近日，CDE官网显示，山东新时代药业有限公司按4类化药注册申报的尼可地尔片上市申请申请已获受理。作为上市40余年的经典抗心绞痛药，尼可地尔院 内年销售额超14亿元，"老药翻红"成为新一代"卷王"，并成功入围新国采。 | 受理品种目录浏览 | 在审品种目录浏览 | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | 2025 | ▼ | 药品类型: | 全部 | レ 申请类型: | 全部 | ਾ | 童询 | | 请输入受理号 | | 药品名称: | 尼可地尔片 | 企业名称: | 请输入企业名称 | | | | 受理号 CYHS2503128 | | 药品名称 尼可地尔片 | 药品类型 化药 | 申请类型 仿制 | 注册分类 ব | 企业名称 山东新时代药业有限公 司;山东新时代药业有 限公司: | 承办日期 2025-08-26 国际军区 | | 年 会睡着: 序号 | | | | | | | | 截图来源：CDE官网 尼可地尔（Nicorandil）作为一类兼具硝酸酯样作用和ATP敏感性钾通道（KATP）开放作用的双重机制药物，用 ...

国药现代（600420）(600420.SH)发布公告，近日，公司全资子公司国药集团容生制药有限公司(简称国 药容生)收到国家药品监督管理局核准签发的注射用尼可地尔《药品注册证书》。注射用尼可地尔主要 适用于治疗不稳定型心绞痛。 本次国药容生获得上述药品注册证书并视同通过一致性评价，丰富了公司心血管领域相关制剂产品群， 有利于进一步增强公司在相关用药领域的综合市场竞争力，为公司未来发展带来积极影响。上述事项对 公司当期经营业绩不会产生重大影响。 ...

智通财经APP讯，国药现代(600420.SH)发布公告，近日，公司全资子公司国药集团容生制药有限公司 (简称国药容生)收到国家药品监督管理局核准签发的注射用尼可地尔《药品注册证书》。注射用尼可地 尔主要适用于治疗不稳定型心绞痛。 本次国药容生获得上述药品注册证书并视同通过一致性评价，丰富了公司心血管领域相关制剂产品群， 有利于进一步增强公司在相关用药领域的综合市场竞争力，为公司未来发展带来积极影响。上述事项对 公司当期经营业绩不会产生重大影响。 ...

格隆汇9月1日｜国药现代(600420.SH)公告称，全资子公司国药容生收到国家药品监督管理局核准签发 的注射用尼可地尔《药品注册证书》。注射用尼可地尔主要适用于治疗不稳定型心绞痛，原研为日本中 外制药株式会社，于1993年在日本获批上市。 ...

国药现代公告，全资子公司国药容生获得国家药品监督管理局核准签发的注射用尼可地尔《药品注册证 书》。该药品主要用于治疗不稳定型心绞痛。根据米内网数据库显示，注射用尼可地尔2024年全国公立 医疗机构销售额为6.24亿元。目前，国药容生用于该项目的累计研发投入约为418.2万元。此次获批将丰 富公司心血管领域的制剂产品，有助于增强公司在相关用药领域的市场竞争力。 ...

Group 1 - The company is building a three-dimensional research and innovation system focusing on short, medium, and long-term goals, actively introducing quality projects and innovative technologies in the short to medium term [1] - The technology center continues to conduct research on new drug imitation and innovation, enhancing the company's product portfolio and competitiveness in specific fields [1] - The company is advancing the development of innovative technologies and products such as nano carbon iron in the long term, and is promoting the independent research and development of cell immunotherapy and personalized innovative medical technologies by its affiliate [1] Group 2 - In the reporting period, the company obtained approvals or supplementary application approvals for various products, including Clindamycin Phosphate Injection and Naloxone Hydrochloride Injection, and passed consistency evaluations [1] - The company’s product Esomeprazole Magnesium Enteric-coated Capsules and others were selected for provincial centralized procurement projects, enhancing market share [1] - Laimei Pharmaceutical reported a revenue of 377 million yuan for the first half of 2025, focusing on consolidating the leading position of its flagship product, Kanalin, in its niche market [2]

Core Viewpoint - Laimei Pharmaceutical reported a revenue of 198 million yuan for Q1 2025, marking a year-on-year increase of 9.54%, but faced a net loss of 13.78 million yuan due to intensified market competition and rising R&D costs [2][3] Group 1: Financial Performance - The company achieved a revenue of 198 million yuan, reflecting a year-on-year growth of 9.54% [2] - The net profit attributable to shareholders was -13.78 million yuan, indicating an increase in losses compared to the previous year [2] Group 2: Strategic Focus - Laimei Pharmaceutical is focusing on its strengths in traditional therapeutic areas such as oncology, digestive system, and specialty drugs, while enhancing the marketing of its core product, Kanalin [2] - The company is actively expanding Kanalin's market beyond thyroid indications and is pursuing international sales to increase global market share [2] Group 3: R&D and Innovation - The company has maintained a path of independent innovation, with R&D investment reaching 13.77 million yuan, a year-on-year increase of 33.71% [3] - Several innovative projects, including a nano carbon iron injection and personalized tumor vaccines, are progressing smoothly, ensuring a robust pipeline for future growth [3] - The company has successfully registered new drugs, including Nicorandil and Clindamycin Phosphate Injection, contributing to a more diversified product structure [3]