糠酸氟替卡松
Search documents
赛托生物:控股子公司药品糠酸氟替卡松获化学原料药欧洲CEP证书
Mei Ri Jing Ji Xin Wen· 2026-01-20 08:09
每经AI快讯,赛托生物(300583)1月20日公告,控股子公司斯瑞药业近日收到欧洲药品质量管理局签发 的原料药欧洲药典适用性证书(简称"CEP证书"),获证化学原料药名称为糠酸氟替卡松,该药品是一 种强效的糖皮质激素,用于鼻喷剂,可治疗2岁及2岁以上季节性和常年性过敏性鼻炎;用于吸入粉雾 剂,可治疗哮喘和慢性阻塞性肺疾病(COPD)。 (文章来源:每日经济新闻) ...
赛托生物(300583.SZ):子公司收到化学原料药欧洲CEP证书
Ge Long Hui A P P· 2026-01-20 08:01
Core Viewpoint - Saito Bio (300583.SZ) announced that its subsidiary, Shandong Sry Pharmaceutical Co., Ltd., has received the Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines (EDQM) for its active pharmaceutical ingredient, fluticasone propionate [1] Group 1: Company Developments - The receipt of the CEP certificate is a significant milestone for Saito Bio, as it validates the quality of its fluticasone propionate product for use in Europe [1] - Fluticasone propionate is a potent glucocorticoid used in nasal sprays to treat seasonal and perennial allergic rhinitis for patients aged 2 years and older, and in inhalation powder for the treatment of asthma and chronic obstructive pulmonary disease (COPD) [1]
赛托生物(300583) - 2025年5月15日投资者关系活动记录表
2025-05-15 09:58
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].