Longshenrongfa Subsidiary's Brexpiprazole Oral Soluble Film Application Rejected by Regulator

Stock News

Sep 17

Gansu Longshenrongfa Pharmaceutical Industry Co.,Ltd. (300534.SZ) has announced that its controlling subsidiary, Gansu Pu'an Pharmaceutical Co., Ltd., recently received a "Notice of Refusal to Approve Drug Marketing Application" issued by the National Medical Products Administration.

The rejected product is brexpiprazole oral soluble film. The grounds for the refusal state that the pharmaceutical assessment and inspection conclusion for the product's chemistry, manufacturing, and controls did not pass. According to Article 92, Paragraph 2, Item (7) of the Drug Registration Regulations, the application is not approved.

The company stated that the failure to obtain marketing approval for this drug will not have a significant impact on its current-period financial performance.

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The grounds for the refusal state that the pharmaceutical assessment and inspection conclusion for the product's chemistry, manufacturing, and controls did not pass. According to Article 92, Paragraph 2, Item (7) of the Drug Registration Regulations, the application is not approved.<br><br>The company stated that the failure to obtain marketing approval for this drug will not have a significant impact on its current-period financial performance.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"300534","symbol_name":"陇神戎发","start_time":0,"source_url":"","article_id":"1184098498","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1184098498","pubTimestamp":1789642936,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Stock News","introduction":"Global Stock News First-Time Broadcast","home_visible":1,"id":"1036600163","head_image":"https://community-static.tradeup.com/news/b3bf6d02ad1a6e9e7377eebbb162346a"},"summary":"Gansu Longshenrongfa Pharmaceutical Industry Co.,Ltd. (300534.SZ) has announced that its controlling subsidiary, Gansu Pu'an Pharmaceutical Co., Ltd., recently received a \"Notice of Refusal to...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"300534":"陇神戎发","BK0132":"高送转概念","IPOS":"Renaissance International IPO ETF","BK0056":"扶贫","BK0239":"医药制造"},"translate_title":"龙神荣发子公司布雷哌唑口服可溶性薄膜申请被监管机构驳回","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"300534":1,"IPOS":1},"content_text":"Gansu Longshenrongfa Pharmaceutical Industry Co.,Ltd. (300534.SZ) has announced that its controlling subsidiary, Gansu Pu'an Pharmaceutical Co., Ltd., recently received a \"Notice of Refusal to Approve Drug Marketing Application\" issued by the National Medical Products Administration.The rejected product is brexpiprazole oral soluble film. The grounds for the refusal state that the pharmaceutical assessment and inspection conclusion for the product's chemistry, manufacturing, and controls did not pass. According to Article 92, Paragraph 2, Item (7) of the Drug Registration Regulations, the application is not approved.The company stated that the failure to obtain marketing approval for this drug will not have a significant impact on its current-period financial performance.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":true,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"}}}