Good news about HIV drug development is frequent

AIDS is a disease caused by HIV (Human Immunodeficiency Virus), a virus that can attack the human immune system.
The WHO (World Health Organization) has listed it as one of the top ten health threats in the world
.

In recent years, due to the excessive demonization of HIV transmission and subsequent disease discrimination, countless people talk about "Ai" in discoloration, and HIV patients have always been in the dark

However, after decades of development, science has gradually gained the upper hand in the fight against HIV
.

Nowadays, if HIV-infected persons can be detected early in the development of the disease and treated with standardized drugs, it is enough to maintain the same life as normal people

HIV drug treatment continues to evolve from monotherapy to cocktail therapy

From the earliest discovery of HIV to the approval of the first therapeutic drug by the FDA, people have not waited too long
.

In 1987, the first weapon for humans to fight HIV-nucleoside reverse transcriptase inhibitors (NRTIs) Retrovir (Chinese name: Zidovudine) developed by GSK (GlaxoSmithKline) passed rapid review in the United States It was approved for marketing and became the first antiretroviral drug, which gave HIV-infected people hope for survival for the first time.

However, the first-generation nucleoside reverse transcriptase inhibitors obviously have not kept up with the HIV disease process.
Studies have found that the level of the virus in the blood quickly rises again in the infected persons whose symptoms have been controlled for a while, and the virus will also mutate.
In order to resist the effects of drugs, HIV drug treatment was still hardly optimistic at the time
.

If the 1.
0 era led by zidovudine is the pioneering period of HIV treatment, then the subsequent 2.
0 era is the harvest period of the emergence of hundreds of HIV drugs
.

In the mid to late 1990s, the number of new HIV drugs approved by the FDA began to increase rapidly.
In addition to nucleoside reverse transcriptase inhibitors, protease inhibitors (PIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), and fusion inhibitors New anti-HIV mechanisms represented by integrase chain transfer inhibitors (INSTI), etc.
have gradually emerged
.

After you sing, I will be on the stage, and HIV treatment has suddenly got rid of the dilemma of being overstretched in the choice of single-drug treatment

Cocktail therapy is a three-drug combination therapy that combines a protease inhibitor and two nucleoside reverse transcriptase inhibitors to reduce the drug resistance caused by a single drug, maximize the inhibition of virus replication, and make the body's immune function destroyed.
Partial or even full recovery can delay the progression of the disease, prolong the life of the patient, and improve the quality of life
.

Because it can not only prevent the reproduction of the HIV virus, but also prevent the development of drug-resistant viruses in the body, cocktail therapy soon became the standard therapy for the treatment of HIV

After this major progress was announced, GSK seized the opportunity and became the first manufacturer to eat crabs.
In September 1997, it launched Combivir (lamivudine + zidovudine) combination therapy.
At that time, the clinical data showed that Combivir combined with other antiviral drugs, the disease progression and mortality rate were reduced by nearly half compared with the mainstream therapy at that time (9.
6% vs 19.
6%).
This was a revolutionary breakthrough.
GSK struck the iron while it was hot in 2000.
Launched the first three-combination therapy Trizivir, which was unparalleled in HIV treatment drugs
.

In addition to GSK, Gilead, Merck, Johnson & Johnson and many other MNCs also quickly joined the HIV cocktail therapy layout

It is also in the development of many cocktail therapies that the HIV drug administration has changed from multiple times a day to once a day, and then once every half a month, which greatly improves treatment compliance
.

More importantly, HIV treatment has also completed a perfect transformation from the confused period in the 1.

The above data is combed from the US NIH official website, all rights reserved

Is GSK qualified to challenge Gilead's dominance?

From the above and the above table, it is not difficult to see that GSK is the pioneer of HIV therapy.

It has the first HIV treatment drug and the first cocktail therapy.
This has also established GSK's absolute dominance in the early HIV drug market.

However, GSK has not been on top of the top seat for a long time.
In 2006, after Gilead launched Atripla, with its good clinical efficacy and low cost, in just a few years, Gilead launched GSK.
Retreat steadily
.
Since then, Gilead has officially replaced GSK as the global hegemon in the HIV market.
With the emergence of Biktarvy (Chinese name: ) in 2018, it swept the world and reached $7.
3 billion in sales in the second year of its listing.
, Became the king of HIV drugs, and Bittovi helped Gilead once occupied more than 60% of the global HIV drug market share.
According to Gilead’s financial report for the first quarter of 2021, Bittovi still maintained a high growth rate of 8%.
For the time being, there is no drug that can shake its status
.

