预约演示
更新于：2025-10-18
Peginterferon alfa-2b (Xiamen Amoytop)
聚乙二醇干扰素α-2b (厦门特宝)
更新于：2025-10-18
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
登录后查看时间轴
关联
24
项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的临床试验CTR20251866
AHB-137注射液联合乙型肝炎疫苗或聚乙二醇干扰素用于经核苷（酸）类似物治疗的HBeAg阴性慢性乙型肝炎受试者的有效性和安全性的随机、开放、多中心Ⅱ期临床试验
CTR20243850
一项评价BRII-179、BRII-835和聚乙二醇干扰素α（PEG-IFNα）联合治疗在慢性乙型肝炎病毒（HBV）感染受试者中有效性和安全性的II期、多中心、随机、双盲研究（ENHANCE研究）
NCT06552429
A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.
100 项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的临床结果
登录后查看更多信息
100 项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的转化医学
登录后查看更多信息
100 项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的专利（医药）
登录后查看更多信息
38
项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的文献（医药）2020-06-01Open forum infectious diseases3区 · 医学
Short-term Peginterferon-Induced High Functional Cure Rate in Inactive Chronic Hepatitis B Virus Carriers With Low Surface Antigen Levels
3区 · 医学
ArticleOA
作者: Liang, Hong-Xia ; Shang, Jia ; Lv, Jun ; Wang, Fu-Sheng ; Xu, Guang-Hua ; Li, Chun-Xia ; Hu, Qiu-Yue ; Sun, Chang-Yu ; Liu, Yan-Min ; Pan, Ya-Jie ; Zhang, Da-Wei ; Li, Zhi-Qin ; Zeng, Qing-Lei ; Liu, Na ; Yu, Zu-Jiang ; Li, Wei
Abstract:
Background:
None of the current guidelines recommend antiviral therapy for inactive hepatitis B virus (HBV) carriers (IHCs).
Methods:
In this real-world, multicenter, nonrandomized study, 32 participants meeting the inclusion criteria were enrolled 1:1 for treatment with peginterferon α-2b or monitoring without treatment based on participant preference. The expected treatment duration was 48 weeks. The primary end point was hepatitis B surface antigen (HBsAg) loss. The HBV vaccine could be injected after HBsAg loss.
Results:
All patients had HBsAg levels of <20 IU/mL. The mean baseline HBsAg levels were 6.6 IU/mL and 5.8 IU/mL in the treated and untreated groups, respectively. Fifteen (93.8%) participants achieved HBsAg loss, 5 obtained HBsAg seroconversion after undergoing a mean of 19.7 weeks of therapy in the treated group, and no one in the follow-up group achieved HBsAg loss during a mean follow-up time of 12.6 months (P < .0001). Generally, the therapy was well tolerated. Nine of 11 individuals who exhibited HBsAg loss benefited from receiving the HBV vaccine.
Conclusions:
This study provides justification for further studies of short-course peginterferon α-2b for the functional cure of IHCs with low HBsAg levels. Additionally, HBV vaccine injection is beneficial after interferon-induced HBsAg loss.
2018-07-01Journal of interferon & cytokine research : the official journal of the International Society for Interferon and Cytokine Research4区 · 医学
Cochlear Changes Caused by Peginterferon α-2b
4区 · 医学
Article
作者: Madian, Yasser T. ; Zittoon, Reham F. ; Nadeem, Hany S. ; Alhennawi, Diaa Eldeen M.
To evaluate the effect of peginterferon α-2b on guinea pigs' hearing and its cochlea, and to determine whether these effects are permanent or reversible. This study is an experimental animal study done on the organs of Corti of 30 guinea pigs after a peginterferon α-2b injection course. The cochleae of guinea pigs were extracted and examined by scanning electron microscopy for the right side and immunohistochemistry for the left side. All guinea pigs were subjected to pinna reflex, otological examination, and distortion product otoacoustic emission (DPOAE) both before and after the receiving of interferon (IFN). Electron microscopic scanning and immunohistochemistry of the cochleae revealed that peginterferon α-2b has a harmful effect on guinea pigs' cochleae, in the form of structural changes in the hair cells and supporting cells with apoptotic changes in the organ of Corti and the stria vascularis. These changes were reversible. DPOAE showed a significant reduction in distortion product mean amplitude and signal-to-noise ratio in all frequencies after 3 days from the last dose of IFN injection except at 1,006 Hz. After 14 days, there was a significant improvement in most of the frequencies, but are still below the normal values.
2018-05-20Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology
[A case of HCV/HBV coininfection treated with sofobuvir and peginterferon α-2b plus ribavirin].
Article
作者: Jing, P ; Gao, X H ; Hao, X F ; Xu, G H
46
项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的新闻（医药）2025-10-13
·医药地理
财报生物类似药上市批准
2025-10-12
·信狐药迅
2025-10-12
·药圈头条
上市批准抗体药物偶联物带量采购
100 项与 聚乙二醇干扰素α-2b (厦门特宝) 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 慢性乙型肝炎 | 中国 | 2016-09-02 | |
| 慢性丙型肝炎 | 中国 | 2016-09-02 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 原发性血小板增多症 | 临床2期 | 中国 | 2024-08-29 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | - | Peginterferon alpha-2b 180 μg/week + Tenofovir Disoproxil Fumarate | 顧觸構襯醖艱願範繭簾(獵製醖積網積衊積窪積) = 鑰鑰鹽構廠獵衊窪簾鹹 獵齋鹹遞築襯網齋構艱 (廠觸夢製鹽鹽網繭齋選 ) 更多 | 积极 | 2025-03-26 | ||
Peginterferon alpha-2b 180 μg/week + Tenofovir Disoproxil Fumarate | 顧觸構襯醖艱願範繭簾(獵製醖積網積衊積窪積) = 齋網獵艱鏇簾淵壓範選 獵齋鹹遞築襯網齋構艱 (廠觸夢製鹽鹽網繭齋選 ) 更多 | ||||||
临床3期 | 367 | TDF monotherapy | 襯鏇願簾網繭繭憲齋願(積餘鏇鏇憲艱觸築廠醖) = 願鏇遞糧簾衊蓋選蓋艱 膚艱繭窪鑰鏇鬱餘鏇襯 (餘膚鏇襯窪製積淵遞膚 ) 更多 | 优效 | 2024-10-15 | ||
襯鏇願簾網繭繭憲齋願(積餘鏇鏇憲艱觸築廠醖) = 構壓衊鬱窪憲蓋願構壓 膚艱繭窪鑰鏇鬱餘鏇襯 (餘膚鏇襯窪製積淵遞膚 ) 更多 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用