Yuhan USA

Janssen Gains China Approval for Lazertinib + Amivantamab Combo in EGFR-Mutant NSCLC Date: 08/01/25 Yuhan Corporation’s novel EGFR-targeting non-small cell lung cancer (NSCLC) therapy Leclaza (lazertinib) has received official marketing approval in China, further solidifying its global footprint. The Chinese National Medical Products Administration (NMPA) approved the combination therapy of Leclaza and Rybrevant (amivantamab), expanding the drug’s availability to the world’s three largest pharmaceutical markets: the U.S., Europe, and now China. The application was submitted by Janssen, which holds global rights to Leclaza, for use in patients with EGFR-mutant progressive or recurrent NSCLC. China represents the largest lung cancer market globally, accounting for over one-third of all lung cancer patients worldwide, with approximately 1 million diagnoses annually. Around 85% of these are NSCLC cases, and an estimated 40% of those patients carry EGFR mutations. As of 2020, the Chinese NSCLC treatment market had already surpassed 2 trillion KRW (~$1.5 billion USD). With this regulatory milestone, Yuhan will receive a $45 million milestone payment from Janssen. Under the licensing agreement, milestone payments are triggered by approvals in the U.S., Europe, Japan, and China. In other regions, Yuhan receives royalties based on sales performance. Previously, Yuhan received $60 million and $15 million in milestone payments for U.S. and Japan approvals, respectively. The payments for Europe and China are expected within this year, with additional royalties tied to future sales. The Leclaza + Rybrevant combination is now approved in seven countries: the U.S. (since August 2024), Europe, South Korea, the U.K., Canada, Japan, and China. Regulatory processes are underway in other countries including Australia and Brazil. Notably, Germany has recognized the clinical value of the combination, with health insurance coverage anticipated in early 2026. In the first half of 2025, global sales of the Leclaza + Rybrevant combination reached $320 million, nearly tripling from $116 million in the same period last year. Approximately 80% of this revenue—$252 million—was generated in the U.S. market. To learn more, please click here: https://lnkd.in/e5bKu9ix #Yuhan, #YuhanUSA, #NSCLC, #Lazertinib+Amivantamab, #NMPA 

Yuhan Presents Phase 1b Part 2 Results for Lesigercept - Shows Efficacy in Omalizumab-Refractory Patients Date: 6/13/25 Yuhan Corporation presented positive Phase 1b Part 2 results for its investigational anti-IgE biologic Lesigercept (YH35324) at the EAACI 2025 Annual Meeting in Glasgow. Lesigercept is a novel Fc-fusion protein that binds to both circulating free IgE and FcεRIα autoantibodies, offering a dual mechanism to alleviate allergic symptoms. The study focused on 9 patients with chronic spontaneous urticaria (CSU) inadequately controlled by omalizumab and H1-antihistamines. A single 6 mg/kg subcutaneous dose of Lesigercept was evaluated over 8 weeks. Results showed stronger and more sustained suppression of free IgE compared to the control, with higher rates of symptom control based on UAS7 scores. In pooled analysis from Part 1 and 2, significant symptom reduction was observed in both omalizumab-naïve and omalizumab-refractory patients. Consistent responses were also seen across subtypes defined by BHRA (Basophil Histamine Release Assay) status, indicating broader applicability across CSU patient populations, including Type IIb BHRA-positive cases, where omalizumab is less effective. According to Yuhan’s Head of R&D, Dr. Yeol-Hong Kim, Lesigercept demonstrated meaningful clinical improvement in patients unresponsive to both antihistamines and omalizumab. Final analyses on repeat dosing safety and PK/PD profiles are underway, with plans being developed for the next stage of clinical development. Lesigercept was originally in-licensed from GI Innovation in 2020. Yuhan holds global rights excluding Japan, which were out-licensed to Maruho in 2023. To learn more, please click here: https://lnkd.in/gHUu7bnq #Yuhan, #YuhanUSA, # Lesigercept, #YH35324, #Omalizumab # EAACI 2025

