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人福医药:子公司二甲磺酸利右苯丙胺胶囊上市许可申请获受理 目前国内暂无该药品上市
Xin Lang Cai Jing· 2025-11-21 08:03
Core Viewpoint - The company has received acceptance for the drug registration application of Dexamfetamine Mesylate Capsules, which is currently not available in the domestic market, indicating a potential expansion of its product line and market competitiveness [1] Group 1: Company Developments - The company's subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received the acceptance notice from the National Medical Products Administration for the drug registration application [1] - The drug is intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged 6 and above [1] - The total R&D investment in this project amounts to approximately 90 million RMB [1] Group 2: Market Implications - The acceptance of the drug registration application marks the entry of the product into the review phase, which, if successfully approved, will enhance the company's product offerings [1] - Currently, there are no similar products approved for sale or import in the domestic market, indicating a unique market opportunity for the company [1]
人福医药:子公司二甲磺酸利右苯丙胺胶囊药品上市许可申请获受理
Di Yi Cai Jing· 2025-11-21 08:02
Core Viewpoint - The approval of the drug registration application for Dextroamphetamine Sulfate Capsules by the National Medical Products Administration marks a significant step for the company, indicating the product is entering the review phase, which could enhance the company's product line and market competitiveness [1] Group 1 - The company's subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received the acceptance notice for the drug registration application of Dextroamphetamine Sulfate Capsules from the National Medical Products Administration [1] - Currently, there are no Dextroamphetamine Sulfate Capsules available in the domestic market, nor have any related products been approved for import [1] - The total R&D investment by Yichang Renfu in this project has reached approximately 90 million RMB [1]
人福医药:子公司二甲磺酸利右苯丙胺胶囊药品上市许可申请获受理 目前国内暂无该药品上市
Ge Long Hui A P P· 2025-11-21 08:02
Core Insights - The company announced that its subsidiary, Yichang Renfu Pharmaceutical Co., Ltd., has received the acceptance notice for the drug registration application of Dexmethylphenidate Hydrochloride Capsules from the National Medical Products Administration [1] - This drug is intended for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients aged 6 and above [1] - Currently, there are no similar products available in the domestic market or approved for import, indicating a potential market opportunity for the company [1] Financial and R&D Investment - The cumulative R&D investment for this project by Yichang Renfu is approximately 90 million RMB [1] - The acceptance of the drug registration application marks the entry of this product into the review phase, which, if successfully approved, will enhance the company's product line and market competitiveness [1]
人福医药(600079) - 人福医药关于子公司药品上市许可申请获受理的提示性公告
2025-11-21 08:00
证券代码:600079 证券简称:人福医药 编号:临 2025-122 人福医药集团股份公司 关于子公司药品上市许可申请获受理的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、 误导性陈述或者重大遗漏,并对其内容的真实性、准确性和完整性承 担法律责任。 人福医药集团股份公司(以下简称"公司")控股子公司宜昌人福药业有限责 任公司(以下简称"宜昌人福",公司持有其80%的股权)近日收到国家药品监督管 理局核准签发的二甲磺酸利右苯丙胺胶囊的药品注册上市许可申请《受理通知书》, 现将相关情况公告如下: 一、药物名称:二甲磺酸利右苯丙胺胶囊 二、剂型:胶囊剂 三、申请事项:境内生产药品注册上市许可 四、注册分类:化学药品3类 五、申请人:宜昌人福药业有限责任公司 六、审查结论:根据《中华人民共和国行政许可法》第三十二条的规定,经审 查,决定予以受理。受理号:CYHS2504001、CYHS2504003、CYHS2504004、 CYHS2504006。 二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市,用于治疗成人和 6 岁及以 上儿科患者的注意缺陷多动障碍(ADHD),以及成人中度至重度暴食症(B ...
人福医药(600079.SH):二甲磺酸利右苯丙胺胶囊上市许可申请获受理
智通财经网· 2025-11-21 07:53
据悉,二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市,用于治疗成人和6岁及以上儿科患者的注意 缺陷多动障碍(ADHD),以及成人中度至重度暴食症(BED)。宜昌人福本次提交本品的上市许可申请申 报的适应症为成人和6岁及以上儿科患者的注意缺陷多动障碍(ADHD)。根据国家药品监督管理局官网 显示,国内目前暂无二甲磺酸利右苯丙胺胶囊上市,也无相关产品获批进口。截至目前,宜昌人福在该 项目上的累计研发投入约9,000万元人民币。 智通财经APP讯,人福医药(600079.SH)发布公告,公司控股子公司宜昌人福药业有限责任公司(以下简 称"宜昌人福",公司持有其80%的股权)近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺 胶囊的药品注册上市许可申请《受理通知书》。 ...
