广西梧州中恒集团股份有限公司关于控股孙公司纳米炭铁混悬注射液联合放疗II期临床试验获得伦理批件的公告

Group 1 - The core announcement is about the approval of the ethical review for the Phase II clinical trial of "Nano Carbon Iron Suspension Injection" by Sichuan Yingrui Pharmaceutical Technology Co., Ltd., a subsidiary of Chongqing Laimei Pharmaceutical Co., Ltd., which is controlled by Guangxi Wuzhou Zhongheng Group Co., Ltd. [1] - The Phase I clinical trial of Nano Carbon Iron has been successfully completed, focusing on safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced solid tumors [1][2] - The Phase II clinical trial aims to validate the effectiveness and safety of the drug in combination with radiotherapy, providing critical data for the final product application [1][3] Group 2 - Nano Carbon Iron is a next-generation nano drug developed based on the company's existing product, utilizing Fe2+ as an effective anti-cancer component and nano carbon as a carrier, targeting the iron death pathway to exert anti-cancer effects [3] - The drug is administered intratumorally and is expected to enhance the efficacy of radiotherapy, particularly in large, hypoxic tumors that are difficult to control with radiotherapy alone [3] - As of the announcement date, the cumulative R&D expenses for Nano Carbon Iron amount to approximately 98.06 million RMB (data unaudited) [4]