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.

Celltrion is solidifying its 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. Its advantages—such as convenience and reduced hospital reliance—are expected to sustain growth in the U.S. IBD market.

HLB is preparing a third, and likely final, FDA submission for its 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.

Alteogen anticipates Phase 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 Biopharmaceuticals continues 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 Phase 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 Pharmaceutical is accelerating its GLP-1-based programs for obesity and MASH. Efinopegdutide, co-developed with MSD, outperformed semaglutide in Phase 2a, achieving a 72.7% liver fat reduction and 8.5% weight loss. Phase 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 Phase 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 Biosciences is advancing multiple ADCs through global trials. LCB84 (MMAE), a Trop2-targeting ADC, completed Phase 1 for TNBC and NSCLC and is set to enter Phase 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 Phase 3 trials in China for third-line breast cancer, with conditional approval expected in early 2025 and commercialization in 2026. A global Phase 1 trial is also ongoing, with key development decisions due later this year.

LCB71, targeting ROR1, is enrolling Phase 1b patients for solid and hematologic cancers, with Phase 2 planned in 2025. LCB73, a CD19-targeted ADC, will soon present Phase 1 results in hematologic malignancies.

Hanall Biopharma is 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. Phase 3 trials via Immunovant. March data showed significant MG-ADL improvements and 74% antibody reduction in the high-dose group.

In CIDP, Phase 2b results demonstrated clinical improvement by aINCAT and 84% response in patients with >70% antibody reduction. Regulatory strategies are being developed for Japan, with Phase 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. Phase 3 trials for Graves' disease in early 2025. Multiple Phase 1 trials are also underway for rheumatoid arthritis and other autoimmune conditions. Hanall is pursuing phased global expansion across the U.S., Japan, and additional key markets.