2011-2020 sales of major varieties in the global HIV market (unit: USD million)

In comparison, the situation of GSK in recent years seems a bit sad.
Although it has blockbuster drugs such as Triumeq (sales in 2020: $2.
96 billion), its growth rate is hardly optimistic.
The first quarter of this year The sales of the company dropped by 23% year-on-year
.
But obviously, GSK will not choose to wait and die.
At the beginning of this year, GSK harvested a blockbuster drug that may lead a new era of HIV treatment-Cabenuva
.

Cabenuva is currently the first and only long-acting injection drug that can completely treat HIV-1 infection.
It can be administered once a month.
In other words, Cabenuva has completed that HIV patients only need to be injected once a month.
Historic breakthrough
.
Of course, Gilead also has an in-depth layout in long-acting therapy.
The Lenacapavir developed by it allows patients to be injected once every 6 months, that is, only two injections a year are needed.
At the end of last month, Gilead also announced that it has officially submitted to the FDA Lenacapavir's new drug listing application, not surprisingly, Lenacapavir will be approved and available early next year
.
In addition, the Phase II clinical data of Islatravir developed by Merck is good.
Unlike the above two, Islatravir is administered orally once a month, and it performs better in terms of compliance
.

GSK expressed its optimistic view on this.
According to GSK’s forecast, Cabenuva’s peak sales in the next few years will reach 7 billion U.
S.
dollars.
It also confidently stated that GSK currently leads other competitors at least five times in terms of new-generation long-acting drug delivery.
Time of year
.
The script seems to be so familiar again.
GSK has mastered revolutionary technology and took the lead, but this time GSK has become a challenger.
Can GSK, which holds a good hand, successfully sound the counterattack horn? How will Gilead see Recruitment and demolition will also have its own conclusion in the future
.

In 2021, local HIV new drug research and development reports are frequent, and the future will launch an impact on imported drugs

2021 will be revolutionary for the development of new HIV drugs in China.
On June 25, a new class 1 drug Ainovirin tablet developed by Aidi Pharmaceuticals was officially approved for marketing by the NMPA, which is the third generation of NNRTIs
.
According to the results of the Phase III clinical study of Enovavirin, its antiviral effectiveness is equivalent to that of efavirenz in the control group, and the domestic market share of efavirenz is as high as 932 million
.
In the future, Enovelin will formally launch an impact on many import manufacturers including Merck
.

Immediately last week, Real Biology's Class 1 new drug Azivudine tablets was also approved for marketing by NMPA.
It is the first HIV virus reverse transcriptase and accessory protein Vif dual-target inhibitor drug, which can selectively enter HIV-1 CD4 cells or CD14 cells in the peripheral blood mononuclear cells of the target cells exert the function of inhibiting virus replication.
Although regretted to lose the position of the first domestically-made anti-AIDS oral drug, azvudine has a broader indication for the future.
More optimistic
.

According to statistics from China Business Industry Research, the size of China’s anti-AIDS treatment drug market has increased from 790 million yuan in 2013 to 2.
02 billion yuan in 2018.
The market is expected to be close to 5 billion yuan in 2023, and the average annual compounding rate is expected to be from 2019 to 2023.
The growth rate is 18.
6%, and the market potential is huge
.
However, in the field of domestic anti-HIV therapeutic drugs, original imported products from MNCs such as Gilead, GSK, and Merck still occupy most of the market for a long time
.

The Insight database shows that among the current new chemical drugs with HIV indications, 38 items are imported, and only 11 items are domestic products
.
Among the domestic new drugs, Abvette, which was previously only Frontier Biotech, was approved for listing in 2018.
It was officially included in the medical insurance at the end of last year.
According to Frontier Bio’s first quarter financial report, I learned that the company’s first quarter sales The income reached 5,765,100 yuan, mainly contributed by Abvette.
Although the current sales are still average, they are expected to increase rapidly after being included in the medical insurance
.

Whether local innovative drugs can replace imported drugs to gain a foothold in the domestic market in the future is still unclear.
After all, no matter from the time of entry or the ability to develop from the market, the current domestic players still lag behind by many positions.
It is also difficult to bridge the gap in a short period of time, but as mentioned above, with the support of clinical data and innovative targets, it is not far to launch an impact on imported drugs
.

Mankind has gone through decades of fighting HIV.
HIV has changed from a super cancer to a controllable chronic disease.
This is scientific progress, and it is also fortunate for mankind.
Although domestic new HIV drugs are available in China It is late, but it is on the right path.
The era of HIV treatment 1.
0 and 2.
0 has become history, and the curtain of the 3.
0 era has been opened.
We look forward to more local innovative drugs that can participate and lead the next era
.