13 Class 1 innovative drugs have been approved for marketing!

With the promulgation and implementation of the "Measures for the Administration of Drug Registration", the reform of the drug review system and the modernization of review capabilities, under the guidance of the "innovation" policy, the overall application pattern has been gradually replaced by innovative drugs from the past based on generic dru.

Drug application acceptance in the first half of 2022

The overall situation of declarations in the first half of 2022

Acceptance in the first half of 2022

According to the latest statistics from Yaozhi data, from January to June 2022, CDE has undertaken a total of 5,850 new drug registration applications (counted by acceptance number, except for review, the same below), including 4,139 for chemical drugs, 740 for traditional Chinese medicine, and 740 for biological produc.

Figure 1 CDE drug acceptance from January to June 2022

Data source: Yaozhi Data, Yaozhi Consulting

Application status of each registration application type in the first half of 2022

In the first half of 2022, the applications accepted by CDE were counted by registration application category, and 1,058 new drug clinical trial applications (hereinafter referred to as IND) were accepted; 168 new drug marketing authorization applications (hereinafter referred to as NDA) were accepted; There are 1,077 acceptance numbers for similar drug marketing authorization applications (hereinafter referred to as ANDAs); 426 registration applications for generic drug quality and efficacy consistency evaluation (hereinafter referred to as consistency evaluation applications for this registration application category); applications from January to June 2022 See Figure 2 for the number of class registration applications accept.

Figure 2 Acceptance of registration applications by application category from January to June 2022

Data source: Yaozhi Data, Yaozhi Consulting

Acceptance of innovative drug registration applications in the first half of 2022

In the first half of 2022, CDE accepted 832 applications for Category 1 innovative drugs, involving anti-tumor, anti-infection and other fields; including 494 applications for chemical drugs, 23 applications for traditional Chinese medicine, and 315 applications for biological products; January-June 1, 2022 See Figure 3 for the acceptance of applications for quasi-innovative dru.

       Figure 3 Acceptance of Class 1 Innovative Drug Applications from January to June 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Application of chemical drugs in the first half of 2022

        Acceptance of chemical drugs in the first half of 2022

       In the first half of 2022, CDE accepted a total of 4,139 chemical drug registration applicatio.

       Figure 4 Application acceptance of chemical drugs by review task category in the first half of 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Application of Class 1 innovative drugs of chemical drugs in the first half of 2022

       In the first half of 2022, CDE accepted 494 chemical drug category 1 innovative drug acceptance numbers, of which 375 were domestically produced and 119 were imported; according to the review task category, there were 478 IND applications involving 227 varieties, and 16 NDA applications involving varieti.

       Figure 5 Acceptance of registration applications for Class 1 innovative drugs of chemical drugs from January to June 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Application of improved new drugs of chemical drugs in the first half of 2022

       According to the current registration classification of chemical drugs, Class 2 refers to "improved new drugs that have not been marketed at home and abroad, and refers to the optimization of their structure, dosage form, prescription process, route of administration, indications, e.

       In the first half of 2022, CDE has newly accepted 164 new drug acceptance numbers for Category 2 improved chemical drugs, including 136 IND applications and 28 NDA applications; details of the acceptance of registration applications for Category 2 improved new drugs for chemical drugs from January to June 2022 See Figure

       Figure 6 Acceptance of registration applications for improved new drug category 2 of chemical drugs from January to June 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Application status of chemical drug consistency evaluation in the first half of 2022

       In the first half of 2022, CDE has newly accepted 426 acceptance numbers for consistency evaluation, involving 198 varieties and 216 companies, of which Shandong Lukang Pharmaceutical has the most applications, followed by Chengdu Better and North China Pharmaceuticals; See Figure 7 for the TOP10 applications for sexuality evaluati.

       Figure 7 Top 10 applications for enterprise consistency evaluation in the first half of 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Application of traditional Chinese medicine in the first half of 2022

        Acceptance of traditional Chinese medicines in the first half of 2022

       Influenced by its own drug characteristics, traditional Chinese medicine applications have always been in a relatively sluggish sta.

       Table 1 New listing applications of traditional Chinese medicines undertaken in the first half of 2022

        Declaration of biological products in the first half of 2022

        Acceptance of biological products in the first half of 2022

       In the first half of 2022, CDE accepted 961 biological product registration applications, including 349 new drug applications, 411 supplementary applications, 171 imported (including 7 one-time imports), and 30 imported re-registrations; biological products in the first half of 2022 See Figure 8 for the acceptance of registration applicatio.

       Figure 8 Acceptance of biological product registration applications in the first half of 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Application of innovative biological products in the first half of 2022

       In the first half of 2022, 315 innovative drugs of class 1 biological products were accepted; according to the review task category, there were 301 IND applications (including 3 preventive biological products and 298 therapeutic biological products), and 14 NDA applications (including preventive biological product.

       Table 2 Newly Undertaken New Drug Listing Applications for Category 1 Biological Products in the First Half of 2022

       Completion of drug registration review in the first half of 2022

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       According to the latest statistics of the Yaozhi registration and acceptance database, in the first half of 2022 (Note: the status start time (Yaozhi) is from January 1, 2022 to June 30, 2022) the number of acceptance numbers that have been reviewed and completed is 5,33 The number of conclusions included in Zhizhi is 5,334 acceptance numbers, including 3,760 for chemical drugs, 673 for traditional Chinese medicine, and 882 for biological produc.

       Figure 9 Details of the conclusion of the registration application review in the first half of 2022

       Data source: Yaozhi Data, Yaozhi Consulting

        Approval of innovative chemical drugs in the first half of 2022

       In the first half of 2022, CDE has reviewed and completed a total of 481 acceptance numbers for Class 1 innovative chemical drugs; of which 464 were IND applications, all of which were approved for clinical use, involving anti-tumor, endocrine system and anti-infection and other fields; 17 NDA applications, 15 1 approved for marketing, involving diabetes, breast cancer, dermatitis and other indications; in the first half of 2022, the newly approved Class 1 chemical drug innovative drugs are shown in Table

       Table 3 Newly approved Class 1 chemical innovative drugs in the first half of 2022

        Approval of innovative biological products in the first half of 2022

       In the first half of 2022, CDE has reviewed and completed a total of 277 biologics category 1 innovative drug acceptance numbers; including 273 IND applications, all of which have been approved for clinical use, involving advanced solid tumors, non-small cell lung cancer, triple-negative breast cancer and other indications; NDA applications 4, all of which have been approved for marketing; in the first half of 2022, the newly approved Class 1 biological product innovative drugs are shown in Table

       Table 4 Newly approved Class 1 biological product innovative drugs in the first half of 2022

       Review of accelerated drug listing registration procedures in the first half of 2022

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       In the first half of 2022, 22 varieties will be included in the priority review process, including 15 chemical drugs and 7 biological produc.

       Table 5 Varieties included in the priority review and approval process in the first half of 2022

        Breakthrough therapy review in the first half of 2022

       In the first half of 2022, 22 varieties were included in the breakthrough therapy review process, including 13 chemical drugs and 9 biological products; indications include epilepsy, non-small cell lung cancer and systemic myasthenia gravis; See Table 6 for the varieties included in the breakthrough therapy review process for half a ye.

       Table 6: Varieties included in the breakthrough therapy review process in the first half of 2022

       Data source: Yaozhi Drug Registration and Acceptance Database