Core Viewpoint - Aopu Mai (688293.SH) announced that its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd. (referred to as "Silun Biotechnology"), successfully passed the Qualified Person (QP) audit by the European Union, receiving a compliance audit report [1] Group 1 - The successful completion of the QP audit indicates that Silun Biotechnology's quality management system meets the EU GMP regulatory requirements [1] - This achievement ensures high-quality research and production services in the field of macromolecular biopharmaceuticals [1] - The compliance lays a solid foundation for the company to further expand into international markets, including the EU [1]

近日，上海奥浦迈生物科技股份有限公司（以下简称"奥浦迈"或"公司"） 全资子公司上海思伦生物科技有限公司（以下简称"思伦生物"）顺利通过欧盟 质量授权人（QP，Qualified Person）审计，正式获得QP签发的符合性审计报告。 现就相关情况公告如下： 一、欧盟QP审计报告内容 证券代码：688293 证券简称：奥浦迈 公告编号：2025-089 上海奥浦迈生物科技股份有限公司 关于自愿披露全资子公司通过欧盟 QP 审计的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 本次顺利通过QP审计，标志着思伦生物质量管理体系已达到欧盟GMP法规 要求，充分保证公司在大分子生物药领域的高品质研发生产服务，为进一步拓展 欧盟等国际市场奠定了坚实的基础。 本次通过欧盟QP审计不会对公司当前业绩产生较大影响，敬请广大投资者 理性投资，注意投资风险。 特此公告。 上海奥浦迈生物科技股份有限公司董事会 2025 年 9 月 27 日 依据EudraLex Volume 4（欧盟药品GMP 法规）及PIC/S 相关指导原则，此 次审 ...

Core Viewpoint - Aopu Mai (688293.SH) announced that its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd. (referred to as "Silun Biotechnology"), successfully passed the EU Qualified Person (QP) audit, receiving a compliance audit report issued by the QP [1] Group 1 - The successful completion of the QP audit indicates that Silun Biotechnology's quality management system meets the EU GMP regulatory requirements [1] - This achievement ensures high-quality research and production services in the field of macromolecular biopharmaceuticals [1] - The accomplishment lays a solid foundation for the company to further expand into international markets, including the EU [1]

Core Viewpoint - The company, Aopumai (688293.SH), announced that its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd. (referred to as "Silun Biotechnology"), successfully passed the Qualified Person (QP) audit by the European Union, receiving a compliance audit report [1] Group 1 - The successful completion of the QP audit indicates that Silun Biotechnology's quality management system meets the EU GMP regulatory requirements [1] - This achievement ensures high-quality research and production services in the field of macromolecular biopharmaceuticals [1] - The compliance lays a solid foundation for the company to further expand into international markets, including the EU [1]

格隆汇9月26日｜奥浦迈(688293.SH)公告称，公司全资子公司思伦生物近日顺利通过欧盟质量授权人 （QP）审计，正式获得QP签发的符合性审计报告。此次审计范围涵盖质量管理、生产管理、厂房设备 设施、物料系统、包装与标签系统等方面，关键环节均进行了细致审查。QP审计报告显示，思伦生物 已建立了基本的组织架构、人员配置、设施、程序等，符合当前欧盟GMP要求。本次通过欧盟QP审计 不会对公司当前业绩产生较大影响。 ...

Core Viewpoint - Aopu Mai (688293.SH) has successfully passed the Qualified Person (QP) audit conducted by its wholly-owned subsidiary, Shanghai Silun Biotechnology Co., Ltd, marking a significant achievement in meeting EU GMP regulatory requirements [1] Group 1: Company Achievements - The successful QP audit indicates that Silun Biotechnology's quality management system meets the standards set by EU GMP regulations [1] - This achievement ensures high-quality research and production services in the field of macromolecular biopharmaceuticals [1] Group 2: Market Implications - The compliance with EU standards lays a solid foundation for the company to expand into international markets, including the EU [1]

