2020 inventory: China's 2 categories of "improved new drugs" analysis, Jiangsu Hengrui, Nanjing Shenghe...

Improved new drugs, for the current research and development of new drugs, one of the hot direction.
And just past December 31, 2020, CDE officials issued more than 20 guiding principles, namely, "Chemical modified new drug clinical trial technical guidelines" to further clarify the clinical advantages of China's improved new drugs definition, and encourage clinical development.
in this statistic just past 2020 China's 2 types of improved new drugs registration declaration and approval status, in order to more objective understanding of China's 2 types of improved new drugs development status.
PS: To understand the 2020 "Class 1 new drugs" first IND situation, you can read the author's 2020 inventory: 164 "Class 1 new drugs" first IND, Zhengda Qing, Dongsong medicine ... A article.
Improved new drugs 2.1 class IND/NDA acceptance-approval statistics First of all, class 2 modified new drugs refers to the structure, dosage form, prescription process, administration pathway, adaptive, etc. on the basis of known active ingredients, and has obvious clinical advantages of drugs.
subdivided into category 2.1 refers to optical isomers containing known active ingredients made by means of splitting or synthesis, or esters of known active ingredients, or salts of known active ingredients (including those containing hydrogen bonds or salt of a bit bond), or alters the acid, base, or metal element of a known active salt ingredient, or forms other non-co-priced bond derivatives (such as complexes, chelates, or envelopes), apidas and their preparations with clear clinical advantages.
the whole of 2020, 2.1 new drugs with improved types, CDE hosted only 4 IND varieties, and the injection HR18034 developed by Jiangsu Hengrui made 2.1 and 2.2 registration declarations, respectively.
NDA varieties, only Nanjing Sheng and Pharmaceutical Co., Ltd.'s zuo nitrosium tablets, approved for production.
Table 1.1 2020 Domestic Chemical Drugs 2.1 Class IND Variety Acceptance Statistics (Data Source: Pharmaceutical Intelligence Data) Improved New Drugs Class 2.2 IND/NDA Acceptance-Approval Statistics Category 2.2 refers to new dosage forms containing known active ingredients (including new drug administration systems), new prescription processes, new administration routes, and preparations with obvious clinical advantages.
this category is an important development direction of 2 types of improved new drugs in China, so the number of registered and declared varieties and approved quantities are relatively large each year.
in terms of IND varieties, more than 40 varieties have been commissioned by CDE, of which, Nanjing Green Leaf Pharmaceuticals' hydrochloric acid ilitifluoroside liposome injection is registered with chemical drug 2.2/2.3, Jiangsu Heng Rui's hydrochloric acid elithic lipid body injection is registered with chemical drugs 2.2/2.4 registration declaration, Jiangsu Osaikang Pharmaceuticals injection with Grebenzene is chemical drugs 2.2/2.4 registration declaration.
table 2.1 2020 domestic chemical drugs 2.2 class IND varieties acceptance statistics (data source: pharmaceutical intelligence data) NDA varieties, a total of 7 varieties were CDE contractor, of which Qilu pharmaceutical declared relatively many varieties;
Table 2.2 2020 Domestic Pharmaceutical 2.2 Class NDA Variety Acceptance Statistics (Data Source: Pharmaceutical Intelligence Data) Improved New Drug Class 2.3 IND/NDA Acceptance-Approval Statistics Class 2.3 refers to new compound preparations containing known active ingredients, and has obvious clinical advantages.
the IND variety declaration, a total of 6 new compounds were accepted throughout 2020.
NDA variety declaration, only 1 variety was accepted, for Changchun Haiyue Pharmaceutical Co., Ltd. XY066 capsules.
table 3.1 2020 domestic chemical drugs 2.3 types of IND varieties acceptance statistics (data source: pharmaceutical intelligence data) improved new drugs 2.4 types of IND/NDA acceptance - approval statistics 2.4 categories, containing known active ingredients of new adaptive agents;
IND varieties, there are nearly 20 chemical entities of the new adaptive disease to obtain the CDE, of which, Jiangyin Beresen Pharmaceutical Co., Ltd.'s Menglust sodium gel is a chemical drug 2.4/2.2 registration declaration, Jiangsu Hengrui Pharmaceutical Co., Ltd. injection HR17020 is a chemical drug 2.4/2.2 registration declaration.
table 4.1 2020 domestic chemical drugs 2.4 types of IND varieties receiving statistics (data source: pharmaceutical data) NDA varieties, a total of 7 varieties in 2020 were accepted, mostly for the domestic market in recent years, 1 class of chemical drugs, of which Jiangsu Hengrui has 2 products were accepted, respectively, fluorine and apatini.
Table 4.2 2020 Domestic Pharmaceutical 2.4 Class NDA Variety Acceptance Statistics (Data Source: Pharmaceutical Intelligence Data) In addition, NDA Varieties, 2020 a total of 3 varieties approved for production in category 2.4 of chemical drugs, namely, Nirapali of Reding Pharmaceuticals, Amrotini of Zhengtiantian, and AstraZeneta of AstraZeneta.
table 4.3 2020 domestic pharmaceutical 2.4 types of NDA varieties batch production statistics (data source: pharmaceutical intelligence data) summary, from the registration classification, the overall development of domestic improved new drugs or new preparations and new adaptors, 2.1 and 2.3 relatively few.
the listing of domestic class 1 new drugs, along with the registration and declaration of 2 types of improved new drugs, has changed from a trend to a normal, with a view to obtaining a greater range of clinical use and adaptive market.
And through many years of statistics, it is not difficult to find that this year, the number of registration declarations of 2 new drugs increased significantly, domestic pharmaceutical companies for 2 new drugs have significantly increased the degree of concern;