Xuanzhu Biopharmaceutical Co., Ltd. (XUANZHUBIO-B) has received formal acceptance from China’s National Medical Products Administration (NMPA) for its New Drug Application covering a new indication—adult reflux esophagitis (RE)—for Anaprazole Sodium Enteric-coated Tablets (brand name: An Jiu Wei).
The submission rests on a Mainland China Phase III, multi-centre, randomized, double-blind, double-dummy study that benchmarked anaprazole sodium 60 mg against rabeprazole sodium 20 mg. At Week 8, the investigator-assessed endoscopic healing rate reached 88.40% for anaprazole versus 84.60% for rabeprazole, a 3.80 percentage-point advantage (95% CI: –2.40% to 10.00%). The trial achieved its predefined primary endpoint, demonstrating non-inferiority and a numerically higher healing rate for anaprazole.
China Insights Consultancy estimates show the country’s RE patient base expanding from 36.70 million in 2018 to 38.30 million in 2024, with a projected rise to 42.40 million by 2032, underscoring substantial unmet demand. RE is the second indication under regulatory review for anaprazole sodium following its June 2023 approval for duodenal ulcers. A Phase III study in China targeting Helicobacter pylori eradication has also begun first-patient dosing.
Anaprazole Sodium incorporates a novel structural design that limits CYP2C19-mediated metabolism to 3.5%, employs multi-enzymatic and non-enzymatic pathways, and offers balanced intestinal-renal excretion. These attributes reduce drug–drug interaction risk and enhance suitability for patients on multiple medications or with renal impairment, positioning the product as a next-generation proton pump inhibitor tailored for the Chinese population.
The NDA acceptance marks a significant milestone for XUANZHUBIO-B, potentially broadening the commercial horizon of An Jiu Wei and offering an additional therapeutic option for millions affected by reflux esophagitis in China.
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