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
germanium (68Ge) chloride;gallium (68Ga) chloride
氯化锗 (68Ge)；氯化镓(68Ga)
Radionuclide Imaging
Curium Romania S.R.L.
Authorised
V09X
2026-01-08
No
rilzabrutinib
Purpura, Thrombocytopenic, Idiopathic
Sanofi B.V.
Authorised
Not yet assigned
2025-12-22
Yes
nipocalimab
尼卡利单抗
Myasthenia Gravis
Janssen Cilag International NV
Authorised
L04AL03
2025-11-28
No
rivaroxaban
利伐沙班
Venous Thromboembolism;Pulmonary Embolism;Venous Thrombosis;Stroke;Embolism
Koanaa Healthcare GmbH
Authorised
B01AF01
2025-11-21
No
Brensocatib
Bronchiectasis;Lung Diseases
Insmed Netherlands B.V.
Authorised
R03
2025-11-18
No
denosumab
地舒单抗
Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
Intas Third Party Sales 2005 S.L.
Authorised
M05BX04
2025-11-17
No
golimumab
戈利木单抗
Arthritis, Rheumatoid;Arthritis, Juvenile;Arthritis, Psoriatic;Axial Spondyloarthritis;Colitis, Ulcerative;Non-Radiographic Axial Spondyloarthritis
Advanz Pharma Limited
Authorised
L04AB06
2025-11-17
No
denosumab
地舒单抗
Bone Resorption;Osteoporosis;Osteoporosis, Postmenopausal
Stada Arzneimittel AG
Authorised
M05BX04
2025-11-17
No
ustekinumab
乌司奴单抗
Crohn Disease;Psoriasis;Arthritis, Psoriatic;Colitis, Ulcerative
Stada Arzneimittel AG
Authorised
L04AC05
2025-11-17
No
denosumab
地舒单抗
Giant Cell Tumor of Bone;Neoplasms, Bone Tissue
Stada Arzneimittel AG
Authorised
M05BX04
2025-11-17
No
donanemab
多奈单抗
Alzheimer Disease;Cognitive Dysfunction
Eli Lilly Nederland B.V.
Authorised
N06DX05
2025-09-24
No
macitentan
马昔腾坦
Hypertension, Pulmonary
Accord Healthcare
Authorised
C02KX04
2025-09-24
No
macitentan
马昔腾坦
Hypertension, Pulmonary
Accord Healthcare
Authorised
C02KX04
2025-09-24
No
denosumab
地舒单抗
Bone Resorption;Osteoporosis, Postmenopausal;Osteoporosis
Sciencepharma Sp. z o.o
Authorised
M05BX04
2025-09-17
No
sebetralstat
色贝阿司他
Angioedemas, Hereditary
Kalvista Pharmaceuticals (Ireland) Limited
Authorised
B06AC08
2025-09-17
Yes
denosumab
地舒单抗
Giant Cell Tumor of Bone;Neoplasms, Bone Tissue
Sciencepharma Sp. z o.o
Authorised
M05BX04
2025-09-17
No
olezarsen
奥来泽生
Hyperlipoproteinemia Type I
Swedish Orphan Biovitrum AB (publ)
Authorised
C10AX
2025-09-17
Yes
ustekinumab
乌司奴单抗
Crohn Disease
Biosimilar Collaborations Ireland Limited
Authorised
L04AC05
2025-09-17
No