中关村(000931.SZ):盐酸羟考酮缓释片(规格:40mg)上市许可申请获得受理

智通财经
13 Mar

智通财经APP讯,中关村(000931.SZ)发布公告,公司下属公司北京华素制药股份有限公司(以下简称:北京华素)于近日收到国家药品监督管理局(以下简称:国家药监局)签发的《受理通知书》,盐酸羟考酮缓释片(规格:40mg)上市许可申请获得受理。

据悉,盐酸羟考酮缓释片临床上用于治疗严重到需要长期持续、每天按时使用阿片类药物治疗、且替代治疗不能充分缓解的疼痛。盐酸羟考酮是一种纯阿片受体激动剂,对μ受体具有相对的选择性,在更高剂量时也能与其它阿片受体结合;羟考酮的主要治疗作用为镇痛。本品的原研药于2021年在中国境内获批上市,目前境内已有2家仿制药获批上市,1家国内企业已递交上市许可申请,北京华素是第4家提交本品仿制药上市许可申请的境内企业。截至本公告披露日,盐酸羟考酮缓释片项目已累计投入研发费用1,391.18万元。

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10