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Medical Network May 28th Recently, China's first bio-new drug recombinant cytokine gene-derived protein injection (trade name: "Le Fu Neng") was awarded the Class 1 Bio-New Drug Certificate by the State Food and Drug Administration.
This is the third type of hepatitis B treatment that has appeared in the world for the first time in more than 30 years, and will break the ceiling with a seroconversion rate of hepatitis B e antigen not exceeding 30%.
"In the antiviral treatment of e antigen-positive hepatitis B patients, the ratio of e antigen seroconversion never exceeds 30%. We pursue the negative conversion and serological conversion of e antigen because of e antigen serological conversion. Later, these patients entered the immune control period, and the incidence of liver cirrhosis and liver cancer was significantly reduced. From the three-phase registration clinical trial of 'Le Fueneng', a short treatment can exceed 30% of the ceiling, and some patients have More than 50% of the e antigen serological conversion rate, in the global chronic hepatitis B antiviral treatment process, its advantages are very prominent." Professor Cheng Jun, president of the Beijing Asia-Pacific liver disease diagnosis and treatment technology alliance said.
In the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2015 edition), the goal of chronic hepatitis B treatment is to maximize the long-term inhibition of HBV replication, reduce hepatic inflammatory necrosis and liver fibrosis, and delay and reduce liver failure. Decompensation of liver cirrhosis, hepatocellular carcinoma and other complications occur to improve quality of life and prolong survival. For some suitable patients, the clinical cure of chronic hepatitis B should be pursued as much as possible, that is, the sustained virological response (type B virus antigen) disappears after stopping treatment, accompanied by improvement of ALT recurrence and liver histology.
Cheng Jun said that in China, the negative seroconversion of e antigen has very important practical application value. The reason why this aspect is emphasized at the therapeutic level, because the e antigen seroconversion is followed by the surface antigen. Then, the control of immune antigens, the subsequent results are significantly reduced in patients with cirrhosis and hepatitis.
Prior to "Le Fu Neng", all the drugs for the treatment of hepatitis B in the world were basically oral nucleoside antiviral drugs or common and long-acting interferon drugs. These two drugs were treated for about 1 year and only about 30%. In the patient, the efficacy of inhibiting the replication of the virus in the liver cells is achieved, and the "Le Fu-energy" treatment reaches about 30% of the therapeutic effect in 3 months, the therapeutic effect reaches 40% in 6 months, and the therapeutic effect reaches about 50% in 9 months. The clinical data of “Le Fu Neng†for the treatment of chronic hepatitis B shows that it is far superior to the existing hepatitis B treatment drugs.
"Chronic hepatitis B treatment is indeed in a state of bottleneck. The drugs that are now on the market, one is the anti-viral treatment of nucleosides, these drugs are only for the replication of the virus, and have no effect on immunity. The other is the drug of interferon, It has an immunomodulator and has certain antiviral effects. Although the two drugs have effectively controlled the progression of the disease after use, objectively speaking, the effect is not very satisfactory. Because the patient is to be treated for a long time, stop The recurrence rate of drugs is high. Interferon therapy is effective and limited. At present, the treatment of chronic hepatitis B can only be said to control disease progression through current antiviral therapy, so that most patients are relatively stable, but once discontinued, it may be A large area of ​​sudden. At the same time through anti-viral treatment, effectively reduce the occurrence of cirrhosis, liver cancer, but some of these patients with liver cirrhosis will still progress to liver cancer. Le complex energy is different from interferon, is more than interferon More powerful immune regulation and anti-viral effect." Wang Guiqiang, chairman of the Chinese Medical Association Infectious Diseases Branch Professor said.
About 2 billion people worldwide have been infected with hepatitis B virus, of which 240 million are chronic hepatitis B infections. About 650,000 people die each year from liver failure, liver cirrhosis and hepatocellular carcinoma caused by hepatitis B virus infection. In China, the proportion of patients with cirrhosis and hepatocellular carcinoma caused by hepatitis B virus infection is 60% and 80%, respectively. According to the 2006 National Hepatitis B Serum Epidemiology Survey, the prevalence of hepatitis B surface antigen in China's general population aged 1-59 is 7.18%. According to this calculation, there are 93 million people with chronic hepatitis B infection in China.
"In this population, more than 40% of chronic hepatitis B is e antigen positive, close to 32 million people, they need immediate appropriate antiviral treatment. But our diagnosis rate of chronic hepatitis B is only 19%, anti- The virus treatment rate is only 11%, so hepatitis B is still a very important clinical medical problem and a public health problem," Cheng Jun said.
Liu Longbin, CEO of Jiehua Bio-Group, said that this new drug is the result of Jiehua Biotech's 18-year investment of 400 million US dollars. This year, it will launch the international clinical trial of the US FDA or EU standards , and apply for new Chinese drug registration simultaneously. Approved. It is expected to receive at least one new drug approved by the FDA or the EU within 2-4 years, and simultaneously apply for new drug registration approval in China according to international clinical trial data.