Inventory of new drugs approved for listing in China, the United States and Europe in February

In February, China, the United States and Europe approved a total of 12 new drugs for the market
.

 

China approves 3 new drugs for the market and 1 is an oral treatment for new coronary pneumonia

 

Three new drugs have been approved for the market in China, namely upadatinib sustained-release tablets, nematicavir tablets/ritonavir tablets (trade name Paxlovid), and evonib tablets (see Table 1 for details)
.

 

AbbVie's upadatinib extended-release tablet is a once-daily, highly selective JAK1 inhibitor
.
In January this year, its atopic dermatitis indication was approved by the U.
S.
Food and Drug Administration (FDA), and this indication has also been approved in China recently
.
Prior to this, the drug has been approved in the United States for the treatment of adults with moderately to severely active rheumatoid arthritis and psoriatic arthritis patients who have an inadequate response to or intolerance to methotrexate
.

 

Neimatevir tablets/ritonavir tablets (trade name Paxlovid) are a combination of two antiviral drugs, nematevir and ritonavir, developed by Pfizer for the treatment of adults with progressive Patients with mild to moderate novel coronavirus pneumonia (COVID-19) with high risk factors for severe disease, such as patients with high risk factors for severe disease such as advanced age, chronic kidney disease , diabetes, cardiovascular disease, and chronic lung disease
.
Among them, nematevir is a new coronavirus 3CL protease inhibitor, which can disrupt the subsequent RNA replication process of the new coronavirus by blocking the activity of 3CL protease; another component, ritonavir, helps to alleviate the It is metabolized or decomposed, so that its effective concentration in the body can be maintained for a long time, so as to continuously express its antiviral activity and enhance the curative effect
.

 

Ivornib is a "firstin-class" (first-in-class) IDH1 inhibitor introduced by CStone Pharmaceuticals.
The indications approved in China this time are relapsed or refractory acute myeloid leukemia (R/ RAML)
.

 

IDH1 mutations can be detected in about 6% to 10% of AML patients, and the mutated IDH1 enzyme leads to up-regulation of D-2-hydroxyglutarate (D-2-HG) levels and blocks normal hematopoietic stem cell differentiation.
This accelerates the development of acute leukemia
.
This is one of the mechanisms by which AML occurs and develops
.
Therefore, by blocking the activity of the IDH1 mutant enzyme, the differentiation of AML cells can be promoted, thereby exerting an anti- tumor effect
.
The approval of the drug is based on a clinical study called CS3010-101, which showed that ivonib showed hematologic remission and good tolerability in the treatment of adults with R/R AML with IDH1 susceptibility mutations
.

 

　　3 new drugs approved by the United States are the first in the world 

 

　　In February, the United States approved 3 new drugs for the market (see Table 2 for details)
.
According to the Pharmadigger database data, these three products are all approved for the first time in the world
.

 

　　Sutimlimab (trade name Enjaymo) is the first complement C1s antibody approved by the US FDA for the treatment of cold agglutinin disease (CAD)
.
The drug has been granted breakthrough therapy designation and priority review by the US FDA
.
In November 2020, the marketing application of Sanofi's complement C1s antibody Sut imlimab for the treatment of cold agglutinin disease received a complete response letter (CRL) from the US FDA
.
In the CRL, the FDA noted that certain deficiencies were identified during pre-approval inspections at the third-party facility responsible for manufacturing the drug, and no clinical or safety deficiencies related to the application were identified
.
After a lapse of more than a year, Sutimlimab was finally approved by the US FDA for marketing
.

 

　　Mitapivat (trade name Pyrukynd) is a "first-in-class" oral pyruvate kinase receptor (PKR) activator that activates both wild-type (normal) and mutant PKR, improving red blood cell performance Energy supply to improve the health of red blood cells
.
This is the first disease-modifying therapy for pyruvate kinase (PK) deficiency
.

 

　　Pacritinib (trade name Vonjo) is a novel oral kinase inhibitor that can specifically inhibit JAK2, IRAK1, and CSF1R, but not JAK1, which can avoid the potential side effects of JAK1 inhibition
.

 

　　The EU approves 6 new drugs, none of which is the first in the world

 

　　In February, the EU approved 6 new drugs for the market, all of which are not the first new drugs approved in the world (see Table 3 for details)
.

 

　　Pfizer has two products approved, namely Somatrogon and 20-valent pneumococcal conjugate vaccine (PCV20)
.
Somatrogon is approved for use in children with growth hormone deficiency
.
Growth hormone deficiency is a rare disease caused by insufficient growth hormone secreted by the pituitary gland
.
Somatrogon is a long-acting human growth hormone that provides additional treatment options for children with growth hormone deficiency
.

