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海欣股份:维生素B6注射液通过仿制药一致性评价
南财智讯12月26日电,海欣股份公告,控股子公司江西赣南海欣药业股份有限公司收到国家药监局核准 签发的化学药品"维生素B6注射液"的《药品补充申请批准通知书》,维生素B6注射液通过仿制药质量 和疗效一致性评价。维生素B6注射液为维生素类药,主要用于维生素B6缺乏的预防和治疗,防治异烟 肼中毒,也可用于妊娠、放射病及抗癌药所致的呕吐、脂溢性皮炎等。该药品为国家医保甲类品种和国 家基药目录品种,米内网数据库显示,2024年全国公立医疗机构销售额约为人民币3.04亿元。此次通过 一致性评价有助于提升产品的市场竞争力,为后续新药研发积累经验,但对公司目前经营业绩不会产生 重大影响。公司提示,药品销售受国家政策、招标采购、市场环境等因素影响,存在不确定性,敬请投 资者注意防范投资风险。 ...
广东众生药业股份有限公司关于获得盐酸氨溴索口服溶液《药品注册证书》的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:002317 公告编号:2025-118 广东众生药业股份有限公司关于获得盐酸氨溴索口服溶液《药品注册证书》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假记载、误导性陈述或重大遗 漏。 广东众生药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局核准签发的盐酸氨溴索 口服溶液《药品注册证书》。现将相关情况公告如下: 一、药品注册证书主要信息 药品名称:盐酸氨溴索口服溶液 剂型:口服溶液剂 规格:10ml∶30mg、100ml∶0.3g 申请事项:药品注册(境内生产) 注册分类:化学药品4类 证书编号:2025S03794、2025S03795 药品批准文号:国药准字H20256278、国药准字H20256279 上市许可持有人:名称:广东众生药业股份有限公司,地址:广东省东莞市石龙镇西湖工业区信息产业 园 生产企业:名称:广东众生药业股份有限公司,地址:广东省东莞市石龙镇西湖工业区信息产业园 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品注册的有关要求, 批准注册,发给药品注册证书。 ...
龙虎榜 | 海马汽车吸金超2.6亿,精智达遭T王近1.3亿减持
Ge Long Hui A P P· 2025-12-22 11:51
Market Overview - The Shanghai Composite Index rose by 0.69% to 3917 points on December 22, with significant gains in the Hainan sector driven by the duty-free concept, while the SPD concept declined, leading to notable losses in the millet economy and banking sectors [1]. High-Performing Stocks - Victory Energy achieved a seven-day consecutive rise, with a price increase of 49.98% to 28.75, attributed to control changes and developments in robotics [3][4]. - Jia Mei Packaging recorded a 10.05% increase, reaching 6.68, benefiting from control changes and its position as a leader in three-piece cans [4]. - Zhuangyuan Pasture and Luyuan Pharmaceutical both saw a 10.04% increase, with prices at 15.02 and 20.09% respectively, driven by the dairy and pet economy [4]. - Changfei Fiber and Shenjian Co. also performed well, with increases of 10% and 10.04% respectively, supported by advancements in optical fiber technology and commercial aerospace [4]. Trading Activity - The top three net buying stocks on the Dragon and Tiger list were Shanzi Gaokao, Haima Automobile, and Shennong Seed Industry, with net purchases of 688 million, 302 million, and 260 million respectively [5][6]. - Conversely, the top three net selling stocks included Wangzi New Materials, Xue Ren Group, and Central Mall, with net sales of 192 million, 111 million, and 88 million respectively [7]. Company Highlights - Snowman Group reported a total revenue of 1.631 billion yuan, a year-on-year increase of 24.26%, and a net profit of 39.17 million yuan, up 16.63%, indicating steady growth in both revenue and profit [19]. - The company is recognized as a leading manufacturer of ice-making systems and is actively expanding into the fuel cell industry, showcasing its diversified technological advantages [19]. - The company has also established a partnership for drug promotion and raw material supply, highlighting its advantages in the industry chain [12]. Stock Performance - Haima Automobile reached a daily limit increase with a turnover rate of 17.18% and a transaction volume of 2.577 billion yuan, with a net purchase of 302 million from the Dragon and Tiger list [20]. - Shenjian Co. also hit the daily limit, with a turnover rate of 31.53% and a transaction volume of 2.225 billion yuan, despite a net sell-off of 40.25 million by institutions [20].
