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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.
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, and sex hormones and skeletal and muscle drugs, with 13, 11 and 4 drugs, respectively
Figure 1: PMDA new drug treatment categories 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 molecule anti-tumor drugs and alkylating agent anti-tumor drugs
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 molecule anti-tumor drugs and alkylating agent anti-tumor drugs
Among the new drugs announced by PMDA in the first quarter, 5 new drugs with new ingredients were approved for marketing in Japan for the first time in the world
Table 2: Japan's First Drugs Among Globally Marketed Drugs
Carotegrast methyl is a prodrug of α4 integrin inhibitor developed by EAPharma (Eisai), which can block α4 integrin on the surface of inflammatory cells and adhesion molecules of vascular endothelial cells such as digestive tract mucosa.
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
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
In addition, in the new drug data for the first quarter of 2022, a total of 38 companies have approved new drugs
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 (China and foreign countries) and Nobelpharma ( Nobelren Pharmaceuticals) was approved for 4 new drugs, and the remaining three were approved for 3 new drugs
Table 3: Top five companies with approved new drugs and their new drugs
From the data of new drugs approved in the first quarter of 2022, it can be seen that Chugai (China and foreign countries) involves many fields, including anti-tumor, bone and muscle, and ophthalmology
