Core Viewpoint - The approval of AcoArt Canna by the National Medical Products Administration of China is a significant milestone for the company, potentially enhancing its market position in the cardiovascular medical device sector [1] Company Summary - The stock of Xianruida Medical-B (06669) increased by over 4%, specifically by 4.63%, reaching HKD 11.97 with a trading volume of HKD 6.2497 million [1] - The company has received registration approval for its sirolimus drug-coated balloon catheter, AcoArt Canna, which is intended for the treatment of primary coronary bifurcation lesions with a vessel diameter between 2.0mm and 4.0mm [1] Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna, with the primary endpoint being the diameter stenosis rate (DS, %) of the target lesion branch at 9 months post-operation [1] - The trial group using AcoArt Canna showed a DS of 30.52% at 9 months, compared to 33.46% in the control group using paclitaxel drug-coated balloon catheters, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present abnormal risks or events compared to the control group [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]

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]

Core Viewpoint - The company received approval from the National Medical Products Administration of China for the AcoArt Canna® drug-coated balloon catheter, indicating a significant advancement in its product offerings for treating coronary artery bifurcation lesions [1] Group 1: Product Approval - The AcoArt Canna® is approved for the treatment of primary coronary artery bifurcation lesions with vessel diameters between 2.0mm and 4.0mm [1] - The approval is set to take effect on July 31, 2025, allowing the company to initiate marketing activities in China [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna®: the primary endpoint showed a target lesion branch vessel diameter stenosis (DS) rate of 30.52% at 9 months post-operation for the trial group [1] - The control group, which used a paclitaxel drug-coated balloon catheter, had a DS rate of 33.46% at the same time point, with no statistically significant difference between the two groups [1] - Safety data analysis indicated that the trial group did not present any abnormal risks or events compared to the control group [1]

Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received approval from the National Medical Products Administration of China for the registration of its drug-coated balloon catheter, AcoArt Canna®, intended for the treatment of coronary artery bifurcation lesions [1] Group 1: Product Approval - AcoArt Canna® is approved for use in patients with a vessel diameter of ≥2.0mm and ≤4.0mm [1] - The approval is significant as it allows the company to market the product in China starting from July 31, 2025 [1] Group 2: Clinical Trial Results - Clinical trial results demonstrated the effectiveness and safety of AcoArt Canna® [1] - The primary endpoint of the trial was the diameter stenosis rate (DS, %) of the target lesion branch at 9 months post-operation, with the trial group showing a DS of 30.52% compared to 33.46% in the control group using paclitaxel-coated balloon catheters [1] - No statistically significant difference was observed between the two groups regarding the DS rates [1] - Safety data analysis indicated that the trial group did not present abnormal risks or events compared to the control group [1] Group 3: Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]