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 ...

Core Viewpoint - The company has received approval for the injectable Nicorandil, which is primarily used for treating unstable angina, enhancing its product portfolio in the cardiovascular field [1] Group 1 - The company's wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd., has obtained the drug registration certificate for injectable Nicorandil from the National Medical Products Administration [1] - The approval is considered equivalent to passing the consistency evaluation, which will enrich the company's cardiovascular product offerings [1] - This development is expected to strengthen the company's overall market competitiveness in related medication fields and bring positive impacts for future growth [1]

Core Viewpoint - China National Pharmaceutical Group Modern (国药现代) announced that its wholly-owned subsidiary, China National Pharmaceutical Group Rongsheng Pharmaceutical Co., Ltd. (国药容生), has received the drug registration certificate for injectable Nicorandil from the National Medical Products Administration, which is primarily used for treating unstable angina pectoris [1] Group 1 - The approval of the drug registration certificate signifies that the product has passed the consistency evaluation, enhancing the company's product portfolio in the cardiovascular field [1] - This development is expected to strengthen the company's overall market competitiveness in related medication areas [1] - The impact of this approval on the company's current operating performance is not expected to be significant [1]

Group 1 - The core point of the article is that China National Pharmaceutical Group Modern (国药现代) announced that its wholly-owned subsidiary, China National Pharmaceutical Container (国药容生), received approval from the National Medical Products Administration for the injection of Nicorandil, which is primarily used for treating unstable angina pectoris [1] - Nicorandil was originally developed by Japan's Chugai Pharmaceutical Co., Ltd. and was approved for marketing in Japan in 1993 [1]

Core Viewpoint - The approval of injectable Nicorandil by the National Medical Products Administration enhances the company's product offerings in the cardiovascular field and strengthens its market competitiveness in related medications [1] Group 1: Product Approval - The company's wholly-owned subsidiary, China National Pharmaceutical Group Modern, has received approval for injectable Nicorandil [1] - The drug is primarily used for the treatment of unstable angina pectoris [1] Group 2: Market Potential - According to the MiNei database, the projected sales for injectable Nicorandil in public medical institutions nationwide is 624 million yuan in 2024 [1] - The cumulative R&D investment for this project by the company is approximately 4.182 million yuan [1] Group 3: Competitive Advantage - The approval of this drug will enrich the company's cardiovascular formulation products [1] - This development is expected to enhance the company's competitiveness in the relevant medication market [1]

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]