Xinhua Pharmaceutical (HKEx: 00719, SZSE: 000756) Gains Approval for Vonoprazan Fumarate API

Bulletin Express

2025/11/17

Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical, HKEx: 00719, SZSE: 000756) announced that it has received approval from the National Medical Products Administration for its domestically produced Vonoprazan Fumarate active pharmaceutical ingredient. The product is primarily indicated for the treatment of reflux esophagitis and is listed as a Category B product in the National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2025).

According to the announcement, sales of Vonoprazan Fumarate-related preparations in China’s public medical institutions reached approximately RMB 825 million in 2024. The new approval is expected to enrich the company’s product line and strengthen its competitiveness, although the pharmaceutical sales business remains vulnerable to policy changes, market fluctuations, and procurement processes. The company affirms that all information in the announcement is accurate and complete.

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The product is primarily indicated for the treatment of reflux esophagitis and is listed as a Category B product in the National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2025).</p>\n<p>According to the announcement, sales of Vonoprazan Fumarate-related preparations in China’s public medical institutions reached approximately RMB 825 million in 2024. The new approval is expected to enrich the company’s product line and strengthen its competitiveness, although the pharmaceutical sales business remains vulnerable to policy changes, market fluctuations, and procurement processes. The company affirms that all information in the announcement is accurate and complete.</p>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"00719","symbol_name":"山东新华制药股份","start_time":0,"source_url":"","article_id":"1193148741","we_media_id":"1053168898","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=1193148741","pubTimestamp":1763370173,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Bulletin Express","introduction":"Full Coverage of HK & US Stock Announcements","home_visible":1,"id":"1053168898","head_image":"https://community-static.tradeup.com/news/ed558ed0402cbe7d1ef4d150458f2b2e"},"summary":"Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical, HKEx: 00719, SZSE: 000756) announced that it has received approval from the National Medical Products Administration for its...","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"00719":"山东新华制药股份"},"translate_title":"新华制药（港交所：00719，深交所：000756）富马酸沃诺拉赞原料药获批","themeId":"","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"00719":1},"content_text":"Shandong Xinhua Pharmaceutical Company Limited (Xinhua Pharmaceutical, HKEx: 00719, SZSE: 000756) announced that it has received approval from the National Medical Products Administration for its domestically produced Vonoprazan Fumarate active pharmaceutical ingredient. The product is primarily indicated for the treatment of reflux esophagitis and is listed as a Category B product in the National Drug Catalogue for Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance (2025).\nAccording to the announcement, sales of Vonoprazan Fumarate-related preparations in China’s public medical institutions reached approximately RMB 825 million in 2024. The new approval is expected to enrich the company’s product line and strengthen its competitiveness, although the pharmaceutical sales business remains vulnerable to policy changes, market fluctuations, and procurement processes. 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