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12 antibody drugs approved for the first time! 20% pipeline growth inventory of antibody drugs approved in 2022

 Last Update: 2023-02-03
 Source: Internet
 Author: User

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As the century of biology in the 21st century, one of the manifestations in the medical field is the rapid growth
of antibody drugs.

Since the birth of the first antibody drug in 1986, there have been more than 140 kinds of antibody drugs, and the application range includes neoplastic diseases, infectious diseases, cardiovascular diseases, autoimmune diseases and other fields
.

Perhaps everyone's first impression of antibody drugs is "effective" and "expensive"
.
In fact, this is the main reason for the increasing number of antibody drugs, "effective" makes more and more scientists devote themselves to the research and development of new drugs, looking for "panacea" for today's various intractable diseases, and "expensive" provides economic power
for the research and development of new drugs.

Recently, an article published in mAbs, "Antibodies to watch in.
" 2023" summarizes the antibody drugs approved in 2022 and predicts
the antibody drugs to be approved in 2023.

12 new antibody drugs were approved for the first time in Europe and the United States

As of mid-November this year, there are a total of 12 antibody drugs approved in the European Union or the United States (Table 1).

Table 1.
The first approved antibody therapy in the EU or USA

Source: References

Of these 12 drugs, 6 are anti-cancer drugs, and the other 6 are mainly used for non-cancer diseases
.
From the perspective of drug mechanism of action, there are 4 biantibodies, namely tebentafusp, faricimab, and mosunetuzumab and teclistamab, and 1 ADC class (mirvetuximab soravtansine).

At present, antibody drugs approved by other countries (mainly China and Japan) in addition to Europe and the United States are also gradually increasing, and 15 new antibody drugs have been approved for marketing or are under review in 2022, including 12 drugs in China and 3 in Japan (Table 2).

Table 2.
Antibody therapies that have been approved or reviewed in other countries

Source: References

Antibody drugs worth watching in 2023

Looking ahead to 2023, 16 antibody drugs are being reviewed by the FDA/EMA and are expected to be approved
by the end of this year or next year.

It is worth noting that four domestic PD-1 monoclonal antibodies (teripulimab, pélilimab, tislelizumab, and sindilimab) will be reviewed by the FDA again next year, and it is worth looking forward to
whether they can successfully land in the United States.

Table 3.
Antibody drugs under FDA/EMA approval

Source: References

In addition to new drugs already under approval, 17 antibody drugs in the field of oncology are expected to submit marketing applications to regulatory authorities by the end of this year or next year (Table 4), including 5 bispecific antibodies and 2 ADCs
.

Table 4.
Antibody drugs to watch in 2023 (Oncology)

Source: References

In the non-oncology sector, six antibody drugs are expected to submit marketing applications to regulatory authorities by the end of this year or next (Table 5).

Table 5.
Antibody drugs of interest in 2023 (non-oncology field)

Source: References

The antibody drug pipeline is growing rapidly

Since the first edition of Antibodies to 2010 Since the publication of Watch, antibody drugs have steadily increased every year, including oncology drugs and non-oncology drugs
.
In the past year (excluding new crown antibodies), the pipeline of antibody drugs in the late clinical stage has increased by about 20%, with a total of 140 drugs in the late clinical stage, of which the number of pipelines targeting oncology drugs has grown faster than that of non-oncology antibody drugs
.
With the advancement of technology, the mechanism of action has gradually diversified (Figure 1).

Figure 1.
Forms and quantities of antibody therapies in late-stage clinical studies 2010-2023

(a) the form and quantity of antibodies in late-stage clinical studies for non-oncological indications (excluding COVID-19 antibodies);

(b) Form and quantity
of antibodies in late-stage clinical studies for tumor indications.

Source: References

Since a variety of diseases in the human body, such as diabetes, systemic lupus erythematosus, rheumatoid arthritis and other non-neoplastic diseases are related to specific ligand-receptor binding, most of the current non-tumor antibody drugs are blocking antibodies, that is, through the synthesis of specific antibodies, block specific ligand-receptor binding in the human body, so as to achieve the purpose of
treatment.

For neoplastic diseases, due to the diversity of their pathogenesis, correspondingly, the mechanism of action of tumor antibody drugs is also very diverse (Figure 2).

Figure 2.
Antibody forms and engineering strategies in clinical research Source: References

Figure 2.
Antibody forms and engineering strategies in clinical research

Due to the limitation of the mechanism of action of early compound drugs, in addition to acting on the lesion site to produce a therapeutic effect, there is also an unavoidable problem is the side effects
when the drug acts on the non-lesion part of the human body.
The inherent advantage of antibody drugs is that the drug binds to specific targets to produce therapeutic effects, so that there are fewer interactions with other non-lesion parts of the human body and side effects
.
This is why antibody drugs work well and have few
side effects.

It is believed that with the continuous discovery of disease discovery mechanisms and the continuous advancement of biotechnology, antibody drugs will be more and more widely used in patients
with more diseases.

References: https://doi.
org/10.
1080/19420862.
2022.
2153410

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