SIHUAN PHARM (00460.HK): Xuanzhu Bio's Phase III Anlarazole Data Presented at UEG Week

NewTimeSpace News: On 21 October 2026, Sihuan Pharmaceutical Holdings Group Ltd. (stock code: 00460) issued a voluntary announcement that the Phase III registration clinical study results of anlarazole sodium enteric-coated tablets, a national Class 1 innovative drug independently developed by its non-wholly-owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd. (stock code: 02575), for the treatment of reflux oesophagitis were presented as a Late-Breaking Abstract (LB25) oral presentation at the 34th United European Gastroenterology Week (UEG Week 2026) recently held in Barcelona, Spain.

The study was a multicentre, randomised, double-blind, double-dummy, active-controlled non-inferiority trial that randomised 500 subjects, of whom 467 were included in the full analysis set (FAS), with subjects randomised 1:1 to receive anlarazole sodium or rabeprazole sodium once daily. Unlike prior studies that largely enrolled Los Angeles (LA) grade A mild patients, this study enrolled only LA grade B-D moderate-to-severe patients and prospectively required at least 20% of subjects to be LA grade C/D. Results showed week-8 endoscopic healing rates of 88.4% versus 84.6% in the FAS (adjusted risk difference 3.8%, 95% CI: -2.3% to 10.0%) and 93.9% versus 89.4% in the per-protocol set (PPS) (difference 4.8%, 95% CI: -0.4% to 10.0%), with both lower bounds well above the pre-specified -10% non-inferiority margin; all treatment-related adverse events were grade 1-2, with no grade 3 or above drug-related events.

Xuanzhu Bio listed on the Main Board of the Stock Exchange in 2025 and focuses on digestive, oncology and metabolic diseases, building a technology system integrating small-molecule, biologics and AI drug discovery platforms. Sihuan was founded in 2001 and listed on the Main Board in 2010, and is an international pharmaceutical and medical aesthetics enterprise pursuing a dual-engine strategy of medical aesthetics and biopharmaceuticals.

Anlarazole sodium enteric-coated tablets (trade name: Anjiuwei) were approved by the National Medical Products Administration in June 2023 for duodenal ulcers; only 3.5% of anlarazole sodium is metabolised via CYP2C19, so it is unaffected by CYP2C19 polymorphisms. In addition to the approved duodenal ulcer indication and the reflux oesophagitis new drug application accepted for review, a Phase III study in China for Helicobacter pylori eradication is also progressing.