中关村(000931.SZ):盐酸丁螺环酮片一致性评价申报收到《受理通知书》
Ge Long Hui· 2025-12-19 08:24
Core Viewpoint - Zhongguancun (000931.SZ) announced that its subsidiary, Beijing Huasu Pharmaceutical Co., Ltd., has received an acceptance notice from the National Medical Products Administration for the consistency evaluation application of the generic drug, Buprenorphine Hydrochloride Tablets [1] Group 1 - The drug Buprenorphine is the first non-benzodiazepine anxiolytic, acting as a 5-HT1A receptor agonist [1] - It selectively binds to the brain's 5-HT1A receptors, reducing excessive 5-HT activity associated with anxiety disorders [1] - The clinical advantage of this drug is its lack of dependency and withdrawal reactions, indicating a higher safety profile [1]
中关村(000931.SZ):盐酸丁螺环酮片一致性评价申报获受理
智通财经网· 2025-12-19 08:05
Core Viewpoint - The company Zhongguancun (000931.SZ) announced that its subsidiary Beijing Huasu Pharmaceutical Co., Ltd. has received a notice of acceptance from the National Medical Products Administration for the consistency evaluation application of the generic drug Buprenorphine Hydrochloride Tablets [1] Group 1: Company Developments - Beijing Huasu has received the acceptance notice for the consistency evaluation of Buprenorphine Hydrochloride Tablets in 5mg and 10mg specifications [1] - Buprenorphine is the first non-benzodiazepine anxiolytic drug, acting as a 5-HT1A receptor agonist to reduce excessive 5-HT activity in anxiety disorders [1] Group 2: Product Characteristics - The clinical advantage of Buprenorphine is its lack of drug dependence and withdrawal reactions, indicating a higher safety profile [1] - The indications for Buprenorphine Hydrochloride Tablets include various anxiety disorders [1]
中关村:下属公司盐酸丁螺环酮片一致性评价申请获受理
Xin Lang Cai Jing· 2025-12-19 08:00
Core Viewpoint - Beijing Huasu Pharmaceutical Co., Ltd., a subsidiary of Zhongguancun, has received the Acceptance Notification from the National Medical Products Administration for the consistency evaluation application of the generic drug Buprenorphine Hydrochloride Tablets (specifications: 5mg, 10mg) [1] Group 1 - Buprenorphine is the first non-benzodiazepine anxiolytic drug [1] - In China, a total of four companies, including Beijing Huasu, have approved generic drugs for market entry, with two companies having passed the consistency evaluation for quality and efficacy of generic drugs [1]
国家药监局局长李利:加快临床急需境外新药、罕见病药品、儿童药品等审评审批
Hua Er Jie Jian Wen· 2025-12-10 14:00
Core Viewpoint - The head of the National Medical Products Administration, Li Li, emphasizes the need to strengthen public awareness and accelerate the fulfillment of clinical medication demands [1] Group 1: Regulatory Approaches - The administration plans to fully utilize breakthrough therapy drugs, conditional approvals, priority reviews, and special approvals to expedite the review and approval of urgently needed overseas new drugs, rare disease medications, and pediatric drugs [1] - There is a commitment to maintain high standards and procedures while steadily expanding the scope of consistency evaluations for the quality and efficacy of generic drugs [1] Group 2: Patient-Centric Initiatives - The administration aims to shorten the distance from laboratory innovations to patient care, ensuring that innovative results benefit the public more quickly [1] - Efforts are being made to promote age-friendly and barrier-free reforms in drug labeling, encouraging the provision of accessible versions of drug instructions [1]
江苏联环药业股份有限公司关于控股子公司药品通过仿制药一致性评价的公告
Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. announced that its subsidiary, Changle Pharmaceutical, has received approval from the National Medical Products Administration for the consistency evaluation of the generic drug Estazolam Tablets, enhancing its product portfolio in the central nervous system treatment field [1][2]. Group 1: Drug Information - Drug Name: Estazolam Tablets - Dosage Form: Tablets - Registration Category: Chemical Drug - Specification: 1mg - Packaging: 10 tablets/board, 10 boards/box; 20 tablets/bottle - Original Drug Approval Number: Guoyao Zhunzi H41020215 - Acceptance Number: CYHB2450585 - Notification Number: 2025B05779 - Application Content: Consistency evaluation of generic drug quality and efficacy [1][3]. Group 2: Market Performance - As of the announcement date, the estimated sales revenue of Estazolam Tablets in domestic sample hospitals for 2024 is approximately 364 million yuan [3]. - Changle Pharmaceutical has obtained 6 production licenses for Estazolam Tablets as of the announcement date [5]. Group 3: R&D Investment - The R&D investment for the consistency evaluation of Estazolam Tablets by Changle Pharmaceutical is approximately 4.752 million yuan (unaudited) as of the announcement date [4]. Group 4: Company Impact - The approval of Estazolam Tablets for consistency evaluation is expected to enhance the company's market share and competitiveness in the generic drug development field, although it is not anticipated to have a significant impact on the company's recent operating performance [6].
联环药业:艾司唑仑片通过仿制药一致性评价
Core Viewpoint - The announcement from Lianhuan Pharmaceutical indicates that its subsidiary, Xinxiang Changle Pharmaceutical, has received approval for the generic drug Estazolam, which is used for treating anxiety and insomnia, enhancing the company's product portfolio in the central nervous system treatment area [1] Company Summary - Lianhuan Pharmaceutical's subsidiary, Xinxiang Changle Pharmaceutical, has been approved by the National Medical Products Administration for the supplemental application of Estazolam tablets [1] - The drug is primarily used for anxiety, insomnia, tension, fear, and has applications in treating epilepsy and seizures [1] - The estimated sales revenue for Estazolam in domestic sample hospitals for 2024 is approximately 364 million yuan [1] - The research and development investment for the consistency evaluation of this drug was about 4.752 million yuan (unaudited) [1] - The company has obtained six production licenses for Estazolam [1] - The approval is expected to enhance the company's market competitiveness but is not anticipated to have a significant impact on recent operating performance [1] Industry Summary - The sales of pharmaceuticals are influenced by national policies and market conditions, which introduce uncertainties [1]
华润双鹤:盐酸吡格列酮分散片获得药品补充申请批准通知书
Zhi Tong Cai Jing· 2025-12-01 09:27
Core Viewpoint - China Resources Double Crane Pharmaceutical (600062.SH) announced that its subsidiary, Double Crane Tianan Pharmaceutical (Guizhou) Co., Ltd., received approval from the National Medical Products Administration for the supplementary application of Pioglitazone Hydrochloride Dispersible Tablets, which is considered to have passed the consistency evaluation of generic drug quality and efficacy [1] Group 1 - The approved drug, Pioglitazone Hydrochloride Dispersible Tablets, is used for the treatment of type 2 diabetes [1] - The successful consistency evaluation is expected to enhance future market sales and competitiveness for the company [1] - This achievement will also provide valuable experience for the company in conducting future evaluations of generic drug consistency [1]