Facing the challenge of "no drug available", a new wave of RSV drugs under development welcomes progress

ArticleMedicine Guanlan

Winter is here, and respiratory diseases caused by viral infections are just around the corner

Another winter, the RSV threat is approaching

Respiratory syncytial virus (RSV) is a very common infectious pathogen that can cause seasonal epidemics of lower respiratory tract infections (LRTI), including bronchiolitis and pneumonia

Worldwide, RSV infection is an important cause of hospitalization of infants

With the recent colder weather, this disease caused by RSV is making a comeback, threatening the health of young children

Most infected people still have "no medicine to cure"

Although the respiratory diseases caused by RSV infection are serious, so far, there is no effective treatment method and preventive vaccine specifically for respiratory syncytial virus in the world

At the same time, the development of previous RSV vaccines, antibodies and therapeutic drugs once faced huge challenges

For most patients infected with RSV, there is still "no medicine available"

Vaccines + innovative drugs, a new round of research and development ushered in the dawn

At present, a new round of research and development battles against respiratory syncytial virus is quietly kicking off

In the field of RSV vaccine research and development, including Johnson & Johnson, Pfizer, GlaxoSmithKline (GSK), AstraZeneca and Sanofi, as well as Aiweixin Biotechnology, etc.

For example, in October this year, Janssen, a subsidiary of Johnson & Johnson, just announced that its Phase 2b clinical trial of RSV vaccine in elderly people over 65 years of age reached the primary and key secondary endpoints, and its effectiveness in preventing lower respiratory tract diseases is 80%

Prior to this in September, Pfizer announced the launch of RENOIR, a phase 3 clinical trial of RSVpreF, a candidate vaccine candidate for the pre-F subunit of the bivalent fusion, to evaluate the effects of single-dose vaccination on the prevention of RSV infection in adults 60 years of age or older.

There is also a vaccine ADV110 from the Chinese company Ai Di Weixin, which is under development to prevent RSV infection.

In the field of RSV drug research and development, the current research products of many companies such as AstraZeneca/Sanofi, Janssen and AGCO are in the late clinical stage

In May 2021, the RSV preventive antibody drug nirsevimab jointly developed by AstraZeneca and Sanofi reached the primary endpoint of the trial in the phase 3 clinical trial MELODY

Janssen also has a new RSV fusion protein inhibitor JNJ-53718678, which has the potential to treat RSV infection

A new RSV fusion protein inhibitor ziresovir (code name: AK0529) developed by AGCO Baifa has also attracted much attention

In addition, there are many other antibody drugs under development, such as Merck’s MK-1654, Enanta’s EDP-938, and Reviral’s RV520, which are also in the clinical development stage
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Looking at the entire field, the rapid progress of a large wave of products under research is expected to open up a new situation in the prevention and treatment of RSV infections
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Image source: AGCO Baifa prospectus

Solve global problems, and the performance of Chinese products under research is eye-catching

As mentioned in the previous article, some Chinese innovative companies are also involved in it, and are developing a series of innovative product pipelines to solve the global problem of RSV infection
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Among them, AGCO Baifa is a biomedical innovation company focusing on this disease field.
In addition to the aforementioned new RSV fusion protein inhibitor ziresovir, the company also has two next-generation RSV drugs in its preclinical pipeline.

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At the same time, the company recently introduced another preclinical RSV antibody drug from the Institute of Microbiology of the Chinese Academy of Sciences for the prevention of RSV infection, further enriching its RSV research and development pipeline
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In addition to AGCO Baifa, there is also the RSV vaccine product ADV110, which is under development including Aidiweixin Biologics, which is a potential RSV protein subunit vaccine candidate containing a novel adjuvant.
It is designed to protect children from 6 months to 5 years of age.
Elderly people over 65 years old are currently in phase 2 clinical phase; another example is TNM001, a long-acting recombinant RSV antibody TNM001, which has also been approved for clinical use in China and is intended to be used to prevent lower respiratory tract diseases caused by RSV
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It is worth mentioning that these developments in China are also closely related to the current attention and concern of the Chinese government and regulatory authorities
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Because the core population of patients with RSV infection is mainly children, except for the elderly and adults with impaired immune function
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In recent years, medicine for children has become the focus of China's reform and attention
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The "Drug Administration Law" promulgated by China in 2019 clearly states that it "encourages the development and innovation of drugs for children"
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The National Food and Drug Administration (NMPA) of China has also issued various guiding principles to encourage and guide drug research and development institutions to more actively and scientifically develop children's drug research and development
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In an interview with WuXi AppTec's content team, the relevant person in charge of the new Chinese innovative drug Aike Baifa pointed out that if a respiratory syncytial virus drug can be developed, it will be able to promptly treat infected children and avoid the development of respiratory and lung damage.
For asthma, asthma and chronic pneumonia, reduce organ damage and protect children's breathing health
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At the same time, from the perspective of pharmacoeconomics, early treatment of childhood infections can avoid chronic diseases in children, thereby greatly saving treatment time and medical funds required
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Therefore, treatment for RSV infection is imperative
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We are very happy to see that breakthroughs are being made in the process of solving this worldwide problem, whether it is therapeutic small molecule drugs, antibody drugs, or preventive vaccines
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I look forward to the success of the follow-up research of these pipelines, which will benefit patients as soon as possible
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