Group 1 - The core point of the news is that Sihuan Pharmaceutical's subsidiary, Xuan Zhu Bio-Tech, has completed the first patient enrollment in a Phase III clinical trial for its innovative drug, Annelazole Sodium Enteric-Coated Tablets, aimed at treating gastroesophageal reflux disease (GERD) [1] - The Phase III clinical trial is a multicenter, randomized, double-blind, positive drug-controlled study led by Shanghai Changzheng Hospital, involving 32 authoritative digestive departments from various hospitals [1] - The trial aims to comprehensively evaluate the efficacy and long-term safety of Annelazole Sodium Enteric-Coated Tablets for GERD, providing critical 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 Zhu Bio-Tech, 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 [2] - A publication in June 2025 indicates that elderly patients and those with renal impairment may benefit more from Annelazole Sodium treatment for GERD [2]
四环医药(00460)：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