格隆汇9月16日丨同和药业(300636.SZ)公布，近日收到欧洲药品质量管理局（EDQM）颁发的变更后的 替格瑞洛原料药欧洲药典适应性证书(CEP)，本次变更主要原因为公司新增生产车间，变更后的证书自 2025年9月12日起生效。替格瑞洛是一种新型、具有选择性的小分子抗凝血药，可以阻断血小板活化， 用于治疗急性冠脉综合征患者，减少血栓性心血管疾病的发生，具有快速、强效的特点。公司替格瑞洛 产品新增生产车间获得EDQM批准，标志着公司替格瑞洛原料药在欧洲市场的供应能力进一步提升，将 对公司维持和扩大国际市场业务起到积极作用。 ...

证券代码：300636 证券简称：同和药业 公告编号：2025-049 江西同和药业股份有限公司 关于获得欧洲药典适应性证书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、 完整，没有虚假记载、误导性陈述或重大遗漏。 江西同和药业股份有限公司（以下简称"公司"）于近日收到欧 洲药品质量管理局（EDQM）颁发的变更后的替格瑞洛原料药欧洲药典 适应性证书(CEP)，本次变更主要原因为公司新增生产车间，变更后 的证书自2025年9月12日起生效，相关信息如下： 江西同和药业股份有限公司董事会 二〇二五年九月十六日 1/ 1 生产商名称：江西同和药业股份有限公司 生产商地址：江西省宜春市奉新高新技术产业园区长乐大道 699 号 认证范围：替格瑞洛原料药 证书编号：CEP 2021-303-Rev 01 签发日期：2025.09.12 替格瑞洛是一种新型、具有选择性的小分子抗凝血药，可以阻断 血小板活化，用于治疗急性冠脉综合征患者，减少血栓性心血管疾病 的发生，具有快速、强效的特点。 公司替格瑞洛产品新增生产车间获得EDQM批准，标志着公司替格 瑞洛原料药在欧洲市场的供应能力进一步提升，将对公司维持和扩大 ...

Investment Rating - The report maintains an "Accumulate" rating for the industry [5] Core Insights - The pharmaceutical and biotechnology industry is expected to experience a turning point and growth resonance, with a focus on the resilience of the raw material drug sector amidst various macro and micro factors [7][10] - The industry is characterized by a significant number of listed companies, totaling 494, with a total market value of 77,409.20 billion and a circulating market value of 70,487.38 billion [2] Summary by Sections Industry Overview - The report analyzes 47 representative raw material drug companies, indicating that despite pressures on revenue, the profit margins are showing improvement, reflecting the industry's resilience [10] - The average revenue growth rate for the 47 companies in the first half of 2025 was -5.38%, while the average growth rate of non-recurring net profit was 14.43% [10][12] Financial Performance - Key companies such as Xinhecheng, Aoruite, Tianyu Co., Meinuohua, and others have achieved over 10% growth in revenue and non-recurring net profit [10] - The report highlights that the non-recurring net profit of Xinhecheng increased significantly by 70.50% year-on-year in the first half of 2025 [10] Market Trends - The report notes that the prices of major raw materials are currently at low levels, particularly for certain categories like sartans and heparins, with expectations for gradual price recovery as excess capacity is cleared [7][10] - The investment strategy for the second half of the year focuses on identifying companies that are at a turning point in their existing business while also exploring new growth opportunities [7][10] Company Recommendations - The report suggests focusing on companies such as Tianyu Co., Sitaly, Tonghe Pharmaceutical, Meinuohua, Xianju Pharmaceutical, and Puluo Pharmaceutical for potential investment opportunities [7][10]

