Appendix: New drugs approved by the NMPA in 2025

Chemical

Drug Name Target Disease China approval
Ciprofloxacin + fluocinolone acetonide Glucocorticoid; bacterial Top II Otitis media; otitis externa 02-Jan-2025
Erdafitinib FGFR1; FGFR2; FGFR3; FGFR4 Urothelial cell carcinoma (UCC) 08-Jan-2025
Prusogliptin DPP-4 Type 2 diabetes 08-Jan-2025
Limertinib BTK; EGFR T790M; ITK Non-small cell lung cancer (NSCLC) 14-Jan-2025
Senaparib PARP1; PARP2 Ovarian cancer (OVC); fallopian tube cancer; peritoneal cancer 14-Jan-2025
Ceftolozane + tazobactam PBP; β -lactamase Intra-abdominal infection (IAI); hospital-acquired bacterial pneumonia (HABP); ventilator-associated bacterial pneumonia (VABP); urinary tract infection (UTI) 08-Feb-2025
Netanasvir NS5A Chronic hepatitis C 08-Feb-2025
Encofosbuvir NS5B polymerase Chronic hepatitis C 08-Feb-2025
Telavancin / Hospital-acquired bacterial pneumonia (HABP); ventilator-associated bacterial pneumonia (VABP) 11-Feb-2025
Tenapanor NHE3 Hyperphosphatemia in chronic kidney disease 20-Feb-2025
Inavolisib PI3K α Hormone receptor-positive breast cancer 11-Mar-2025
Tazemetostat EZH2 Follicular lymphoma (FL) 18-Mar-2025
Ivarmacitinib JAK1 Rheumatoid arthritis (RA); ankylosing spondylitis (AS); atopic dermatitis; alopecia areata 18-Mar-2025
Tafluprost + timolol β -adrenergic receptor; PGF2 α Glaucoma or ocular hypertension 25-Mar-2025
Suraxavir marboxil CEN Influenza 25-Mar-2025
Ibrexafungerp Glucan synthase Vulvovaginal candidiasis (VVC) 01-Apr-2025
Pemafibrate PPAR α Hypertriglyceridemia (HTG) 08-Apr-2025
Capivasertib Akt-1; Akt-2; Akt-3 Hormone receptor-positive breast cancer 15-Apr-2025
Adapalene + benzoyl peroxide RAR γ ; RAR β Acne vulgaris 30-Apr-2025
Asciminib STAMP Chronic myeloid leukemia (CML) 13-May-2025
Anrikefon κ opioid receptor Uremic pruritus; post-operative pain 13-May-2025
Bireociclib CDK2; CDK4; CDK6 Hormone receptor-positive breast cancer 13-May-2025
Lemborexant OX1R; OX2R Insomnia 20-May-2025
Allisartan + sacubitril AT1R; NEP Hypertension 20-May-2025
Glecirasib KRAS G12C Non-small cell lung cancer (NSCLC) 20-May-2025
Onradivir PB2 Influenza 20-May-2025
Retagliptin + metformin DPP-4; PEN2 Type 2 diabetes 20-May-2025
HR20013 5-HT3 receptor; NK1 Chemotherapy-induced nausea and vomiting (CINV) 27-May-2025
Allisartan isoproxil + indapamide AT1R; NCC Hypertension 27-May-2025
Deutenzalutamide AR Prostate cancer 27-May-2025
Famitinib PDGFR; c-Kit; VEGFR Cervical cancer 27-May-2025
Fovinaciclib CDK4; CDK6 Hormone receptor-positive breast cancer 27-May-2025
Gecacitinib JAK1; JAK2; JAK3; TYK2; ALK2 Myelofibrosis (MF) 27-May-2025
Lerociclib CDK4; CDK6 Hormone receptor-positive breast cancer 27-May-2025
Luvometinib MEK1; MEK2 Neurofibromatosis; Langerhans cell histiocytosis (LCH) 27-May-2025
Revefenacin M3 receptor Chronic obstructive pulmonary disease (COPD) 10-Jun-2025
Daridorexant OX1R; OX2R Insomnia 17-Jun-2025
