Sihuan’s Xuanzhu Wins NMPA NDA Acceptance for New Reflux Esophagitis Use of Anaprazole
I'm LongbridgeAI, I can summarize articles.Sihuan Pharmaceutical Holdings announced that China's NMPA has accepted a New Drug Application for Anaprazole to treat adult reflux esophagitis. This follows positive Phase III trial results showing superior endoscopic healing rates compared to rabeprazole. If approved, this marks the second indication for Anaprazole, expanding its commercial potential and reinforcing Sihuan's position in gastroenterology treatments.
Sihuan Pharmaceutical Holdings Group ( (HK:0460) ) has shared an update.
Sihuan Pharmaceutical Holdings Group announced that China’s National Medical Products Administration has accepted a New Drug Application for a new indication of Anaprazole Sodium Enteric-coated Tablets, marketed as An Jiu Wei, for treating adult reflux esophagitis. The submission follows a Phase III trial in China in which anaprazole showed endoscopic healing rates numerically higher than the active comparator rabeprazole, meeting the predefined primary endpoint.
Reflux esophagitis represents a large and growing clinical burden in China, with prevalence projected to reach 42.4 million cases by 2032, underscoring substantial demand for effective acid-suppressive therapies. If approved, the new indication would be the second for anaprazole after duodenal ulcer and is expected to enhance the drug’s competitiveness and commercial potential, reinforcing Sihuan and Xuanzhu Biopharm’s strategic positioning in innovative gastroenterology treatments as they advance additional Phase III studies, including for Helicobacter pylori eradication.
More about Sihuan Pharmaceutical Holdings Group
Sihuan Pharmaceutical Holdings Group is a Bermuda-incorporated pharmaceutical company listed in Hong Kong, with a focus on innovative therapies through its subsidiaries. Xuanzhu Biopharm, a non wholly-owned unit listed in 2025, concentrates on major diseases including digestive disorders, oncology and non-alcoholic steatohepatitis, leveraging small and large molecule R&D platforms to develop Class 1 innovative drugs for the Chinese and global markets.
Xuanzhu Biopharm’s pipeline spans small molecule chemistry, large molecule biopharmaceuticals and antibody-drug conjugates, targeting unmet clinical needs with proprietary intellectual property. Its flagship product Anaprazole Sodium Enteric-coated Tablets, a domestically developed next-generation proton pump inhibitor, is positioned as a safer, more suitable option for Chinese patients due to its low CYP2C19 metabolism and reduced drug interaction risk, strengthening Sihuan’s presence in the gastroenterology segment.
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