[Edaily Reporter Minji Son ] “While antibody therapies have driven the growth of the pharmaceutical and biotech industries in the past, I believe gene therapies will take up the baton going forward. However, gene therapies cannot be developed with the therapeutic substance alone; a delivery system to transport the drug to its target site within the body is absolutely essential. This is why, as the gene therapy market expands, the importance of and demand for drug delivery platforms will inevitably grow as well.”

Ki Min-hyo, CEO of Medici Bio, made these remarks in a recent interview with PharmEdaily, the premium pharmaceutical and biotech content platform of Edaily. He explained that as the gene therapy market expands, the importance of drug delivery technology will inevitably grow as well.

In fact, according to market research firm NovaOne Advisors, the gene and cell therapy market is projected to grow from $25.9 billion last year to $119.3 billion by 2034. During the same period, according to Precedence Research, the gene delivery technology market is also expected to expand from $6.2 billion to $22.8 billion by 2034.

MediciBio is a biotech startup developing a lipid nanoparticle (LNP) platform—used as a drug delivery system for gene therapies—based on its proprietary ionizable lipid library and freedom-to-operate (FTO) status. Founded in November 2021, the company was launched by a team of researchers who previously conducted research on drug delivery and new drug development at Chong Kun Dang and Samjin Pharmaceutical. CEO Ki also gained extensive R&D experience in new drugs, drug delivery, and improved new drugs while serving as a laboratory director at Chong Kun Dang for 21 years and as the head of a research institute at Samjin Pharmaceutical for 6 years.

Local Injections Designed to “Remain in Place,” Systemic Injections Designed for “Repeated Administration”

The key differentiator of MediciBio’s LNP platform, as emphasized by the company, is that the delivery system is designed differently depending on the route of administration. The company explains that this approach addresses the issues of repeated administration and immunogenicity, which have been identified as limitations of existing global LNP delivery systems.

In particular, the LNP for local delivery—administered intramuscularly—is designed to remain at the injection site as long as possible, while the LNP for systemic delivery—administered intravenously—is designed to maintain delivery efficiency even with repeated doses. This strategy targets different unmet medical needs depending on the route of administration.

CEO Ki stated, “Topical LNPs, which are widely used in vaccines, carry the risk of antigen expression in unexpected tissues if they spread unnecessarily throughout the body beyond the injection site,” adding, “‘Localizing’ technology—which ensures the LNP remains concentrated around the muscle or in lymph nodes—is crucial.” He added, “MediciBio’s LNP for local delivery is characterized by superior vaccine efficacy with less systemic spread compared to existing technologies from Pfizer or Moderna.” The company selected candidate ionizable lipids suitable for local delivery through screening of its proprietary lipid library.

In systemic delivery LNPs, which are primarily used in gene therapies, the potential for repeated administration is a key competitive advantage. CEO Ki said, “The biggest hurdle in gene therapy development is that LNPs are captured by immune cells as they circulate through the body,” adding, “The more frequently the LNPs are administered, the faster they are cleared, leading to a decline in therapeutic efficacy.”

He added, “We are in the process of securing systemically administered LNPs capable of maintaining delivery efficiency even under repeated dosing conditions.”

In addition, MediciBio possesses targeted delivery LNP technology that can be utilized in the development of next-generation in vivo CAR-T and CAR-M-based cell therapies. The company explained that by expanding its portfolio beyond local and systemic delivery to include targeted delivery, it is enhancing its growth potential as a universal platform company for the development of next-generation cell therapies.

Platform Commercialization and Technology Application ‘Taking Shape’ Through Government Projects

Based on its universal LNP delivery platform applicable to various modalities, MediciBio was recently selected for three government research and development (R&D) projects: △ the Ministry of SMEs and Startups’ Startup Leap Package (Deep Tech Specialization) △ the Korea Disease Control and Prevention Agency’s Hantavirus vaccine development project △ and the Korea Health Industry Development Institute’s gene-editing therapy project.

The Startup Leap Package is a government initiative that supports the commercialization of core and platform technologies in the next-generation bio and health sectors. MediciBio was selected for the project under the theme “Commercialization of High-Efficiency mRNA-LNP Delivery Systems for the Development of mRNA Gene Therapies.”

The KDCA project is being carried out as part of the “Project to Establish Rapid Development Technologies in Preparation for Pandemics of Priority Infectious Diseases.” MediciBio is participating in research to develop an sa-mRNA-based hantavirus vaccine in collaboration with the Vaccine Innovation Center at Korea University College of Medicine and iGene, and is responsible for developing the LNP platform technology, which serves as the core delivery vehicle.

CEO Ki stated, “The hantavirus vaccine (Hantavax) previously developed in Korea is administered in military units and other settings because the infection is transmitted to humans by rats or rodents; however, it is reported that its preventive efficacy has declined since it was developed nearly 20 years ago.” He added, “We have commenced development with the goal of securing the core technologies that this consortium can develop and preparing for an Investigational New Drug (IND) application within two years.”

The Korea Health Industry Development Institute’s gene-editing therapy project aims to conduct “research on the clinical optimization of gene therapies based on gene, RNA, and epigenetic editing and control technologies.” MediciBio is conducting research with Daehan Newpharm to develop a root-cause HBV gene therapy based on epigenetic editing technology. The company is responsible for developing a liver-targeted mRNA-LNP delivery system and optimizing the formulation, and plans to validate the scalability of its gene therapy platform as a next-generation gene therapy field.

CEO Ki stated, “We are simultaneously working on commercializing the platform itself and applying LNP to actual vaccines and therapeutics,” adding, “Through this government-funded project, we will be able to validate the platform’s performance and secure a track record that can lead to the clinical stage.”

Secured Series A Funding Last Month… Ensuring Revenue Stability Through a ‘Two-Track Strategy’

MediciBio has adopted a so-called

“two-track

strategy” in terms of profitability. Unlike typical biotech ventures, whose performance and corporate value are heavily dependent on the success of technology exports, MediciBio’s strategy is to secure a stable revenue base through the production and supply of its LNP platform while simultaneously pursuing a major in vivo CAR-T technology transfer.

CEO Ki explained, “For our LNP platforms for topical and systemic administration, we are entering into ‘one-to-many agreements’ that grant usage rights for individual pipelines to multiple partners, rather than transferring all rights to a single company,” adding “When a partner conducts its own R&D and enters the clinical phase, we generate revenue by directly producing and supplying the GMP-grade LNP raw materials or delivery agents required for clinical trials,” he explained. In other words, this is a business model where revenue from supplying clinical materials automatically follows in addition to licensing revenue.

CEO Ki said, “Although our current annual revenue is not high, we expect it to increase to over 1 billion won starting this year,” adding, “We plan to gradually expand revenue and establish a stable revenue base through our LNP production business, which began in earnest last year.”

He added, “We expect to achieve approximately 15 billion won in revenue by 2029 through our existing LNP production and supply business alone.” The company has set 2029—when its revenue base is expected to stabilize—as the target date for its initial public offering (IPO).

Another key upside factor cited is the technology transfer of the in vivo CAR LNP platform. CEO Ki said, “We are aiming for a major global deal for the in vivo CAR LNP platform in 2027–2028,” adding, “If the technology transfer is successful, it will enable a significant expansion of profits separate from the currently projected 15 billion won in revenue from the LNP business.”

Meanwhile, Medici Bio secured a total of 4.5 billion won in investment from Kolon Investment, ES Investor, and Daedeok Venture Partners during its Series A funding round last month. Including existing Series A investors such as iGene, Oracle Venture Investment, and Myriad Partners, the total amount raised in the Series A round amounts to 6.4 billion won.