Recraza & K-Bio: New Drug Candidates Show Promise | MEDI:GATE NEWS

by Liam O'Connor Sports Editor

South Korean Biotech Sector Gains Momentum with New Drug Pipeline and Government Support

A surge in innovative drug development is underway in South Korea, bolstered by significant government investment and promising clinical trial data. Following the success of domestically produced drugs like Leclaza and the world’s first recombinant protein anthrax vaccine, a new wave of candidates is advancing through the development pipeline, signaling a growing global competitiveness for the nation’s biotech industry.

National Project Fuels Innovation

The National New Drug Development Project, a comprehensive R&D initiative, is playing a pivotal role in accelerating this progress. The project provides support throughout the entire drug development lifecycle, from initial substance discovery to Phase 1 and Phase 2 clinical trials. In 2025, 57 projects were selected from a pool of 231 applications, demonstrating strong interest and a robust pipeline of potential therapies.

The selected projects span a diverse range of modalities, with small molecules representing the largest proportion at 40%. Antibodies account for 19%, while emerging technologies like target protein degradation (TPD) at 11%, recombinant protein and gene/nucleic acid therapeutics (9% each), cell therapy (5%), and radiopharmaceuticals (3%) are also gaining traction. Oncology remains the dominant therapeutic area, capturing 51% of the projects, followed by neurology (16%), immunology (10%), and respiratory/ophthalmology (5% each).

Leading the Charge: Key Companies and Candidates

Several companies are at the forefront of this innovation, pursuing groundbreaking therapies across various disease areas.

Yuhan Corporation is targeting the global market with two promising candidates: YH34180A, a chronic kidney disease treatment, and YH32367 (ABL105), a HER2/4-1BB double antibody immunotherapy. Phase 1 data for YH32367, jointly developed with ABL Bio, revealed an objective response rate of 23% and a disease control rate of 55% in patients with HER2-expressing solid tumors, with no dose-limiting toxicities observed.

VIVOZON is developing VVZ-2471, a dual antagonist targeting serotonin 5-HT2A and mGluR5 receptors, for neuropathic pain and addiction. The drug has received Phase 1b Clinical Trial Design (IND) approval from the U.S. Food and Drug Administration (FDA) in November, paving the way for future global trials. Furthermore, the National Institute on Drug Abuse (NIDA) has selected VVZ-2471 for development as a treatment for opioid use disorder (OUD).

Avelos Therapeutics is advancing AD1208 (AVS1001), a MASTL inhibitor designed to disrupt cancer cell division by blocking DNA repair mechanisms. The company is collaborating with Mayo Clinic and MD Anderson Cancer Center to explore its potential in prostate and blood cancers. Results from Phase 1a trials are expected in the first half of this year.

Cellid is focused on an immunotherapy vaccine, BVAC-E6E7, targeting HPV 16/18 positive head and neck squamous cell cancer. The vaccine utilizes the CeliVax platform to simultaneously activate both adaptive and innate immune responses.

Ubix Therapeutics is developing UBX-303-1, a Bruton’s tyrosine kinase (BTK) degrader for relapsed/refractory B-cell lymphoma. Utilizing targeted protein degradation (TPD) technology, UBX-303-1 aims to overcome resistance to existing BTK inhibitors and reduce side effects.

ImmunAbs is progressing IM-101, a monoclonal antibody targeting autoimmune diseases by inhibiting complement C5 cleavage. The drug received Phase 2 IND approval from the FDA in June of last year and is being prepared for global Phase 2 trials.

ILIAS Biologics is pioneering exosome-based drug delivery with its EXODUS technology, currently being applied to an endometriosis treatment.

MedPacto is developing MP010, a first-in-class immunotherapy drug that targets TGF-β in the tumor microenvironment. Animal studies have demonstrated high complete response rates and long-term survival in pancreatic and triple-negative breast cancers.

A Growing Ecosystem

Beyond these leading companies, a broad network of organizations – including Inventera, Kukje Pharmaceutical, Nsage, Celvion, Kine Science, Chong Kun Dang, Hallim Pharmaceutical, Daewoong Pharmaceutical, Jeil Pharmaceutical, Vigencell, Aimed Bio, Curogen, and Panoros Bioscience – are actively engaged in non-clinical projects under the 2nd National New Drug Development Project. This collaborative effort underscores a national commitment to fostering a thriving and globally competitive pharmaceutical industry.

The momentum building within South Korea’s biotech sector suggests a promising future for innovative drug development and a growing contribution to global healthcare solutions.

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