海思科医药集团股份有限公司 关于创新药环泊酚注射液获得拓展 儿童人群批准的公告

Group 1 - The core announcement is about the approval of the drug Remimazolam injection for use in children, expanding its application in anesthesia [1][2] - The drug, developed by the company, is a new class of intravenous anesthetic that was approved for domestic use in December 2020 and has shown significant clinical value, especially in pediatric patients [2][3] - The drug has demonstrated good tolerance and lower pain response at the injection site, making it a safer and more comfortable option for patients requiring anesthesia [2] Group 2 - The company has submitted a New Drug Application (NDA) to the FDA for the product, which was accepted for review in July 2025 [3] - The drug has already received registration certificates for multiple indications, including sedation and anesthesia during non-intubation surgeries and in intensive care settings [2] - The company emphasizes the cardiovascular safety of the drug, supported by comprehensive clinical trials [2]