Yuhan USA

RYBREVANT® plus LAZCLUZE™ by Johnson & Johnson got approved by the U.S. FDA as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. LAZCLUZE™ is anti-cancer drug developed by Yuhan Corporation licensed out to Janssen Biotech in 2018.     Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.  Yuhan Corporation in-licensed lazertinib in 2015 from Genosco Inc. In 2018, Jassen Biotech Inc., based on results from the phase 1/2 clinical trial conducted in Korea, entered a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (lazertinib, marketed as LACLAZA in Korea).   RYBREVANT® plus LAZCLUZE™ becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.   RYBREVANT® is an EGFR- and MET*-directed bispecific antibody that engages the immune system, and LAZCLUZE™ is a highly selective, brain-penetrant, third-generation oral EGFR TKI. RYBREVANT® plus LAZCLUZE™ is the only multitargeted regimen targeting both the common EGFR mutations directly. 

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Yuhan USA team attended NEBS 2024 32nd Annual Conference on May 18th at the Harvad Medical School. Yuhan is a proud sponsor of NEBS and It’s always great to connect with such a talented group of scientists. Special congratulations to Dr. Won-Seok Lee for receiving NEBS-Yuhan award! His work on “Cells with intranuclear Huntingtin aggregates have long (>150) somatic CAG-repeat expansions and associated transcriptional pathology” was indeed impressive. We look forward to reconnecting at the next event!   New England Bioscience Society, Inc. (NEBS) is a non-profit organization of Korean scientists in the fields of life sciences and biotechnology in New England and Pennsylvania areas. Since its foundation in 1984, NEBS has been dedicated to promoting scientific and social communications and networking among the members.

Yuhan USA will be participating in 2024 BIO International Convention on June 3-6. Attending BIO 2024? Let’s connect! Send us a meeting request in the BIO partnering system! #BIO2024 https://lnkd.in/eByHFz94

Yuhan Corporation's 'IgE Trap; YH35324' Surpasses 'Xolair' in Phase 1 Trials, Delivering Superior IgE Suppression in High IgE Patients YH35324 is an IgE class Fc fusion protein, "IgE Trap," that improves allergy symptoms by lowering the levels of free IgE in the blood through merging the extracellular domain of the IgE receptor with a hybrid Fc. IgE mediates allergic reactions in the body by involving immune cells such as eosinophils and mast cells, and to mitigate allergies, the IgE antibody 'Xolair (omalizumab)' is currently available as a treatment. Yuhan Corporation is developing YH35324 as a treatment for IgE-mediated allergic diseases such as chronic urticaria (CSU), atopic dermatitis, and allergic asthma. YH35324 possesses stronger IgE binding capabilities compared to Xolair and can suppress IgE even in patients with autoantibodies, targeting patients with high IgE levels and those who are unresponsive to Xolair. Additionally, YH35324 does not bind to Fcγ receptors, which is expected to reduce the risk of anaphylaxis associated with current IgE antibody medications. Yuhan Corporation has published the results of a 'first-in-class' Phase 1 clinical trial for preliminary proof of concept (PoC) in chronic urticaria patients in the International Immunopharmacology journal. According to the results, YH35324 demonstrated stronger and more sustained IgE suppression activity compared to Xolair and placebo, especially in patients with elevated IgE levels (>700 IU/mL), showing a superior safety profile and more potent and sustained free IgE suppression activity. The Phase 1a trial was conducted with a total of 68 participants, including healthy subjects, patients with mild allergic rhinitis and atopic dermatitis, and patients with food allergies and urticaria. 유한양행 ‘IgE Trap;YH35324’ 임상1상 결과 IgE 높은 환자서 ‘졸레어’ 대비 높은 IgE 억제능 확인 YH35324는 IgE 계열의 Fc 융합단백질 ‘IgE Trap’이며, IgE 수용체의 세포외도메인과 하이브리드 Fc를 융합시킨 형태로 혈중 유리 IgE의 수준을 낮춰 알러지 증상을 개선시킨다. IgE는 체내에서 면역 세포가 알러지 반응을 일으키게 매개하며, 이에 IgE를 억제해 알러지를 완화시키는 기존 알러지 치료제로는 IgE 항체 ‘졸레어(Xolair, omalizumab)’가 시판되고 있다. 유한양행은 YH35324를 만성두드러기 (CSU), 아토피피부염, 알러지성 천식 등의 알러지 질환 치료제로 개발하고 있으며 YH35324가 졸레어 대비 강한 IgE 결합력을 가지며 자가항체를 가진 환자에게서도 IgE를 억제할 수 있어 IgE 수치가 높은 환자 및 졸레어 불응성 환자가 타겟이다. 또한 YH35324는 Fcγ 수용체에 결합하지 않아 기존 IgE 항체 의약품 투여 시 나타날수 있는 아나필락시스 위험을 낮출 것으로 기대한다. 유한양행은 만성 두드러기 환자에서 YH35324의 예비적 개념입증 (PoC)을 위한 ‘first-in-class’ 임상 1상 결과를 국제면역약리학회지 (International Immunopharmacology)에 게재하였다. 이에 따르면 YH35324가 졸레어와 위약 대비 더 강력하고 지속적인 IgE 억제 활성을 보여주었으며 특히 IgE 수치가 상승(>700 IU/mL)돼 있는 환자에서도 우수한 안정성 프로파일과 기존 치료제 대비 더 강력하며 유리 IgE 억제 활성을 보여주었다. 이번 임상 1a상은 건강한 피험자, 경증 알러지 비염이 있는 아토피 환자, 식품알러지 및 두드러기 환자 총 68명을 대상으로 진행되었다. https://lnkd.in/g8cEMQa8