证券代码：603520 证券简称：司太立 公告编号：2025-054 浙江司太立制药股份有限公司 关于全资子公司获得药品注册证书的公告 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。 浙江司太立制药股份有限公司（以下简称"公司"）全资子公司上海司太立 制药有限公司（以下简称"上海司太立"）于近日收到国家药品监督管理局（以 下简称"国家药监局"）核准签发的钆喷酸葡胺注射液《药品注册证书》，现将 具体情况公告如下： 本药品适应症：主要用于中枢神经（脑及脊髓）、腹、胸、盆腔、四肢等人 体脏器和组织的磁共振成像。 本药品的药品注册分类为化学药品 4 类。根据国家药监局《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）文件相关规定， 本药品视为通过仿制药质量和疗效一致性评价。 截至目前，该药品累计研发投入共计约 707.67 万元。 三、药品市场情况 钆喷酸葡胺注射液经静脉注射进入体内后能改变局部组织的弛豫时间，增强 磁共振成像图像的清晰度和对比度。其适应症广泛、成像品质高、临床使用效果 好、不良反应发 ...

证券代码：603520 证券简称：司太立 公告编号：2025-053 浙江司太立制药股份有限公司 关于选举第五届董事会职工董事的公告 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。 本次选举职工董事工作完成后，公司第五届董事会中兼任公司高级管理 人员职务以及由职工代表担任的董事人数，合计未超过公司董事总数的二分 之一，符合有关法律法规、规范性文件及《公司章程》的规定。 特此公告。 浙江司太立制药股份有限公司董事会 2025 年 11 月 26 日 附： 根据《中华人民共和国公司法》（以下简称"《公司法》"）和修订后 的《公司章程》等有关规定，浙江司太立制药股份有限公司(以下简称"公司") 于近日召开职工代表大会，民主选举郑方卫先生（简历详见附件）为公司第 五届董事会职工董事，任期自选举之日（2025 年 11 月 24 日）至公司第五届 董事会任期届满为止。 郑方卫先生，男，1978 年出生，中国国籍，无境外永久居住权，本科学 历。2004 年至 2008 年任浙江司太立制药股份有限公司车间工艺员；2008 年 至 2016 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Gadobutrol Injection, which is primarily used for magnetic resonance imaging of various organs and tissues in the human body [1] Group 1 - The drug is indicated for use in central nervous system imaging, including the brain and spinal cord [1] - It is also applicable for imaging of abdominal, thoracic, pelvic, and limb organs and tissues [1]

Core Viewpoint - The company has received approval for a new drug, Gadobutrol Injection, which is primarily used for MRI imaging of various organs and tissues in the human body [1] Company Summary - The company's wholly-owned subsidiary, Shanghai Sital Pharmaceutical Co., Ltd., has been granted a drug registration certificate by the National Medical Products Administration [1] - The approved drug is indicated for use in central nervous system imaging, including the brain and spinal cord, as well as imaging of abdominal, thoracic, pelvic, and limb organs and tissues [1]

Core Viewpoint - The company is positioned as a leading integrated enterprise in the iodine contrast agent market, with a focus on expanding its international strategy and enhancing production capacity to meet growing demand [8][10][12]. Company Overview - The company, Zhejiang Sital Pharmaceutical Co., Ltd., was established in 1997 and listed in 2016, specializing in X-CT non-ionic contrast agents and related products, making it the largest manufacturer in China in terms of product variety and scale [8]. - The company has a clear shareholding structure, with the controlling shareholders being Hu Jian and Hu Jinsheng, who collectively hold 22.33% of the shares [10]. - The company has four major production bases, focusing on releasing production capacity after a phase of significant expansion [12][13]. Revenue and Profitability - The company's revenue has shown steady growth, with total revenue increasing from 1.367 billion yuan in 2020 to an estimated 2.350 billion yuan in 2024, reflecting a compound annual growth rate (CAGR) of 14.51% [15]. - The iodine contrast agent business contributes approximately 80% of total revenue, with a growth from 1.214 billion yuan in 2020 to 1.870 billion yuan in 2024 [15]. - The company faced profitability pressures due to rising raw material costs, with net profit declining from 239 million yuan in 2020 to a projected loss in 2024, although a recovery is expected in 2025 [17]. Industry Insights - The global iodine contrast agent market is characterized by high barriers to entry and significant concentration, with major players including GE Healthcare and Bayer [21][32]. - The iodine contrast agent market is projected to grow, driven by increasing demand for medical imaging and advancements in healthcare infrastructure, particularly in emerging markets [23][27]. - The company is expected to capture a significant share of the global iodine contrast agent raw material market, with a projected capacity of 3,000 tons by the end of 2025, representing nearly one-third of global demand [36][38]. Production Capacity and Quality - The company has achieved substantial production capacity in iodine contrast agents, with 2,400 tons already built and expected to reach 3,000 tons by the end of 2025 [36][37]. - The company has completed quality certifications for approximately 1,800 tons of its production capacity, ensuring compliance with international standards [37]. - The company’s main products, including Iohexol and Iopamidol, have significant market shares, with sales revenues of 68.28 million USD and 26.16 million USD respectively in 2024 [38][39].

