[Edaily Reporter YU JIN-HEE ] EyeGene,Inc(185490)is partnering with its largest shareholder, Korea BMI, to commercialize a next-generation recombinant botulinum toxin. The company plans to accelerate its entry into the global market by leveraging proprietary technology that eliminates controversies over the origin of the bacterial strain and maximizes efficacy.

EyeGene,Inc. announced on the 12th that its largest shareholder, Korea BMI, has applied to the Ministry of Food and Drug Safety for an export license for “EG-rBTX100,” a next-generation recombinant botulinum toxin currently under joint development with EyeGene,Inc.

To obtain an export license, the companies must undergo an inspection under Good Manufacturing Practice (GMP) standards and complete the validation of manufacturing processes for both the bulk drug substance and the finished pharmaceutical product. In accordance with the approval review process, the Ministry of Food and Drug Safety will thoroughly examine the stability of the raw materials and finished products, the establishment of process controls to ensure consistent product quality, and compliance with manufacturing processes in accordance with GMP regulations. Both companies expect to receive approval within this year.

Once approval is granted, Korea BMI will begin full-scale exports starting in 2027, focusing primarily on the Asian market. The two companies have set a goal of achieving stable annual sales of over 10 billion won from their recombinant toxin product line starting in 2027, their first year of market entry. EyeGene,Inc. anticipates that exporting its in-house developed products will generate sustained sales and profits while also improving its financial structure.

Furthermore, following the successful completion of preclinical trials, EyeGene,Inc plans to submit an Investigational New Drug (IND) application in Korea after obtaining the export license and begin domestic clinical trials in the first half of 2027.

EG-rBTX100 is a technology that EyeGene,Inc acquired last May from Embric, a bio-platform development company. It employs a proprietary production method that expresses the toxin protein in E. coli. Rather than using the conventional A1 type, it has been optimized by recombining specific domains from each subtype (A1, A2, A6) in a novel configuration, and EyeGene,Inc has secured worldwide exclusive development and marketing rights for cosmetic applications.

Existing commercial formulations have traditionally relied on directly culturing wild-type Clostridium botulinum strains to extract the toxin. As a result, legal disputes over the origin of the strains and regulatory risks have long been cited as chronic issues in the industry.

It also offers superior competitiveness in terms of productivity and cost savings. The E. coli expression system allows the toxin to remain in an inactive state until the later stages of the process. Consequently, production is possible in a Biosafety Level 2 (BL2) facility rather than a Biosafety Level 3 (BL3) facility, enabling simultaneous reductions in manufacturing operating costs and improvements in productivity.

An EyeGene,Inc official explained, “Unlike the conventional method of culturing wild-type strains, EG-rBTX100 is designed through genetic recombination, making it completely free from controversies regarding strain origin,” adding, “We have secured preclinical data showing that by combining the core domains of subtypes A1, A2, and A6, we have shortened the onset time of action while extending its duration.”

The representative added, “We have demonstrated excellent efficacy through potency testing using the mouse LD50 assay and the toe abduction score (DAS) analysis.”

Meanwhile, according to industry sources, the global botulinum toxin market, currently valued at approximately 9 trillion won, is projected to grow at an average annual rate of about 10% and expand to 25 trillion won within the next 10 years.