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京新藥業(002020.SZ):“JX11502MA膠囊”獲批臨牀試驗
格隆匯 08-18 18:06

格隆匯 8 月 18日丨京新藥業(002020.SZ)公佈,近日,公司收到國家藥品監督管理局(以下簡稱“國家藥監局”)核准簽發的《藥物臨牀試驗批准通知書》,並將於近期開展臨牀試驗。現將相關情況公告如下:

藥物基本情況

1、藥品名稱:JX11502MA膠囊

2、劑型:口服膠囊劑

3、申請事項:臨牀試驗

4、受理號CXHL2000274、CXHL2000275、CXHL2000276

5、申請人:浙江京新藥業股份有限公司

6、審批結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,JX11502MA膠囊符合藥品註冊的有關要求,同意開展精神分裂症的臨牀試驗。

由於醫藥產品具有高科技、高風險、高附加值的特點,藥品的前期研發以及產品從研製、臨牀試驗報批到投產的週期長、環節多,容易受到技術、審批、政策等多方面因素影響,臨牀試驗進度及結果、未來產品市場競爭形勢均存在諸多不確定性。公司將根據後續進展情況及時履行信息披露義務,敬請廣大投資者謹慎決策,注意防範投資風險。

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