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方盛制药:蛭龙通络片获得II期临床试验总结报告,系公司独家产品
Cai Jing Wang· 2025-09-24 07:30
Group 1 - The core viewpoint of the news is that Fangsheng Pharmaceutical has announced the completion of a Phase II clinical trial summary report for Zhilong Tongluo Tablets, which are indicated for the treatment of ischemic stroke recovery and related symptoms [1][2] - The clinical trial involved 240 planned participants, with 214 actually enrolled, and utilized a randomized, double-blind, placebo-controlled design to evaluate the efficacy and safety of Zhilong Tongluo Tablets [1] - The trial results indicated that Zhilong Tongluo Tablets improved neurological function and daily living abilities, showing effectiveness in treating symptoms associated with ischemic stroke, with no significant safety concerns reported [2] Group 2 - Zhilong Tongluo Tablets are classified as a Class 1 innovative traditional Chinese medicine and are currently the exclusive product of the company, with no other enterprises having obtained production approval for this product [2] - The market for traditional Chinese medicine treatments for stroke includes several products such as Naoxintong Capsules and Tongxinluo Capsules, indicating a competitive landscape [2]
湖南方盛制药股份有限公司 关于蛭龙通络片获得II期临床试验总结报告的公告
Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. announced the completion of the Phase II clinical trial report for its innovative traditional Chinese medicine, Zhilong Tongluo Tablets, which is aimed at treating ischemic stroke recovery [1][2]. Group 1: Basic Information - Drug Name: Zhilong Tongluo Tablets - Dosage Form: Tablets - Research Type: Phase II Clinical Trial - Clinical Approval Number: 2011L01961 - Clinical Approval Date: November 5, 2011 - Cumulative R&D Expenditure: Approximately 13.566 million RMB (unaudited) [1]. - Indication: Aims to invigorate qi and blood, dispel stasis, and is suitable for treating symptoms related to ischemic stroke recovery [1]. Group 2: Clinical Research Details - The clinical trial was conducted at seven national drug clinical trial institutions across various provinces, with a total of 240 planned participants, of which 214 were actually enrolled [2][3]. - The trial design was randomized, double-blind, and included a placebo control, with participants divided into high-dose (7.5g/day), low-dose (4.5g/day), and placebo groups, receiving treatment for 12 weeks [3]. Group 3: Clinical Research Results - Efficacy results indicated that both high and low doses of Zhilong Tongluo Tablets showed better outcomes compared to the placebo in terms of the Modified Rankin Scale, NIHSS score changes, and quality of life measures [4]. - Safety results showed no significant differences in severe adverse events among groups, with all serious adverse events related to acute stroke recurrence, indicating good safety [4]. - The low-dose group is recommended to proceed to Phase III clinical research due to comparable efficacy with the high-dose group [4]. Group 4: Market Situation - Zhilong Tongluo Tablets are classified as a Class 1 innovative traditional Chinese medicine and are currently the company's exclusive product, with no other companies having obtained production approval for this product [5]. - Other traditional Chinese medicines for treating ischemic stroke include various products with significant sales figures, indicating a competitive market landscape [5].
湖南方盛制药股份有限公司关于蛭龙通络片获得II期临床试验总结报告的公告
Core Viewpoint - Hunan Fangsheng Pharmaceutical Co., Ltd. announced that its innovative traditional Chinese medicine, Zhilong Tongluo Tablets, has obtained the Phase II clinical trial summary report, indicating progress in its development for treating ischemic stroke recovery [1][3]. Group 1: Basic Information - Drug Name: Zhilong Tongluo Tablets - Dosage Form: Tablets - Research Type: Phase II Clinical Trial - Clinical Approval Number: 2011L01961 - Clinical Approval Date: November 5, 2011 - Cumulative R&D Expenditure: Approximately 13.566 million RMB (unaudited) [1][2]. - Indication: Aimed at treating ischemic stroke recovery symptoms such as numbness, pain, and fatigue [1]. Group 2: Clinical Research Details - The Phase II clinical trial was conducted across seven national drug clinical trial institutions in Tianjin, Guangxi, Liaoning, Sichuan, Heilongjiang, and Anhui, with a total of 240 planned participants, of which 214 were actually enrolled [2][4]. - The trial design was randomized, double-blind, and included a placebo control, with participants assigned to high-dose (7.5g/day), low-dose (4.5g/day), and placebo groups [4]. Group 3: Clinical Results - The trial results indicated that both high and low doses of Zhilong Tongluo Tablets showed better efficacy compared to the placebo in improving neurological function and quality of life, with no significant difference in safety across groups [4][5]. - The low-dose group demonstrated comparable efficacy to the high-dose group, suggesting it may be suitable for further Phase III clinical research [5]. Group 4: Market Context - Zhilong Tongluo Tablets are classified as a Class 1 innovative traditional Chinese medicine and are currently the company's exclusive product, with no other companies holding production approval for it [6]. - Competing traditional Chinese medicines for treating ischemic stroke include Naoxin Tong Capsules and Tongxinluo Capsules, with reported sales figures for 2024 indicating significant market presence for these products [6].
