[Edaily Reporter YU JIN-HEE ] EyeGene,Inc(185490)is set to reinvent itself as a company generating its own revenue, led by its next-generation botulinum toxin product based on recombinant DNA technology. The company plans to break free from the limitations of a research-focused biotech startup and establish a solid revenue structure.

Application for Export Approval of Recombinant Botulinum Toxin Next Month

According to industry sources on the 1st, EyeGene,Inc. plans to apply to the Ministry of Food and Drug Safety this month for an export license for its recombinant botulinum toxin candidate “EG-rBTX100.” Considering that the approval review typically takes around three months, the export license is expected to be granted within the fourth quarter of this year.

Based on this, EyeGene,Inc aims to achieve annual sales of 10 billion won in overseas markets next year and 20 billion won within three years. Internal analysis suggests these targets will be easily met, as Korea BMI—the co-developer and largest shareholder—has proactively secured a supply channel in China, and the product is highly competitive.

EG CORPORATION rBTX100 differs fundamentally from existing products on the market, starting with its production method. Unlike the conventional method of culturing live botulinum strains to extract the toxin, it directly designs and manufactures the toxin protein using genetic recombination technology. This means it has the distinct advantage of being fundamentally free from the controversy over strain origins—a chronic issue in the medical aesthetics industry.

This differentiated design approach has yielded innovative data in terms of efficacy. EyeGene,Inc optimized the product by recombinantly combining the key functional domains of subtypes A1, A2, and A6—which are specific subtypes of Type A botulinum toxin protein, the most widely used for cosmetic and medical purposes.

Type A1 is the standard toxin subtype used in most existing Botox products worldwide. I-Gene combined the strengths of Type A2—which is rapidly absorbed into cells and delivers rapid onset of action—with the characteristics of Type A6—which provides a long duration of nerve block—much like interlocking Lego blocks. By designing the product to combine only the superior core regions of each subtype, the company was able to secure significant data demonstrating a clear advantage—meeting all the requirements for a high-quality botulinum toxin—during the ongoing preclinical phase.

First, we obtained overwhelming results in terms of efficacy and duration. According to Digital Anesthesia Score (DAS) evaluations, EG-rBTX100 demonstrated twice the duration of action compared to existing 900 kilodalton (kDa) A1-type products. While the control group’s efficacy declined rapidly after administration, EG-rBTX100 maintained its effective paralysis score for an extended period. The onset of action was also shortened to E-type levels. The DAS score rose steeply immediately after administration, significantly outperforming the control group, demonstrating its ability to meet market demand for rapid efficacy.

Data on safety and reduced resistance were also obtained. Chromatography analysis showed that EG-rBTX100 exhibited only a single peak corresponding to the toxin protein, indicating a high purity of 100%. Unlike existing products, which induced antibody formation due to their complex protein composition, a recombinant production process has been established that produces only the pure core toxin, excluding the complex protein. Since it does not contain non-toxin proteins derived from the complex protein, the potential for resistance to develop with repeated dosing has been eliminated at the source. This demonstrates the product’s competitiveness as a next-generation toxin agent through both technology and clear clinical indicators.

Based on this achievement, the application for an export license is an essential step toward identifying global partners and proceeding with formal overseas registration. To obtain an export license, the company must undergo an Good Manufacturing Practice (GMP) inspection and complete the validation of manufacturing processes for both the bulk drug substance and the finished drug product. EyeGene,Inc plans to demonstrate consistent quality by passing the review of standards and test methods (GMP) based on data verifying potency—which indicates physical and pharmacological activity—and safety. Following the export license approval, the company intends to submit an Investigational New Drug (IND) application for domestic clinical trials, entering the domestic clinical phase sometime next year to accelerate commercialization.

Targeting the Global Meningococcal Vaccine Market, Aiming for Marketing Approval by the End of Next Year

“EG-MCV4,” a quadrivalent meningococcal conjugate vaccine currently under joint development with Korea BMI, is also nearing entry into Phase 3 clinical trials. EG-MCV4 received approval from the Ministry of Food and Drug Safety (MFDS) for its Phase 2/3 clinical trial plan last year and has successfully completed Phase 2 dosing. It is currently in the process of preparing the final report (CSR) through a contract research organization (CRO). EyeGene,Inc plans to finalize the report within the third quarter and begin Phase 3 clinical trials by the end of the year. The company has already completed preliminary preparations for the Phase 3 trials with several institutions, including major hospitals.

The global meningococcal vaccine market is projected to grow rapidly, reaching $5.1 billion (approximately 7 trillion won) by 2027. To secure a leading position in the market, EyeGene,Inc has established a concrete roadmap to obtain domestic marketing authorization by the end of next year. Starting in 2028, following the acquisition of marketing authorization, the company plans to generate substantial revenue by entering the domestic public procurement sector, including the military procurement market. Building on the success of domestic marketing authorization, the company aims to enter the South American market in 2029 through the Pan American Health Organization (PAHO) procurement program. At the same time, it will begin selling vaccines in the Southeast Asian market to sequentially expand its global market share.

Development of its core messenger RNA (mRNA) vaccine is also accelerating, focusing on key issues. In fact, EyeGene,Inc was recently selected as the lead institution for both the Hantavirus and Severe Fever with Thrombocytopenia Syndrome (SFTS) vaccine projects under the Infectious Disease Preparedness mRNA Vaccine Development Support Program, led by the Korea Disease Control and Prevention Agency (KDCA). The company has proven its core platform capabilities by prevailing over competition from major domestic pharmaceutical and biotech firms.

The hantavirus vaccine, being developed in collaboration with Korea University and MediciBio, utilizes self-amplifying messenger RNA (sa-mRNA) technology. It addresses the shortcomings of existing inactivated vaccines, such as a short duration of immunogenicity, the inconvenience of requiring three doses, and low cross-immunity. By utilizing the “alpha-virus-based cap-dependent self-amplifying RNA platform” developed by Korea University and the Korea Advanced Institute of Science and Technology (KAIST), the company has enhanced the stability of negative-strand RNA and maximized antigen expression efficiency. For the delivery vehicle, the company used MediciBio’s proprietary patented lipid nanoparticle (LNP) technology, thereby resolving concerns regarding global patent disputes. Designed entirely with domestic technology, it facilitates the mass production of customized, improved vaccines in the event of a new infectious disease outbreak and enables a response to variants—such as the “Andes variant hantavirus”—through cross-reactivity.

The SFTS vaccine project is based on a cap-dependent linear mRNA platform. Rather than relying on a self-amplifying mechanism, it focuses on the structural stabilization of linear mRNA and antigen optimization to lead the way in non-clinical efficacy validation.

An EyeGene,Inc official stated, “We have internalized an ‘end-to-end’ mRNA vaccine development platform that spans from candidate design to the development of quality control (QC) analytical methods, in-house immunogenicity evaluation, and GMP-scale process development,” adding, “Through this project, our mass production protocols, linked to the infrastructure of Korea BMI’s GMP plant in Osong, North Chungcheong Province, will be further refined.”