AIDS is an important public health issue, and the length of life and quality of life of HIV patients have been greatly improved
over the years by adhering to standardized treatment and popularization of science.
But when AIDS becomes a chronic disease, it means that infected people should take long-term drugs
like diabetics and high blood pressure patients.
It is understood that there is a huge unmet treatment demand in the current large patient population
.
Therefore, in the face of a huge market, domestic and foreign pharmaceutical companies are accelerating their layout
.
Affected by this, in recent years, a large number of innovative drugs at home and abroad have emerged in the domestic anti-HIV drug market
.
Since 2022, a number of AIDS treatment drugs have been approved in China, providing patients with more choices
.
For example, on October 21, the latest public information of the State Food and Drug Administration showed that the new drug application for dual-drug HIV therapy - doluvervivirin tablets submitted by GlaxoSmithKline (GSK) has been approved
.
According to the priority review announcement of the Center for Drug Evaluation of the State Food and Drug Administration, the approved indication is for the treatment of specific adult patients with human immunodeficiency virus type 1 (HIV-1) infection
.
It is the first dual-agent therapy approved by the FDA for maintenance therapy in virologically suppressed patients
.
Limiting the number of drugs in HIV therapy is expected to reduce toxicity
to patients compared with HIV regimens containing no fewer than 3 drugs.
On October 29, the website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration showed that GSK/ViiV Healthcare's HIV (HIV) drug Cabotegravir injection and cattegravir sodium tablets were declared for marketing for new indications, which is expected to become the first complete long-acting HIV therapy on the domestic market, which will shorten the number of days for infected patients from 365 days to 6 or 12 days
.
Caltegravir is an HIV integrase chain transfer inhibitor (INSTI) that has been approved
in the European Union, the United States and Japan.
In November 2021, the drug was declared for marketing
for the first time in China.
It is worth mentioning that in addition to imported new drugs, in recent years, with the accelerated layout of local pharmaceutical companies in this field, innovative drugs in the field of domestic anti-HIV are also rising
.
For example, Addison Pharmaceutical's anti-AIDS new drug innomide tablets have already submitted a new drug application in May 2021 and are now close to approval
.
It is understood that inomidine tablets are the first three-in-one compound drug with innovative patents in China independently developed by Addison Pharmaceutical, which is composed of
inoverin, lamivudine and tenofovir.
Among them, inoverin, as the core component of enomide tablets, is a non-nucleoside reverse transcriptase inhibitor, which was officially approved in June last year, and has obvious advantages in adverse reactions, treatment effects and drug interactions, and has been included in China's AIDS guidelines
.
In addition to Addi Pharmaceutical, there are many local pharmaceutical companies in China, including frontier biology and real biology, which have laid out in the field of anti-HIV drug research and development, and have achieved fruitful
innovation results.
Among them, on October 10, CDE website information showed that Real Bio CL-197 capsules were approved for clinical trial approval for the treatment of adult patients
with HIV-1 infection.
CL-197 is a potential long-acting novel oral HIV candidate that belongs to the purine nucleoside reverse transcriptase inhibitor (NRTI).
It takes about 168 hours for CL-197 to drop below 50% of its peak concentration of active ingredient in PBMCs, confirming its potential long-term efficacy and promising weekly administration
.
This relatively convenient regimen may also improve medication adherence and thus clinical outcomes
.
At present, in the anti-HIV drug market, Gilead, GSK, Bristol-Myers Squibb, Merck, AbbVie and Johnson & Johnson occupy the main market share
.
From the perspective of the domestic market pattern, it is also occupied by foreign-funded enterprises in the main market
.
However, industry insiders believe that in the future, as domestic pharmaceutical companies accelerate their layout and innovation in this field, China's single-tablet program represented by enomiti tablets will bring new treatment options to more HIV-infected patients and help
achieve the goal of "eliminating the AIDS epidemic by 2030" faster and better.
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