Aztreonam + avibactam PBP; β -lactamase Intra-abdominal infection (IAI); hospital-acquired bacterial pneumonia (HABP); ventilator-associated bacterial pneumonia (VABP) 24-Jun-2025
Mazdutide GLP-1R; GCGR; OXM Type 2 diabetes; obesity or overweight 24-Jun-2025
Perfluorohexyloctane / Dry eye syndrome (DES); meibomian gland dysfunction (MGD) 30-Jun-2025
Encorafenib BRAF Colorectal cancer (CRC) 30-Jun-2025
Ifupinostat HDAC; PI3K Diffuse large B-cell lymphoma (DLBCL) 30-Jun-2025
Tibremciclib CDK4; CDK6 Hormone receptor-positive breast cancer 30-Jun-2025
TPN171 PDE5 Erectile dysfunction (ED) 08-Jul-2025
Lisaftoclax Bcl-2 Chronic lymphocytic leukemia (CLL); small lymphocytic lymphoma (SLL) 08-Jul-2025
ZX-7101A CEN Influenza 15-Jul-2025
Tunodafil PDE5 Erectile dysfunction (ED) 22-Jul-2025
Lazertinib EGFR T790M Non-small cell lung cancer (NSCLC) 29-Jul-2025
Atrasentan ETA IgA nephropathy (IgAN) 19-Aug-2025
XZP-3621 ALK; ROS1 Non-small cell lung cancer (NSCLC) 19-Aug-2025
Zongertinib HER2 Non-small cell lung cancer (NSCLC) 26-Aug-2025
Zeprumetostat EZH2 Peripheral T-cell lymphoma (PTCL) 26-Aug-2025
Fexuprazan Proton pump Gastro-esophageal reflux disease (GERD); reflux esophagitis 02-Sep-2025
Tolvaptan sodium phosphate AVPR2 Heart failure; body fluid retention; congestive heart failure; cardiac edema 30-Sep-2025
Zilucoplan C5 Myasthenia gravis (MG) 30-Sep-2025
Mufemilast PDE4 Plaque psoriasis 30-Sep-2025
Relmapirazin / Renal function assessment 14-Oct-2025
Nerandomilast PDE4B Idiopathic pulmonary fibrosis (IPF); progressive pulmonary fibrosis (PPF) 21-Oct-2025
Mefatinib EGFR; HER2 Non-small cell lung cancer (NSCLC) 21-Oct-2025
Retagliptin + henagliflozin + metformin DPP-4; SGLT2; PEN2 Type 2 diabetes 21-Oct-2025
Olgotrelvir SARS-CoV-2 3CLpro; CTSL COVID-19 28-Oct-2025
Sarecycline 30S subunit Acne vulgaris 04-Nov-2025
Mometasone furoate + olopatadine Glucocorticoid; H1 receptor Allergic rhinitis 04-Nov-2025
Lutetium Lu 177 vipivotide tetraxetan PSMA Prostate cancer 04-Nov-2025
Visepegenatide GLP-1R Type 2 diabetes 12-Nov-2025
68 Ga-gozetotide PSMA Prostate cancer 25-Nov-2025
Remibrutinib BTK Chronic spontaneous urticaria (CSU) 25-Nov-2025
Solriamfetol DAT; NET Obstructive sleep apnea (OSA); excessive daytime sleepiness (EDS) 03-Dec-2025
Cenobamate GABAA receptor; sodium channel Epilepsy; seizure; generalized tonic-clonic seizure (GTCS); focal onset seizure; status epilepticus (SE); photosensitive epilepsy 03-Dec-2025
SPH3127 Renin Hypertension 03-Dec-2025
Fitusiran AT III Hemophilia 09-Dec-2025
Culmerciclib CDK2; CDK4; CDK6 Hormone receptor-positive breast cancer 09-Dec-2025
Pixavir marboxil CEN Influenza 09-Dec-2025
Zurletrectinib Trk NTRK fusion-positive solid tumors 09-Dec-2025
Aficamten Myosin Hypertrophic cardiomyopathy (HCM) 16-Dec-2025
Pimicotinib CSF-1R Tenosynovial giant cell tumor (TGCT) 16-Dec-2025
Eplontersen TTR Transthyretin familial amyloid polyneuropathy (TTR-FAP) 22-Dec-2025
Xanomeline + trospium chloride mAChR; M1 receptor; M4 receptor Schizophrenia 22-Dec-2025