Yuhan Corporation Receives $15 Million Milestone from Janssen for Launch of Lazertinib + Amivantamab Combination Therapy in Japan Yuhan Corporation announced that it will receive a milestone payment of $15 million (approximately 20.7 billion KRW) from Janssen Biotech, a subsidiary of the multinational pharmaceutical company Johnson & Johnson. The milestone amount is expected to be received within 60 days. This milestone was triggered by the commercialization of Yuhan’s “Lazertinib” (brand name Leclaza in Korea, Ruziluclast in the U.S.) in combination with Janssen Biotech’s “Amivantamab” (brand name Rybrevant) in Japan. The combination therapy of “Lazertinib + Amivantamab” was approved in March by the Japanese Ministry of Health, Labour and Welfare as a first-line treatment for EGFR-mutated non-small cell lung cancer (NSCLC). The approval in Japan was based on the results of a Phase 3 clinical trial (MARIPOSA) conducted by Janssen Biotech, which involved 1,074 patients. This trial compared the efficacy and safety of the combination therapy “Lazertinib + Amivantamab” with the current first-line treatment “Osimertinib” (brand name Tagrisso) and Lazertinib monotherapy. According to the study results, the combination therapy “Lazertinib + Amivantamab” reduced the risk of disease progression or death by 30% compared to Osimertinib monotherapy. The median progression-free survival (PFS) for the combination therapy group was 23.7 months, which was significantly longer than the 16.6 months observed in the Osimertinib monotherapy group. The duration of response (DoR) for the combination therapy was 25.8 months, which was 9 months longer than the 16.7 months in the Osimertinib monotherapy group. The median overall survival (mOS) of the “Lazertinib + Amivantamab” combination is expected to be extended by more than one year compared to Osimertinib monotherapy. Previously, in November 2018, Yuhan Corporation signed a license-out agreement with Janssen Biotech for Lazertinib worth a total of $1.26 billion. Since then, the combination therapy “Lazertinib + Amivantamab” has received approvals from the U.S. FDA in August last year and the European Commission (EC) in January this year. As a result, Yuhan Corporation has already received milestone payments of $60 million and $30 million from Janssen Biotech for U.S. and EU approvals, respectively. To learn more, please click here: https://lnkd.in/e9srnbrA #Yuhan, #YuhanUSA, #Lazcluze, #Amivantamab, #Johnsonandjohnson #NSCLC

Yuhan Presents Preclinical Data on Targeted Therapy YH42946 and Bispecific Immunotherapy YH32364 At the AACR 2025 Annual Meeting, Yuhan Corporation unveiled promising preclinical results for two of its cancer drug candidates: YH42946, a HER2/EGFR tyrosine kinase inhibitor (TKI), and YH32364, an EGFR×4-1BB bispecific antibody co-developed with ABL Bio. YH42946, licensed from J INTS BIO in 2023, targets tumors with HER2 and EGFR exon 20 insertions, mutations often resistant to conventional TKIs, especially in non-small cell lung cancer (NSCLC). Preclinical studies using patient-derived cells demonstrated potent inhibition across a broad range of HER2 and EGFR mutations, including HER2 amplification and overexpression. A global Phase 1/2 clinical trial is already underway in patients with advanced solid tumors harboring these genetic alterations. YH32364, also known as ABL104, is a bispecific antibody that selectively binds EGFR-expressing tumor cells to block growth signals while stimulating 4-1BB-mediated T cell activation. In vitro studies showed strong antitumor activity in EGFR+/KRAS-mutant lung and colorectal cancer cell lines, outperforming competitor compounds. In vivo models confirmed immune cell infiltration, enhanced tumor microenvironment, and durable antitumor effects, particularly in head and neck cancers, where synergy with anti-PD-1 antibodies was observed. YH32364 recently received IND clearance from South Korea’s Ministry of Food and Drug Safety and is expected to enter clinical trials in the first half of 2025. https://lnkd.in/eAAuX2uf #Yuhan, #YuhanUSA, #YH42946, #YH32364

Yuhan’s HER2×4-1BB Bispecific Antibody YH32367 Shows Early Efficacy and Safety in Phase 1 Solid Tumor Trial At the AACR 2025 Annual Meeting, Yuhan Corporation presented encouraging interim results from a Phase 1 trial of YH32367, a bispecific antibody targeting HER2 and 4-1BB, in patients with HER2-positive solid tumors refractory or resistant to trastuzumab (Herceptin). The study showed an objective response rate (ORR) of 22.6% and a disease control rate (DCR) of 55% among 32 patients, including those with cholangiocarcinoma and gastric cancer. Notably, the cholangiocarcinoma subgroup achieved an ORR of 31% and DCR of 62%, with no dose-limiting toxicity (DLT) observed across all eight dose levels (0.3-30 mg/kg). YH32367, co-developed with Korea-based ABL Bio (development code: ABL105), is engineered to locally activate 4-1BB in HER2-positive tumors while minimizing off-target toxicity. The candidate showed a favorable safety profile, with the most common adverse events being fever (16%) and chills (13%). One death occurred in the 0.75 mg/kg cohort but was not attributed to the drug. Yuhan concluded that the compound demonstrated promising early antitumor activity, manageable safety, and a non-linear pharmacokinetic (PK) profile, supporting continued development and dose optimization efforts. https://lnkd.in/eQX2GSP8 #Yuhan, #YuhanUSA, #YH32367

