Progress in research and development of new antiviral chemistry drugs: cure ideal VS short drug reality

In contrast to this is the incidence of various viral diseases continues to increase. According to the latest WHO data, there were approximately 35 million people living with HIV in 2013 and 2.1 million new infections. In terms of hepatitis, more than 240 million people worldwide suffer from chronic (long-term) liver infections. About 780,000 people die each year from acute or chronic hepatitis B, and 130 million to 150 million people suffer from chronic hepatitis C infection. 10,000 to 500,000 people died of liver diseases associated with hepatitis C. The flu virus is also ravaged by the whole world. Only seasonal flu kills 250,000 people every year in the world, and SARS, avian flu, and influenza A are frequently mutated.

CDE New Drug Overview: Low Position

In the past five years, the number of applications per year has not exceeded 15 , and the number of acceptances has not exceeded 50 .

According to the CDE review data, in the past five years, the number of new antiviral chemical drugs applied by CDE has been relatively stable. The number of new drug applications per year has not exceeded 15, and the number of acceptance has not exceeded 50. In 2014, there were only 49 acceptance numbers, involving 14 varieties.

From the perspective of treatment subcategories, the application of new chemical drugs in the past five years has mainly focused on anti-hepatitis virus drugs. In 2014, the number of varieties was the highest, with 7 and the number of acceptance numbers was 38. Anti-AIDS varieties range from 2 to 4, and the acceptance number is also less than 6. The anti-influenza species began to have only one variety per year in 2011, and in 2014 there was no corresponding new drug variety declaration.

In terms of registration type, the number of anti-virus 1.1 new chemical drugs in the past five years is small, the number of varieties is less than 4, the number of acceptance numbers is not more than 11, and the number of new types of 3.1 drugs is also less, and the number of varieties is less than 7. However, there are more acceptance numbers, from 8 in 2010 to 25 in 2014.

From 2010 to 2014, there were only two types of 1.1 new anti-AIDS chemical applications, namely Affitta, which was applied for by the Tianjin Pharmaceutical Research Institute in 2011, and Azfudine, which was applied for by Zhengzhou University in 2013. Azfj is the world's leading and domestically pioneered new generation of AIDS drugs. It is currently in a leading position in the world. Its activity is much better than the listed anti-AIDS drugs (such as 3TC, etc.), and its toxicity is much smaller.

There were only one 3.1 and two 3.2 categories of new drugs applied in 2014 and all were exclusively declared. Among them, the 3.1 new drug efavirenz was used as the first-line drug for AIDS. The original drug was Merck's Stony, and the global sales scale was about 800 million US dollars. The 3.2 new drug lamivudine tenofovir tablets is used to treat AIDS with chronic viral hepatitis B. Both lamivudine and tenofovir are nucleoside (acid) anti-reverse enzyme inhibitors, both of which inhibit human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Because patients have better tolerance to lamivudine, lamivudine is a first-line antiviral drug for patients with AIDS complicated with chronic viral hepatitis B, but it has a higher incidence of drug resistance. Studies have shown that tenofovir has a good inhibitory effect on wild-type HBV strains and lamivudine-resistant strains. For chronic hepatitis B, combination therapy may play a better role in inhibiting the virus and reducing the incidence of drug resistance, especially in patients with HIV infection.