Disclosure of Phase III Clinical Results of Hausen's Class 1 New Drug "Imitenofovir"

Recently, according to the Insight database, the first round of supplementary information for Hausen Pharmaceutical's Class 1 new drug "Imitenofovir Tablets" has been submitted.

Image source: Insight database (https://db.

Emitenofovir is a new type 1 drug independently developed by Hansen Pharmaceuticals.

As a prodrug of tenofovir (TFV), by optimizing the structure, imitenofovir has higher plasma stability than tenofovir, lower TFV exposure, and higher safety; it is metabolized by hepatocytes and is active The metabolite tenofovir diphosphate (TFV-DP) accumulates in a high concentration in the liver to achieve liver targeting and improve the availability of drugs.

Compared with tenofovir disoproxil fumarate (Viread, TDF) 300 mg, imitenofovir only needs less than 1/10 of the dose to obtain similar antiviral effects, and the drug has an effect on bone density and kidneys.

2021 Asia-Pacific Society of Liver Diseases Annual Meeting (2021APASL), researchers from Southern Medical University Nanfang Hospital and Jiangsu Haosen Pharmaceutical Group Co.

The study was carried out in 49 research centers in China, and a total of 1,005 subjects were enrolled.

The 48-week results showed that among the HBeAg-negative population, the proportion of subjects with HBV DNA <20 IU/mL in the test group was 90.

The percentage changes of hip and lumbar spine BMD from baseline in the imitenofovir group were significantly lower than those in the control group (p<0.

Among the HBeAg positive and negative populations, the test group showed a higher ALT reversion rate than the control group (AASLD defines the normal range), and among the HBeAg-positive population, the test group also showed a higher rate than the control group.

In summary, the researchers believe that imitenofovir not only guarantees a good anti-hepatitis B virus effect, but also shows superior safety, and will become an excellent choice for long-term medication for adult patients with chronic hepatitis B.

According to the data released by The Lancet, in 2016, the infection rate of hepatitis B among children in China was 0.

According to estimates by the World Health Organization (WHO), if my country does not provide antiviral treatment to patients with chronic hepatitis B and C, from 2015 to 2030, an estimated 10 million people will die from chronic hepatitis-related cirrhosis and liver cancer, of which the vast majority Most of them are caused by HBV [4], and the clinical unmet needs of domestic hepatitis B treatment still cannot be ignored.

Hansen Pharmaceuticals is a leading innovation-driven pharmaceutical company in China, and has always been committed to the innovative development of therapeutic areas where there is a huge gap in clinical demand in the Chinese market.

references:

[1] Razavi-Shearer D, Gamkrelidze I, Nguyen MH, et al.

[3] Guidelines for Prevention and Treatment of Chronic Hepatitis B (2019 Edition) [J].
Chinese Journal of Hepatology (Electronic Edition), 2019,11(4): 5-27.

[4] Zhuang Hui, to achieve the goal of eliminating viral hepatitis proposed by the World Health Organization [J], Dr.
Liver, 2019, (01).