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According to incomplete statistics, in the first half of 2022 (as of June 30, 2022), a total of 789 new drug clinical applications (calculated by acceptance number, the same below) were accepted by CDE, which was basically the same as that in the first half of 2021 (785 application.
In terms of registration classification, Category 1 new drugs have the most (accounting for 79%), reaching 627; Category 2 new drugs have 133, accounting for about 17%; Category 3 new drugs are less, only 2
In terms of therapeutic areas, anti-tumor and immunomodulatory agents (categories) are still far ahead, with a total of 363, accounting for 46%, of which anti-tumor drugs (subcategories) are the main ones (339); More than 50; another 142 unpublished therapeutic are.
In recent years, the morbidity and mortality of tumors in China have continued to increase, and the cost of treatment is high, which has become a heavy economic burden for patients, families and the count.
In terms of homogenization competition, in addition to the anti-tumor drug track, there is also a phenomenon of target groupi.
Previous data show that among the ophthalmic drugs under development, the first indication is retinal diseases, mainly diabetic retinopathy and AMD, accounting for nearly 50%; followed by glaucoma, accounting for about 20%; the third is dry eye disease, accounting for 1
From this perspective, in addition to the most popular anti-tumor drugs, drugs for the treatment of diabetes and related diseases have become the second-largest research and development hotspot among the new drugs submitted for clinical application in the first half of 202
Although glucose control drugs with various mechanisms of action are available, the blood glucose control of diabetic patients is still not ide.
The second place is Qilu Pharmaceutical, which has declared 28 new drug clinical trials, of which 13 are class 2 new drugs, including atropine sulfate eye drops and oseltamivir phosphate oral dissolving fi.
The third place is Fosun Pharma, which has applied for 16 new drug clinical tria.
Other companies with more than 10 declarations include Chia Tai Tianqing (14), BeiGene (12), Langlai Technology (12), Junshi Biology (11), Kelun Pharmaceutical (10) ), Yaojie Ankang (10), Qiyuan Biological (1
Among the top ten companies in the number of declarations, there are 6 listed companies and their subsidiari.