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Hepatitis B is a disease of liver infection caused by hepatitis B virus (HBV)
.
It is estimated that there are about 70 million cases of HBV infection in China, of which about 20-30 million patients with chronic hepatitis B require antiviral treatment.
However, from the perspective of the diagnosis rate and antiviral treatment rate of hepatitis B patients in China, the proportion is still very low.
, So there is an unmet clinical treatment demand on the market
.
Recently, the 2021 national medical insurance catalog released the results of the negotiations, Hansen Pharmaceutical Class 1 hepatitis B drug constant Mu ® (tenofovir tablets Amy) (TMF) also passed Medicare to negotiate for the treatment of chronic hepatitis B in adult patients
.
Imitinofovir tablets are a new type of nucleotide reverse transcriptase inhibitors, which inhibit reverse transcriptase in a similar way to nucleoside reverse transcriptase inhibitors, thereby simultaneously having potential anti-HIV-1 activity
.
Early clinical research results confirmed that the drug is well tolerated and safe in healthy volunteers and patients with chronic hepatitis B (CHB), and the PK characteristics and efficacy are in line with expectations
.
The products on June 22, 2021 approved the listing in China, only after five months on the successful access to health insurance, it will help improve China-made innovative pharmaceutical drugs accessibility and affordability, benefit more hepatitis B patients
.
Data show that in recent years, the scale of China's hepatitis B drug market has been expanding, and it has exceeded 15 billion yuan at present
.
With the launch of more innovative drugs, the hepatitis B market is expected to reach US$1.
6 billion in 2021, and it will significantly increase to US$2.
3 billion by 2025
.
From the perspective of hepatitis B drug market, antiviral drug nucleoside analogues have become the main force, including entecavir, tenofovir disoproxil, lamivudine, telbivudine, adefovir dipivoxil and propofol Tenofovir and others are commonly used varieties
.
The "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition)" also recommend the use of potent and low-resistance drugs, such as propofol tenofovir, entecavir, tenofovir disoproxil and peginterferon, further Emphasizes the therapeutic status of nucleoside analogs
.
Since the treatment of patients with chronic hepatitis B is a long-term process, in order to reduce the burden of drug costs for patients with hepatitis B and improve the availability of medicines, in recent years, entecavir, tenofovir disoproxil and arbutazone have been included in the national drug collection.
Defovir dipivoxil and other commonly used hepatitis B drugs
.
It is worth mentioning that the sales of hepatitis B medicines that have been included in the collection have declined significantly.
Among them, the sales of entecavir have fallen from 8.
841 billion yuan in 2018 to 2.
577 billion yuan in 2020
.
In addition, there are many generic drug companies in the deployment of this product, and the market is very fierce
.
In contrast, innovative drugs have ushered in an opportunity to take off
.
For example, Gilead's tenofovir propofol fumarate tablets were approved for import in China in November 2018, and sales have continued to rise after the listing
.
According to data from Mi Nei.
com, in 2020, the sales of this product in China's public medical institutions will exceed 370 million yuan.
In the first half of 2021, its sales have exceeded the full year of 2020, a year-on-year increase of 241.
03%
.
The imitenofovir tablets that Hansen Pharmaceutical entered the medical insurance this time are domestically produced Class 1 new drugs.
With the rapid convergence of this product and the medical insurance catalog, it will become a key driving force for the sustainable development of China's innovative pharmaceutical industry
.
At the same time, the market structure of tens of billions of hepatitis B drugs is also expected to be reshaped
.
At present, in addition to imitinofovir tablets, Hansen Pharma’s ametinib mesylate, flumatinib mesylate tablets, polyethylene glycol losenatide injection, morpholinidazole sodium chloride injection Innovative drug pipelines such as liquid have entered the national medical insurance catalogue
.
Hansen Pharmaceutical's announcement shows that in the first half of 2021, the company's sales of innovative drugs accounted for 28.