　　In February, China, the United States and Europe approved a total of 12 new drugs for the market
.

 

　　China approves 3 new drugs for the market and 1 is an oral treatment for new coronary pneumonia

 

　　Three new drugs have been approved for the market in China, namely upadatinib sustained-release tablets, nematicavir tablets/ritonavir tablets (trade name Paxlovid), and evonib tablets (see Table 1 for details)
.

 

　　AbbVie's upadatinib extended-release tablet is a once-daily, highly selective JAK1 inhibitor
.
In January this year, its atopic dermatitis indication was approved by the U.
S.
Food and Drug Administration (FDA), and this indication has also been approved in China recently
.
Prior to this, the drug has been approved in the United States for the treatment of adults with moderately to severely active rheumatoid arthritis and psoriatic arthritis patients who have an inadequate response to or intolerance to methotrexate
.

 

　　Neimatevir tablets/ritonavir tablets (trade name Paxlovid) are a combination of two antiviral drugs, nematevir and ritonavir, developed by Pfizer for the treatment of adults with progressive Patients with mild to moderate novel coronavirus pneumonia (COVID-19) with high risk factors for severe disease, such as patients with high risk factors for severe disease such as advanced age, chronic kidney disease , diabetes, cardiovascular disease, and chronic lung disease
.
Among them, nematevir is a new coronavirus 3CL protease inhibitor, which can disrupt the subsequent RNA replication process of the new coronavirus by blocking the activity of 3CL protease; another component, ritonavir, helps to alleviate the It is metabolized or decomposed, so that its effective concentration in the body can be maintained for a long time, so as to continuously express its antiviral activity and enhance the curative effect
.

 

　　Ivornib is a "firstin-class" (first-in-class) IDH1 inhibitor introduced by CStone Pharmaceuticals.
The indications approved in China this time are relapsed or refractory acute myeloid leukemia (R/ RAML)
.

 

　　IDH1 mutations can be detected in about 6% to 10% of AML patients, and the mutated IDH1 enzyme leads to up-regulation of D-2-hydroxyglutarate (D-2-HG) levels and blocks normal hematopoietic stem cell differentiation.
This accelerates the development of acute leukemia
.
This is one of the mechanisms by which AML occurs and develops
.
Therefore, by blocking the activity of the IDH1 mutant enzyme, the differentiation of AML cells can be promoted, thereby exerting an anti- tumor effect
.
The approval of the drug is based on a clinical study called CS3010-101, which showed that ivonib showed hematologic remission and good tolerability in the treatment of adults with R/R AML with IDH1 susceptibility mutations
.

 

　　3 new drugs approved by the United States are the first in the world 

 

　　In February, the United States approved 3 new drugs for the market (see Table 2 for details)
.
According to the Pharmadigger database data, these three products are all approved for the first time in the world
.

 

　　Sutimlimab (trade name Enjaymo) is the first complement C1s antibody approved by the US FDA for the treatment of cold agglutinin disease (CAD)
.
The drug has been granted breakthrough therapy designation and priority review by the US FDA
.
In November 2020, the marketing application of Sanofi's complement C1s antibody Sut imlimab for the treatment of cold agglutinin disease received a complete response letter (CRL) from the US FDA
.
In the CRL, the FDA noted that certain deficiencies were identified during pre-approval inspections at the third-party facility responsible for manufacturing the drug, and no clinical or safety deficiencies related to the application were identified
.
After a lapse of more than a year, Sutimlimab was finally approved by the US FDA for marketing
.

 

　　Mitapivat (trade name Pyrukynd) is a "first-in-class" oral pyruvate kinase receptor (PKR) activator that activates both wild-type (normal) and mutant PKR, improving red blood cell performance Energy supply to improve the health of red blood cells
.
This is the first disease-modifying therapy for pyruvate kinase (PK) deficiency
.

 

　　Pacritinib (trade name Vonjo) is a novel oral kinase inhibitor that can specifically inhibit JAK2, IRAK1, and CSF1R, but not JAK1, which can avoid the potential side effects of JAK1 inhibition
.

 

　　The EU approves 6 new drugs, none of which is the first in the world

 

　　In February, the EU approved 6 new drugs for the market, all of which are not the first new drugs approved in the world (see Table 3 for details)
.

 

　　Pfizer has two products approved, namely Somatrogon and 20-valent pneumococcal conjugate vaccine (PCV20)
.
Somatrogon is approved for use in children with growth hormone deficiency
.
Growth hormone deficiency is a rare disease caused by insufficient growth hormone secreted by the pituitary gland
.
Somatrogon is a long-acting human growth hormone that provides additional treatment options for children with growth hormone deficiency
.