中关村公告，下属公司北京华素制药股份有限公司于近日收到国家药品监督管理局签发的《受理通知 书》，盐酸丁螺环酮片（规格：5mg、10mg）仿制药一致性评价申请获得受理。丁螺环酮是第一个非 苯二氮䓬类的抗焦虑药，目前中国境内包括北京华素共有4家企业的仿制药获批上市，其中有2家已通过 仿制药质量与疗效一致性评价。 ...

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]

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。 江苏联环药业股份有限公司（以下简称"公司"）控股子公司新乡市常乐制药有限责任公司（以下简 称"常乐制药"）于近日收到国家药品监督管理局核准签发的关于艾司唑仑片（以下简称"本品"或"该药 品"）《药品补充申请批准通知书》，批准常乐制药本品通过仿制药质量和疗效一致性评价（以下简 称"一致性评价"）。现将相关情况公告如下： 通知书编号：2025B05779 申请内容：仿制药质量和疗效一致性评价。 审批结论：经审查，本品通过仿制药质量和疗效一致性评价。 一、药品基本信息 药品名称：艾司唑仑片 剂型：片剂 注册分类：化学药品 规格：1mg 包装规格：10片/板，10板/盒；20片/瓶 原药品批准文号：国药准字H41020215 受理号：CYHB2450585 由于药品销售受到国家政策、市场环境、市场接受度、市场竞争力等因素影响，存在不确定性，敬请广 大投资者审慎决策，注意投资风险。 特此公告。 江苏联环药业股份有限公司董事会 2025年12月5日 二、药品的其他情况 艾司唑仑片主要用于抗焦 ...

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]

盐酸吡格列酮分散片用于2型糖尿病的治疗。本次盐酸吡格列酮分散片通过一致性评价将有利于未来的 市场销售和市场竞争，并为后续开展仿制药一致性评价积累了宝贵的经验。 华润双鹤（600062）(600062.SH)发布公告，近日，公司控股子公司双鹤天安药业(贵州)股份有限公司 (简称"双鹤天安")收到了国家药品监督管理局颁发的盐酸吡格列酮分散片《药品补充申请批准通知 书》。经审查，该药品视同通过仿制药质量和疗效一致性评价。 ...

智通财经APP讯，华润双鹤(600062.SH)发布公告，近日，公司控股子公司双鹤天安药业(贵州)股份有限 公司(简称"双鹤天安")收到了国家药品监督管理局颁发的盐酸吡格列酮分散片《药品补充申请批准通知 书》。经审查，该药品视同通过仿制药质量和疗效一致性评价。 盐酸吡格列酮分散片用于2型糖尿病的治疗。本次盐酸吡格列酮分散片通过一致性评价将有利于未来的 市场销售和市场竞争，并为后续开展仿制药一致性评价积累了宝贵的经验。 ...

Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd., has passed the consistency evaluation for Tramadol Hydrochloride Injection, which is primarily used for treating moderate to severe pain [1] Summary by Categories Product Development - The company has invested approximately RMB 1.52 million in the research and development of this drug for the consistency evaluation [1] Market Impact - Products that pass the consistency evaluation will receive greater support in areas such as medical insurance payments and procurement by medical institutions, which is expected to help expand the market share of this drug and enhance its market competitiveness [1] Risks and Uncertainties - There is a possibility that the sales of this drug may not meet expectations, indicating significant uncertainty regarding its market performance [1]

Core Viewpoint - The announcement indicates that the company has received approval from the National Medical Products Administration for its epinephrine injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1: Company Developments - The company submitted the application materials in February 2024 and received acceptance, with approval granted in November 2025 [1] - The epinephrine injection is indicated for severe respiratory distress and anaphylactic shock, classified as a Category A drug under medical insurance [1] Group 2: Market Insights - The estimated sales of epinephrine in Chinese public medical institutions is approximately 270 million yuan in 2024 [1] - The successful evaluation is expected to enhance the company's market competitiveness, although drug sales are subject to uncertainties influenced by policies and market conditions [1]

Strong Stocks - As of November 26, the Shanghai Composite Index fell by 0.15% to 3864.18 points, while the Shenzhen Component Index rose by 1.02% to 12907.83 points, and the ChiNext Index increased by 2.14% to 3044.69 points [1] - A total of 76 stocks in the A-share market hit the daily limit up, with the top three strong stocks being: TeFa Information (000070), Huanrui Century (000892), and Leike Defense (002413) [1] - The top 10 strong stocks showed significant trading activity, with TeFa Information achieving a 4-day limit up and a turnover rate of 25.84%, while Huanrui Century also had a 4-day limit up with a turnover rate of 37.38% [1] Strong Concept Sectors - The top three concept sectors based on A-share performance were: Horse Racing Concept, Duty-Free Shops, and Guangdong Free Trade Zone, with respective increases of 1.95%, 1.72%, and 1.5% [2] - The Horse Racing Concept had 50% of its constituent stocks rising, while the Duty-Free Shops sector saw 68.97% of its stocks increase [2] - The top 10 concept sectors displayed a mix of performance, with sectors like Medical E-commerce and CPO (Co-Packaged Optics) also showing positive growth [2]

Core Viewpoint - The approval of the injectable Cefoperazone Sodium and Sulbactam Sodium by the National Medical Products Administration of China enhances the company's position in the anti-infection sector and is expected to generate greater returns for the company and its shareholders [1] Group 1: Product Approval - The company's wholly-owned subsidiary, Zhuhai United Pharmaceutical Co., Ltd., has received approval for the injectable Cefoperazone Sodium and Sulbactam Sodium (specification: 2.0g) [1] - This product has passed the consistency evaluation for generic drug quality and efficacy [1] Group 2: Product Characteristics - Injectable Cefoperazone Sodium and Sulbactam Sodium is a third-generation cephalosporin antibiotic with broad-spectrum antibacterial activity [1] - It can be used alone or in combination for treating infections caused by sensitive bacteria, including respiratory, urinary, intra-abdominal infections, sepsis, meningitis, skin and soft tissue infections, bone and joint infections, and reproductive tract infections [1] Group 3: Market Position and Future Plans - The product is listed as a Class B drug in the National Medical Insurance Directory (2024 edition) [1] - The approval is expected to help the company strengthen its competitive advantage in the anti-infection field [1] - The company will continue to focus on new product development and advancing consistency evaluations to create greater value for the company and its shareholders [1]