2022 inventory 416 domestic improved new drugs accepted, Qilu, Chia Tai Tianqing, Yueyang...

As a Class 2 improved new drug, according to the registration application, it can be refined into Class 2.
1, 2.
2, 2.
3 and 2.
4; Among them, the category with more attention and greater difficulty is category 2.
1, that is, "APIs and preparations containing known active ingredients prepared by separation or synthesis, or esters of known active ingredients, or salts of known active ingredients, or changes the acid, base or metal elements of the active ingredients of known salts, or forms other non-covalent bond derivatives, and has obvious clinical advantages"
。 Category 2.
2 focuses on "new dosage forms, new prescription processes, and new routes of administration containing known active ingredients", Category 2.
3 focuses on "new compound preparations containing known active ingredients", and Class 2.
4 focuses on "preparations containing new indications of known active ingredients"; At the same time, it is necessary to focus on "having clear clinical advantages"
.

Based on the above registration classification requirements, and looking at the registration application data of Class 2 new drugs in 2022, it can be found that the number of acceptance numbers for Class 2.
1 is 9, which is the lowest number of categories among the four subcategories; The combined quantity of 2.
2 and 2.
4 accounts for 86% of the total number of new drugs declared for the entire class 2, and the specific technology points to new dosage forms and new indications
.

Figure 2 Statistics on the number of domestic 2.
1-2.
4 acceptance numbers in 2022