Policy Developments - Jiangxi Province is promoting the development of brain-computer interface medical devices, emphasizing the need for regulatory compliance and collaboration among industry players to seize opportunities in emerging technologies [1] - The market for brain-computer interface medical devices is noted to have significant potential, with a strong development momentum in Jiangxi Province [1] Medical Device Approvals - In October, the National Medical Products Administration approved 204 medical device products, including 173 domestic Class III devices, 10 imported Class III devices, and 21 imported Class II devices [2] Pharmaceutical Logistics - The Shanghai Municipal Drug Administration encourages the development of modern pharmaceutical logistics, advocating for improved storage and management systems to enhance operational efficiency and reduce costs [3] Drug Approvals - Fangsheng Pharmaceutical announced that its Indobufen tablets received a drug registration certificate from the National Medical Products Administration, allowing for production [4] - Saito Bio's application for the chemical raw material drug Mometasone Furoate has been approved, indicating its use in treating asthma and skin conditions [5] - Tianyao Pharmaceutical received a drug registration certificate for Metoclopramide injection, which is used for treating nausea and vomiting [6] Capital Market Activities - Yingsi Intelligent submitted a listing application to the Hong Kong Stock Exchange, aiming to raise funds for its AI-driven drug development initiatives [7][8] - Rejuve Bio plans to repurchase shares worth between 100 million and 200 million yuan to support employee stock ownership plans [9] Industry Developments - AstraZeneca's Baxdrostat demonstrated significant reductions in 24-hour average systolic blood pressure in treatment-resistant hypertension patients during the Bax24 Phase III trial, achieving a reduction of 14.0 mmHg compared to placebo [10][11] - The drug showed good overall tolerability and consistent safety profiles, with a notable percentage of patients achieving target blood pressure levels [11] - Maiwei Bio's IL-11 monoclonal antibody 9MW3811 received approval for Phase II clinical trials targeting pathological scars, marking it as the first IL-11 targeted drug to enter clinical trials for this indication [12] - Aiwei Technology's subsidiary obtained a medical institution practice license, enabling it to provide third-party medical testing services [13] - Anke Bio signed an exclusive agency framework agreement with Boshengji for the PA3-17 injection product, aimed at enhancing its product portfolio in the innovative drug market [14][15]

Core Viewpoint - Saito Biopharmaceuticals (300583) announced that its subsidiary, Shandong Sry Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the marketing application of Mometasone Furoate, a potent anti-inflammatory drug [1] Group 1: Product Approval - The approval notification allows for the use of Mometasone Furoate in inhalation and topical formulations [1] - As an inhalation agent, it can be combined with β2-adrenergic agonists and/or long-acting acetylcholine receptor antagonists, primarily for asthma treatment [1] - For topical use, it is indicated for conditions such as eczema, neurodermatitis, atopic dermatitis, and pruritus [1]

Core Viewpoint - 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 Mometasone Furoate, which has strong anti-inflammatory properties and is used in inhalers and topical skin medications [1] Group 1: Product Approval - The approval pertains to Mometasone Furoate, which can be used as an inhalant in combination with β2-adrenergic agonists and/or long-acting acetylcholine receptor antagonists, primarily for asthma treatment [1] - As a topical medication, Mometasone Furoate is indicated for conditions such as eczema, neurodermatitis, atopic dermatitis, and skin pruritus [1]

Core Viewpoint - The announcement indicates that the company's subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has received approval for the listing application of Mometasone Furoate, a chemical raw material drug, from the National Medical Products Administration, enhancing the company's product line and market competitiveness in the chemical raw material drug sector [1] Group 1 - The approval of Mometasone Furoate signifies that the raw material drug meets national drug review technical standards [1] - Mometasone Furoate is known for its potent anti-inflammatory properties and is used in inhalants and topical medications for treating asthma, eczema, neurodermatitis, atopic dermatitis, and skin itching [1] - This approval will further enrich the company's product offerings, contributing positively to its competitive position in the chemical raw material drug market [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 Mometasone Furoate [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 skin itching [1]

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]