XUANZHUBIO-B(02575.HK): NDA for Anaprazole Sodium in New Indication of Reflux Esophagitis Accepted by NMPA

NewTimeSpace · 2026/06/30 13:20 · By Boyuan Chen

NewTimeSpace News: Xuanzhu Biopharmaceutical Co., Ltd. (02575.HK) announced that the New Drug Application (NDA) for Anaprazole Sodium Enteric-coated Tablets (trade name: An Jiu Wei®), a Class 1 innovative drug independently developed by the Company, for the treatment of adult reflux esophagitis has been formally accepted by the National Medical Products Administration (NMPA). Phase III clinical data showed the 8-week endoscopic healing rate reached 88.4% in the Anaprazole Sodium group, higher than 84.6% of the Rabeprazole Sodium group.

NewTimeSpace News: On 30 June 2026, Xuanzhu Biopharmaceutical Co., Ltd. (02575.HK) issued a voluntary announcement, disclosing that the NDA of self-developed Class 1 new drug Anaprazole Sodium Enteric-coated Tablets (brand: An Jiu Wei^®) for treating adult reflux esophagitis has obtained official acceptance from NMPA.

The acceptance is supported by a multi-center, randomized, double-blind, double-dummy, positive-controlled pivotal Phase III clinical trial conducted in China. Taking Rabeprazole Sodium as the control, the primary efficacy endpoint was the 8-week endoscopic healing rate of reflux esophagitis. Trial results demonstrated that the healing rate of the 60mg Anaprazole Sodium arm was 88.4%, versus 84.6% for the 20mg Rabeprazole Sodium arm, with a treatment difference of 3.8% that met the pre-specified primary endpoint.

Anaprazole Sodium was approved for duodenal ulcer treatment in June 2023, and this marks its second NDA filing for a new therapeutic indication. The number of patients suffering from reflux esophagitis in China is projected to hit 42.4 million by 2032.

The Company stated that the drug undergoes both non-enzymatic and multi-enzymatic metabolism with balanced dual intestinal-renal excretion pathways. It is unaffected by CYP2C19 genetic polymorphism, leading to low risks of drug-drug interactions during combined medication.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.

Tags：

XUANZHUBIO-B 02575.HK New Drug Application