'To Reduce Children's Injections' LG Chem and Ubio Collaborate to Develop 6-Valent Vaccine for Major Infant Infectious Diseases

To accelerate the development of infant combination vaccines, which currently rely entirely on imports, LG Chem has partnered with UbioLogics.

Heesul Park, Executive Vice President and Head of Specialty Care Division at LG Chem (left in the photo), and Youngok Baek, CEO of U-BioLogics, are taking a commemorative photo for the contract signing of vaccine bulk clinical sample contract manufacturing (CMO).
[Photo by LG Chem]

On the 25th, LG Chem announced that it had signed a contract to outsource the production of the purified pertussis (aP) bulk antigen, a key component of the 6-valent combination vaccine LR20062, to UbioLogics.

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 the pentavalent vaccine (DTaP-IPV/Hib) and hepatitis B vaccine are administered separately for free through the National Immunization Program (NIP), APV006 can reduce the number of vaccinations for children by two times. Currently, the pentavalent vaccine is given three times at 2, 4, and 6 months of age, and the hepatitis B vaccine is administered three times immediately after birth, at 1 month, and at 6 months, totaling six doses. Once APV006 is commercialized, the 6-valent vaccine will be administered three times at 2, 4, and 6 months, and the hepatitis B vaccine only once immediately after birth, reducing the total number of doses to four.

Under this contract, LG Chem will provide UbioLogics with the aP strain, transfer the bulk antigen manufacturing process and testing technology, and UbioLogics will supply the pertussis bulk antigen to LG Chem starting from the Phase 3 clinical trial stage. Additionally, LG Chem plans to make further investments in UbioLogics to establish a Good Manufacturing Practice (GMP) certified facility to secure long-term bulk antigen supply. Through this, it is expected that up to 20 million doses of the vaccine will be supplied annually after commercialization. Currently, LG Chem has completed the Phase 1 clinical trial of LR20062, which began in August last year, and anticipates entering Phase 2 within this year. The Phase 1 trial confirmed safety and immunogenicity similar to existing commercial 6-valent combination vaccines.

LG Chem’s partnership with UbioLogics aims to timely develop combination vaccines preferred by customers and play a stable role in the domestic supply chain amid situations where differentiated supply strategies by overseas manufacturers and stockout issues significantly impact domestic vaccine supply. After comprehensively comparing the establishment of an in-house pertussis bulk antigen manufacturing facility and outsourcing production, LG Chem concluded that outsourcing is more suitable from the perspective of timely development and has been discussing cooperation with UbioLogics accordingly.

Currently, globally, the 6-valent combination vaccines developed are Sanofi’s Hexaxim and GlaxoSmithKline (GSK)’s Infanrix Hexa, with only Sanofi’s Hexaxim distributed domestically. Considering this situation, LG Chem sees a strong need for an additional supplier to respond to mid- to long-term demand and plans to commercialize LR20062 domestically by 2030.

Park Hee-sul, Executive Vice President and Head of LG Chem’s Specialty-Care Business Division, said, “We will accelerate clinical development through close cooperation with UbioLogics, a leading domestic vaccine company. Amid concerns over domestic vaccine supply shortages, we will actively contribute to creating an environment where our children can reliably receive essential vaccines.”