Core Viewpoint - Laimei Pharmaceutical's subsidiary, Sichuan Yingrui Pharmaceutical Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its innovative anti-cancer drug, "Nano Carbon Iron Suspension Injection," in combination with standard radiotherapy for solid tumor patients [1] Group 1 - The approved clinical trial aims to further validate the safety and potential efficacy of the "Nano Carbon Iron + Radiotherapy" combination therapy [1] - The trials will be initiated at multiple clinical centers, focusing on solid tumors that are difficult to treat locally [1] - The objective is to explore the clinical value of the combination therapy while ensuring safety [1]

Core Viewpoint - Lai Mei Pharmaceutical's subsidiary Yingrui Pharmaceutical has received approval from the National Medical Products Administration for clinical trials of its innovative anti-cancer drug, "Nano Carbon Iron Suspension Injection" [2] Group 1: Product Development - The new generation nano drug, Nano Carbon Iron, is developed based on the existing Nano Carbon Suspension Injection, utilizing Fe2+ as the active anti-cancer ingredient [2] - Nano Carbon serves as a carrier for Fe2+, and the drug exerts its anti-cancer effects by regulating the ferroptosis pathway [2] Group 2: Clinical Trials - The second phase of clinical trials for Nano Carbon Iron is progressing smoothly, with some patient enrollments already completed [2] - There are currently no similar products on the market or in late-stage research [2]

智通财经APP讯，莱美药业(300006.SZ)发布公告，近日，公司控股子公司四川瀛瑞医药科技有限公司 (简称"瀛瑞医药")自主研发的创新抗癌药物"纳米炭铁混悬注射液"(简称"纳米炭铁")获国家药品监督管理 局签发《药物临床试验批准通知书》，同意纳米炭铁联合标准放疗在实体瘤患者中开展临床试验。 本次获批的临床试验将进一步验证"纳米炭铁+放疗"联合方案的安全性和潜在疗效，陆续在多个临床中 心启动"纳米炭铁+放疗"研究，重点关注局部治疗难度较大的实体瘤，以期在确保安全性的前提下，进 一步探索联合疗法的临床价值。 ...

证券代码：300006 证券简称：莱美药业 公告编号：2025-057 重庆莱美药业股份有限公司 2、申请人：四川瀛瑞医药科技有限公司 3、适应症：实体瘤 4、注册分类：化学药品 2 类 5、受理号：CXHL2501026 近日，重庆莱美药业股份有限公司（以下简称"公司"或"莱美药业"）控 股子公司四川瀛瑞医药科技有限公司（以下简称"瀛瑞医药"）自主研发的创新 抗癌药物 "纳米炭铁混悬注射液" （以下简称"纳米炭铁"）获国家药品监督 管理局签发《药物临床试验批准通知书》，同意纳米炭铁联合标准放疗在实体瘤 患者中开展临床试验。现将相关情况公告如下： 一、药品基本情况 1、药品名称：纳米炭铁混悬注射液 6、通知书编号：2025LP03253 7、审批结论：纳米炭铁混悬注射液符合药品注册的有关要求，同意本品联 合标准放疗在实体瘤患者中开展临床试验。 二、药品的其他相关情况 纳米炭铁是在公司产品纳米炭混悬注射液基础上研究开发的新一代纳米药 物，以 Fe 2+作为抗癌有效成分，纳米炭作为 Fe 2+的载体，通过调控铁死亡通路发 挥抗癌作用。纳米炭铁通过瘤内注射，具有抑制肿瘤生长的功能。纳米炭铁是一 种新机理抗癌药物，与 ...

