[E-Daily Reporter KIM SUNG-JIN ] LGCHEM,LTD(051910) The research and development schedule for the “hexavalent combination vaccine” intended for supply to developing countries has been delayed yet again. Following the initial pushback of the development timeline—which had originally targeted 2023—to 2030, concerns are now being raised that even this revised schedule is becoming increasingly tight. Although the plan was to supply the vaccine worldwide through international relief bidding organizations, it is reported that progress on research and development has been slow due to the high level of difficulty involved. The 6-in-1 combination vaccine is a research project that has attracted interest and sponsorship from the Gates Foundation, founded by Microsoft co-founder Bill Gates, and is considered crucial for bridging the global vaccine gap.

Schedule for ‘wP-based’ 6-in-1 Vaccine Delayed by 20 Months

According to the U.S. clinical trial registry site ClinicalTrials.gov on the 9th, LGCHEM,LTD recently postponed the Phase 3 clinical trial plan for “LBVD,” a 6-in-1 combination vaccine based on whole-cell pertussis (wP) that is currently under development with the goal of entering the international procurement market. While the study was originally scheduled to be completed by April 2027, the timeline has been pushed back by approximately 20 months to December 31, 2028. The initial completion date for the clinical trial, which had been set for November 2026, has also been postponed to the end of February 2028.

A 6-in-1 combination vaccine refers to a vaccine that can prevent six infections—including diphtheria, tetanus, and pertussis (DTaP), hepatitis B, polio (IPV), and Haemophilus influenzae type b (Hib)—with a single injection. Thanks to these advantages, demand is high in developing countries such as Africa and Southeast Asia, where access to healthcare is limited and there is a shortage of vaccination personnel.

LGCHEM,LTD is currently developing two types of 6-in-1 combination vaccines simultaneously. The 6-in-1 combination vaccine is broadly categorized into whole-cell (wP) and acellular (aP) types, depending on the type of pertussis component used. The wP method involves incorporating the pertussis bacterium without purification; while it may cause side effects such as fever, it has the advantage of a relatively simple manufacturing process, which helps reduce production costs. In contrast, the aP method involves purifying only the necessary protein components from the pertussis bacterium; while it has fewer side effects, the manufacturing process is complex, resulting in a higher price compared to wP. With the exception of international organizations distributing vaccines to developing countries, most individual nations have adopted the aP antigen as the standard.

South Korea currently relies entirely on imports for its 6-in-1 combination vaccine, and LGCHEM,LTD is developing an aP-based 6-in-1 combination vaccine (APV006) with the goal of domestic production. Currently, it is understood that only a few companies, such as the multinational pharmaceutical firms Sanofi and GSK, supply the 6-in-1 combination vaccine. LGCHEM,LTD, which enrolled participants in a Phase 1 clinical trial for its aP-based 6-in-1 combination vaccine in August 2023, has invested over 200 billion won in the clinical development and construction of production facilities for APV006 and plans to bring it to market by 2030.

Nine Years in Development… Gates Foundation Invests 44.6 Billion Won

The 6-valent combination vaccine, whose schedule has now been postponed, is wP-based and is being developed by LGCHEM,LTD for supply to developing countries through the World Health Organization (WHO). LGCHEM,LTD began developing LBVD nine years ago, in 2017.

Since the LBVD is intended for infants and young children in developing countries who lack access to vaccines, it has also received support from the Gates Foundation, which is renowned for its charitable donations. In 2019, the Gates Foundation provided $33.4 million (approximately 44.6 billion won) to support the development of the LBVD.

This is not the first time the Gates Foundation has invested in LGCHEM,LTD. Previously, in 2017, the foundation provided $12.6 million (approximately 16.8 billion won) to support a polio vaccine that LGCHEM,LTD had been developing since 2014. Founder Bill Gates also discussed plans for vaccine development cooperation with SK BIOSCIENCE during his visit to South Korea in 2025.

However, LGCHEM,LTD’s LBVD development is falling significantly behind schedule. As recently as 2019, when it received investment from the Gates Foundation, the company had planned to supply the vaccine globally by 2023, but LBVD development remains stuck in Phase 2 clinical trials. Looking at the four protocols related to LGCHEM,LTD’s LBVD published on ClinicalTrials.gov, there appears to be a gap of about two years between the second protocol (September 2019) and the third protocol (which began in July 2022).

The fourth protocol, currently underway, was newly initiated in April 2025; LGCHEM,LTD designed this clinical trial to conduct Phases 2 and 3 concurrently. The scheduled completion date for the clinical trials, including Phase 3, is December 31, 2028; considering the time required for the WHO Prequalification (PQ) process, the timeline for commercialization by 2030 is quite tight.

PQ is a WHO program that evaluates the quality and safety of pharmaceuticals with the aim of supplying vaccines to less developed and developing countries. Once certified, a company is eligible to participate in international relief tenders organized by organizations such as UNICEF and PAHO. Since the vaccine market in developing countries is structured around bulk purchases by the Global Alliance for Vaccines and Immunization (Gavi), companies must receive WHO PQ certification to enter the market.

The high level of development difficulty is cited as the reason for the repeated delays in the vaccine development schedule. LGCHEM,LTD had already succeeded in developing the 5-in-1 combination vaccine “Eupenta” in May 2016 and obtained WHO PQ certification at that time. A 6-in-1 combination vaccine adds protection against polio to the 5-in-1 vaccine; although it involves adding just one more type of vaccine, development is challenging because it requires combining such a large number of different vaccines. An industry official stated, “A 6-in-1 combination vaccine literally involves mixing six vaccines, so the technical difficulty is quite high.”

An LGCHEM,LTD official explained, “When we began R&D in 2019, we anticipated commercialization around 2023, but we have found that the technical development is proving more challenging than expected.” The official added, “We plan to conduct a small-scale Phase 2 clinical trial and then move on to Phase 3 as quickly as possible; the delay is not due to business strategy.”

“We Haven’t Given Up on Developing the Hexavalent Vaccine”

As LGCHEM,LTD’s LBVD development continues to face delays, concerns about its commercialization potential are growing. However, LGCHEM maintains that the LBVD project has neither been put on hold nor canceled. An LGCHEM official emphasized, “While it is true that development is delayed, we have not halted or abandoned this vaccine project,” adding, “It remains a significantly important initiative in the global vaccine market, as evidenced by our investment from the Gates Foundation.”

In fact, it is understood that only a very small number of wP-based 6-valent combination vaccines have currently obtained WHO PQ certification. It is also reported that organizations such as the WHO and UNICEF are encouraging the development of multiple products to ensure a stable vaccine supply.

Some argue that vaccines supplied to developing countries through the WHO serve to bridge the vaccine wealth gap with developed nations, making it a business venture where pharmaceutical companies cannot expect significant profits. This is also why the Gates Foundation provides financial support for vaccine development. However, others argue that the project offers the potential for substantial sales and positive publicity in the global market.

An industry official stated, “As a global vaccine company, the increase in credibility and brand value is also a factor that cannot be ignored.”