Serdexmethylphenidate + dexmethylphenidate DAT; NET Attention deficit hyperactivity disorder (ADHD) 30-Dec-2025
Sonrotoclax Bcl-2 Chronic lymphocytic leukemia (CLL); mantle cell lymphoma (MCL); small lymphocytic lymphoma (SLL) 30-Dec-2025

Biologic

Drug Name Target Disease China approval
Amimestrocel / Graft-versus-host disease (GVHD) 02-Jan-2025
Isatuximab CD38 Multiple myeloma (MM) 08-Jan-2025
Recaticimab PCSK9 Hypercholesterolemia; mixed dyslipidemia; heterozygous familial hypercholesterolemia (HeFH) 08-Jan-2025
Efsubaglutide alfa GLP-1; GLP-1R Type 2 diabetes 24-Jan-2025
Amivantamab EGFR; c-Met Non-small cell lung cancer (NSCLC) 08-Feb-2025
Talquetamab CD3; GPRC5D Multiple myeloma (MM) 08-Feb-2025
Finotonlimab PD1 Hepatocellular carcinoma (HCC); squamous cell carcinoma of the head and neck (SCCHN) 08-Feb-2025
Siltartoxatug Tetanus toxoid Tetanus 11-Feb-2025
Risankizumab IL-23p19 Crohn’s disease 04-Mar-2025
Elranatamab BCMA; CD3 Multiple myeloma (MM) 04-Mar-2025
Ocrelizumab CD20 Multiple sclerosis (MS) 25-Mar-2025
Rozanolixizumab FcRn Myasthenia gravis (MG) 25-Mar-2025
Dalnacogene ponparvovec Factor IX Hemophilia B 08-Apr-2025
Ravulizumab C5 Myasthenia gravis (MG); neuromyelitis optica (NMO) 15-Apr-2025
Ebdarokimab IL-12p40 Plaque psoriasis 15-Apr-2025
Tenecteplase tPA Ischemic stroke 13-May-2025
Tafasitamab CD19 Diffuse large B-cell lymphoma (DLBCL) 13-May-2025
CAN103 GBA Gaucher’s disease 13-May-2025
Brolucizumab VEGF-A Diabetic macular edema (DME) 27-May-2025
Zanidatamab HER2 Non-small cell lung cancer (NSCLC) 27-May-2025
Recombinant HPV 9-valent vaccine (Innovax Biotech) HPV HPV infection 27-May-2025
Y-shaped pegylated rhGH GH Growth hormone deficiency (GHD) 27-May-2025
Albipagrastim alfa G-CSF Chemotherapy-induced neutropenia (CIN) 27-May-2025
Trastuzumab rezetecan HER2 Non-small cell lung cancer (NSCLC) 27-May-2025
Firsekibart IL-1 β Gouty arthritis 30-Jun-2025
Sevacizumab VEGF-A Ovarian cancer (OVC); fallopian tube cancer; peritoneal cancer 30-Jun-2025
Recombinant human albumin injection (Oryza sativa) Albumin Liver cirrhosis; hypoproteinemia 15-Jul-2025
Anti-CD19 CAR-T (Hrain Biotechnology) CD19 Diffuse large B-cell lymphoma (DLBCL); large B-cell lymphoma (LBCL) 29-Jul-2025
Datopotamab deruxtecan TROP2 Hormone receptor-positive breast cancer 19-Aug-2025
Oral hexavalent reassortant rotavirus live vaccine Rotavirus Rotavirus infection 19-Aug-2025
Teplizumab CD3 Type 1 diabetes 02-Sep-2025
Trastuzumab botidotin HER2 HER2-positive breast cancer 14-Oct-2025
Becotatug vedotin EGFR Nasopharyngeal carcinoma (NPC) 28-Oct-2025
Caplacizumab vWF Thrombotic thrombocytopenic purpura (TTP) 04-Nov-2025
Puzolcabtagene autoleucel CD19 B-cell acute lymphoblastic leukemia 04-Nov-2025
Marstacimab TFPI Hemophilia 18-Nov-2025
Picankibart IL-23p19 Plaque psoriasis 25-Nov-2025
Romosozumab SOST Osteoporosis 16-Dec-2025
Somapacitan GH Growth hormone deficiency (GHD) 22-Dec-2025
Sotatercept ACVR2A Pulmonary hypertension 30-Dec-2025