YUBIOLOGICS Receives Approval for Phase 1 Clinical Trial of Meningococcal Conjugate Vaccine

[Asia Economy Reporter Yoo Hyun-seok] UbioLogics announced on the 15th that it has received approval from the Ministry of Food and Drug Safety for a Phase 1 clinical trial of ‘EuMCV4ju,’ the first domestically developed meningococcal conjugate vaccine using its proprietary platform technology EuVCTTM (conjugate vaccine manufacturing technology). EuVCTTM is a platform technology that exhibits excellent immune effects by conjugating bacterial polysaccharide antigens with a self-developed recombinant carrier protein (EuCRM197®).

Meningococcus resides in the human nose or throat (nasopharynx) and spreads through secretions such as saliva, nasal mucus, and sputum from infected individuals. Bacterial meningitis begins with symptoms similar to a cold, such as fever, nausea, and headache, but it is an acute disease that can cause death within 24 to 48 hours even in healthy individuals.

The fatality rate of meningococcal infection is 10-15%, which is very high compared to other infectious diseases. Approximately 500,000 people worldwide contract the disease annually, with 75,000 deaths caused by meningococcal disease. Meningococcal conjugate vaccines are the most effective means to reduce the risk of death from meningococcal infections.

‘EuMCV4ju’ was selected as a project under the Ministry of Health and Welfare’s Infectious Disease Crisis Response Technology Development Program in 2017 and was developed with 2.3 billion KRW in funding over four years. It provides long-lasting preventive effects and can be used not only in adults but also in children. The Phase 1 clinical trial will be conducted at Seoul National University Hospital and will evaluate the safety and immunogenicity of ‘EuMCV4ju’ in adults.

Upon completion of the development of ‘EuMCV4ju,’ the company plans to enter both domestic and overseas markets and supply to UN agencies. The global market size for meningococcal vaccines is estimated at approximately 2 trillion KRW, with the domestic market estimated at about 20 billion KRW. The company plans to initially enter the domestic procurement market targeting military personnel and the infant market.

In particular, during the Islamic pilgrimage period, more than 2 million people gather annually in Mecca, Saudi Arabia, where meningococcal vaccination is mandatory. The company plans to pursue licensing in major Islamic countries such as Saudi Arabia and Malaysia after the Phase 1 clinical trial. Furthermore, based on the successful experience with the cholera vaccine ‘Ubicol’ and close networks with international organizations such as GAVI, UNICEF, and WHO, the company plans to enter the public market and maximize sales through various channels.

A company representative stated, “Based on EuVCTTM technology, the typhoid conjugate vaccine (EuTCV®) is currently undergoing Phase 3 clinical trials in the Philippines, and following the pneumococcal conjugate vaccine (EuPCV15ju) domestically, the meningococcal conjugate vaccine (EuMCV4ju) will also proceed with Phase 1 clinical trials. The second plant (V Plant), which held its completion ceremony last April, is ready for in-house production of conjugate vaccines, and starting with the typhoid conjugate vaccine (EuTCV®), sequential supply will begin from 2021,” the representative said.

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