Caregen (CEO Yong-ji Jeong), a peptide-based biopharmaceutical company, announced on the 13th that it has entered into a strategic partnership with UNITHER Pharmaceuticals (hereinafter UNITHER), a global contract development and manufacturing organization (CDMO). This collaboration is part of Caregen's global market entry strategy that combines the accelerated global commercialization of ophthalmic treatment drugs with UNITHER's formulation and production capabilities.
Through this partnership, Unider will be responsible for the production and formulation of Phase 2 clinical samples for Caregen's core pipelines: CG-P5, a treatment for wet AMD, and CG-T1, a treatment for dry eye syndrome (DED). Both pipelines are peptide new drugs in eye-drop formulations that feature improved patient convenience and compliance.
Unider is the world's largest Blow-Fill-Seal (BFS)-based sterile single-dose formulation CDMO, with production facilities in eight countries, including France, the United States, Brazil, and China. It is also a well-known production partner for global ophthalmic pharmaceutical companies such as Bausch + Lomb, Théa, and Santen. BFS is a cutting-edge formulation technology that prevents contamination through an aseptic filling and sealing process, and is considered essential for the commercialization of disposable eye drops.
This collaboration allows Caregen to leverage Unider's FDA-certified BFS facility to quickly secure the sterile formulation infrastructure necessary for US clinical trials and New Drug Applications (NDAs). This will establish a full value chain encompassing clinical sample production, CMC (chemistry, manufacturing, and quality control) documentation, and commercial product production, thereby reducing development time and costs.
In particular, CG-T1 is a first-in-class candidate substance that acts on PAC1R, a major receptor that induces tear secretion, to simultaneously promote secretion, suppress inflammation, and improve corneal and conjunctival damage. The preclinical stage is currently complete, and the clinical trial plan (IND) is scheduled to be submitted to the US FDA in the first quarter of 2026, and then enter phase 2 clinical trials immediately. This strategy of skipping phase 1 clinical trials is attracting attention from global pharmaceutical companies because safety and the validity of the pharmacological mechanism have been secured in the preclinical stage.
CG-P5 is expected to receive the final report from its Phase 1 clinical trial in the US later this month, and plans to apply for Breakthrough Therapy Designation from the FDA alongside Phase 2 clinical trials. The Phase 2 trial will be conducted in multinational locations and will expand the indication beyond wet macular degeneration to include dry macular degeneration.
Caregen CEO Yong-ji Jeong said, “This partnership will serve as an important foundation for Caregen’s peptide-based ophthalmic disease treatment technology to enter the global market,” and “We will accelerate the commercialization of our pipeline through Unider’s formulation technology and global production infrastructure and also actively pursue global licensing cooperation.”
A Unider official said, “Caregen’s pipeline possesses technological differentiation that overcomes the limitations of existing eye drops,” and “Based on Unider’s BFS technology and global customer network, we will be able to maximize mutual synergy.”
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