"We will achieve the dream of conquering infectious disease pandemics through rapid, high-throughput diagnostic equipment that protects patients and medical professionals, and the development of siRNA (small interfering RNA) therapeutics administered via pulmonary inhalation."
Bioneer Chairman Park Han-oh presented this next-generation pandemic response system during an interview with MoneyToday at Bioneer's Global Center headquarters in Yuseong-gu, Daejeon.
Since its founding in 1992, Bioneer has accumulated infectious disease response capabilities through the SARS, MERS, and coronavirus outbreaks. The diagnostic technology of Bioneer, which started with synthetic DNA (deoxyribonucleic acid) and PCR (polymerase chain reaction) reagent businesses from a farm warehouse, served as a "shield" against successive pandemics, saving countless lives.
Bioneer has advanced both diagnostic reagents and equipment technology through research and development (R&D). As a result, following the development of the ultra-high-speed fully automated molecular diagnostic device "ExiStation FA 96," the company demonstrated global competitiveness by obtaining "Class D," the most stringent grade under the European In Vitro Diagnostic Regulation (CE-IVDR), for its quantitative kits for △HIV-1 (Human Immunodeficiency Virus) △Hepatitis B, and △Hepatitis C. The HIV-1 quantitative kit's acquisition of Class D is a first in South Korea, and only two companies worldwide, including Bioneer, have obtained the "highest grade" for all three chronic viruses.
Chairman Park said, "While molecular diagnostic reagents for general infectious diseases are easy to develop due to the universalization of technology, fully automated molecular diagnostic reagents capable of efficiently responding to pandemics can only be developed if one possesses its own platform equipment." He added, "Therefore, we invested approximately 100 billion won over 10 years in the development and commercialization of next-generation fully automated molecular diagnostic systems, a cost comparable to new drug development."
Extracting pathogen DNA·RNA (ribonucleic acid) and precisely measuring the base sequence is the core of infectious disease diagnosis, considered a strength of Bioneer, which has advanced DNA·RNA reagent and equipment technology for 34 years. Based on this oligonucleotide synthesis capability, Bioneer invented the siRNA (small interfering RNA) platform "SAMiRNA" and successfully launched "CosmeRNA," a scalp and hair care cosmetic utilizing it.
After being listed in the International Cosmetic Ingredient Dictionary (ICID) in the United States, CosmeRNA was registered with the European CPNP (Cosmetic Products Notification Portal) in 2022 and has been actively sold in the global market for four years.
Park said, "CosmeRNA is a product applying RNA technology that regulates the process itself of producing hair loss-related proteins." He added, "As a topical cosmetic, it acts locally on hair follicles, reducing concerns about systemic side effects while delivering high efficacy."
SAMiRNA stands for Self-Assembled Micelle inhibitory RNA and is also an Influenza A (Type A flu) therapeutic platform that Bioneer is developing to combat pandemics. It works by recognizing the sequence of the influenza RNA virus, binding to that site, and then cleaving it to neutralize the virus.
In particular, research gained momentum after being selected for the Ministry of Health and Welfare's "Innovation-Driven R&D Project" last year. Chairman Park stated, "We plan to submit an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety next year for a clinical trial of an Influenza A therapeutic administered via inhalation through a nebulizer."
Influenza A is the causative virus of novel flu, Hong Kong flu, and avian flu. It is considered the virus with the highest potential to cause a future pandemic due to its susceptibility to mutation.
The inhaled SAMiRNA therapeutic has the advantage of "tailored response," as it can be developed immediately based on analyzed sequences even if a new RNA virus emerges. It is explained that because it has the characteristic of long-lasting activity within cells, the drug effect lasts for several months, offering an effect similar to vaccination.
Bioneer plans to invest 10 billion won to build a facility meeting GMP (Good Manufacturing Practice) standards at its Daejeon Daedeok Center, where it will produce and supply clinical research reagents for domestic and international biotech companies, including siRNA therapeutics.
Park said, "If we begin full-scale operations in early next year, the period of receiving clinical reagents from overseas will be shortened by one-tenth, significantly accelerating the clinical development speed of RNA new drugs and reducing costs." He added, "Our goal is to respond to pandemics faster than anyone else in the world using molecular diagnostics and RNAi (RNA interference) therapeutics as 'fundamental weapons.'"
in THEBIO
