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As of the end of March, the number of new drugs approved in the first quarter of 2022 announced by Japan's independent administrative agency for pharmaceuticals and medical devices (PMDA) is 56 (PMDA defines a new drug as its active ingredient, quantity, usage, dosage, efficacy, etc.
Drugs that are significantly different from approved drugs are mainly drugs containing new active ingredients, new compound drugs, new route of administration drugs, new indication drugs, new dosage form drugs, new dose drugs, etc.
)
.
Among them, there are 22 new drugs containing new ingredients
.
According to the classification of drug treatment categories, the drug categories with the largest number of new drug approvals are anti-tumor drugs, reproductive system drugs, sex hormones and skeletal and muscle drugs, with 13, 11 and 4 drugs respectively
.
The drug categories with the most new ingredients and new drugs are antitumor drugs, digestive system drugs and nervous system drugs
.
Figure 1: Therapeutic categories of new PMDA drugs in the first quarter of 2022 Among the most popular new anti-tumor drugs, 3 are new drugs containing new ingredients, and the most approved drugs including new drugs are monoclonal antibodies, targeted small molecules Antineoplastic drugs and alkylating agent antineoplastic drugs
.
Among the 13 new drugs, in China, selpercatinib was declared for marketing, nivolumab, pembrolizumab, and pertuzumab were imported for marketing, asciminib and sotorasib were declared for clinical stage, and fornetupitant was not declared.
and listing information, the rest of the new drugs are listed as domestic products of the same variety in China, and the specific drugs are shown in the table below (among them, new drugs with new ingredients are marked in yellow)
.
Table 1: Antineoplastic Drugs and Their Situation Among the new drugs announced by PMDA in the first quarter, five new drugs with new components were approved for listing in Japan for the first time in the world
.
Table 2: Carotegrast methyl, Japan's first drug in the global market, is a prodrug of α4 integrin inhibitor developed by EAPharma (Eisai), which can block the α4 integrin on the surface of inflammatory cells and the adhesion of vascular endothelial cells such as digestive tract mucosa.
Attachment molecule, suitable for patients with moderate ulcerative colitis who are not ideally treated with 5-aminosalicylic acid (5-ASA) preparations
.
Clazosentan is an endothelin receptor antagonist developed by Idorsia for the treatment of cerebral vasospasm, cerebral infarction, and cerebral ischemia-related vasospasm after cerebral infarction and aneurysm
.
Gefapixant is the first selective P2X3 receptor antagonist developed by MSD for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC)
.
Nemolizumab is a humanized anti-human IL-31 receptor A monoclonal antibody originally developed by Chugai (Chongwai), which is suitable for the treatment of pruritus associated with allergic dermatitis when the current treatment effect is not satisfactory
.
IL-31, an itch-inducing cytokine, has been reported to be associated with pruritus in patients with atopic dermatitis
.
Olipudaseα is the world's first non-central neuropathy treatment drug for adults and children with acid sphingomyelinase deficiency (ASMD) developed by Sanofi
.
In addition, in the new drug data for the first quarter of 2022, a total of 38 companies have approved new drugs
.
Among them, 11 companies have been approved for new anti-tumor drugs, and 7 companies have been approved for reproductive system drugs and sex hormone drugs
.
Figure 2: PMDA approved new drug companies and treatment categories in the first quarter of 2022 Among all the approved companies, the companies with the largest number of approved new drugs are Chugai (China and foreign countries), Bayer (Bayer), Nobelpharma (Nobelen Pharmaceuticals), Novartis (Novartis) and Pfizer (Pfizer), Chugai (Zhongwai) and Nobelpharma (Nobelpharma) were approved for 4 new drugs, and the remaining three were approved for 3 new drugs
.
The specific drugs are shown in the table below (among them, the ones marked with yellow are new ingredients and new drugs)
.
Table 3: Top five companies with new drug approvals and their new drug status From the data on new drugs approved in the first quarter of 2022, it can be seen that Chugai (Chinese and foreign) involves many fields, including anti-tumor, bone and muscle, and ophthalmology.
field
.
The main development focus of Bayer and Nobelpharma is on reproductive system drugs and sex hormone drugs
.
