A shift has been detected in the global new drug competition landscape in 2025. The U.S. Food and Drug Administration (FDA) approved only 46 new drugs last year, while China's National Medical Products Administration (NMPA) approved 68, surpassing the United States for the first time.

According to the Bioeconomy Research Center at the Korea Biotechnology Industry Organization on the 4th, the number of FDA approvals in the United States fell by 4 from 50 in 2024 and by 9 from 55 in 2023. Budget cuts and staff reductions are believed to have played a role. The decline in approvals could negatively affect the pace of new drug development and global investor sentiment, drawing attention to this year's trend.

Looking at approval trends over the past seven years, the U.S. FDA showed ups and downs with 48 in 2019, 53 in 2020, 50 in 2021, 37 in 2022, 55 in 2023, 50 in 2024, and 46 in 2025. Over the same period, China's NMPA steadily increased from 10 in 2019 to 68 in 2025.

The U.S. Food and Drug Administration (FDA) headquarters in Maryland, United States./Courtesy of Reuters Yonhap News

Among the 46 new drugs approved by the FDA, notable therapies include two programmed cell death protein 1 (PD-1) inhibitors and two Antibody-Drug Conjugate (ADC) therapies. PD-1 drugs help immune cells attack cancer cells, and the approved products are Merck's "Keytruda (Keytruda Qlex)" in the United States and Akeso Biopharma's "Penpulimab" in China. ADCs attach a drug to an antibody to attack cancer cells directly, and Daiichi Sankyo's "Datroway" in Japan and AbbVie's "Emrelis" in the United States were approved.

Breaking down the 46 new drugs by type, there were 34 new molecular entities (NME) and 12 biologics license applications (BLA). NMEs are drugs with novel chemical structures not previously available and represent treatments that address diseases in new ways. Biologics are medicines made using biological substances such as proteins or antibodies and are mainly used to treat cancer and immune disorders.

By corporations, GSK, Novartis, Merck, Boehringer Ingelheim, Sanofi, and Bayer Healthcare each received approval for two new drugs, the most among peers.

By indication, oncology led with 16 drugs (35%), followed by five cardiovascular therapies (11%) and four treatments for allergies and inflammatory diseases (9%).

In 2025, the U.S. FDA approves a total of 46 new drugs, with small-molecule drugs making up the largest share. There are 31 small-molecule drugs in total: 20 made through conventional chemical synthesis, 10 kinase inhibitors used to suppress cancer cell growth, and 1 peptide drug, a small protein. Kinase inhibitors block abnormally activated enzymes inside cancer cells to inhibit their growth./Courtesy of Korea Biotechnology Industry Organization Bioeconomy Research Center
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