Core Viewpoint - Tianyu Co., Ltd. has received the European Pharmacopoeia Certificate of Suitability (CEP) for the active pharmaceutical ingredient Brivaracetam, which is used as an adjunctive treatment for partial seizures, particularly in patients who do not respond adequately to other antiepileptic drugs [1] Group 1 - Tianyu Co., Ltd. announced the receipt of the CEP certificate from the European Medicines Agency on August 1 [1] - Brivaracetam is specifically indicated for the adjunctive treatment of partial seizures [1] - The certification highlights the company's commitment to meeting European quality standards for its pharmaceutical products [1]

Group 1 - The company Tianyu Co., Ltd. (300702.SZ) has received the Certificate of Suitability for European Pharmacopoeia (CEP) issued by the European Medicines Agency for the active pharmaceutical ingredient Brivaracetam [1] - Brivaracetam is indicated for the adjunctive treatment of partial-onset seizures, particularly in patients who have inadequate response to other antiepileptic drugs [1]

天宇股份(300702.SZ)公告称，公司收到欧洲药品质量管理局签发的布立西坦原料药的欧洲药典适用性 认证证书。该证书的获得表明该原料药符合欧洲药典的质量要求，可以在欧洲市场及承认CEP证书的其 他规范市场进行销售，为公司进一步丰富产品及拓展国际市场带来积极影响。 ...

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].