Recently, the 34th United European Gastroenterology Week (UEG Week 2026) was held in Barcelona, Spain. The Phase III registration clinical study results of Anaprazole Sodium Enteric-Coated Tablets (brand name: Anjiuwei®), a National Class 1 innovative drug independently developed by Xuanzhu Biopharma, for the treatment of reflux esophagitis, were presented as a Late-Breaking Abstract (LB25) oral presentation at this top-tier international academic event in the field of gastroenterology, showcasing to the world the latest clinical evidence for China's independently developed proton pump inhibitor.

I. Focusing on "difficult-to-treat" patients:

Only patients with LA B–D grade reflux esophagitis were enrolled

This study was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group non-inferiority trial. A total of 500 subjects were randomized, of whom 467 were included in the full analysis set (FAS). Subjects were assigned 1:1 to receive Anaprazole Sodium or Rabeprazole Sodium once daily. Unlike previous similar studies that enrolled a large number of patients with Los Angeles (LA) grade A mild disease, this study enrolled only patients with LA B–D grade moderate-to-severe erosive esophagitis, and prospectively required that no less than 20% of subjects be LA C/D grade—the highest enrollment criteria among registration studies of similar products. This means that the study population had more severe esophageal mucosal injury and greater treatment difficulty—verifying efficacy in "harder-to-treat" patients makes the results more meaningful and clinically relevant.

II. Primary endpoint robustly met, efficacy data comprehensively superior

The study results showed that Anaprazole Sodium successfully met the prespecified non-inferiority primary endpoint, and the endoscopic healing rate at Week 8 was higher than that of the active comparator Rabeprazole Sodium in both the full analysis set (FAS) and the per-protocol set (PPS), showing a clear trend of efficacy advantage: · Full analysis set (FAS): 88.4% in the Anaprazole Sodium group vs. 84.6% in the Rabeprazole Sodium group, rate difference 3.8% (95% CI: −2.3% to 10.0%); · Per-protocol set (PPS): 93.9% in the Anaprazole Sodium group vs. 89.4% in the Rabeprazole Sodium group, rate difference 4.8% (95% CI: −0.4% to 10.0%). The lower limits of the confidence intervals in both groups were clearly above the prespecified non-inferiority margin of −10%, and the non-inferiority conclusion was robust. Particularly noteworthy is the PPS: the lower limit of the 95% CI was only −0.4%, infinitely close to zero—on the premise that efficacy is comparable to the active comparator, the signal of advantage is clear. In terms of speed of onset, Anaprazole Sodium also demonstrated potential for early benefit: the Week 4 healing rate reached 81.6%, numerically higher than 78.7% in the Rabeprazole group. Efficacy trends were consistent across prespecified subgroups, and the results were robust and reliable.

III. Comprehensive symptom control with concurrent improvement in quality of life

In terms of symptom relief, the heartburn relief rate in the Anaprazole Sodium group reached 92.6%, and the regurgitation relief rate reached 90.3%; improvement in GERD-HRQL quality-of-life scores was comparable to that of the comparator, achieving dual benefits of "mucosal healing" and "symptom control."

IV. Favorable safety and tolerability

In terms of safety, all treatment-related adverse events were grade 1–2; no grade 3 or higher drug-related adverse events occurred, and overall tolerability was favorable.

V. About Anaprazole Sodium Enteric-Coated Tablets (Anjiuwei®)

Anaprazole Sodium Enteric-Coated Tablets were approved for marketing by the National Medical Products Administration (NMPA) in June 2023 for the treatment of duodenal ulcers. As a new-generation proton pump inhibitor, Anaprazole Sodium features an innovative molecular structure design, non-enzymatic plus multi-enzymatic metabolism, and balanced dual-channel intestinal and renal excretion. Only about 3.5% is metabolized via CYP2C19, so it is less affected by CYP2C19 genetic polymorphisms and is expected to reduce the risk of drug interactions, providing a new medication option for patients on multiple medications and those with renal impairment. What is particularly noteworthy is that the efficacy and safety evidence for Anaprazole Sodium is derived from clinical trials in the Chinese population, making it more aligned with the clinical medication scenarios of Chinese patients. As a National Class 1 innovative drug, Anaprazole Sodium fills the gap in domestically developed proton pump inhibitors in China and brings a brand-new treatment option to Chinese patients. Currently, in addition to the approved indication for duodenal ulcers and the reflux esophagitis indication for which the NDA has been accepted, a Chinese Phase III clinical study of Anaprazole Sodium Enteric-Coated Tablets for Helicobacter pylori eradication is also being advanced in parallel, further deepening the pipeline layout. From duodenal ulcers to reflux esophagitis and then to Helicobacter pylori eradication, Anaprazole Sodium is steadily moving toward broader clinical application with solid Chinese clinical evidence. The debut of these Phase III data on the international academic stage is not only a highlight moment for China's independently developed innovative drugs, but also brings new hope to patients with moderate-to-severe reflux esophagitis.

Statement: The clinical study data contained in this article are quoted from public reports at academic conferences and are intended solely for academic exchange and informational reference. They do not constitute any diagnostic or treatment advice or medication guidance; for drug use, please follow the instructions approved by the national drug regulatory authority.

About Xuanzhu Biopharma

Xuanzhu Biopharma (Stock Code: 02575.HK) is an innovative pharmaceutical company rooted in China with a global vision, focusing on major disease areas such as digestion, oncology, and non-alcoholic steatohepatitis, and dedicated to the R&D, production, and commercialization of Class 1 new drugs with core independent intellectual property. The company has a first-class R&D team, and its core personnel all have many years of new drug R&D experience. As an emerging commercialization-oriented innovative drug company driven by R&D and empowered by AI, the company has formed a product pipeline rare in China that simultaneously covers multiple types such as small molecule chemical drugs, large molecule biologics, and antibody-drug conjugates. Guided by unmet clinical needs, the company is committed to developing into a first-class innovative drug enterprise with independent R&D, production, and sales capabilities.