SHANDONG XINHUA (00719) Receives Approval Notice for Vonoprazan Fumarate API Marketing Application

Stock News

Nov 17

SHANDONG XINHUA (00719) announced that it recently received the "Chemical Drug API Marketing Approval Notice" for vonoprazan fumarate ("the product") issued by China's National Medical Products Administration (NMPA).

In March 2024, the company submitted the domestic production registration application for vonoprazan fumarate API to NMPA's Center for Drug Evaluation (CDE), which was subsequently accepted. The approval notice was obtained in November 2025, with the evaluation conclusion approving production of the product.

The product is primarily used for treating reflux esophagitis and is classified as a Category B drug in China's National Reimbursement Drug List (2025). According to relevant statistics, sales of vonoprazan fumarate-related preparations in China's public medical institutions reached approximately RMB 825 million in 2024.

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The approval notice was obtained in November 2025, with the evaluation conclusion approving production of the product.</p>\n<p>The product is primarily used for treating reflux esophagitis and is classified as a Category B drug in China's National Reimbursement Drug List (2025). According to relevant statistics, sales of vonoprazan fumarate-related preparations in China's public medical institutions reached approximately RMB 825 million in 2024.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1191","symbol_name":"制药","start_time":0,"source_url":"","article_id":"1109804504","we_media_id":"1036600163","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1109804504","pubTimestamp":1763369432,"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":"SHANDONG XINHUA (00719) announced that it recently received the \"Chemical Drug API Marketing Approval Notice\" for vonoprazan fumarate (\"the product\") issued by China's National Medical Products...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1191":"制药","00719":"山东新华制药股份","BK1515":"抗疫概念"},"translate_title":"山东新华(00719)收到富马酸沃诺拉赞原料药上市申请批准通知书","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00719":1},"content_text":"SHANDONG XINHUA (00719) announced that it recently received the \"Chemical Drug API Marketing Approval Notice\" for vonoprazan fumarate (\"the product\") issued by China's National Medical Products Administration (NMPA).\nIn March 2024, the company submitted the domestic production registration application for vonoprazan fumarate API to NMPA's Center for Drug Evaluation (CDE), which was subsequently accepted. The approval notice was obtained in November 2025, with the evaluation conclusion approving production of the product.\nThe product is primarily used for treating reflux esophagitis and is classified as a Category B drug in China's National Reimbursement Drug List (2025). According to relevant statistics, sales of vonoprazan fumarate-related preparations in China's public medical institutions reached approximately RMB 825 million in 2024.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}