Ildong Pharmaceutical will release its first chronic hepatitis B therapy of nucleotide series “Besivo” as an insurance benefit drug next month, the company said Thursday.
Besivo is a treatment for chronic hepatitis B based on the nucleotide sequence, which is composed of besifovir.
The price of the insurance is 3,403 won ($3.02) per tablet, which was recently confirmed by the Ministry of Health and Welfare보건복지부. Insurance benefits also cover El-carnitine medications used in combination, and the insurance price for one tablet (330mg) is 111 won.
According to the results of clinical trials, Besivo has demonstrated comparable levels of therapeutic efficacy in a randomized, double-blind trial compared with traditional therapies such as Entecavir (trade name: Baraclude) and Tenofovir (trade name: Viread). Besivo improved the prospects as a valid option for the treatment of chronic hepatitis B by improving the side effects found in the existing medications.
In particular, further analysis of clinical trials has shown that typical side effects such as decreased renal function and decreased bone density, which was a problem in the existing Tenofovir. Knodell necro-inflammatory score, was also superior to the control group regarding the histological improvement of the liver.
For the deterioration of renal function, the rate of increase in serum creatinine -- a test that measures kidney function - was significantly lower than that of Tenofovir.
With the case of measuring bone mineral density, the proportion of patients showing bone turnover increased and the percentage of patients showing average bone mineral density decreased in the case of Tenofovir. With Besivo, the rate of patients with bone loss decreased, and the percentage of patients with average bone mineral density increased.
Ildong Pharma 일동제약 (CEO: Yun Woong-sup윤웅섭) plans to go on marketing with the idea that Besivo is a domestic drug that secures safety by improving side effects of existing medicines as well as treatment effects that are comparable to that of foreign pharmaceutical companies. In particular, the company expects the cost of pharmaceuticals to be 25 percent lower than that of Viread, the leading drug in the market.
"Due to the nature of chronic hepatitis B treatment for long-term use, safety is critical, and there are few side effects, so Besivo is highly valuable as a few nucleotide drugs existing in consideration of cross-resistance,” said Professor Ahn Sang-hoon안상훈 of Severance Hospital세브란스병원 who participated in the clinical study.
"There is a strong competitive edge regarding the advantages of Besivo in connection with the entry into the Asian market, where the demand for therapeutic drugs is increasing as a major outbreak of hepatitis B,” he added.