5%, a year-on-year increase of 66.
8%
.
.
It is estimated that there are about 70 million cases of HBV infection in China, of which about 20-30 million patients with chronic hepatitis B require antiviral treatment.
However, from the perspective of the diagnosis rate and antiviral treatment rate of hepatitis B patients in China, the proportion is still very low.
, So there is an unmet clinical treatment demand on the market
.
Recently, the 2021 national medical insurance catalog released the results of the negotiations, Hansen Pharmaceutical Class 1 hepatitis B drug constant Mu ® (tenofovir tablets Amy) (TMF) also passed Medicare to negotiate for the treatment of chronic hepatitis B in adult patients
.
Imitinofovir tablets are a new type of nucleotide reverse transcriptase inhibitors, which inhibit reverse transcriptase in a similar way to nucleoside reverse transcriptase inhibitors, thereby simultaneously having potential anti-HIV-1 activity
.
Early clinical research results confirmed that the drug is well tolerated and safe in healthy volunteers and patients with chronic hepatitis B (CHB), and the PK characteristics and efficacy are in line with expectations
.
The products on June 22, 2021 approved the listing in China, only after five months on the successful access to health insurance, it will help improve China-made innovative pharmaceutical drugs accessibility and affordability, benefit more hepatitis B patients
.
Data show that in recent years, the scale of China's hepatitis B drug market has been expanding, and it has exceeded 15 billion yuan at present
.
With the launch of more innovative drugs, the hepatitis B market is expected to reach US$1.
6 billion in 2021, and it will significantly increase to US$2.
3 billion by 2025
.
From the perspective of hepatitis B drug market, antiviral drug nucleoside analogues have become the main force, including entecavir, tenofovir disoproxil, lamivudine, telbivudine, adefovir dipivoxil and propofol Tenofovir and others are commonly used varieties
.
The "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition)" also recommend the use of potent and low-resistance drugs, such as propofol tenofovir, entecavir, tenofovir disoproxil and peginterferon, further Emphasizes the therapeutic status of nucleoside analogs
.
Since the treatment of patients with chronic hepatitis B is a long-term process, in order to reduce the burden of drug costs for patients with hepatitis B and improve the availability of medicines, in recent years, entecavir, tenofovir disoproxil and arbutazone have been included in the national drug collection.
Defovir dipivoxil and other commonly used hepatitis B drugs
.
It is worth mentioning that the sales of hepatitis B medicines that have been included in the collection have declined significantly.
Among them, the sales of entecavir have fallen from 8.
841 billion yuan in 2018 to 2.
577 billion yuan in 2020
.
In addition, there are many generic drug companies in the deployment of this product, and the market is very fierce
.
In contrast, innovative drugs have ushered in an opportunity to take off
.
For example, Gilead's tenofovir propofol fumarate tablets were approved for import in China in November 2018, and sales have continued to rise after the listing
.
According to data from Mi Nei.
com, in 2020, the sales of this product in China's public medical institutions will exceed 370 million yuan.
In the first half of 2021, its sales have exceeded the full year of 2020, a year-on-year increase of 241.
03%
.
The imitenofovir tablets that Hansen Pharmaceutical entered the medical insurance this time are domestically produced Class 1 new drugs.
With the rapid convergence of this product and the medical insurance catalog, it will become a key driving force for the sustainable development of China's innovative pharmaceutical industry
.
At the same time, the market structure of tens of billions of hepatitis B drugs is also expected to be reshaped
.
At present, in addition to imitinofovir tablets, Hansen Pharma’s ametinib mesylate, flumatinib mesylate tablets, polyethylene glycol losenatide injection, morpholinidazole sodium chloride injection Innovative drug pipelines such as liquid have entered the national medical insurance catalogue
.
Hansen Pharmaceutical's announcement shows that in the first half of 2021, the company's sales of innovative drugs accounted for 28.
5%, a year-on-year increase of 66.
8%
.
