2019 has come to an end, the national CDE into the priority review and approval channel of varieties, nearly 100, of which the number of chemical drugs significantly more than biological drugs, innovation and imported varieties accounted for nearly 50%, and the inclusion of varieties are mostly reported production status, covering many tumors, rare diseases in the field of large varieties, relatively high degree of attention! "Priority Review and Approval" Policy Brief In February 2013, the former CFDA (now NMPA) promulgated the Opinions on Deepening Drug Review and Approval Reform to Further Encourage Drug Innovation, proposing to speed up the review of innovative drugs, children's drug use, and priority review of generic drugs in clinical urgent need saucy and market shortage, which is the first time that priority review has been submitted in the text.
November 2015, the original CFDA issued the "Announcement on A number of policies on the review and approval of drug registration", which clearly states that the relevant policies to be formulated and issued for priority review and approval, to encourage market shortage and research and production of innovative drugs, and to put the construction of priority review system on the agenda.
February 2016, the original CFDA officially issued the Implementation of the Opinionon on The Implementation of Priority Review and Approval to Address the Backlog of Drug Registration Applications, which clearly states that new drugs with clinical value and clinically urgent lysing drug research and development are marketed in the current situation of review backlog.
the new varieties of chemical drugs included in the priority review and approval in 2019 as of the time, in 2019 the current category 1 new drug varieties (including imported varieties) included in the priority review, a total of 8, are currently in the NDA stage, in chronological order of Enshatini, Heize Mayb, Sinimod, Ometinib, toluene sulfonate remaline, HSK3486, zoo nitrosephine, imetavir, among which, the relatively high degree of attention of the varieties are ometinib and Ensatini.
declaration enterprises involved in Beida, Haizheng, Haussen, Hengrui, Haicisco, Yangzijiang, Dongsun and other domestic large-scale pharmaceutical companies.
4 new drug varieties (2.2 and 2.4) currently included in the priority review in 2019, are currently in the NDA stage, in chronological order for entikave particles, maxitentan tablets, hydrated chloral/syrup combination packaging, and ethyl sulfonate nidanib softgels.
, enthikawe in the country, although a large variety, but "4 plus 7" after its profit margin has been greatly reduced.
the five types of imported drugs (5.1) currently included in the priority review in 2019, a total of 7, in chronological order, the Praqualsa injection, apalumine tablets, the Avalapson sodium chloride injection, the qumetinib tablets, darafini capsules, the chlorinated radon (223Ra) injections.
, Apaluahas has been approved for import.
Table 1: The "Chemical Drugs Category 1, 2, 5.1" varieties included in the priority review in 2019 have been included in the priority review and approval of generic varieties of chemical drugs as of 2019, 24 generic drugs of the chemical drugs currently included in the priority review in 2019, a total of 28 generic drugs, declared enterprises are domestic pharmaceutical enterprises.
, the largest number of generic varieties included in the priority review, there are 4, respectively, succinic acid de-mevenlafisin slow release tablets, midazolam oral solution, hydrochloric acid amphetamine slowly release tablets, hydrochloric acid metformin slow release tablets.
other enterprises, such as Shiqiao Bio, Yiling Bio, Chengdu Yuandong Bio, Lizhu Group, Shanghai Xuantai Haimen Pharmaceuticals, Sichuan Huiyu Pharmaceuticals, etc., have 2 varieties included in the priority review.
Table 2: Biopharmaceutical species in categories "Category 3 and 4" that were included in the priority review in 2019 are as of the time being issued, and biopharmaceuticals currently included in the priority review in 2019, mainly biological products for therapeutic use, and most of them are anti-tumor monotonicas.
, the declared type of "therapeutic biological products imported" varieties are mainly Navuliu monoidat, Paboli bead monoidat, patobead monoidat, cucciu monoidat, sitoxiformer monoidandagain and so on.
"Therapeutic biological products 1 class, 2 category, 15 category" varieties are mainly for reilly bead monosar, Carelli bead monosar, recombinant newland green, Adamu monosar, belavbead monosar, rituximab, qutodzumab and so on.
enterprises, Cinda Bio, Fuhong Hanxuan, Roche (China) included in the biopharmaceutical priority review and approval of the number of varieties is relatively large.
Table 3: Biopharmaceutical species included in priority review in 2019 Data source: 1.NMPA Official Website 2.CDE Official Website 3.Yaozh Data 4. Information on the official websites of major companies.