GC Biopharma has reorganized its new drug research and development (R&D) strategy under a "selection and concentration" policy and selected five core pipelines to drive future growth.
GC Biopharma said on the 25th that it recently held the "2026 R&D portfolio review workshop" and selected the five core pipelines to concentrate companywide capabilities, dubbed "THE FAB FIVE."
The Fab Five takes its name from the "Fabulous Five," a famous freshman lineup in U.S. college basketball history. The company said it narrowed down the core tasks after a comprehensive assessment of market size, business potential, and strategic importance.
The selected pipelines are five in total: ▲ 20% subcutaneous immunoglobulin SCIG (GC5136B) ▲ coronavirus disease mRNA Vaccine mCOVID (GC4006A) ▲ Epstein-Barr virus (EBV) subunit vaccine (GC1140B) ▲ Fabry disease treatment (GC1134A·HM15421) ▲ EGFR X cMET bispecific antibody-based Antibody-Drug Conjugate (ADC·GC1148A).
The selection is seen as a strategy to strengthen GC Biopharma's established strengths in plasma-derived products and vaccines while expanding the scope of research and development into high-growth areas such as rare disease therapies and anticancer drugs.
The most notable asset is the 20% SCIG. It is being developed as a follow-up pipeline to the immunoglobulin product "ALYGLO," which was launched in the U.S. market last year.
It is currently in the preclinical stage, with a target of submitting a U.S. phase 3 investigational new drug (IND) application in 2027. The company expects that its proprietary manufacturing process will improve production efficiency compared with existing products.
The mCOVID vaccine has been selected as a project under the Korea Disease Control and Prevention Agency's "pandemic preparedness mRNA Vaccine development support program" and is in a domestic phase 1 trial. As the first candidate to apply GC Biopharma's in-house developed mRNA-LNP platform, it aims to enter phase 2 this year and obtain phase 3 IND approval next year.
The EBV subunit vaccine targets an area where no vaccine has yet been approved globally. EBV is known to cause infectious mononucleosis and increase the risk of certain autoimmune diseases and cancers. GC Biopharma is conducting preclinical studies with the goal of filing a phase 1 IND next year.
In the rare disease field, the Fabry disease treatment being co-developed with Hanmi Pharmaceutical was cited as a core asset. Phase 1/2 trials are underway in the United States, Korea, and Argentina, and no serious adverse events were reported in the recent evaluation of the first patient cohort (cohort 1). The company plans to begin enrolling patients in the dose-escalation cohort within this month.
In oncology, the EGFR×cMET ADC being co-developed with Kanaph Therapeutics was included. This is a bispecific antibody-based anticancer drug that targets two markers simultaneously, and the selection of a clinical candidate is underway in the preclinical stage.
Beyond these core tasks, GC Biopharma plans to continue operating its vaccine and rare disease treatment pipelines while pursuing early-stage research projects using diverse modalities. The company said it has also built an internal evaluation system to continuously review the business potential and development priorities of its pipelines.
Jeong Jae-uk, head of research and development at GC Biopharma, said, "We are accumulating meaningful experience through ALYGLO's U.S. approval, the world's first recombinant anthrax vaccine approval, and global technical achievements with our shingles vaccine candidate," adding, "We will strengthen research and development capabilities and continue strategic investments centered on the Fab Five."
Meanwhile, GC Biopharma is also expanding its next-generation pipeline, including by signing a joint research agreement with AbClon for an in vivo CAR-T therapy based on the mRNA-LNP platform.