Priority review of panoramic scanning, Dongyang Sunshine, Hengrui, China Biopharmaceutical......

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5em;box-sizing:border-box ;overflow-wrap:break-word ;'> 5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>In recent years, in order to speed up the development and marketing of new drugs with clinical value and clinically urgently needed generic drugs, the National Bureau has played a series of combo punches.
The new "Administrative Measures for Drug Registration" provides for the accelerated registration procedures for drugs in the form of a special chapter, and establishes four accelerated channels for breakthrough therapeutic drugs , conditional approval , priority review and approval, and special approval .
Among them, the priority review and approval has played a very important role.

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>In recent years, in order to speed up the development and marketing of new drugs with clinical value and clinically urgently needed generic drugs, the National Bureau has played a series of combo punches.
The new "Administrative Measures for Drug Registration" provides for the accelerated registration procedures for drugs in the form of a special chapter, and establishes four accelerated channels for breakthrough therapeutic drugs , conditional approval , priority review and approval, and special approval .
Among them, the priority review and approval has played a very important role.
Breakthrough treatment drugs with conditional approval, priority review, review and approval, special approval544px;text-align:justify;white-space:normal;background-color:#FFFFFF;line-height:1.
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5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>As of March 26, 2021, the number of drug acceptances included in the priority review has reached 1,247 (of which 15 have unpublished acceptance numbers).

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>According to statistics based on the publication time of the priority review of included drugs, since the national implementation of priority review and approval, the declaration of innovative drugs has increased rapidly from 2017 to 2018, and has declined in 2019.
The rapid increase is related to national policies.
When the priority review and approval policy was first opened in 2016, it was very attractive to enterprises.
In addition, China had a drug gap in the field of major diseases at that time, and a batch of new drugs was urgently needed to fill the gap.
At the same time, in order to shorten the time for foreign new drugs to be marketed in China, China announced the acceptance of overseas clinical trial data, which greatly improved the efficiency of new drugs' listing in China.
Benefiting from this policy, a batch of original research drugs were included in the priority review and approval queue, so there was a peak of imported drugs in 2017.
Since 2018, the number of generic drugs has gradually decreased, and priority review resources are focusing more on drugs with obvious clinical value, urgent clinical needs and clinical advantages.
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5px;box-sizing:border-box ;overflow-wrap:break-word ;">Enterprise Priority Review Ranking,5px;box-sizing:border-box ;overflow-wrap:break-word ;"> Enterprise Priority Review Ranking,5px;box-sizing:border-box ;overflow-wrap:break-word ;"> Enterprise Priority Review Ranking,

544px;white-space:normal;background-color:#FFFFFF;text-align:center;line-height:2em;box-sizing:border-box ;'> 5px;box-sizing:border-box ;overflow-wrap:break-word ;">East Sunshine tops the list

5px;box-sizing:border-box ;overflow-wrap:break-word ;">East Sunshine tops the list5px;box-sizing:border-box ;overflow-wrap:break-word ;"> East Sunshine tops the list5px;box-sizing:border-box ;overflow-wrap:break-word ;"> East Sunshine tops the list544px;white-space:normal;background-color:#FFFFFF;text-align:center;line-height:1.
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5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>Among the 1,247 acceptance numbers that have been included in the priority review, 275 companies are involved.

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>In terms of the number of application acceptance numbers, Dongyang Sunshine has the largest number of applications, reaching 55, followed by China Biopharmaceuticals and Hengrui Pharmaceuticals.

5px;box-sizing:border-box ;overflow-wrap:break-word ;">"Children's medicine" is the starting point,5px;box-sizing:border-box ;overflow-wrap:break-word ;"> "Children's medicine" is the starting point, and5px;box-sizing:border-box ;overflow-wrap:break-word ;"> "Children's medicine" is the starting point.

5px;box-sizing:border-box ;overflow-wrap:break-word ;">Now "obvious therapeutic advantage" is the hottest product,5px;box-sizing:border-box ;overflow-wrap:break-word ;"> now "obvious therapeutic advantage" is the hottest product,5px;box-sizing:border-box ;overflow-wrap:break-word ;"> now "obvious therapeutic advantage" is the hottest product544px;white-space:normal;background-color:#FFFFFF;text-align:center;line-height:1.

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>We have also made statistics on the reasons for the inclusion of 1,247 acceptance numbers in the list, as shown in the figure below:544px;white-space:normal;background-color:#FFFFFF;text-align:center;line-height:1.

5px;box-sizing:border-box ;overflow-wrap:break-word ;">According to statistics, the reason for being included in the priority review is that it has “obvious therapeutic advantages compared with existing treatment methods”, involving 274 drugs, accounting for 21.

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>Judging from the situation of approved production, there are the most varieties of priority review on the grounds of "obvious therapeutic advantages compared with existing treatment methods".
At present, 103 such drugs have been approved for marketing in China, and among the approved drugs, imported drugs account for up to 77% (according to the acceptance number).
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5em;box-sizing:border-box ;overflow-wrap:break-word ;'>The following is the approved 5px;box-sizing:border-box ;overflow-wrap:break-word ;">category 1 drug information that "has obvious therapeutic advantages over existing treatments":The following is the approved 5px;box-sizing:border-box ;overflow-wrap:break-word ;">category 1 drug information with5px;box-sizing:border-box ;overflow-wrap:break-word ;"> "obvious therapeutic advantage compared with existing treatments" 5px;box-sizing:border-box ;overflow-wrap:break-word ;">: Information on category 1 drug5px;box-sizing:border-box ;overflow-wrap:break-word ;"> with "obvious therapeutic advantage compared with existing treatments":

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5em;box-sizing:border-box ;'> 5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>Hengrui Medicine has 3 models, namely: remazolam tosylate for injection, fluzoparib capsules, and carrelizumab for injection.

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>Hengrui Medicine has 3 models, namely: remazolam tosylate for injection, fluzoparib capsules, and carrelizumab for injection.
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5em;box-sizing:border-box ;'> 5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>Undoubtedly, according to relevant national policies, drugs are included in the priority review sequence, which means that the review and approval time for drug listing will be shortened, which will accelerate the listing of drugs, benefit related patients, and also help companies to seize the market.

5px;font-size:15px;font-family:, "Microsoft YaHei";color:#494949;letter-spacing:1px;'>Undoubtedly, according to relevant national policies, drugs are included in the priority review sequence, which means that the review and approval time for drug listing will be shortened, which will accelerate the listing of drugs, benefit related patients, and also help companies to seize the market.