Core Viewpoint - The restructuring plan of Aopumai (688293.SH) to acquire Chengli Biotechnology has faced dissent from independent director Tao Hua'an, who believes the company currently lacks the necessity for acquisitions and has not expressed an opinion on the rationality of the merger [1][3][4] Summary by Sections Restructuring Plan - Aopumai plans to acquire 100% of Chengli Biotechnology for a total consideration of approximately 14.5 billion yuan, consisting of 7.1 billion yuan in cash and 7.4 billion yuan in shares [2][5] - The valuation of Chengli Biotechnology is set at 14.52 billion yuan, with an appraisal increase rate of 56.92% [2][6] - Aopumai aims to enhance its business model from "cell culture media + CDMO" to "cell culture media + CRDMO" through this acquisition [2][5] Independent Director's Concerns - Tao Hua'an has consistently opposed the restructuring, citing that the acquisition does not align with the company's goals of improving the profitability of cell culture products and reducing losses in the CDMO business [1][4][6] - He has raised concerns about the low capacity utilization of CDMO services, which has led to declining performance, arguing that the merger will not directly improve this situation [4][6] Financial Performance - Aopumai has experienced a decline in net profit for two consecutive years, with a significant drop in CDMO service revenue in 2024, down 25.66% and a gross margin of -25.29% [5][6] - In the first half of 2025, Aopumai reported a revenue of 1.78 billion yuan, a year-on-year increase of 23.77%, but the CDMO service still faced a gross margin of -47.53% [5][6] Future Projections - The acquisition is expected to generate an additional goodwill of 6.17 billion yuan, which will account for 15.34% of the total assets and 21.76% of the net assets attributable to the parent company by the end of 2024 [6] - Chengli Biotechnology has made performance commitments for the years 2025 to 2027, with net profits not less than 52 million yuan, 65 million yuan, and 78 million yuan respectively [6]

Market Overview - The biopharmaceutical sector experienced a decline of 0.21% on September 25, with Nossland leading the drop [1] - The Shanghai Composite Index closed at 3853.3, down 0.01%, while the Shenzhen Component Index closed at 13445.9, up 0.67% [1] Stock Performance - Notable gainers in the biopharmaceutical sector included: - Aopu Mai (688293) with a closing price of 62.85, up 7.42% and a trading volume of 30,600 [1] - Rongchang Biotech (688331) closed at 108.50, up 3.43% with a trading volume of 89,200 [1] - Baipusais (301080) closed at 62.16, up 3.43% with a trading volume of 43,500 [1] - Major decliners included: - Nossland (430047) closed at 22.99, down 3.69% with a trading volume of 57,000 [2] - Wufan Biotech (301393) closed at 53.12, down 3.42% with a trading volume of 24,600 [2] - Kexing Pharmaceutical (688136) closed at 38.75, down 3.34% with a trading volume of 53,500 [2] Capital Flow - The biopharmaceutical sector saw a net outflow of 207 million yuan from institutional investors, while retail investors contributed a net inflow of 45.07 million yuan [2] - Notable capital flows included: - Rongchang Biotech (688331) with a net inflow of 1.021 billion yuan from institutional investors [3] - Junshi Biosciences (688180) with a net inflow of 35.36 million yuan from institutional investors [3] - Aopu Mai (688293) with a net inflow of 9.41 million yuan from institutional investors [3]

Group 1 - The core viewpoint of the news is that Aopumai's stock price increased by 5.01% to 61.44 CNY per share, with a total market capitalization of 6.976 billion CNY as of the report date [1] - Aopumai Biotechnology Co., Ltd. was established on November 27, 2013, and went public on September 2, 2022. The company primarily engages in cell culture products and services, with revenue composition being 87.34% from products, 12.53% from services, and 0.13% from other sources [1] Group 2 - Among Aopumai's top ten circulating shareholders, one fund from China Europe Fund, the China Europe Medical Health Mixed A (003095), entered the top ten in the second quarter, holding 1.4824 million shares, which is 1.92% of the circulating shares. The estimated floating profit today is approximately 4.3435 million CNY [2] - The China Europe Medical Health Mixed A (003095) fund was established on September 29, 2016, with a latest scale of 15.638 billion CNY. Year-to-date returns are 31.78%, ranking 2963 out of 8173 in its category; the one-year return is 47.69%, ranking 3188 out of 8003; and since inception, the return is 127.43% [2] Group 3 - The fund managers of China Europe Medical Health Mixed A (003095) are Ge Lan and Zhao Lei. As of the report date, Ge Lan has a cumulative tenure of 10 years and 243 days, with a total fund asset size of 39.908 billion CNY, achieving a best fund return of 122.55% and a worst return of -35.13% during the tenure. Zhao Lei has a tenure of 84 days, with a fund asset size of 30.801 billion CNY, achieving a best return of 15.73% and a worst return of 15.53% during the tenure [3]

Group 1 - The CRO concept stocks experienced significant fluctuations, with JiuZhou Pharmaceutical hitting the daily limit up [1] - ProLogis Pharmaceutical rose over 5%, indicating strong market interest [1] - Other companies such as Zhaoyan New Drug, Kangpeng Technology, Aopu Mai, and Haoyuan Pharmaceutical also saw increases in their stock prices [1]