商品名
通用名
中文名称
治疗领域
上市许可持有人
市场状态
ATC代码
批准日期
孤儿药
zanidatamab
泽尼达妥单抗
Biliary Tract Neoplasms
Jazz Pharmaceuticals Ireland Limited
Authorised
L01FD07
2025-06-27
Yes
denosumab
地舒单抗
Neoplasms, Bone Tissue;Giant Cell Tumor of Bone
Biosimilar Collaborations Ireland Limited
Authorised
M05BX04
2025-06-25
No
denosumab
地舒单抗
Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
Gedeon Richter Plc.
Authorised
M05BX04
2025-06-23
No
denosumab
地舒单抗
Neoplasms, Bone Tissue;Giant Cell Tumor of Bone
Gedeon Richter Plc.
Authorised
M05BX04
2025-06-23
No
sepiapterin
Phenylketonurias
PTC Therapeutics International Limited
Authorised
A16A
2025-06-19
Yes
givinostat
吉维司他
Muscular Dystrophy, Duchenne
Italfarmaco S.p.A.
Authorised
M09AX14
2025-06-06
Yes
ustekinumab
乌司奴单抗
Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative;Crohn Disease
Celltrion Healthcare Hungary Kft.
Authorised
L04AC05
2025-06-02
No
denosumab
地舒单抗
Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
Accord Healthcare S.L.U.
Authorised
M05BX04
2025-05-26
No
denosumab
地舒单抗
Neoplasms, Bone Tissue;Giant Cell Tumor of Bone
Accord Healthcare S.L.U.
Authorised
M05BX04
2025-05-26
No
human normal immunoglobulin
人血丙种球蛋白
Immunologic Deficiency Syndromes;Purpura, Thrombocytopenic, Idiopathic;Guillain-Barre Syndrome;Mucocutaneous Lymph Node Syndrome;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Takeda Manufacturing Austria AG
Authorised
J06BA02
2025-05-02
No
trabectedin
曲贝替定
Sarcoma;Ovarian Neoplasms
Accord Healthcare S.L.U.
Authorised
L01CX01
2025-04-25
No
linvoseltamab
Multiple Myeloma
Regeneron Ireland Designated Activity Company (DAC)
Authorised
L01FX
2025-04-23
No
beremagene geperpavec
戈合贝基
Epidermolysis Bullosa Dystrophica
Krystal Biotech Netherlands B.V.
Authorised
D03AX16
2025-04-23
Yes
lecanemab
仑卡奈单抗
Cognitive Dysfunction;Alzheimer Disease
Eisai GmbH
Authorised
N06DX04
2025-04-15
No
datopotamab deruxtecan
德达博妥单抗
Breast Neoplasms
Daiichi Sankyo Europe GmbH
Authorised
L01FX35
2025-04-04
No
pegfilgrastim
培非司亭
Neutropenia;Cancer
CuraTeQ Biologics s.r.o
Authorised
L03AA13
2025-03-28
No
eltrombopag
艾曲泊帕
Purpura, Thrombocytopenic, Idiopathic
Accord Healthcare S.L.U.
Authorised
B02BX05
2025-03-28
No
tisotumab vedotin
维替索妥尤单抗
Uterine Cervical Neoplasms
Genmab A/S
Authorised
L01FX23
2025-03-28
No