly for its Grabbody double antibody platform, marking one of the largest biotech deals in South Korea's history.
  • Eli Lilly made a strategic equity investment of 22 billion won ($180 million) in ABL Bio, representing the first such investment by a global pharmaceutical company in a domestic Korean biotech firm.
  • The partnership will focus on expanding Grabbody platform applications to high unmet medical need areas including obesity and muscle diseases, with ABL Bio receiving $40 million upfront and potential milestone payments up to $2.56 billion.
  • ABL Bio's clinical pipeline includes multiple programs with ABL001 receiving FDA fast-track designation and ABL111 showing encouraging combination therapy data at recent medical conferences.

Lecanemab Clears Alzheimer's Plaques but Fails to Restore Brain's Waste Clearance System

Monoclonal Antibody
  • Researchers from Osaka Metropolitan University found that lecanemab reduces amyloid-β plaques but does not restore the brain's glymphatic waste clearance system within three months of treatment.
  • The study used DTI-ALPS imaging to measure glymphatic function and found no significant improvement in the index between pre-treatment and three months post-treatment.
  • The findings suggest that neuronal damage and clearance system deficits are already well-established by the time symptoms appear, highlighting the need for multi-targeted therapeutic approaches.
  • Future research will examine factors like age, disease stage, and white matter lesions to better understand treatment outcomes and optimize patient care.

Mabwell's Anti-IL-11 Antibody 9MW3811 Becomes World's First IL-11 Therapeutic to Enter Phase II for Pathological Scarring

Monoclonal Antibody
  • Mabwell's novel anti-IL-11 monoclonal antibody 9MW3811 has received NMPA approval to initiate Phase II clinical trials for pathological scarring, marking the world's first IL-11-targeting therapeutic to reach clinical stage for this indication.
  • The humanized monoclonal antibody demonstrates superior target affinity and a half-life exceeding one month, making it suitable for chronic diseases requiring long-term treatment.
  • Preclinical studies showed 9MW3811 effectively alleviates skin fibrosis and reduces existing scar volume in human-derived keloid animal models, with Phase I trials demonstrating favorable safety profiles.
  • The therapeutic has broad application potential across multiple fibrotic diseases including IPF, thyroid eye disease, and aging-related conditions, with an exclusive licensing agreement established with Alphabet's CALICO Life Sciences.

Amgen Expands Patent Litigation Against Denosumab Biosimilar Developers in Latest BPCIA Filings

Monoclonal Antibody
  • Amgen filed three new BPCIA lawsuits in November 2025 against multiple companies developing biosimilars of its blockbuster denosumab products Prolia® and Xgeva®.
  • The litigation targets Dr. Reddy's/Alvotech's AVT03, Amneal's MB09, and Alkem's ENZ215 biosimilars, asserting 31-35 patents per case covering manufacturing and composition claims.
  • These cases represent Amgen's eighth through tenth denosumab biosimilar litigations, with five previous cases having settled and several others ongoing.
  • Amgen reported combined FY24 U.S. sales of $4.392 billion for Prolia® and Xgeva®, highlighting the significant commercial stakes in these patent disputes.

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