創新研發

Innovative Research


研發產品名稱注冊分類1進展情況適應癥或功能主治
黃花蒿花粉變應原舌下滴劑治療用生物制品第4類——變態反應原制品2021年1月30日獲得《藥品注冊證書》(國藥準字S20210001)本品是一種變應原提取物,作為特異性免疫治療用于經過敏原檢測為黃花蒿/艾蒿花粉過敏引起的變應性鼻炎(或伴有結膜炎)的成年患者
黃花蒿花粉變應原舌下滴劑2治療用生物制品第4類——變態反應原制品

Ⅲ期臨床試驗階段

(兒童變應性鼻炎)

本品是一種變應原提取物,作為特異性免疫治療用于經過敏原檢測為黃花蒿/艾蒿花粉過敏引起的變應性鼻炎(或伴有結膜炎)的兒童患者
塵螨合劑治療用生物制品第4類——變態反應原制品Ⅱ期臨床試驗階段用于塵螨過敏引起的過敏性鼻炎與過敏性哮喘的脫敏治療
粉塵螨滴劑3治療用生物制品第4類——變態反應原制品

Ⅲ期臨床試驗階段

(特應性皮炎)

用于粉塵螨過敏引起的特應性皮炎的脫敏治療
黃花蒿花粉點刺液等點刺產品4治療用生物制品第4類——變態反應原制品Ⅲ期臨床試驗階段用于點刺試驗,輔助診斷Ⅰ型變態反應性疾病
懸鈴木花粉點刺液等點刺產品5治療用生物制品第4類——變態反應原制品Ⅲ期臨床試驗階段用于點刺試驗,輔助診斷Ⅰ型變態反應性疾病


注:

1 根據相應產品提出藥品注冊申請時適用的《藥品注冊管理辦法》對應的分類。

黃花蒿花粉變應原舌下滴劑用于黃花蒿/艾蒿花粉過敏引起的兒童變應性鼻炎的脫敏治療。

公司“粉塵螨滴劑”已批準的適應癥為用于粉塵螨過敏引起的過敏性鼻炎和過敏性哮喘的脫敏治療,增加了適應癥為用于粉塵螨過敏引起的特應性皮炎的脫敏治療,因而進行臨床試驗。

4 黃花蒿花粉點刺液、葎草花粉點刺液、白樺花粉點刺液、豚草花粉點刺液、變應原皮膚點刺試驗對照液。上述藥品用于點刺試驗,輔助診斷因相應變應原致敏引起的I型變態反應性疾病,與已獲準上市的“粉塵螨皮膚點刺診斷試劑盒”相互補充,可以滿足更多過敏性疾病患者的變應原檢測需求。

5 懸鈴木花粉點刺液、德國小蠊點刺液、貓毛皮屑點刺液、狗毛皮屑點刺液、豚草花粉點刺液、變應原皮膚點刺試驗對照液。上述藥品用于點刺試驗,輔助診斷因相應變應原致敏引起的I型變態反應性疾病,與已獲準上市的“粉塵螨皮膚點刺診斷試劑盒”相互補充,可以滿足更多過敏性疾病患者的變應原檢測需求。



以上信息更新至2021年3月31日。

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