U.S. FDA Approval of Listed Drugs and my country's Domestic Application Status in the First Quarter of 2021

In the first quarter of 2021, the U.

BLA is the abbreviation of Biologic License Application.

Table 1 Biologics license application drugs in the first quarter of 2021

Among the 30 NDA applications, there are Type 1 – 15 new molecular entities and new drugs, Type 2 – 1 new active ingredient classification, Type 3 – 4 new dosage forms, and Type 4 – 3 new compound drugs, Type 5-9 new preparations or new manufacturers of new drugs, of which CABENUVA KIT and AZSTARYS are both new molecular entities and new compounds.

Type 1-New Molecular Entities (NME)

A new molecular entity refers to an active ingredient that has never been approved or sold as a drug in the United States.

Among the 15 NMDs, the top three according to the ATC first-level classification are anti-tumor drugs and immunomodulators (6 new drugs), systemic anti-infective drugs (3 new drugs) and neurological drugs (3 new drugs) .

Table 2 NMD applications for new molecular entities in the first quarter of 2021

Note: NSCLC: metastatic non-small cell lung cancer; MZL: relapsed or refractory marginal zone lymphoma; FL: relapsed or refractory follicular lymphoma; ADHD: attention deficit hyperactivity disorder

Type 2-new active ingredients

The new active ingredients include active entities that have been approved or have been marketed in the United States, and are specific esters, salts, or non-covalent bond derivatives of active entities that have not been approved or marketed.

If the active ingredient is an enantiomer and the racemic mixture contains an enantiomer that has been approved by the FDA or has been marketed in the United States, or the active ingredient is a racemic mixture and contains an enantiomer that has been approved by the FDA or has been marketed in the United States, Then the NDA application will be classified as a new active ingredient.

Selenium is the most important anti-aging element discovered so far.

Table 3 NMD applications for new active ingredients in the first quarter of 2021

Type 3-new dosage form

The NDA application for a new dosage form applies to a new dosage form for which a certain active ingredient has not been approved or has not been marketed in the United States.

There are 4 new drug applications for Type 3 NMD, among which MYRBETRIQ GRANULES has been approved through the priority review channel, pemetrexed has the same variety of domestic products listed in my country, and 20 domestic enterprises of the same variety have been approved.

Table 4 New dosage form NMD drugs applied for in the first quarter of 2021

Type 4-new compound medicine

The NDA application for a new compound drug is applicable to a new compound drug with two or more active ingredients.

CABENUVA KIT is a compound of Cabotvir and Ripivirin.

Table 5 New compound NMD application drugs in the first quarter of 2021

Note: ADHD: attention deficit hyperactivity disorder; LDL-C: low-density lipoprotein cholesterol

Type 5-new formulation or new manufacturer

NDA applications for new preparations or new manufacturers are for products rather than new dosage forms, and include new indications, new applicants, or new manufacturers.

There are 9 new formulations or new manufacturer's drugs in the NMD new drug application, of which DOLUTEGRAVIR SODIUM passed the priority review.

Table 6 NMD applications for new preparations or new manufacturers in the first quarter of 2021

Figure 1 Number of Type 5 new drugs approved by the FDA in the first quarter of 2021

Data source: China Pharmaceutical Industry Information Center, CPM New Drug Research and Development Monitoring Database

Compared with new drug applications, the number of ANMD generic drug registration applications is very large, a total of 223.

Figure 2 Statistics on the number of generic drugs approved by the FDA in the first quarter of 2021 (according to the ATC primary classification)

Data source: China Pharmaceutical Industry Information Center, CPM New Drug Research and Development Monitoring Database