EuBiologics announced on the 25th that its second factory in Chuncheon received a good manufacturing practice (GMP) adequacy judgment from the Ministry of Food and Drug Safety for its oral cholera vaccine 'Euvichol-S.'
Previously, the company expanded its raw material and finished goods facilities in its second factory with approximately $10 million in support from the Bill and Melinda Gates Foundation over the past three years to increase the supply of cholera vaccines. It received approval from the Ministry of Food and Drug Safety for its raw material manufacturing facility in May of last year and has now also received adequacy judgment for its finished goods manufacturing facility.
The company expects that if it receives prequalification (PQ) approval from the World Health Organization (WHO) in the second quarter of this year, all raw material and finished goods facilities in its first and second factories will be operational, leading to an annual maximum production volume of 80 million to 90 million doses of the cholera vaccine.
Park Young-shin, executive director of EuBiologics' second factory, said, “The additional approval from the Ministry of Food and Drug Safety for the finished goods manufacturing facility of the second factory marks an important step toward WHO PQ.” He noted, “If we receive additional amendment approval for WHO PQ in the second quarter, the supply of cholera vaccines will more than double, enabling a smooth and stable supply and reducing the cholera vaccine supply risk for UNICEF.”
The company is preparing to enter the global private market following its monopoly supply of cholera vaccines in the public market. It has applied for export approval for the typhoid vaccine (EuTYPH-C), which completed a phase 3 clinical trial in Africa, and the phase 3 trial for the five-valent meningococcal vaccine (EuNmCV-5) is expected to conclude within the year. For premium vaccines using its proprietary platform technology, including the respiratory syncytial virus (RSV) and varicella vaccines, the company plans to complete phase 1 clinical trials in South Korea by the first half of this year.