招商证券股份有限公司 关于江西同和药业股份有限公司 三、公司及股东承诺事项履行情况 | 公司及股东承诺事项 | 是否履行承诺 | 未履行承诺的原因及解决 | | --- | --- | --- | | | | 措施 | | 1、关于股份流通限制及锁定的承诺 | 是 | 不适用 | | 2、关于不存在虚假记载、误导性陈 述或者重大遗漏方面的承诺 | 是 | 不适用 | | 3、关于避免同业竞争、规范和减少 关联交易的承诺 | 是 | 不适用 | | 4、关于填补被摊薄即期回报的承诺 | 是 | 不适用 | 四、其他事项 2025年半年度持续督导跟踪报告 | 保荐人名称：招商证券股份有限公司 | 被保荐公司简称：同和药业 | | --- | --- | | 保荐代表人姓名：刘海燕 | 联系电话：0755-82943666 | | 保荐代表人姓名：鄢坚 | 联系电话：0755-82943666 | 一、保荐工作概述 | 项目 | 工作内容 | | --- | --- | | 1.公司信息披露审阅情况 | | | （1）是否及时审阅公司信息披露文件 | 是 | | （2）未及时审阅公司信息披露文件的次数 | 不适用 ...

Group 1 - The core viewpoint of the articles highlights the recent performance and financial metrics of Tonghe Pharmaceutical, including stock price movements and trading volumes [1][2] - As of September 9, Tonghe Pharmaceutical's stock price was 9.11 yuan per share, with a market capitalization of 3.826 billion yuan [1] - The company has seen a year-to-date stock price increase of 14.88%, with a slight decline of 0.98% over the last five trading days [1] Group 2 - For the first half of 2025, Tonghe Pharmaceutical reported a revenue of 427 million yuan, reflecting a year-on-year growth of 11.88% [2] - The net profit attributable to shareholders for the same period was approximately 58.49 million yuan, showing a decrease of 15.91% compared to the previous year [2] - The company has distributed a total of 96.55 million yuan in dividends since its A-share listing, with 49.42 million yuan distributed over the last three years [2]

Group 1 - The core viewpoint is that Tonghe Pharmaceutical (300636.SZ) has seen growth in its CMO/CDMO business in the second quarter and has positive prospects for the future [1] - The company has increased the number of new projects in the CMO/CDMO sector in recent years, while gradually phasing out some older projects [1] - The company aims to actively serve existing projects and vigorously explore new projects to compensate for the decline in orders from older projects [1] Group 2 - The CMO/CDMO business is expected to achieve rapid growth in 2027 and 2028 [1]

Core Viewpoint - The company has a low proportion of direct exports to the United States, indicating that the recent tariff increases on this segment will have minimal impact on its operations [1] Group 1: Impact of Tariffs - The company's direct exports to the U.S. are limited, thus the impact of U.S. tariffs on this business segment is considered minor [1] - Indirect business may be affected by U.S. tariffs, as domestic and Indian manufacturers exporting to the U.S. are adopting a wait-and-see approach due to tariff uncertainties [1] - Further assessment is needed to evaluate the overall impact of these tariff changes on the company's operations [1]

Core Viewpoint - The company, Tonghe Pharmaceutical, has indicated significant growth potential for its second-tier product lineup over the next 3-5 years, alongside ongoing registration of eight other products that will contribute to revenue [1] Group 1 - The company has 17 new products in its second-tier lineup that are expected to have substantial growth opportunities in the next 3-5 years [1] - The eight products currently in the registration process will gradually contribute to the company's revenue [1] - The total production capacity of the company is projected to reach 2 billion in the next 3-5 years [1]

Core Viewpoint - The company has reported growth in its CMO/CDMO business in the second quarter and anticipates further growth in the future [1] Group 1: Business Performance - The CMO/CDMO business has seen an increase in new projects in recent years, despite some older projects gradually exiting the market [1] - The company aims to actively serve existing projects while aggressively exploring new projects to compensate for the decline in orders from older projects [1] Group 2: Future Outlook - The CMO/CDMO business is expected to achieve rapid growth in 2027 and 2028 [1]

Group 1 - The core viewpoint of the article highlights that Tonghe Pharmaceutical (300636.SZ) anticipates rapid growth in new products in the first half of 2025, reaching 195 million yuan [1] - The high-end regulatory market is expected to contribute 160 million yuan, while emerging markets are projected to add 35 million yuan to the growth [1] - The company expects a positive growth trend in the future as a result of a concentration of new product patents expiring over the past three years [1]