Lazertinib + Amivantamab Combo from J&J Posts Strong Q1 Sales, Strengthening Its Position in NSCLC Treatment Johnson & Johnson (J&J) reported that the combination therapy of Lazertinib (brand name Leclaza in Korea) and Amivantamab (brand name Rybrevant) achieved impressive global sales of $141 million (approx. 200 billion KRW) in Q1 2025. Of this, $113 million (approx. 161 billion KRW) was from the U.S. market alone, accounting for 80% of total revenue. These figures mark the therapy’s first full quarter since FDA approval in August 2024. Sales are expected to grow further following recent regulatory approvals in Korea, Japan, the UK, and the EU. The success of the combination therapy significantly contributed to J&J’s overall Q1 revenue of $21.89 billion—a 2.4% year-over-year increase—and a remarkable 237.9% jump in net income, reaching $10.99 billion. Joaquin Duato, J&J’s CEO, highlighted the contribution of the Lazertinib + Amivantamab combo, alongside other key therapies, to the company’s growth across its pipeline. Recent Phase 3 MARIPOSA trial results presented at ELCC 2025 in Paris indicated a projected overall survival (OS) of over 48 months—more than 12 months longer than the comparator drug, Tagrisso (osimertinib). Leclaza, developed by South Korea’s Yuhan Corporation and licensed to Janssen in 2018, was approved in Korea in 2021 as the country’s 31st domestically developed new drug. https://lnkd.in/eB8-KeGq #Yuhan, #YuhanUSA, #Lazcluze, #Amivantamab, #JohnsonandJohnson, #NSCLC

유한양행 한국 본사 중앙 연구소에서 경력사원을 채용하고자 합니다. 채용일정, 지원 자격 등의 정보는 아래의 링크를 확인해 주시기 바랍니다. https://lnkd.in/eDYFfyPp #hiring

RYBREVANT® plus LAZCLUZE™ shows statistically significant and clinically meaningful improvement in overall survival versus osimertinib  J&J는 EGFRxMET 이중항체 ‘아미반타맙 (제품명 리브리반트)’와 유한양행이 개발해 J&J에 라이선스아웃한 3세대 EGFR TKI ‘레이저티닙 (제품명 라즈클루즈)’가 타크리소 대비 환자의 OS를 통계적으로, 임상적으로 유의미하게 개선했다고 밝힘. Johnson & Johnson has announced that its chemotherapy-free combination of Rybrevant® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib) has demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC).  This combination therapy is the first to show a survival benefit over the current standard of care in the first-line treatment of EGFR-mutated lung cancer. The improvement in median OS is expected to exceed one year.  These findings are based on the Phase 3 MARIPOSA study, which previously demonstrated that the Rybrevant and lazertinib combination significantly reduced the risk of disease progression or death by 30% compared to osimertinib.  In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LACLAZA in Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. https://lnkd.in/euSWT5V2 #Yuhan, #YuhanUSA, #JandJ, #JohnsonandJohnson, #JanssenBiotech, #Lazcluse, #Lazertinib, #Rybrevant ,#amivantamab, #Laclaza, #NSCLC

European Commission approves RYBREVANT® in combination with LAZCLUZE® for the first-line treatment of patients with EGFR-mutated advanced non-small cell lung cancer  유럽연합 집행위원회는 EGFR 변이 진행성 비소세포폐암 환자의 1차 치료제로 J&J의 RYBREVANT®(amivantamab)와 유한양행이 개발해 J&J에 라이선스아웃한LAZCLUZE®(lazertinib)와의 병용 요법을 승인함. The European Commission has approved the combination of RYBREVANT® (amivantamab) and LAZCLUZE® (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or L858R substitution mutations.  This approval is based on results from the Phase 3 MARIPOSA study, which demonstrated that the amivantamab and lazertinib combination significantly reduced the risk of disease progression or death by 30% compared to osimertinib monotherapy.  The study also showed a nine-month improvement in median duration of response for patients receiving the combination therapy. This chemotherapy-free regimen offers a new standard of care for patients with EGFR-mutated advanced NSCLC. In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (marketed as LACLAZA in Korea). LAZCLUZE™ is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. https://lnkd.in/eVHpGZGQ #Yuhan, #YuhanUSA, #JandJ, #JohnsonandJohnson, #JanssenBiotech, #Lazcluse, #Lazertinib, #Rybrevant, #amivantamab, #Laclaza, #NSCLC

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.