(Health Korea News / Lee Soon-ho) The first and currently only domestically produced hepatitis A vaccine developed by Borung has completed follow-up clinical trials. This is to expand the previously restricted vaccination age to all ages, and if the relevant indications are secured, it is expected that it will be able to compete on equal terms with imported vaccines that monopolize the domestic market.
According to the Ministry of Food and Drug Safety on the 19th, Borung Biopharma, a vaccine subsidiary of Borung Group, recently completed the multinational phase 3 clinical trial of ‘Boryung Hepatitis A Vaccine Prefilled Syringe Injection’ targeting children aged 24 months to 15 years.
After selecting the final subjects in August 2023, the company administered the second dose at six-month intervals, completed observation of the final subjects on the 1st of last month, and reported the end of the clinical trial to the Ministry of Food and Drug Safety. It is expected that the company will proceed with expanding age indications after analyzing the clinical trial data in the future.
‘Boryung Hepatitis A Vaccine Prefilled Syringe Injection’ is the first domestically produced hepatitis A vaccine introduced by Borung. The hepatitis A vaccine was converted to the National Immunization Program (NIP) in 2015, but since there were no domestic products at the time, only three imported finished products were supplied: GSK’s ‘Havrix’, Sanofi-aventis’ ‘Avaxim’, and MSD’s ‘Bakta’.
As a result, there was not enough supply to fit the domestic situation, and the medical field had to suffer from supply and demand instability every year. To resolve this supply and demand instability, Boryung Biopharma began developing ‘Boryung Hepatitis A Vaccine Prefilled Syringe Injection’, a cell culture-based hepatitis A vaccine, in 2012.
After long-term research and clinical trials, the vaccine received product approval from the Ministry of Food and Drug Safety in December 2020, and was released in March 2022, a little over a year later. It was evaluated to have contributed greatly to resolving the supply-demand imbalance in clinical settings in the domestic market, which was dominated by imported vaccines.
However, the fact that it was initially approved for use in children aged 12 to 23 months and 16 years of age or older limited its competitiveness compared to imported vaccines that can be administered to all ages aged 12 months or older. This is the result of conducting clinical trials only on adults, who are relatively easy to recruit, and children aged 12 to 23 months to whom the NIP applies, in order to accelerate the domestic production of the hepatitis A vaccine.
Accordingly, Boryung Biopharma immediately began preparing for follow-up clinical trials after the launch of ‘Boryung Hepatitis A Vaccine Prefilled Syringe Injection’, and received approval for a phase 3 clinical trial plan targeting children aged 24 months to 15 years in December 2022, nine months after the product launch, and began full-scale clinical trials in March of the following year.
Meanwhile, as Borung Biopharma completes the clinical trial that it has conducted for about two years, it is expected that Borung Hepatitis A Vaccine Prefilled Syringe Injection will be available for all age groups, like imported hepatitis A vaccines, as early as next year or at the latest the year after.
As multinational clinical trials have been conducted, overseas expansion is also expected. Boryung Biopharma conducted phase 3 clinical trials of ‘Boryung Hepatitis A Vaccine Prefilled Syringe Injection’ by recruiting more subjects overseas than domestically. This is a passage that allows us to read the company’s intention to target the global market in the future.
Meanwhile, hepatitis A is caused by the hepatitis virus, and when infected, symptoms such as high fever, vomiting, and jaundice appear. In Korea, it occurs frequently in people in their 20s to 40s, and especially when people with chronic liver disease are infected, it can develop into a serious situation, so the country recommends vaccination.
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Source: www.hkn24.com
