Core Viewpoint - Saito Bio (300583.SZ) announced that its subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has received the approval notice for the listing application of Mometasone Furoate from the National Medical Products Administration [1] Group 1: Product Information - Mometasone Furoate is known for its strong anti-inflammatory properties and can be used in inhalers and topical skin medications [1] - When used as an inhaler, it can be combined with β2-adrenergic agonists and/or long-acting acetylcholine receptor antagonists, primarily for the treatment of asthma [1] - As a topical medication, it is effective in treating eczema, neurodermatitis, atopic dermatitis, and pruritus [1]

证券代码：300583 证券简称：赛托生物 编号：2025-042 山东赛托生物科技股份有限公司 关于子公司收到化学原料药上市申请批准通知书的公告 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。 山东赛托生物科技股份有限公司（以下简称"公司"）控股子公司山东斯瑞 药业有限公司近日收到国家药品监督管理局签发的糠酸莫米松《化学原料药上市 申请批准通知书》，现将相关情况公告如下： 生产地址：山东省菏泽市定陶区东外环路南段 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品 符合药品注册的有关要求，批准注册。质量标准、标签及生产工艺照所附执行。 二、原料药的相关情况 糠酸莫米松具有强效抗炎作用，可用于吸入剂和局部皮肤外用药，用作吸入 剂时，可与β2-肾上腺素能激动剂和/或长效乙酰胆碱受体拮抗剂组合，主要用 于治疗哮喘；用作皮肤外用药时，可治疗湿疹、神经性皮炎、异位性皮炎及皮肤 瘙痒症等。 三、对公司的影响及风险提示 一、原料药登记信息 化学原料药名称：糠酸莫米松/Mometasone Furoate 登记号：Y20240000435 包装规格：500g ...

Core Viewpoint - Saito Biopharmaceuticals (300583.SZ) has received approval from the National Medical Products Administration for the marketing application of Methylprednisolone, a corticosteroid used in emergency treatment for critical illnesses and various other medical conditions [1] Group 1: Company Developments - Saito Biopharmaceuticals' subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has been granted a marketing approval notice for Methylprednisolone [1] - Methylprednisolone is classified as a medium-acting, non-halogenated corticosteroid [1] Group 2: Product Applications - The drug is indicated for emergency treatment in critical illnesses and can also be used for endocrine disorders, rheumatic diseases, collagen diseases, skin diseases, allergic reactions, ophthalmic diseases, gastrointestinal diseases, blood diseases, leukemia, shock, cerebral edema, multiple neuritis, myelitis, and to prevent vomiting caused by cancer chemotherapy [1]

Core Viewpoint - The company Saito Bio (300583.SZ) announced that its subsidiary Shandong Sry Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Methylprednisolone [1] Group 1: Company Developments - The approval pertains to Methylprednisolone, a medium-acting corticosteroid that is used in emergency treatment for critical illnesses [1] - Methylprednisolone is indicated for various conditions including endocrine disorders, rheumatic diseases, collagen diseases, skin diseases, allergic reactions, ophthalmic diseases, gastrointestinal diseases, blood diseases, leukemia, shock, cerebral edema, multiple neuritis, myelitis, and to prevent vomiting caused by cancer chemotherapy [1]

Group 1 - The core point of the article is that Saito Bio (300583.SZ) announced that its subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of Methylprednisolone [1] - Methylprednisolone is a medium-acting, non-halogenated corticosteroid used for emergency treatment in critical illnesses and is applicable for various conditions including endocrine disorders, rheumatic diseases, collagen diseases, skin diseases, allergic reactions, ophthalmic diseases, gastrointestinal diseases, blood diseases, leukemia, shock, cerebral edema, multiple neuritis, myelitis, and to prevent vomiting caused by cancer chemotherapy [1]

Core Viewpoint - The announcement indicates that the company's subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of Methylprednisolone, a corticosteroid used in various critical medical conditions [1] Group 1: Product Approval - Shandong Sry Pharmaceutical has been granted a marketing approval notice for Methylprednisolone [1] - Methylprednisolone is classified as a medium-acting, non-halogenated corticosteroid [1] Group 2: Medical Applications - The drug is utilized for emergency treatment in critical illnesses [1] - It is also indicated for endocrine disorders, rheumatic diseases, collagen diseases, skin diseases, allergic reactions, ophthalmic diseases, gastrointestinal diseases, hematological diseases, leukemia, shock, cerebral edema, multiple neuritis, myelitis, and to prevent vomiting caused by cancer chemotherapy [1]

