-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
As of the end of March 2022, the US FDA has announced 252 approved drugs this year, including 10 BLA biological products, 35 NDA chemical original drugs, and 207 ANDA chemical generic dru.
The therapeutic areas of new biologics and chemical originator drugs approved this quarter focus on anti-tumor and immunomodulatory agents, while generic drugs focus on neurological dru.
Approved new biological drugs and similar drugs
Both biosimilars are immunomodulato.
Both biosimilars are immunomodulato.
Half of the 8 new biological drugs are anti-tumor drugs, including Kimmtrak (tebentafusp), Carvykti (Sidaki Aurexa), Opdivo (nivolumab) and Opdualag (relatlimab + nivolumab, compoun.
Table 1: FDA-approved BLA biologics in the first quarter of 2022
Data source: China Pharmaceutical Industry Information Center, Pharma ONE intelligent drug big data analysis platform
Approved original chemical drug
Approved original chemical drugAmong the 35 approved NDA drugs, 6 Type1-new molecular entity new drugs are worthy of attention, including 3 anti-tumor and immunomodulatory agents: Vonjo (pairitinib) is an inhibitor of JAK2, IRAK1 and CSF
Among the 35 approved NDA drugs, 6 Type1-new molecular entity new drugs are worthy of attention, including 3 anti-tumor and immunomodulatory agents:
Among the approved new molecular entity new drugs, there are 2 neurological dru.
Among the approved new molecular entity new drugs, there are 2 neurological dru.
Table 2: FDA Approved Q1 2022
Type1-New molecular entity class of new drugs
Data source: China Pharmaceutical Industry Information Center, Pharma ONE intelligent drug big data analysis platform
Chinese companies in generic drugs
Chinese companies in generic drugsIn the first quarter, the FDA approved a total of 207 chemical generic dru.
The 12 ANDA approval numbers were obtained by Chinese companies, half of which are anti-tumor drugs and neurological dru.
Overall, half of the approved generic drug applications from Chinese companies are antitumor drugs and neurological drugs, and the rest are antibacterial and antiviral drugs, lipid-lowering and antihypertensive drugs,e.
Figure 1: ATC Tier 1 classification of FDA-approved ANDA drugs in the first quarter of 2022
Data source: China Pharmaceutical Industry Information Center, Pharma ONE intelligent drug big data analysis platform
Table 3: FDA-approved ANDA generic drugs from Chinese companies in the first quarter of 2022
Data source: China Pharmaceutical Industry Information Center, Pharma ONE intelligent drug big data analysis platform
