AIDS Day Features . . 5 billion market, 4 domestic research new drugs, who will be the first to kill?

December 1, 2020 is the 33rd World AIDS Day.
The office of the State Council's AIDS Committee has issued a notice on the theme of "World AIDS Day" to do a good job, this year's theme of China's publicity activities is "together to prevent and combat AIDS shared health responsibilities" (the English theme is "Global solidarity, Shared responsibility"), aims to emphasize the global fight against the new crown pneumonia epidemic background, strengthen unity and cooperation, strengthen the pressure of government, departments, society and individuals "quartet responsibility", work together to address the new crown pneumonia, AIDS and other major infectious diseases around the world challenges, jointly fight AIDS, to achieve AIDS prevention and control goals, build a human health community efforts.
at this time, this article on the current treatment of AIDS drugs, the market and domestic research and development progress to do a simple combing, inappropriate, please point out.
aids overview aids, acquired immunodeficiency syndrome (AIDS), the pathogen of the human immunodeficiency virus (HIV), also known as HIV.
HIV can specifically attack and destroy human immune cells, causing damage to the human immune system, the gradual loss of related immune function, and gradually become the target of many diseases, resulting in a variety of serious opportunity infections, tumors and so on.
, AIDS has become a serious threat to the health of the world's people an important public health problem.
According to UNAIDS' Global AIDS Progress Report 2020, 38 million people living with HIV worldwide, 690,000 died from AIDS-related diseases, and 12.6 million of the 38 million people living with HIV still do not have access to life-saving treatment.
about 1.7 million new infections by 2019, more than three times the global target.
only 14 countries have achieved the 90-90-90 HIV treatment target, i.e. 90 per cent of people living with HIV are aware of their infection status, 90 per cent of whom receive antiretroviral treatment and 90 per cent of those receiving treatment have their virus suppressed.
the world's efforts to prevent new HIV infections fall far short of their targets.
the number of people infected with HIV in China increased from 809,000 in 2013 to 1.250 million in 2018, with a compound annual growth rate of 9.1% between 2013 and 2018, exceeding the global average, according to the Cdcs.
2019 National Statutory Infectious Disease Outbreak Profile of the National Health And Wellness Commission, the number of AIDS cases nationwide (excluding Hong Kong, Macao Special Administrative Region and Taiwan) reached 71,204 in 2019, and the number of deaths reached 20,999, with a morbidity rate of 5.0986 per 100,000 and a mortality rate of 1.5036 per 100,000.
Anti-HIV drugs At present, the world has not completely cured AIDS drugs, aids are now mainly achieved the following goals: reduce the incidence and mortality of HIV infection, reduce the incidence of non-AIDS-related diseases and mortality, so that patients have a normal life expectancy, improve quality of life;
At present, most of the clinical use of three or more drugs combined use (cocktail therapy) to treat AIDS, each drug has a different role in the process or for HIV replication cycle of different links, so as to avoid the resistance of a single drug.
There are currently more than 30 drugs (including compound preparations) in 6 categories, namely nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrated enzyme inhibitors (INSTIs), fusion enzyme inhibitors (FIs) and CCR5 inhibitors.
antiretroviral therapy drugs in China are NRTIs, NNRTIs, PIs, INSTIs, and FIs5 (including compound preparations), as in Table 1.
Table 1 Introduction of major antiretroviral (ARV) drugs available in China. According to the China AIDS Treatment Guidelines (2018) version, HIV treatment methods have two types of treatment and treatment.
the recommended program for primary treatment patients is 2 NRTIs class backbone drugs combined with class III drug therapy.
the third class of drugs can be NNRTIs or enhanced PIs (including litonavir or cobbisto) or INSTIs;
based on antiviral drugs available in China, and recommended and alternatives for patients who have not received HAART are available in Table 2.
