Group 1 - The core announcement is that the Phase III clinical study for Annelazole Sodium Enteric-Coated Tablets (brand name: Anjiuwei) for the treatment of gastroesophageal reflux disease has completed its first patient enrollment, marking the second indication expansion for this drug [1] - The study is a multicenter, randomized, double-blind, positive drug-controlled trial led by Shanghai Changzheng Hospital, with participation from 32 authoritative digestive departments, aiming to evaluate the efficacy and long-term safety of Annelazole Sodium for gastroesophageal reflux disease [1] - The study is crucial for providing key data support for the approval of this indication [1] Group 2 - Annelazole Sodium Enteric-Coated Tablets is a new generation proton pump inhibitor (PPI) developed by Xuan Bamboo Biotechnology, holding global intellectual property rights and being the first and only PPI fully developed in China [2] - It is currently the only innovative PPI in China with no approved generics, featuring advantages such as multi-enzyme and non-enzyme metabolism, as well as dual-channel excretion through the intestine and kidneys, resulting in a low risk of drug interactions [2] - A publication in June 2025 indicated that elderly patients and those with renal impairment may benefit more from Annelazole Sodium treatment for gastroesophageal reflux disease [2]
四环医药：创新药安奈拉唑钠用于反流性食管炎的新适应症III期临床完成首例受试者入组