百特官方表示环磷酰胺供应持续受限,国产替代加速到来!!

2026-10-21 13:36:384℃


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百特官方表示环磷酰胺供应持续受限,注射用环磷酰胺从挂网价约24元/支飙升至非正规渠道600元以上,涨幅超24倍,临床刚需下替代性极低。公司其合资子公司持有注射剂批文,同时原料端公司自身拥有环磷酰胺原料药资质。





◎ 4月,注射用环磷酰胺“断货”现象开始持续在医院蔓延。/ 图:杭州市第一人民医院官网



欧盟官网:

环磷酰胺——供应短缺 |欧洲药品管理局(EMA)


Baxter短缺沟通函PDF::

2026_03_05_Cyclophosphamide_adopted by MSSG.pdf


Medicine Shortage Communication

(cyclophosphamide, <100 mg / 200
mg / 500 mg / 1 g / 2 g> powder for solution for injection or
infusion): supply shortage
Dear Healthcare Professional,
Baxter is notifying healthcare professionals about a shortage of intravenous
Endoxan/Sendoxan/Genoxal (cyclophosphamide).
Overview of situation
A technical disruption at Baxter’s contract manufacturing site led to an
interruption in the manufacturing and product release for cyclophosphamide
powder for solution for injection or infusion
(, powder for solution for injection or
infusion, <100 mg / 200 mg / 500 mg / 1 g / 2 g >).
This has led, or is expected to lead, to a shortage of the medicine in all EU
countries. While the timing of supply interruptions will differ between
countries, the supply shortage is expected to continue through Q3 2026.
Baxter is working with the manufacturing partner to restore normal supply
as quickly as possible.
The supply of Baxter cyclophosphamide in tablet form is unaffected.
The shortage is not due to any safety, efficacy or quality concern with
currently available supplies of cyclophosphamide.
Mitigation measures
In order to manage the shortage, Baxter is engaging with the European Medicines Agency and the
National Competent Authority on mitigation measures.
During the shortage, healthcare professionals should:
confirm that there are adequate supplies of intravenous
cyclophosphamide
available to complete a treatment course before starting any new patients
on treatment.
be aware that Baxter is the primary supplier of cyclophosphamide in the EU,
however, there are other suppliers of intravenous cyclophosphamide in
many EU Member States.
note that the supply of Baxter cyclophosphamide in tablet form is
unaffected.
consult EMA’s shortage catalogue and country-specific shortage registers
(where available) or your national competent authority for additional
information on the shortage.
advise concerned patients and caregivers to seek medical advice from their
healthcare provider.
Background on the shortage
Cyclophosphamide is used in clinical practice for the treatment of a broad range of haematologic
malignancies and solid tumours, as well as in conditioning regimens for bone-marrow transplantation.
It is also used in the management of certain severe autoimmune conditions.
Baxter’s contract manufacturing organisation recently experienced a technical disruption that affected
site operations, including production planning and inventory systems. At the same time, the site has
been implementing corrective actions following a regulatory inspection. Together, these factors have
led to a short-term interruption in manufacturing and product release for cyclophosphamide powder for
solution for injection or infusion ().
Baxter, as the marketing authorisation holder, is working closely with the manufacturing partner to
resolve the situation and restore supplies as quickly as possible. Manufacturing has now resumed at
the facility.
While Baxter is a key supplier of cyclophosphamide across the EU, there are other marketing
authorisation holders who can supply intravenous cyclophosphamide. The supply of Baxter
cyclophosphamide in tablet form is unaffected.
Company contact point
Please contact Baxter’s Medical Information service, details of which can be found on Baxter’s country
specific websites.






澳大利亚联邦 |:

药品短缺信息倡议 |治疗用品管理局(TGA)


产品详情供应影响日期更多详情ENDOXAN 环磷酰胺 1g(单水合物)注射用粉末
AUST R: 82129
活性成分:
环磷酰胺一水合物

剂型:
注射剂,粉末

赞助商:
Baxter Healthcare Pty Ltd

电话:
1300302409

2026
年5月1
日至
2026年11月30日

短缺状态:
当前

供应情况:
供应有限

原因:
消费者需求意外增长

管理层行动:
赞助方严格控制供应,努力加快下一批发货。海外注册产品已根据第19A条获批供应。请访问官网,搜索活性成分:https://www.tga.gov.au/resources/section-19a-approvals。
最新的TGA网络声明可在以下网站获取:https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medicine-shortages/major-or-ongoing-medicine-shortages/about-cyclophosphamide-and-ifosfamide-injection-shortages

ENDOXAN 环膦胺 2g(单水合物)注射用粉末
AUST R: 82128
活性成分:
环膦酰胺一水合物

剂型:
注射剂,粉末

赞助商:
Baxter Healthcare Pty Ltd

电话:
1300302409

2026

年3月16日至2026年11月
30日

短缺状态:
当前

供应情况:
供应有限

原因:
制造业

管理措施:
根据第19A条,海外注册产品已获批准供应。请访问官网,搜索活性成分:https://www.tga.gov.au/resources/section-19a-approvals。
最新的TGA网络声明可在以下网站获取:https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medicine-shortages/major-or-ongoing-medicine-shortages/about-cyclophosphamide-and-ifosfamide-injection-shortages




涨价一千多元!!某宝某东:进口环磷酰胺1200元,国产环磷酰胺也来到900元关口!-韭研公社

注射用环磷酰胺从24元暴涨到1200元,誉衡药业上半年该产品增长133%-韭研公社



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