GC Biopharma headquarters building.
GC Biopharma headquarters building.

The Ministry of Food and Drug Safety rejected GC Biopharma's application for approval of its tuberculosis vaccine (BCG). The possibility of domestic production of the tuberculosis vaccine, which has relied entirely on foreign imports, has become slim.

GC Biopharma noted in a public announcement on the 8th that it would withdraw its domestic sales plan following the decision to reject its application for the approval of the BCG vaccine, which relies entirely on imports.

The company began development after being selected as the consignment contractor for the 'National Tuberculosis Vaccine Production Facility Construction and Production' as part of the government's 'Tuberculosis Elimination 2030 Plan' in 2009. It received a budget of 8.7 billion won and established BCG vaccine production facilities at its factory in Hwasun, South Jeolla Province, in 2011.

However, delays in securing master strains for vaccine development led to continual postponements of the schedule. The domestic clinical phase 1 trial began in 2017, and after 6 years, it completed clinical trials in 2023 and submitted its application for approval to the Ministry of Food and Drug Safety at the end of last year.

GC Biopharma reported that while it demonstrated statistical significance in the efficacy evaluation indicators from clinical results, the Ministry of Food and Drug Safety made the rejection decision considering clinical usefulness.

The tuberculosis vaccine is an essential medicine recommended for vaccination of all newborns within the first month of life. The injectable tuberculosis vaccine for which GC Biopharma is responsible for domestic production is also included in the National Immunization Program (NIP). However, as it relies entirely on foreign imports, supply stability domestically has become uncertain depending on the situation in the importing country, prompting the government to conduct support projects for domestic production.

Currently, in addition to GC Biopharma, Quratis is developing a tuberculosis vaccine for adolescents and adults.