一、药物基本信息 药物名称：DCTY0801 注射液 适应症：EGFRvIII 阳性的复发或进展高级别脑胶质瘤 证券代码：000597 证券简称：东北制药 公告编号：2025-063 东北制药集团股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误 导性陈述或重大遗漏。 近日，东北制药集团股份有限公司（以下简称"公司"）控股子公司北京鼎 成肽源生物技术有限公司（以下简称"鼎成肽源"）收到国家药品监督管理局核 准签发的《药物临床试验批准通知书》（受理号：CXSL2500568，通知书编号： 2025LP02565），现就相关情况公告如下： 药品研发具有高投入、高风险、长周期等特点，临床试验进度及结果、未来 产品市场竞争形势均存在不确定性，会受到不可预测因素的影响。公司将积极推 进上述研发进度，并严格按照有关规定及时对项目后续进展情况履行信息披露义 务。敬请广大投资者注意防范投资风险。 特此公告。 二、其他相关信息 DCTY0801 注射液是针对 EGFRvIII 突变抗原的 CAR-T 细胞产品。EGFRvIII 仅存在于肿瘤细 ...

Core Viewpoint - The approval of the clinical trial for DCTY0801 injection marks a significant milestone in the product development process for the company, enhancing its competitiveness in the oncology treatment sector [1] Group 1 - The company's subsidiary, Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration [1] - The drug DCTY0801 is indicated for EGFRvIII positive recurrent or progressive high-grade glioma [1] - This clinical trial approval is expected to accelerate the progress of the company's research and development products [1]

Core Viewpoint - The company emphasizes that quality is the foundation of pharmaceutical enterprises and is focusing on enhancing quality management to drive transformation and upgrade in the context of high-quality development in the pharmaceutical industry [1][5]. Group 1: Quality Management Initiatives - The company is committed to building a comprehensive quality control system that covers the entire supply chain, from raw material procurement to production and product delivery [2]. - A special audit team has been established to conduct in-depth on-site audits of key raw material suppliers across 13 provinces, ensuring stringent quality checks at critical stages [2][3]. - The company has set up a drug safety monitoring department to proactively track and manage product quality issues, transitioning from passive responses to active prevention [3]. Group 2: Compliance and Certifications - The company has successfully passed multiple certifications, including BRC and ISO22000, and its raw material products are exported to over 100 countries and regions [4]. - In the first eight months of the year, the raw material production facility hosted 63 audits from domestic and international clients, achieving a 100% pass rate [4]. Group 3: Cultural and Systematic Quality Focus - The company is fostering a culture of quality among all employees, emphasizing that quality awareness and professional capability are core competitive advantages in quality control [5][6]. - A "simulated flight inspection" mechanism has been established to conduct regular, comprehensive evaluations of production lines, identifying system vulnerabilities and optimizing management processes [6]. - The company aims to enhance its product quality management level and expand both domestic and international markets, laying a solid foundation for its transformation into a biotechnology enterprise [6].

Core Viewpoint - Northeast Pharmaceutical emphasizes quality as the foundation of its business, focusing on enhancing quality management and manufacturing processes to drive market expansion and value creation [1][5]. Group 1: Quality Management Initiatives - The company is committed to building a comprehensive quality control system that spans from raw material procurement to product delivery, enhancing its systematic management capabilities [2]. - A special audit team has been established to conduct in-depth on-site audits of key raw material suppliers across 13 provinces, ensuring stringent quality checks at the source [2][3]. - Northeast Pharmaceutical has formed a cross-departmental task force to address changes required by the 2025 edition of the Pharmacopoeia of the People's Republic of China, identifying quality risk points and creating actionable implementation plans [3]. Group 2: Compliance and Certifications - The company has successfully passed multiple certifications, including BRC and ISO22000, and its raw materials are exported to over 100 countries [4]. - In the first eight months of the year, the raw material production facility hosted 63 audits with a 100% pass rate, while the formulation facility also met high standards during inspections by regulatory bodies [4]. Group 3: Cultural and Operational Enhancements - Northeast Pharmaceutical is fostering a quality culture among all employees, emphasizing that quality awareness and professional capability are core competitive advantages [5][6]. - The company has implemented a "simulated flight inspection" mechanism to regularly assess production lines against GMP standards, identifying and addressing potential weaknesses in the quality management system [6]. - The commitment to quality is ingrained in the company's culture, with a focus on maintaining a "zero tolerance" approach to quality control, ensuring that every product meets the highest standards [6].

Core Viewpoint - The company emphasizes the importance of quality as the foundation of its operations and is committed to enhancing its quality management systems to drive market expansion and value creation [1][4]. Group 1: Quality Management Initiatives - The company has established a comprehensive quality control system that spans from raw material procurement to product delivery, ensuring a closed-loop quality management process [1][4]. - A special audit team has been formed to conduct in-depth on-site audits of 25 key raw material suppliers across 13 provinces, focusing on critical aspects such as raw material traceability and production processes [2]. - The company has set up a drug safety monitoring department to proactively track and manage product quality issues, transitioning from a reactive to a proactive approach [2][3]. Group 2: Compliance and Certifications - The company successfully passed a surprise inspection by the FDA with a "zero defect" score, demonstrating its commitment to maintaining high-quality standards [2][3]. - The raw material products have received multiple certifications, including BRC and ISO22000, and are exported to over 100 countries and regions [3]. - The company has achieved a 100% pass rate for audits conducted by domestic and international clients in its raw material production facilities [3]. Group 3: Cultural and Operational Enhancements - The company is fostering a culture of quality among all employees, emphasizing that quality awareness and professional capability are core competitive advantages [3][4]. - A "simulated flight inspection" mechanism has been established to conduct regular internal audits based on GMP standards, identifying system vulnerabilities and optimizing management processes [4]. - The company is committed to a "zero tolerance" policy regarding drug quality, reinforcing the idea that every product must meet the highest standards to ensure public health [4].

