布立西坦原料药

Search documents
天宇股份布立西坦原料药获得CEP证书
Bei Jing Shang Bao· 2025-08-01 12:41
公告显示,布立西坦适用于部分性癫痫发作的辅助治疗,尤其是对其他抗癫痫药物疗效不足的患者。 北京商报讯(记者王寅浩实习记者宋雨盈)8月1日,天宇股份(300702)发布公告称,公司收到欧洲药品 质量管理局签发的关于布立西坦原料药的欧洲药典适用性认证证书(CEP证书)。 ...
天宇股份(300702.SZ):布立西坦原料药产品获得CEP证书
Ge Long Hui A P P· 2025-08-01 12:25
格隆汇8月1日丨天宇股份(300702.SZ)公布,公司收到欧洲药品质量管理局签发的关于布立西坦原料药 的欧洲药典适用性认证证书(简称"CEP证书")。布立西坦适用于部分性癫痫发作的辅助治疗,尤其是对 其他抗癫痫药物疗效不足的患者。 ...
诚达药业股份有限公司2024年年度报告摘要
Shang Hai Zheng Quan Bao· 2025-04-24 23:24
Core Viewpoint - The company is focused on expanding its CDMO services and developing innovative biopharmaceuticals, with significant investments in R&D and strategic partnerships to enhance its product offerings and market presence [1][6][7]. Company Overview - The company provides key pharmaceutical intermediates and raw material CDMO services to multinational pharmaceutical companies and research institutions, with a focus on various therapeutic areas including antiviral, oncology, and cardiovascular diseases [1][2]. - The company has established a subsidiary, Jiuqian Cheng Bio, to enter the biopharmaceutical sector, particularly in cell therapy [4][6]. R&D Investment - The company invested CNY 93.71 million in R&D, accounting for 28.13% of its revenue, representing a 241.20% increase year-on-year [5]. - The company has developed several advanced technology platforms for drug synthesis and is enhancing its capabilities in high-end raw material and formulation development [5]. Market Expansion - The company is actively developing its market presence by participating in major industry exhibitions and strengthening relationships with international pharmaceutical companies [7]. - The company aims to become a significant small molecule CDMO service provider in China, offering comprehensive lifecycle services to global innovative drug clients [7]. Talent Development - The company has a workforce of 607 employees, with a significant proportion holding advanced degrees, and has increased its R&D personnel by 36.26% [9]. - The company emphasizes a comprehensive training system to enhance employee skills and support its strategic goals [9]. Project Investment - The company is upgrading its production facilities to improve efficiency and reduce costs, with new projects expected to add 519,000 liters of production capacity [10]. - The company is also focusing on energy-saving technologies and green production methods to enhance sustainability [10]. Quality Management - The company has undergone 26 quality audits and has maintained compliance with various regulatory inspections, ensuring a robust quality management system [10][11]. - The company has integrated safety and environmental management into its core operations, receiving recognition for its green development initiatives [11]. Strategic Partnerships - The company has entered into a collaboration with Chiron Pharma for cell therapy projects, with a total project value of USD 17 million, focusing on heart and brain stroke treatments [6][13]. - The projects have received FDA clinical approvals, with ongoing clinical trials in the U.S. and plans for implementation in China [6][13][14].