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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.
Approved new biological drugs and similar drugs
Both biosimilars are immunomodulato.
Also used as an immunosuppressant is a new biological drug, Enjaymo (sutimlimab), designed to address the serious and long-term unmet medical needs of adults with the rare disease cold agglutinin disease (CA.
The remaining 3 new biological drugs are Spikevax (new coronavirus mRNA vaccine), Nucala (mepolizumab) and Vabysmo (faricimab), which are respectively used to prevent COVID-19 and treat severe eosinophilic asthma (SEA) in school-age childr.
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
Among 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 approved new molecular entity new drugs, there are 2 neurological dru.
Additionally, the orphan drug Pyrukynd (mitapivat) is an oral small molecule pyruvate kinase activator indicated for the treatment of adults with pyruvate kinase (PK) deficient hemolytic anem.
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
In 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.
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 Smart 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 Smart Drug Big Data Analysis Platform
