'To Reduce Children's Injections' LG Chem Begins Domestic Production of 6-Valent Vaccine for Major Infant Infectious Diseases

'APV006' Domestic Phase 1 Clinical Trial Participant Enrollment
Vaccination Frequency Reduced by 2 Compared to Existing Methods

LG Chem has begun clinical trials to domestically produce the 6-in-1 combination vaccine for infants, which is currently entirely dependent on imports. Once commercialized, the number of vaccinations can be reduced by two compared to the existing vaccination method, easing the burden on children and parents, while stable supply through domestic production is expected.

LG Chem CI [Photo by LG Chem]

On the 1st, LG Chem announced that it has registered the first subject for Phase 1 clinical trials of the domestically developed 6-in-1 vaccine 'APV006,' based on the acellular pertussis (aP) vaccine. This clinical trial will be conducted at Seoul National University Hospital, comparing the safety and immunogenicity of APV006 with an already commercialized 6-in-1 vaccine in 42 healthy adults. LG Chem explained, "Preclinical results met all criteria for toxicity, safety, and efficacy tests."

Since Phase 1 focuses on safety evaluation, it is conducted on healthy adults, while Phases 2 and 3 will be conducted on actual infants. LG Chem plans to invest over 200 billion KRW in clinical development and facility construction and aims to commercialize the vaccine domestically by 2030. Notably, if development succeeds, the pertussis vaccine is divided into whole-cell pertussis (wP) antigen, which uses the entire pertussis bacterium, and acellular pertussis (aP) antigen, which uses specific antigens of the pertussis bacterium to improve safety. Currently, aP antigen development technology is held only by overseas developers, so this could become the first domestically produced aP vaccine. Except for international organizations distributing vaccines to underdeveloped countries, most individual countries have adopted aP vaccines as the standard.

APV006 is a DTaP-IPV-HepB-Hib vaccine that prevents six infectious diseases: diphtheria (D), tetanus (T), pertussis (aP), poliomyelitis (IPV), hepatitis B (HepB), and Haemophilus influenzae type b (Hib). Compared to the current method in South Korea, where a 5-in-1 vaccine (DTaP-IPV/Hib) and hepatitis B vaccine are administered separately through the National Immunization Program (NIP) free of charge, APV006 can reduce the number of vaccinations by two. This is because instead of administering the 5-in-1 vaccine at 2, 4, and 6 months and the hepatitis B vaccine immediately after birth, at 1 month, and at 6 months, the 6-in-1 vaccine can be given at 2, 4, and 6 months, and the hepatitis B vaccine only once immediately after birth. However, although one type of 6-in-1 combination vaccine is currently distributed domestically, it is not yet included in the free national immunization program.

LG Chem explained the development purpose by stating that, amid the absolute influence of overseas manufacturers' country-specific supply strategies and quality issues on domestic vaccine supply, they aim to develop the highly preferred combination vaccine domestically for the first time and play a role in establishing a stable domestic supply chain. In fact, recent supply interruptions by overseas vaccine suppliers have caused several vaccination crises, forcing children to switch vaccines mid-course. The currently distributed 6-in-1 combination vaccine in South Korea is also a product of a global big pharma company.

Son Ji-woong, Head of LG Chem's Life Sciences Business Division, said, “This development project is highly meaningful as it internalizes the manufacturing technology of all six vaccine antigens to create an environment where our children can reliably receive essential vaccines amid supply concerns.” He added, “We will accelerate domestic commercialization through timely investment and continuously expand the countries we enter to actively contribute to the prevention of infectious diseases worldwide.”

LG Chem's pentavalent combination vaccine 'Upenta'
[Photo by LG Chem]

Meanwhile, LG Chem is also conducting Phase 2 clinical trials of the wP-based 6-in-1 combination vaccine ‘LBVD,’ targeting entry into the international procurement market. This combines the poliovirus (IPV) vaccine 'Upolio' and the diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b (DTwP-HepB-Hib) 5-in-1 vaccine 'Upenta,' both developed by LG Chem. In March, LG Chem signed a contract worth 200 million USD (approximately 256 billion KRW) with UNICEF, supplying Upolio for 2 years at 100 million USD and Upenta for 5 years at 100 million USD.

This content was produced with the assistance of AI translation services.