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科兴生物制药股份有限公司自愿披露关于人干扰素α1b吸入溶液纳入突破性治疗品种名单的公告

Core Viewpoint - The company announced that its inhaled human interferon α1b solution has been included in the list of breakthrough therapeutic drugs by the National Medical Products Administration (NMPA) of China, marking a significant advancement in its antiviral drug development [1][2]. Group 1: Drug Information - The inhaled human interferon α1b solution is designed for pediatric patients suffering from respiratory syncytial virus (RSV) infections, which are a leading cause of acute respiratory infections in children [2]. - RSV infections accounted for over 60% of acute respiratory infections in children, with 33 million cases reported globally in 2019 among children under five years old [2]. - In China, approximately 3.5 million cases of RSV infections were reported in 2019, representing over 10% of the global total, with hospitalization rates between 620,000 to 950,000, accounting for 18-27% of global hospitalizations [2]. Group 2: Clinical Development Status - As of the date of the announcement, the inhaled human interferon α1b solution is in the Phase III clinical trial stage [3]. Group 3: Impact on the Company - The inclusion of the inhaled human interferon α1b solution in the breakthrough therapy list will not have a significant immediate impact on the company's financial performance [5]. - The company acknowledges the long and uncertain nature of drug development, which involves substantial investment and multiple stages, and will continue to communicate progress in accordance with regulatory requirements [5].