Market Overview - The chemical pharmaceutical sector increased by 0.16% on December 1, with Changshan Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3914.01, up 0.65%, while the Shenzhen Component Index closed at 13146.72, up 1.25% [1] Top Gainers in Chemical Pharmaceutical Sector - Changshan Pharmaceutical (300255) closed at 67.70, up 8.93% with a trading volume of 353,700 shares and a transaction value of 2.379 billion [1] - Laimei Pharmaceutical (300006) closed at 5.42, up 5.24% with a trading volume of 821,100 shares [1] - Oukang Pharmaceutical (920230) closed at 13.22, up 3.44% with a trading volume of 11,400 shares [1] Top Losers in Chemical Pharmaceutical Sector - Yifang Bio (688382) closed at 27.05, down 8.24% with a trading volume of 315,300 shares [2] - Keyuan Pharmaceutical (301281) closed at 27.96, down 4.51% with a trading volume of 44,300 shares [2] - Kangzhiyue Pharmaceutical (300086) closed at 12.17, down 4.32% with a trading volume of 864,700 shares [2] Capital Flow Analysis - The chemical pharmaceutical sector experienced a net outflow of 1.011 billion from institutional investors, while retail investors saw a net inflow of 466 million [2] - The sector's overall capital flow indicates a mixed sentiment, with institutional investors withdrawing funds while retail investors are actively buying [2] Individual Stock Capital Flow - Maiwei Bio (688062) had a net inflow of 48.528 million from institutional investors, but a net outflow of 65.659 million from retail investors [3] - Lijun Group (000513) saw a net inflow of 23.529 million from institutional investors, with a net outflow of 25.007 million from retail investors [3] - Huadong Pharmaceutical (000963) had a net inflow of 18.642 million from institutional investors, while retail investors experienced a net inflow of 10.459 million [3]

证券日报网讯11月27日晚间，莱美药业（300006）发布公告称，近日，重庆莱美药业股份有限公司(以 下简称"公司")收到国家药品监督管理局核准签发的注射用氨曲南(规格：0.5g)《药品补充申请批准通知 书》。 ...

Core Viewpoint - Lai Mei Pharmaceutical has received approval from the National Medical Products Administration for the injection of Aztreonam (0.5g), which is indicated for the treatment of infections caused by sensitive Gram-negative bacteria [1] Group 1 - The approved drug, Aztreonam, is suitable for treating various infections, including urinary tract infections (both uncomplicated and complicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]

证券代码：300006 证券简称：莱美药业 公告编号：2025-056 | 药品名称 | 通用名称：注射用氨曲南 | | --- | --- | | | 英文名/拉丁名：Aztreonam for Injection | | 剂型 | 注射剂 | | 注册分类 | 化学药品 | | 规格 | 0.5g | | 包装规格 | 瓶/盒 10 | | 通知书编号 | 2025B05696 | | 原药品批准文号 | 国药准字 H20059939 | | 药品注册标准编号 | YBH31162025 | | 申请内容 | 申请注射剂仿制药质量和疗效一致性评价，其他变更事项包括：1.变更 | | | 药品质量标准（包括有效期和贮藏条件）；2.变更直接接触药品的包装 | | | 材料和容器。 根据《中华人民共和国药品管理法》《国务院关于改革药品医疗器械审 | | | 评审批制度的意见》（国发〔2015〕44 号）《关于仿制药质量和疗效一 | | | 致性评价工作有关事项的公告》（2017 年第 100 号）和《国家药监局关 | | | 于开展化学药品注射剂仿制药质量和疗效一致性评价工作的公告》 | | 审批结论 | （2 ...

Core Viewpoint - Recently, the company received approval from the National Medical Products Administration for the injectable Amikacin (specification: 0.5g), which has passed the consistency evaluation for generic injectable drugs and includes changes to quality standards and packaging materials [1] Group 1 - The injectable Amikacin is indicated for the treatment of various infections, with 12 manufacturers having passed the consistency evaluation to date [1] - The sales revenue for injectable Amikacin in the Chinese hospital market is projected to be 259 million yuan, 220 million yuan, and 40 million yuan for the years 2023, 2024, and the first half of 2025, respectively [1] - The approval is expected to facilitate market expansion for the product, although there are uncertainties regarding production and sales [1]

Core Viewpoint - Lai Mei Pharmaceutical has received approval from the National Medical Products Administration for the injection of Aztreonam (0.5g), which is indicated for the treatment of infections caused by sensitive Gram-negative bacteria [1] Group 1 - The approved drug, Aztreonam, is suitable for treating various infections, including urinary tract infections (both uncomplicated and complicated), lower respiratory tract infections, sepsis, skin and skin structure infections, intra-abdominal infections, and gynecological infections [1]