方盛制药:关于蛭龙通络片获得Ⅱ期临床试验总结报告的公告
Zheng Quan Ri Bao· 2025-09-23 12:37
(文章来源:证券日报) 证券日报网讯 9月23日晚间,方盛制药发布公告称,2025年9月22日,公司研发的中药创新药蛭龙通络 片取得了Ⅱ期临床研究报告。 ...
方盛制药(603998.SH):蛭龙通络片获得II期临床试验总结报告
智通财经网· 2025-09-23 09:48
Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) announced the completion of Phase II clinical research for its innovative traditional Chinese medicine, Zhilong Tongluo Pian, which shows promising results for treating ischemic stroke recovery [1] Group 1: Clinical Research Findings - The drug is indicated for conditions such as post-stroke recovery, including symptoms like hemiplegia, speech difficulties, and fatigue [1] - Safety results indicate no statistically significant differences in severe adverse events or reactions among groups, with all severe events related to acute stroke recurrence and no fatalities reported [1] - Zhilong Tongluo Pian demonstrated effectiveness in improving the Rankin scale for disability, enhancing neurological function, and increasing daily living capabilities [1] Group 2: Efficacy and Recommendations - The drug is effective for symptoms related to blood stasis and Qi deficiency, including upper limb paralysis and fatigue, with a trend towards efficacy in lower limb paralysis and speech difficulties [1] - Both low-dose and high-dose groups showed comparable efficacy, with a recommendation to continue Phase III clinical research for the low-dose group [1]
方盛制药:蛭龙通络片获得II期临床试验总结报告
Zhi Tong Cai Jing· 2025-09-23 09:44
Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) announced the completion of Phase II clinical research for its innovative traditional Chinese medicine, Zhilong Tongluo Pian, which shows promising results for treating ischemic stroke recovery [1] Group 1: Clinical Research Findings - The drug is indicated for conditions such as post-stroke recovery, including symptoms like hemiplegia, speech difficulties, and fatigue [1] - Safety results indicate no statistically significant differences in severe adverse events or reactions among groups, with all severe events related to acute stroke recurrence and no fatalities reported [1] - Zhilong Tongluo Pian demonstrated effectiveness in improving the Rankin scale for disability, enhancing neurological function, and increasing daily living capabilities [1] Group 2: Efficacy and Recommendations - The drug is effective for symptoms related to blood stasis and Qi deficiency, including upper limb paralysis and speech issues, with a trend towards efficacy in lower limb paralysis and other symptoms [1] - Both low-dose and high-dose groups showed comparable efficacy, with a recommendation to continue Phase III clinical research for the low-dose group [1]
方盛制药:蛭龙通络片获II期临床试验总结报告
Xin Lang Cai Jing· 2025-09-23 09:37
Core Viewpoint - Fangsheng Pharmaceutical announced that its innovative traditional Chinese medicine, Zhilong Tongluo Tablets, has obtained the Phase II clinical research report, demonstrating significant efficacy in treating recovery from cerebral infarction (ischemic stroke) with good safety profile [1] Company Summary - Zhilong Tongluo Tablets are currently the company's exclusive product, with no other enterprises having obtained production approval for this product [1] - The clinical trial results indicate that both high-dose and low-dose groups show comparable efficacy [1] Market Summary - The sales revenue for traditional Chinese medicines treating cerebral infarction, such as Naoxintong Capsules and Tongxinluo Capsules, is projected to be 2.927 billion yuan and 2.273 billion yuan respectively in 2024 [1]