Table 2 Recommends Antiviral Treatment Options for Adult and Adolescent Primary Patients (4) The global anti-HIV drug market The global market size of anti-HIV drugs is increasing year by year and is expected to reach more than US$45 billion by 2023.
the global market for anti-HIV drugs increased from $22.9 billion in 2013 to $33.96 billion in 2018, with a compound annual growth rate of 8.2%, according to the Consulting Report.
the global anti-HIV market to reach $46.75 billion by 2023, with a compound annual growth rate of 6.0% between 2019 and 2023.
regional structure, North America and Central and Western Europe are the mainstream markets for the anti-HIV drug market, accounting for 91% of the market share.
2018, the market for anti-HIV drugs in North America and Central and Western Europe reached $30.97 billion, accounting for 91.2% of the global market.
4.12 per cent of the overall drug market in developing countries, with a market size of about $1.40 billion.
the drug market in developing countries is expected to grow at a compound annual growth rate of 3.1% between 2019 and 2023, reaching $1.57 billion by 2023.
china's anti-HIV drug market is small, accounting for only 0.91% in 2018 and is expected to rise to 1.6% by 2023.
the global market for anti-HIV drugs is more concentrated, Gilead is the leading company on the track, Biktarvy (Vitavi) sales in the first half of 2020 increased significantly, reaching $3,297 million, a growth rate of 72.71 percent.
Gilead company by virtue of a number of oral drugs to dominate, in recent years continue to introduce innovative heavy-weight products, the overall market share of more than 50%, in the pipeline products are also leading major enterprises, followed by GlaxoSmithKline, Johnson and Johnson, Mercado and other foreign giants monopolize the high-end market.
China's anti-HIV drug market According to the consultation report, it is expected that by 2023, China's anti-HIV drug market size will reach 4.96 billion yuan, of which the medical insurance drug market is 1.20 billion yuan, the self-funded drug market is 990 million yuan, the total size of the self-funded and medical insurance anti-HIV drug market will reach 2.19 billion yuan, accounting for The overall market size is about 44%; by 2025, China's anti-HIV drug market is expected to reach 6.35 billion yuan, of which the medical insurance drug market is 1.86 billion yuan, the out-of-the-fund drug market is 1.17 billion yuan, and the total out-of-the-country and medical insurance anti-HIV drug market size will reach 3.02 billion yuan, accounting for about 48% of the overall market size.
health care market will continue to grow at a relatively fast pace.
present, the national free anti-HIV drug programme consists of eight anti-HIV drugs under three different mechanisms of action, mainly NRTI, NNRTI and PI drugs, mainly traditional antiretroviral drugs (see table 3).
, however, the current national free drug range belongs to the earlier anti-AIDS drug, in the drug use convenience, drug interaction and other aspects are often difficult to meet the growing differential needs of AIDS patients.
Anti-HIV drugs from the past centralized procurement of free treatment by the state is to the government free treatment , health insurance payment and out-of-the-fund market combination of transformation, will be to meet the needs of different groups of patients, improve the accessibility of clinical drugs and advanced trends.
Table 3 National Health Insurance Directory of AIDS-Related Drugs: China's anti-HIV drugs in the study of China's anti-HIV drugs to import drugs and domestic generic drugs as the lead, with the United States and Western Europe and other developed markets still have a large difference, its market share of high proportion of drugs are approved by the FDA at the beginning of the 21st century drugs.
present, there are more than 40 domestic companies involved in the anti-HIV generic drug market, DiSano, Chengdu Bett Pharmaceuticals, Qilu Pharmaceuticals, Anhui Baker Biopharmaceuticals, Northeast Pharmaceuticals and other companies are the main participants in the generics market.
, china's anti-HIV innovative drugs are relatively scarce, at present, most of the domestic pipeline products in the early clinical stage, with greater uncertainty.
The domestic independent research and development of new anti-AIDS drugs with new molecular entities only cutting-edge organisms of the Ai Corning approved for market, in addition, Eddie Pharmaceuticals, Fusin Biology, Real Life, etc. are also in the field of AIDS treatment layout (Table 4).