人福医药(600079.SH):二甲磺酸利右苯丙胺胶囊药品上市许可申请获受理
Ge Long Hui A P P· 2025-11-21 07:50
格隆汇11月21日丨人福医药(维权)(600079.SH)公布,控股子公司宜昌人福药业有限责任公司(简 称"宜昌人福",公司持有其80%的股权)近日收到国家药品监督管理局核准签发的二甲磺酸利右苯丙胺 胶囊的药品注册上市许可申请《受理通知书》,二甲磺酸利右苯丙胺胶囊原研最早于美国获批上市,用 于治疗成人和6岁及以上儿科患者的注意缺陷多动障碍(ADHD),以及成人中度至重度暴食症 (BED)。 ...
人福医药:二甲磺酸利右苯丙胺胶囊上市许可申请获受理 目前国内暂无该药品上市也无相关产品获批进口
Mei Ri Jing Ji Xin Wen· 2025-11-21 07:48
每经AI快讯,11月21日,人福医药(600079.SH)公告称,控股子公司宜昌人福近日收到国家药品监督管 理局核准签发的二甲磺酸利右苯丙胺胶囊的药品注册上市许可申请《受理通知书》。该药物用于治疗成 人和6岁及以儿科患者的注意缺陷多动障碍(ADHD)。目前国内暂无该药品上市,也无相关产品获批 进口。宜昌人福在该项目上的累计研发投入约9000万元人民币。药品注册上市许可申请被受理,标志着 该品种境内生产药品注册工作进入了审评阶段,如顺利通过审评审批,将丰富公司的产品线,有利于提 升公司的市场竞争力。 (文章来源:每日经济新闻) ...
人福医药:二甲磺酸利右苯丙胺胶囊上市许可申请获受理
人民财讯11月21日电,人福医药(600079)11月21日公告,公司控股子公司宜昌人福近日收到国家药监 局核准签发的二甲磺酸利右苯丙胺胶囊的药品注册上市许可申请《受理通知书》。二甲磺酸利右苯丙胺 胶囊原研最早于美国获批上市,用于治疗成人和6岁及以上儿科患者的注意缺陷多动障碍(ADHD),以 及成人中度至重度暴食症(BED)。国内目前暂无二甲磺酸利右苯丙胺胶囊上市,也无相关产品获批进 口。 ...
芬太尼概念下跌1.68%,主力资金净流出5股
Core Viewpoint - The fentanyl concept sector experienced a decline of 1.68% as of the market close on November 17, with companies such as Enhua Pharmaceutical, Renfu Pharmaceutical, and Lingrui Pharmaceutical leading the losses [1] Market Performance - The fentanyl concept sector ranked among the top decliners, with a notable drop compared to other sectors such as military restructuring, which increased by 4.72% [1] - Other sectors that saw declines include cell immunotherapy (-1.87%), weight loss drugs (-1.87%), and innovative drugs (-1.72%) [1] Capital Flow - The fentanyl concept sector saw a net outflow of 153 million yuan, with five stocks experiencing significant capital outflows [1] - Renfu Pharmaceutical had the highest net outflow at 83.49 million yuan, followed by Lingrui Pharmaceutical (36.78 million yuan) and Enhua Pharmaceutical (24.86 million yuan) [1] - Conversely, the stocks with net inflows included Guoyao Co., Botao Bio, and Dongfang Bio, with net inflows of 2.91 million yuan, 849,400 yuan, and 285,900 yuan respectively [1] Individual Stock Performance - The top stocks in the fentanyl concept sector by net outflow include: - Renfu Pharmaceutical: -2.36% with a net outflow of 83.49 million yuan - Lingrui Pharmaceutical: -2.12% with a net outflow of 36.78 million yuan - Enhua Pharmaceutical: -2.93% with a net outflow of 24.86 million yuan [1] - In contrast, Guoyao Co. and Botao Bio showed slight positive movements with net inflows [1]
人福医药跌2.02%,成交额1.33亿元,主力资金净流出809.73万元
Xin Lang Cai Jing· 2025-11-17 02:13
Core Viewpoint - Renfu Pharmaceutical's stock has experienced a decline of 11.71% year-to-date, with a recent drop of 2.02% on November 17, 2023, indicating potential challenges in the market [1]. Financial Performance - For the period from January to September 2025, Renfu Pharmaceutical reported a revenue of 17.883 billion yuan, a year-on-year decrease of 6.58%, while the net profit attributable to shareholders was 1.689 billion yuan, reflecting a year-on-year growth of 6.22% [2]. - Cumulative cash dividends since the company's A-share listing amount to 3.113 billion yuan, with 1.779 billion yuan distributed over the past three years [3]. Shareholder Information - As of September 30, 2025, the number of shareholders for Renfu Pharmaceutical increased to 69,400, a rise of 38.71%, while the average circulating shares per person decreased by 27.91% to 22,222 shares [2]. - Among the top ten circulating shareholders, Hong Kong Central Clearing Limited holds 42.1832 million shares, a decrease of 1.3907 million shares compared to the previous period [3].