Core Viewpoint - The company, Shengxiang Biology, announced on October 31 that several of its nucleic acid testing kits for respiratory viruses have received medical device registration certificates from the National Medical Products Administration of China, indicating regulatory approval for these products [1] Product Approval - The approved products include nucleic acid testing kits for respiratory syncytial virus, influenza A and B viruses, adenovirus, and mycoplasma pneumoniae, all utilizing fluorescent PCR methods [1] - The approval of these products is expected to enhance the company's market presence and product offerings in the diagnostic sector [1] Future Performance Uncertainty - The future performance of these products will be influenced by multiple factors, including market expansion efforts, brand influence, and actual market demand [1] - The company has indicated that the sales and profit contributions from these products remain uncertain, making it difficult to predict their specific impact on future performance [1]

先瑞达医疗-B(06669)发布公告，于2025年7月31日，集团收到中国国家药品监督管理局对西罗莫司药物 涂层冠脉球囊扩张导管AcoArt Canna®的注册批准。 AcoArt Canna®用于血管直径≥2.0mm且≤4.0mm的 原发冠状动脉分叉病变狭窄的扩张治疗。临床试验结果证明了AcoArt Canna®在临床应用的有效性和安 全性：临床试验的主要终点指标为术后9个月时血管造影显示的靶病变分支血管直径狭窄率 (DS, %)， 使用AcoArt Canna®的试验组在术后9个月的D.S.为30.52%，使用紫杉醇药物涂层冠脉球囊扩张导管的对 照组在术后9个月的D.S.为33.46%，两组数据无统计学差异;而基于临床安全性数据分析，试验组相对于 对照组也并未呈现出异常风险及事件。公司将适时在中国开展营销活动。 ...