Sihuan Pharmaceutical Holdings Group Ltd. (“Sihuan Pharmaceutical”) reported that China’s National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for a new indication of Anaprazole Sodium Enteric-coated Tablets (trade name: An Jiu Wei). The drug, a Class 1 innovative proton-pump inhibitor (PPI) developed by the Group’s non-wholly-owned subsidiary Xuanzhu Biopharmaceutical Co., Ltd. (“Xuanzhu Biopharm”), is now seeking approval for the treatment of adult reflux esophagitis (RE).
Key clinical data underpinning the filing come from a multi-centre, randomized, double-blind, double-dummy Phase III trial in Mainland China. Anaprazole Sodium 60 mg achieved an 88.4% endoscopic healing rate at Week 8 versus 84.6% for the active control rabeprazole sodium 20 mg, yielding a rate difference of 3.8% (95% CI: ‑2.4%–10.0%) and meeting the study’s predefined primary endpoint.
Reflux esophagitis, a major subtype of gastroesophageal reflux disease, affected an estimated 38.30 million people in China in 2024 and is projected by China Insights Consultancy to rise to 42.40 million by 2032, underscoring significant unmet demand. This is the second NDA submission for Anaprazole Sodium after its June 2023 approval for duodenal ulcer treatment. A Phase III trial in China targeting Helicobacter pylori eradication recently completed first-patient dosing.
Anaprazole Sodium’s molecular design offers non-enzymatic plus multi-enzymatic metabolism with only 3.5% CYP2C19 involvement, reducing drug-drug interaction risk and enhancing suitability for patients with renal impairment—features positioned to differentiate it within the PPI class upon approval.
Xuanzhu Biopharm, listed on the Hong Kong Stock Exchange since 2025, focuses on innovative therapies across digestion, oncology and non-alcoholic steatohepatitis, supported by dual R&D platforms in small-molecule chemistry and biopharmaceuticals. Parent company Sihuan Pharmaceutical, founded in 2001 and listed in 2010, is pursuing a “two-wheel” strategy spanning medical aesthetics and biopharmaceuticals, leveraging a broad pipeline and integrated manufacturing-to-commercialization capabilities.