山东赛托生物科技股份有限公司 关于子公司收到化学原料药上市申请批准通知书的公告 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。 山东赛托生物科技股份有限公司（以下简称"公司"）控股子公司山东斯瑞 药业有限公司近日收到国家药品监督管理局签发的甲泼尼龙《化学原料药上市申 请批准通知书》，现将相关情况公告如下： 一、原料药登记信息 证券代码：300583 证券简称：赛托生物 编号：2025-041 二、原料药的相关情况 甲泼尼龙是中效、不含卤素皮质激素类药物，用于危重疾病的急救，还可用 于内分泌失调、风湿性疾病、胶原性病、皮肤疾病、过敏反应、眼科疾病、胃肠 道疾病、血液疾病、白血病、休克、脑水肿、多发性神经炎、脊髓炎及防止癌症 化疗引起的呕吐等。 三、对公司的影响及风险提示 公司化学原料药甲泼尼龙获得《化学原料药上市申请批准通知书》，表明该 原料药已符合国家相关药品审评技术标准，已批准在国内制剂中使用，本次获批 将进一步丰富公司的产品线，有利于提升公司在化学原料药领域的市场竞争力。 目前，公司甲泼尼龙原料药暂无销售，受 GMP 符合性检查进度以及市场环境变化 化学原 ...

Company Overview - Seto Bio was established on January 19, 2010, and listed on the Shenzhen Stock Exchange on January 6, 2017. The company is headquartered in Heze, Shandong Province. It is the first domestic producer to scale the production of steroid drug raw materials using biotechnology, holding a leading position in this field [1]. Business Performance - In Q3 2025, Seto Bio reported revenue of 749 million yuan, ranking 22nd among 47 companies in the industry. The top company, Prolo Pharmaceutical, had revenue of 7.764 billion yuan, while the industry average was 1.466 billion yuan [2]. - The net profit for the same period was -79.1285 million yuan, placing the company 45th in the industry. The leading company, Zhejiang Pharmaceutical, reported a net profit of 867 million yuan, with the industry average at 133 million yuan [2]. Financial Ratios - As of Q3 2025, Seto Bio's debt-to-asset ratio was 37.15%, higher than the previous year's 35.26% and above the industry average of 27.75% [3]. - The gross profit margin for Q3 2025 was 12.53%, significantly lower than the previous year's 26.38% and below the industry average of 35.38% [3]. Executive Compensation - The chairman, Mi Qi, received a salary of 960,000 yuan in 2024, which remained unchanged from 2023. Mi Qi has held various positions within the company since 2014 and currently serves as chairman [4]. Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 7.91% to 13,700, while the average number of circulating A-shares held per shareholder decreased by 7.33% to 13,600 [5].

Core Viewpoint - The 2025 High-Quality Development Forum for Listed Companies and the 27th Golden Bull Award Ceremony took place in Nantong, Jiangsu, highlighting the importance of transparency and investor relations in the capital market [1][4]. Group 1: Company Overview - Saito Bio focuses on the research and production of steroid drug intermediates, leveraging gene engineering and microbial transformation technologies [4]. - The company has achieved large-scale application of biopharmaceutical technology in the steroid drug sector through years of independent research and technology introduction [4]. Group 2: Awards and Recognition - The Golden Bull Award is a prestigious evaluation event organized by China Securities Journal, emphasizing transparency and professionalism in the capital market [4][5]. - The awards include categories such as "Most Investment Value Award," "Golden Bull Outstanding Entrepreneur Award," and "Golden Bull Secretary Award," with the latter recognizing outstanding performance in corporate governance and investor relations [5]. Group 3: Investor Relations - Saito Bio has prioritized information disclosure and investor relations management since its listing, actively engaging with investors through various channels and timely responses [4]. - The company has received positive feedback from investors for its commitment to transparency and effective communication [4].

Core Insights - Saito Bio (300583.SZ) released its Q3 2025 report on October 29, 2025, indicating a total institutional holding of 43.2974 million shares, representing 22.82% of the company's total equity [1] Institutional Holdings - As of October 28, 2025, there is one institutional investor holding shares in Saito Bio, which is Shandong Runxin Investment Co., Ltd. [1] - The total institutional holding percentage decreased by 0.45 percentage points compared to the previous quarter [1] Public Fund Information - In this reporting period, 32 public funds were not disclosed compared to the previous quarter, including funds such as Guojin Quantitative Multi-Factor A, Guojin Quantitative Selected A, and others [1]