证券代码：603520 证券简称：司太立 公告编号：2025-052 浙江司太立制药股份有限公司 2025年第一次临时股东会决议公告 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。 重要内容提示： 本次会议是否有否决议案：无 一、 会议召开和出席情况 (一)股东大会召开的时间：2025 年 11 月 20 日 (二)股东大会召开的地点：浙江省仙居县现代工业集聚区丰溪西路 9 号公司行政 楼会议室现场结合线上方式 (三)出席会议的普通股股东和恢复表决权的优先股股东及其持有股份情况： | 1、出席会议的股东和代理人人数 | 263 | | --- | --- | | 2、出席会议的股东所持有表决权的股份总数（股） | 94,560,266 | | 3、出席会议的股东所持有表决权股份数占公司有表决权股 | | | 份总数的比例（%） | 21.5689 | (四)表决方式是否符合《公司法》及《公司章程》的规定，大会主持情况等。 本次会议由公司董事会召集，董事长胡健先生主持，会议以现场投票结合网络投 票的方式进行表决，会议的召集、召开 ...

北京金诚同达律师事务所 关于 浙江司太立制药股份有限公司 2025 年第一次临时股东会的 法律意见书 北京市朝阳区建国门外大街 1 号国贸大厦 A 座 10 层 电话：010-5706 8585 传真：010-6518 5057 金诚同达律师事务所 法律意见书 北京金诚同达律师事务所 关于浙江司太立制药股份有限公司 2025 年第一次临时股东会的 法律意见书 金证法意【2025】字 1118 第 0978 号 致：浙江司太立制药股份有限公司 北京金诚同达律师事务所（以下简称"本所"）接受浙江司太立制药股份有 限公司（以下简称"司太立"或"公司"）的聘请，指派本所律师出席公司 2025 年第一次临时股东会（以下简称"本次股东会"）并对会议的相关事项出具法律 意见书。 本所律师根据《中华人民共和国公司法》（以下简称"《公司法》"）、《中 华人民共和国证券法》《上市公司股东会规则》（以下简称"《股东会规则》"） 《律师事务所从事证券法律业务管理办法》《律师事务所证券法律业务执业规则 （试行）》等有关法律、法规和规范性文件的要求以及《浙江司太立制药股份有 限公司章程》（以下简称"《公司章程》"）的规定，对本次股东会的 ...

Market Overview - The chemical pharmaceutical sector experienced a decline of 1.44% on November 19, with Hainan Haiyao leading the drop [1] - The Shanghai Composite Index closed at 3946.74, up 0.18%, while the Shenzhen Component Index closed at 13080.09, unchanged [1] Stock Performance - Notable gainers in the chemical pharmaceutical sector included: - Shanhe Pharmaceutical (300452) with a closing price of 15.07, up 9.04% and a trading volume of 390,200 shares, totaling 586 million yuan [1] - ST Suhao (600200) closed at 1.02, up 5.15% with a trading volume of 429,200 shares [1] - ST Jingfeng (000908) closed at 66.8, up 5.02% with a trading volume of 354,800 shares [1] - Major decliners included: - Muan Nanhai (000566) with a closing price of 7.20, down 10.00% and a trading volume of 2,192,500 shares, totaling 1.625 billion yuan [2] - Sitaili (603520) closed at 10.66, down 6.74% with a trading volume of 315,600 shares [2] - Yatai Pharmaceutical (002370) closed at 7.79, down 6.59% with a trading volume of 1,044,700 shares [2] Capital Flow - The chemical pharmaceutical sector saw a net outflow of 2.278 billion yuan from institutional investors, while retail investors contributed a net inflow of 2.139 billion yuan [2] - The top stocks by net inflow from institutional investors included: - Changshan Pharmaceutical (300255) with a net inflow of 71.90 million yuan, accounting for 6.20% of total inflow [3] - Xingqi Eye Medicine (300573) with a net inflow of 70.33 million yuan, representing 12.29% [3] - Shanhe Pharmaceutical (300452) with a net inflow of 68.13 million yuan, making up 11.62% [3]

Core Viewpoint - Pacific Securities report indicates that Sitaili is a leading enterprise in the iodine contrast agent "API + formulation" integration, with a steadily advancing internationalization strategy. The competitive landscape of the contrast agent industry is relatively concentrated, and the market size is expected to double in the future. [1] Group 1: Company Overview - Sitaili is positioned as a leader in the iodine contrast agent sector, focusing on both active pharmaceutical ingredients (API) and formulations [1] - The company is nearing the completion of large-scale production capacity investments, which will support the anticipated increase in demand for raw materials [1] Group 2: Market Potential - The contrast agent industry is expected to see a doubling in market size due to its concentrated competitive landscape [1] - Domestic formulation products are expected to gradually increase in volume through centralized procurement [1] Group 3: Growth and Profitability - The overseas formulation business is entering a phase of rapid growth as production processes are streamlined [1] - Profitability is anticipated to improve gradually, with the potential for accelerated profit growth [1] - The company's valuation is expected to command a premium, leading to a "buy" rating for the stock [1]

Group 1 - The core viewpoint of the article is that Pacific Securities has issued a "buy" rating for Sital (603520.SH) with a latest price of 11.43 yuan, highlighting its strong market position and growth potential [1] - Sital is recognized as a leading enterprise in the integrated production of iodine contrast agents, with a steady advancement in its internationalization strategy [1] - The company is expected to improve its profitability due to the expansion of its active pharmaceutical ingredient (API) production capacity and various factors driving growth [1] - Sital is overcoming production capacity bottlenecks in its formulations, which will drive growth both domestically and internationally [1]