From U.S. approvals to next-gen pipelines, Korean drugmakers advance commercialization, late-stage trials, and global licensing strategies.
In the first half of 2025, Korea’s major pharmaceutical and biotech companies are approaching key global milestones, including regulatory decisions, late-stage clinical data, and label expansions. From biosimilars and metabolic disease drugs to immunotherapies and antibody-drug conjugates (ADCs), firms are entering a pivotal period likely to shape licensing outcomes and commercial success in the second half of the year.
Celltrionis solidifying 슬롯 머신 일러스트 presence in the U.S. with Zymfentra SC (infliximab, subcutaneous), launched in February 2023. The biosimilar achieved early traction after gaining coverage from Cigna, one of the top three U.S. pharmacy benefit managers. 슬롯 머신 일러스트 advantages—such as convenience and reduced hospital reliance—are expected to sustain growth in the U.S. IBD market.
HLBis preparing a third, and likely final, FDA submission for 슬롯 머신 일러스트 liver cancer combination therapy (Rivoceranib + Camrelizumab) following two prior Complete Response Letters. The company passed BIMO inspections in late 2023, and the resubmission is planned for May. Industry attention is focused on whether a China-origin immunotherapy regimen can secure FDA approval.
Alteogenanticipates 슬롯 머신 일러스트 3 topline results and a September 23 PDUFA decision for Keytruda SC, a subcutaneous pembrolizumab formulation co-developed with Merck using Alteogen’s ALT-B4 hyaluronidase. Approval would validate its subcutaneous oncology platform, increase royalties, and revitalize licensing prospects for its pipeline.
SK Biopharmaceuticalscontinues to grow its U.S. presence with Xcopri (cenobamate) for epilepsy, leveraging a direct-sales model. Following the NDA submission for Asia, the company expects 슬롯 머신 일러스트 3 data for the PGTC indication and a pediatric NDA by year-end. Development has also begun on SKL35501, a radiopharmaceutical for solid tumors, with secured supply deals from TerraPower (U.S.) and PANTERA (Belgium).
Hanmi Pharmaceuticalis accelerating its GLP-1-based programs for obesity and MASH. Efinopegdutide, co-developed with MSD, outperformed semaglutide in 슬롯 머신 일러스트 2a, achieving a 72.7% liver fat reduction and 8.5% weight loss. 슬롯 머신 일러스트 2b data are due this year. MSD is targeting high-risk populations requiring 9–10% weight loss.
Hanmi’s next-gen triple agonist, HM15275 (GLP-1/GIP/glucagon), completed 슬롯 머신 일러스트 1 enrollment in the U.S., with data expected by September. Preclinical trials showed 39.9% weight reduction—surpassing Wegovy (15%) and Zepbound (25.3%). The company aims to demonstrate muscle preservation and cardio-renal benefits for best-in-class positioning.
Ligachem Biosciencesis advancing multiple ADCs through global trials. LCB84 (MMAE), a Trop2-targeting ADC, completed 슬롯 머신 일러스트 1 for TNBC and NSCLC and is set to enter 슬롯 머신 일러스트 2 in the second half of 2025. The drug was licensed to Janssen in 2023, with additional milestones tied to independent development.
LCB14 (MMAF), targeting HER2, is in 슬롯 머신 일러스트 3 trials in China for third-line breast cancer, with conditional approval expected in early 2025 and commercialization in 2026. A global 슬롯 머신 일러스트 1 trial is also ongoing, with key development decisions due later this year.
LCB71, targeting ROR1, is enrolling 슬롯 머신 일러스트 1b patients for solid and hematologic cancers, with 슬롯 머신 일러스트 2 planned in 2025. LCB73, a CD19-targeted ADC, will soon present 슬롯 머신 일러스트 1 results in hematologic malignancies.
Hanall Biopharmais expanding its autoimmune pipeline with late-stage trials and new indications. Batoclimab (IMVT-1401), an anti-FcRn antibody, completed a BLA filing in China for myasthenia gravis and is in U.S. 슬롯 머신 일러스트 3 trials via Immunovant. March data showed significant MG-ADL improvements and 74% antibody reduction in the high-dose group.
In CIDP, 슬롯 머신 일러스트 2b results demonstrated clinical improvement by aINCAT and 84% response in patients with 70% antibody reduction. Regulatory strategies are being developed for Japan, with 슬롯 머신 일러스트 3 results in thyroid eye disease expected later this year.
The follow-up drug, IMVT-1402, a next-generation FcRn inhibitor, will enter U.S. 슬롯 머신 일러스트 3 trials for Graves' disease in early 2025. Multiple 슬롯 머신 일러스트 1 trials are also underway for rheumatoid arthritis and other autoimmune conditions. Hanall is pursuing 슬롯 머신 일러스트d global expansion across the U.S., Japan, and additional key markets.