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
ustekinumab
乌司奴单抗
Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative;Crohn Disease
Celltrion Healthcare Hungary Kft.
Authorised
L04AC05
2025-06-02
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
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
Pfizer Europe MA EEIG
Authorised
L01FX23
2025-03-28
No
pneumococcal polysaccharide conjugate vaccine (21-valent)
Pneumococcal Infections
Merck Sharp & Dohme B.V.
Authorised
J07AL02
2025-03-24
No
imetelstat
伊美司他
Anemia;Myelodysplastic Syndromes
Geron Netherlands B.V.
Authorised
L01XX80
2025-03-07
Yes
eplontersen
依普隆特生
Amyloid Neuropathies, Familial
AstraZeneca AB
Authorised
N07XX21
2025-03-06
No
methylphenidate hydrochloride
盐酸哌甲酯
Attention Deficit Disorder with Hyperactivity
Neuraxpharm Pharmaceuticals S.L.
Authorised
N06BA04
2025-02-28
No
Chikungunya vaccine (recombinant, adsorbed)
Chikungunya virus
Bavarian Nordic A/S
Authorised
2025-02-28
No
guanfacine
胍法辛
Attention Deficit Disorder with Hyperactivity
Neuraxpharm Pharmaceuticals S.L.
Authorised
C02AC02
2025-02-26
No
denosumab
地舒单抗
Osteoporosis, Postmenopausal;Osteoporosis;Bone Resorption
Celltrion Healthcare Hungary Kft.
Authorised
M05BX04
2025-02-14
No
tocilizumab
托珠单抗
Arthritis, Rheumatoid;Arthritis, Juvenile Rheumatoid;Cytokine Release Syndrome;COVID-19 virus infection
Celltrion Healthcare Hungary Kft.
Authorised
L04AC07
2025-02-14
No
denosumab
地舒单抗
Giant Cell Tumor of Bone;Neoplasms, Bone Tissue
Celltrion Healthcare Hungary Kft.
Authorised
M05BX04
2025-02-14
No
ustekinumab
乌司奴单抗
Psoriasis;Arthritis, Psoriatic;Crohn Disease
Biosimilar Collaborations Ireland Limited
Authorised
L04AC05
2025-02-14
No
denosumab
地舒单抗
Osteoporosis, Postmenopausal;Osteoporosis;Bone Resorption
Samsung Bioepis NL B.V.
Authorised
M05BX04
2025-02-12
No