西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna®
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港股异动 | 先瑞达医疗-B(06669)涨超4% 近日西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna®注册获批
智通财经网· 2025-08-12 07:03
消息面上,近日,先瑞达医疗-B发布公告,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。 据介绍,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。 智通财经APP获悉,先瑞达医疗-B(06669)涨超4%,截至发稿,涨4.63%,报11.97港元,成交额624.97万 港元。 ...
港股公告掘金 | 心动公司预期上半年净利润同比大增约215%
Zhi Tong Cai Jing· 2025-08-04 15:23
Major Events - China Mobile Hong Kong acquired 14.44% stake in Hong Kong Broadband for HKD 1.084 billion, bringing its total ownership close to 30% [1] - Senrada Medical-B received approval from the National Medical Products Administration for the AcoArt Canna® drug-coated balloon catheter [1] - Zhaoke Ophthalmology-B obtained a medical device registration certificate for the TONO-i, used for measuring intraocular pressure [1] - Zhongji Changshou Science plans to acquire 100% equity of the Comprehensive Cell Bank [1] - Fourth Paradigm intends to establish a joint venture with Haibo Si Chuang to deepen its focus on the "AI + Energy Storage" sector [1] - Chifeng Jilong Gold Mining's subsidiary received new mining rights and integrated mining rights to enhance gold production capacity and resource security [1] Financial Reports - CLP Holdings reported a mid-year profit attributable to shareholders of HKD 5.624 billion, a decrease of 5.49% year-on-year, with an interim dividend of HKD 0.63 per share [1] - Liaoning Port Group's half-year earnings report showed a net profit of CNY 956 million, an increase of 110.78% year-on-year [1] - Heyu-B reported a mid-year net profit of CNY 328 million, up 58.84% year-on-year [1] - Yuan Zheng Technology announced a mid-year net profit of CNY 195 million, an increase of 27.74% year-on-year [1] - Yimai Sunshine expects a mid-year net profit growth of approximately 1350% to 1550% year-on-year [1] - LeCang Logistics anticipates a mid-year profit increase of 759% to 993% [1] - Xindong Company expects a net profit of no less than CNY 790 million for the first half, an increase of about 215% year-on-year [1] - China Sanjiang Chemical expects a mid-year profit attributable to shareholders exceeding CNY 300 million, an increase of about 95% year-on-year [1] - Bioatlast-B reported a 50% increase in revenue for the first half, achieving sustained profitability [1] - China Resources Medical issued a profit warning, expecting a year-on-year decline of about 20% to 25% in mid-year profit attributable to shareholders [1] - Xiaobu Xiaobu issued a profit warning, expecting a mid-year net loss of approximately CNY 80 million to 100 million, a narrowing of about 63.2% to 70.5% year-on-year [1]
先瑞达医疗-B(06669):西罗莫司药物涂层冠脉球囊扩张导管AcoArt Canna的注册批准获中国国家药监局批准
智通财经网· 2025-08-04 10:32
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。 ...
先瑞达医疗-B(06669.HK):西罗莫司药物涂层冠脉球囊扩张导管ACOART CANNA®的注册申请获中国国家药品监督管理局批准
Ge Long Hui· 2025-08-04 10:19
格隆汇8月4日丨先瑞达医疗-B(06669.HK)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。 ...