In March 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) approved a total of 6 new FDCs across multiple therapeutic areas.

Suzetrigine received approval from the FDA on January 30, 2025, as a small-molecule pharmaceutical for the treatment of moderate to severe acute pain in adults.

The combination drug Meloxicam and Rizatriptan, received approval from the U.S. Food and Drug Administration (FDA) on January 30, 2025, for the treatment of migraine.

Limertinib is a newly developed small-molecule chemical drug, specifically designed as an inhibitor targeting the epidermal growth factor receptor (EGFR) T790M mutation.

Senaparib is a next-generation, highly potent PARP1/2 inhibitor developed by IMPACT Therapeutics.

Prusogliptin, developed by CSPC Ouyi Pharmaceutical, is a novel oral dipeptidyl peptidase-4 (DPP-4) inhibitor that was approved by NMPA on January 8, 2025.

Finotonlimab, developed by Sinocelltech, is a recombinant humanized anti-programmed death receptor-1 (PD-1) monoclonal antibody.

Efsubaglutide Alfa received its first regulatory approval in China on January 24, 2025, from the National Medical Products Administration (NMPA).

Garadacimab is an innovative, fully human IgG4 monoclonal antibody specifically designed to target activated Factor XII (FXIIa).

Datopotamab Deruxtecan (Dato-DXd) is a Trop-2-targeting antibody-drug conjugate (ADC) developed jointly by Daiichi Sankyo and AstraZeneca.

Recaticimab, a monoclonal antibody developed by Hengrui Medicine, was approved by the National Medical Products Administration (NMPA) in China on January 8, 2025.

Repotrectinib, marketed under the brand name Augtyro, was FDA approved on November 15, 2023.