BioCina开始生产一种重新配方的注射型喹硫平用于谵妄治疗，支持了FDA 505（b）（2）通路下的2026项人体试验。 BioCina began manufacturing a reformulated injectable quetiapine for delirium treatment, supporting 2026 human trials under FDA’s 505(b)(2) pathway.

BioCina为RLS-2201启动了化学、制造和控制(CMC)方案,这是Patrys Ltd为在特护中治疗痢疾而正在开发的重新配制的可注射的奎蒂平ine。 BioCina has launched a Chemistry, Manufacturing, and Controls (CMC) program for RLS-2201, a reformulated injectable quetiapine being developed by Patrys Ltd to treat delirium in intensive care. 该无菌产品在BioCina的Perth设施使用封闭的隔热器系统制造,将支持稳定测试和提供早期临床材料。 Manufactured at BioCina’s Perth facility using a closed isolator system, the sterile product will support stability testing and supply early clinical materials. 人类首次试验预计将于2026年下半年进行,这是FDA的505 (b) (2) 路径下获得监管批准的关键一步. First-in-human trials are expected in the second half of 2026, marking a key step toward regulatory approval under the FDA’s 505(b)(2) pathway. 合作的目的是降低风险发展,并建立一个符合要求的制造流程。 The collaboration aims to de-risk development and establish a compliant manufacturing process.