Novartis (Novartis) focuses on the development of antineoplastic and immunomodulatory drugs, while Pfizer (Pfizer) is more prominent in anti-infective drugs
.
Drugs that are significantly different from approved drugs are mainly drugs containing new active ingredients, new compound drugs, new route of administration drugs, new indication drugs, new dosage form drugs, new dose drugs, etc.
)
.
Among them, there are 22 new drugs containing new ingredients
.
According to the classification of drug treatment categories, the drug categories with the largest number of new drug approvals are anti-tumor drugs, reproductive system drugs, sex hormones and skeletal and muscle drugs, with 13, 11 and 4 drugs respectively
.
The drug categories with the most new ingredients and new drugs are antitumor drugs, digestive system drugs and nervous system drugs
.
Figure 1: Therapeutic categories of new PMDA drugs in the first quarter of 2022 Among the most popular new anti-tumor drugs, 3 are new drugs containing new ingredients, and the most approved drugs including new drugs are monoclonal antibodies, targeted small molecules Antineoplastic drugs and alkylating agent antineoplastic drugs
.
Among the 13 new drugs, in China, selpercatinib was declared for marketing, nivolumab, pembrolizumab, and pertuzumab were imported for marketing, asciminib and sotorasib were declared for clinical stage, and fornetupitant was not declared.
and listing information, the rest of the new drugs are listed as domestic products of the same variety in China, and the specific drugs are shown in the table below (among them, new drugs with new ingredients are marked in yellow)
.
Table 1: Antineoplastic Drugs and Their Situation Among the new drugs announced by PMDA in the first quarter, five new drugs with new components were approved for listing in Japan for the first time in the world
.
Table 2: Carotegrast methyl, Japan's first drug in the global market, is a prodrug of α4 integrin inhibitor developed by EAPharma (Eisai), which can block the α4 integrin on the surface of inflammatory cells and the adhesion of vascular endothelial cells such as digestive tract mucosa.
Attachment molecule, suitable for patients with moderate ulcerative colitis who are not ideally treated with 5-aminosalicylic acid (5-ASA) preparations
.
Clazosentan is an endothelin receptor antagonist developed by Idorsia for the treatment of cerebral vasospasm, cerebral infarction, and cerebral ischemia-related vasospasm after cerebral infarction and aneurysm
.
Gefapixant is the first selective P2X3 receptor antagonist developed by MSD for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC)
.
Nemolizumab is a humanized anti-human IL-31 receptor A monoclonal antibody originally developed by Chugai (Chongwai), which is suitable for the treatment of pruritus associated with allergic dermatitis when the current treatment effect is not satisfactory
.
IL-31, an itch-inducing cytokine, has been reported to be associated with pruritus in patients with atopic dermatitis
.
Olipudaseα is the world's first non-central neuropathy treatment drug for adults and children with acid sphingomyelinase deficiency (ASMD) developed by Sanofi
.
In addition, in the new drug data for the first quarter of 2022, a total of 38 companies have approved new drugs
.
Among them, 11 companies have been approved for new anti-tumor drugs, and 7 companies have been approved for reproductive system drugs and sex hormone drugs
.
Figure 2: PMDA approved new drug companies and treatment categories in the first quarter of 2022 Among all the approved companies, the companies with the largest number of approved new drugs are Chugai (China and foreign countries), Bayer (Bayer), Nobelpharma (Nobelen Pharmaceuticals), Novartis (Novartis) and Pfizer (Pfizer), Chugai (Zhongwai) and Nobelpharma (Nobelpharma) were approved for 4 new drugs, and the remaining three were approved for 3 new drugs
.
The specific drugs are shown in the table below (among them, the ones marked with yellow are new ingredients and new drugs)
.
Table 3: Top five companies with new drug approvals and their new drug status From the data on new drugs approved in the first quarter of 2022, it can be seen that Chugai (Chinese and foreign) involves many fields, including anti-tumor, bone and muscle, and ophthalmology.
field
.
The main development focus of Bayer and Nobelpharma is on reproductive system drugs and sex hormone drugs
.
Novartis (Novartis) focuses on the development of antineoplastic and immunomodulatory drugs, while Pfizer (Pfizer) is more prominent in anti-infective drugs
.
