格隆汇10月9日丨赛托生物(300583.SZ)公布，控股子公司山东斯瑞药业有限公司（简称"斯瑞药业"）近 日收到欧洲药品质量管理局（简称"EDQM"）签发的原料药欧洲药典适用性证书（简称"CEP证书"）， 化学原料药名称：DEXAMETHASONE SODIUM PHOSPHATE 地塞米松磷酸钠。地塞米松磷酸钠是一 种肾上腺皮质激素类药，具有抗炎、抗过敏、抗风湿以及免疫抑制作用，主要用于过敏性与自身免疫性 炎症性疾病，多用于结缔组织病、活动性风湿病、类风湿性关节炎、红斑狼疮、严重支气管哮喘、严重 皮炎、溃疡性结肠炎、急性白血病等，也用于某些严重感染及中毒、恶性淋巴瘤的综合治疗。 ...

Core Viewpoint - Saito Bio's subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has received the CEP certificate for Dexamethasone Sodium Phosphate from the European Directorate for the Quality of Medicines (EDQM), enhancing its position in the pharmaceutical market [1] Company Summary - Saito Bio's subsidiary, Shandong Sry Pharmaceutical, applied for the CEP certificate for Dexamethasone Sodium Phosphate in April 2024 and received it in October 2025 [1] - The drug Dexamethasone Sodium Phosphate is a corticosteroid with anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive properties, primarily used for allergic and autoimmune inflammatory diseases [1] Industry Summary - There are a total of 9 companies globally that hold valid CEP certificates for Dexamethasone Sodium Phosphate, including Shandong Sry Pharmaceutical [1]

Core Insights - The report maintains a positive outlook on the pharmaceutical and biotechnology sector, with a focus on raw material prices as of July 2025 [1][3] Hormonal Drug Price Situation - In July 2025, prices for hormonal drugs such as progesterone, medroxyprogesterone acetate, saponin, dexamethasone sodium phosphate, hydrocortisone, and acetate hydrocortisone remained stable month-on-month. Year-on-year, progesterone prices remained unchanged, while medroxyprogesterone acetate, saponin, dexamethasone sodium phosphate, hydrocortisone, acetate hydrocortisone, and saponin saw declines of 1.85%, 3.23%, 84.22%, 14.04%, 12.15%, and 5.66% respectively [6][10] Antibiotic Intermediate Price Situation - In July 2025, prices for antibiotic intermediates such as 4-AA remained stable month-on-month, while 7-ADCA, 7-ACA, 6-APA, and penicillin industrial salt saw decreases of 1.92%, 2.08%, 8.33%, and 7.89% respectively. Year-on-year, 7-ADCA, 7-ACA, 6-APA, 4-AA, and penicillin industrial salt prices fell by 1.92%, 4.08%, 45.00%, 13.92%, and 41.67% respectively [10][11] β-Lactam Antibiotic Price Situation - In July 2025, prices for β-lactam antibiotics such as cephalexin, ampicillin, cefotaxime sodium, and cefaclor remained stable month-on-month. However, ceftriaxone sodium, cefixime, and amoxicillin saw declines of 1.55%, 1.37%, and 11.36% respectively. Year-on-year, cephalexin, ampicillin, ceftriaxone sodium, cefotaxime sodium, cefixime, and amoxicillin prices decreased by 1.82%, 2.22%, 9.29%, 3.40%, 12.20%, and 35.00% respectively, while cefaclor saw an increase of 6.12% [15][17] Cardiovascular Drug Price Situation - In July 2025, prices for cardiovascular raw materials such as valsartan, irbesartan, telmisartan, lisinopril, enalapril maleate, and atorvastatin calcium remained stable month-on-month. Year-on-year, valsartan prices decreased by 1.54%, while the other drugs remained unchanged [19][20]

Core Viewpoint - The antitrust case involving dexamethasone raw material has concluded, resulting in significant fines for Jiangsu Lianhuan Pharmaceutical Co., Ltd. and its competitors, impacting their financial performance and future operations [1][2][4]. Group 1: Regulatory Actions and Financial Impact - Jiangsu Lianhuan Pharmaceutical was fined a total of 61.0382 million yuan, which represents 72.53% of its net profit for the previous year [3][4]. - The total fines imposed on the three companies involved in the price-fixing agreement amount to 326 million yuan [4]. - The fines include the confiscation of illegal gains of 17.8992 million yuan and an 8% penalty based on the company's 2023 sales [2][4]. Group 2: Financial Performance and R&D Investment - In 2024, Jiangsu Lianhuan reported a revenue of 2.16 billion yuan, a slight decrease of 0.63% year-on-year, and a net profit of 84.16 million yuan, down 37.66% from the previous year [6]. - The company has significantly increased its R&D investment, with expenses rising from 66 million yuan in 2021 to 155 million yuan in 2024, reflecting a compound annual growth rate of over 51% [7][8]. - The increase in R&D spending has pressured profit margins, leading to a decline in net profit despite revenue growth [7][8]. Group 3: Market Position and Competitive Landscape - Dexamethasone phosphate sodium is included in the treatment guidelines for severe COVID-19 patients, highlighting its importance in the pharmaceutical market [3]. - The company is shifting focus towards high-end formulations and innovative drugs, including projects targeting cancer and Alzheimer's disease [7][8]. - The innovative drug LH-1801, currently in phase III clinical trials, faces competition from several similar products already on the market [9].

Product Line and Applications - The company's intermediate product line includes five main series: Androstenedione (AD), Androstenedione (ADD), 9-Hydroxyandrostenedione (9OH-AD), 17α-hydroxy derivatives (A ring), and Dihydrotestosterone (BA), primarily used in the production of steroid drugs for various medical applications [1][2]. Quality Control and Management - The company adheres to strict quality management systems across all production stages, implementing international GMP standards to ensure product quality stability and consistency [2][3]. - In 2024, the company reported a net cash flow from operating activities of approximately ¥194.46 million, a 309.44% increase from the previous year, attributed to reduced cash payments for purchased goods and increased receipts from sales [4]. Research and Development - R&D investments have steadily increased from ¥50.21 million in 2022 to ¥58.38 million in 2024, supporting the company's industrial upgrades and performance growth [4][5]. - The company has accumulated nearly ¥400 million in R&D investments, with over 90 patents, including 25 invention patents, enhancing its competitive edge in the market [6]. Environmental and Sustainability Initiatives - The company is recognized as a national-level green factory, utilizing synthetic biology and genetic engineering technologies to improve environmental sustainability in production processes [3][5]. - Various energy-saving measures have been implemented to reduce carbon emissions, including advanced technology adoption to lower material consumption and pollution [5]. Market Position and Strategy - The global steroid hormone drug market is growing at over 10% annually, with the company positioned to capitalize on this trend, as China's steroid hormone raw material production accounts for about one-third of the global total [7][9]. - The company aims to integrate its operations across the pharmaceutical value chain, focusing on the production of intermediates, raw materials, and finished formulations [10][11]. Employee and Labor Relations - The company emphasizes employee rights protection, adhering to labor laws and establishing a comprehensive human resource management system to foster a harmonious labor relationship [11]. Future Outlook - The company plans to expand its international market presence, with overseas revenue accounting for 18.55% of total revenue in 2024, and aims to register multiple raw materials in the US and EU to facilitate exports [11].