South Korean pharmaceutical and biotech companies are aggressively pursuing product approvals and clinical trials with the U.S. Food and Drug Administration (FDA). As the world’s largest pharmaceutical market, the U.S. represents a critical milestone for "K-Bio" in its quest to develop globally recognized new drugs.
According to industry sources on the 17th, HK inno.N’s U.S. partner, Sebela Pharmaceuticals, recently submitted a New Drug Application (NDA) for K-CAB (tegoprazan), a treatment for gastroesophageal reflux disease (GERD). Already launched in 19 countries, K-CAB is seeking FDA approval for three indications: the treatment of non-erosive GERD, erosive esophagitis, and maintenance therapy. As South Korea's 30th domestically developed new drug, K-CAB demonstrated clinical superiority over conventional proton pump inhibitors (PPIs) in global Phase 3 trials.
NDA and BLA Submissions for Cancer Therapies
HLB and its U.S. subsidiary, Eleva Therapeutics, have submitted an NDA for Rivoceranib as a first-line combination therapy for hepatocellular carcinoma (liver cancer). Simultaneously, its partner, Jiangsu Hengrui Pharmaceuticals (referenced via its affiliate Anhui Zhaoke), submitted a Biologics License Application (BLA) for the immuno-oncology drug Camrelizumab.
While an NDA is required for chemically synthesized drugs like Rivoceranib, a BLA is necessary for biologics like Camrelizumab. This marks the third FDA approval attempt for the Rivoceranib-based combination therapy, highlighting the persistent effort to enter the U.S. oncology market.
Expanding Frontiers in Oncology and CNS Clinical Trials
Several other companies have successfully moved into the clinical trial stage for innovative candidates:
PharmaResearch (Pharmarise): Received Phase 1 approval for PRD-101, an anti-cancer candidate utilizing its proprietary DNA Optimizing Technology (DOT). Known for its popular skin booster Rejuran, the company is leveraging its expertise in nucleotide purification to expand from aesthetic medicine into the oncology sector.
ABL Bio: Its dual-antibody Antibody-Drug Conjugate (ADC), ABL206, has entered Phase 1 trials. Managed by its U.S. subsidiary Neox Bio, ABL206 targets proteins highly expressed in cancer cells (B7-H3, ROR1) combined with a topoisomerase I inhibitor.
SK Biopharm: Initiated Phase 1 trials for its radiopharmaceutical (RPT) candidate, SKL35501. This drug targets NTSR1—overexpressed in pancreatic and colorectal cancers—by pairing a specific ligand with a radioactive isotope.
Vivozon: Received Investigational New Drug (IND) approval for VVZ-2471, a non-narcotic treatment for central nervous system (CNS) diseases. The drug regulates neural signals via a dual mechanism involving serotonin (5-HT2A) and metabotropic glutamate (mGluR5) receptors.
This surge in FDA applications and clinical clearances signals a shift for Korean biotech firms, moving beyond domestic success to compete on the global stage with cutting-edge modalities like ADCs and radiopharmaceuticals.