(1) Abbot Weitai (Aykonen): Abo Weitai is a long-acting fusion inhibitor developed by Frontier Biopharmaceity (Nanjing) Co., Ltd. and has new molecules and long-acting properties that inhibit HIV-1.
(2) ACC007 (NDA): ACC007 was developed by Jiangsu Eddy Pharmaceutical Co., Ltd. to test non-nucleoside retrovirase inhibitors for new structures.
The preliminary clinical trial results are good, compared with the current clinical first-line treatment program commonly used in iveren, in terms of safety, tolerance and compliance has advantages, was included in the 13th National 13th Five-Year Plan "major new drug creation" science and technology major special projects, and strive to be approved for listing by the end of 2020.
(3) Sifwepeptide (Phase II Clinical Trial): Sifwepeptide was developed by Tianjin Fusin Biotechnology Co., Ltd., is an HIV fusion protein gp41 inhibitor, the structure and mechanism of action is similar to Enfvetide.
April 2015, the first subjects were admitted to the group in a clinical Phase II trial of safety and pharmacodynamics with different dosing intervals of sifweptide.
(4) AzfDing (Phase II Clinical Trial): Azfding was jointly developed by Zhengzhou University and Henan Real Biotech Co., Ltd., a nucleoside reverse transcriptase inhibitor.
In October 2017, Azfding completed the first group of subjects in a multi-center, randomized, double-blind double simulation, positive control, dose-exploring clinical Phase II study among those infected without anti-HIV treatment, and in mid-2019, CDE has agreed to advance the results of Azfding's Phase II clinical trial.
(5) Seravino (Phase I Clinical Trials): Developed jointly by shanghai Pharmaceutical Research Institute and Kunming Zoology Research Institute, it is a CCR5 antagonist with a new skeleton.
May 2019, it has received a notice of clinical trials from the National Drug Administration and has agreed to conduct clinical trials.
Table 4 Domestic anti-HIV infection field is mainly in the research varieties (excluding compound preparations) 6: China's leading anti-AIDS drug enterprises frontier biological independent research and development of Aykonin is the first innovative drug to treat AIDS, but also the Only approved anti-HIV long-acting injection drug in the Chinese market, the joint use of other antiretroviral drugs, only one injection a week.
May 2018, Ai Corning was approved by the State Drug Administration for production and marketing, and began selling in China in August of the same year.
2018, the company achieved sales revenue of 1.911 million yuan, and in 2019, the company realized sales revenue of 20.86 million yuan, compared with 201 In the 8th year, the company increased by 18.949 million yuan, up 991.55 percent year-on-year, and as of September 30, 2020, the company's operating income was 23.22 million yuan, up 111.57 percent year-on-year.
addition, Frontier Biology is actively exploring clinical trials of combination therapies ("Aykonen plus 3BNC117").
company's official website, Aykonen and broad-spectrum and antibody 3BNC117 form a combination of full injection, two-drug combination therapy.
3BNC117 is the world's leading broad-spectrum medium-sum antibody (bNAb) that not only inhibits HIV replication in the same way as other anti-AIDS drugs, but also mediates immune responses to HIV and infected cells.
the antibody 3BNC117 half-life is long, acting on the CD4 binding point of gp120 on HIV virus, preventing the virus from entering the cell.
, which uses Aykonin in a joint effort with 3BNC117, aims to maximize the suppression of different hiv viruses, including drug-resistant viruses, using different antiviral mechanisms in both molecules.
years, with the global attention to AIDS prevention and control work, pharmaceutical research and development enterprises invested a lot of resources for new anti-HIV drugs research and development and commercialization.
, the development direction of anti-HIV drugs around the world mainly revolves around the long-term ability of anti-HIV drugs, AIDS immunotherapy and AIDS prevention drugs in-depth research and development.
The global market for anti-HIV drugs is expected to continue to grow at a faster rate in the future, with more leading mechanisms, better efficacy, better safety and better drug compliance.
will eventually achieve the 90-90-90 HIV treatment target globally.
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