Core Viewpoint - The article highlights the production capabilities and advancements of Northeast Pharmaceutical, emphasizing its role in the pharmaceutical industry and its commitment to innovation and quality [1] Group 1: Company Overview - Northeast Pharmaceutical has made significant investments in modernizing its production facilities to enhance efficiency and output [1] - The company is focusing on expanding its product range to meet the growing demand in both domestic and international markets [1] Group 2: Industry Context - The pharmaceutical industry is experiencing rapid growth, driven by increasing healthcare needs and advancements in medical technology [1] - There is a rising trend towards the adoption of innovative manufacturing processes within the industry, which Northeast Pharmaceutical is actively pursuing [1]

Core Viewpoint - L-Carnitine is increasingly recognized as a crucial "conditional nutrient" that aids in fat metabolism and energy production, leading to a growing demand in the health and fitness market [1][4][11] Industry Definition and Production Process - L-Carnitine is a naturally occurring amino acid that transports long-chain fatty acids into mitochondria for energy production, playing a vital role in energy metabolism [2][3] - The main production methods include direct extraction, chemical synthesis, enzymatic conversion, and bacterial fermentation [3][6] Current Industry Status - The demand for L-Carnitine in China is projected to grow from 1,343 tons in 2018 to 3,171 tons in 2024, with the market size increasing from 21.165 billion yuan to 39.060 million yuan [5] - China has become the largest producer and exporter of L-Carnitine globally, with production expected to reach 10,043 tons and exports to 6,872 tons in 2024 [5][6] Industry Supply Chain - Early production methods relied on animal sources, which were inefficient and costly, leading to the adoption of more effective methods [6] - L-Carnitine can be synthesized in the body but is often supplemented in specific populations such as athletes, vegetarians, and the elderly [6] Competitive Landscape - Major players in the Chinese L-Carnitine market include Guangzhou Longsha Pharmaceutical Co., Northeast Pharmaceutical Group, and Chengda Pharmaceutical Co., with Chengda being the largest producer [7][9] - Chengda Pharmaceutical's production capacity is around 4,000 tons annually, making it a significant global supplier [9] Industry Development Trends - The market for L-Carnitine is expected to grow steadily due to increasing health awareness and an aging population [11] - Future trends indicate a diversification of L-Carnitine products to cater to personalized health management and a broader range of applications [11]

Core Insights - Northeast Pharmaceutical (000597) released its 2025 semi-annual report, showcasing resilience in growth and quality of development amid industry policy adjustments and intensified market competition [1][2] R&D Investment - The company significantly increased its R&D investment, reaching 83.49 million yuan in the first half of the year, a year-on-year growth of 84.09%, focusing on both independent research and external collaborations to accelerate the development of innovative drugs and high-tech generics [1] - Notable breakthroughs in cell therapy were achieved by its subsidiary, including the DCTY1102 injection, which is the first domestic and second globally to enter Phase I clinical trials for targeted KRASG12D TCR-T cell therapy, applicable for advanced pancreatic and colorectal cancer [1] - The DCTY3201 injection is a globally pioneering multi-target next-generation TCR-T product, filling a gap in the field, while the CAR-T product DCTY0801 injection received orphan drug designation from the FDA and its clinical trial application was accepted by the National Medical Products Administration in July [1] Cost Management - The company implemented comprehensive fine management across the entire chain to uncover cost potential, achieving significant results in cost reduction and efficiency enhancement [2] - Utilizing smart manufacturing systems and big data technology, the company automated and visualized key processes, enhancing operational precision and efficiency from raw material procurement to finished product dispatch [2] - Strengthening production and sales coordination, the company maintained reasonable inventory through centralized production and balanced scheduling, while optimizing the supply chain to lower raw material costs [2] Social Responsibility - Northeast Pharmaceutical actively pursued economic benefits alongside social responsibility, advancing rural revitalization projects in Gansu's Linxia Prefecture, which improved project profitability and increased local income [2] - The company donated 10 million yuan in disaster relief materials to the earthquake-affected area in Tibet, demonstrating corporate responsibility and enhancing brand image [2] Future Outlook - Looking ahead, Northeast Pharmaceutical plans to deepen its "R&D + Management" dual-driven strategy, increase efforts in innovative drug development, and further advance fine management while steadily fulfilling social responsibilities to enhance core competitiveness and market influence [2]

Group 1 - Northeast Pharmaceutical announced the appointment of Li Xin as the Chief Financial Officer after approval from the board's nomination committee and audit committee [1] - For the first half of 2025, Northeast Pharmaceutical's revenue composition is as follows: 52.0% from pharmaceutical manufacturing, 46.18% from pharmaceutical commerce, and 1.82% from other industries [1] - As of the report date, Northeast Pharmaceutical has a market capitalization of 8.1 billion [1]

Group 1 - The company appointed Ms. Li Xin as the new Chief Financial Officer (CFO) during the sixth meeting of the tenth board of directors held on September 6, 2025 [1][4] - Ms. Li Xin's term as CFO will commence from the date of the board's approval until the next board election [1][3] - The board meeting was attended by all 11 directors, and the resolution to appoint the CFO was passed unanimously with 11 votes in favor [7] Group 2 - Ms. Li Xin, born in 1980, has a bachelor's degree and extensive experience in finance, having held positions such as Finance Department Head and CFO at various companies [3] - She currently serves as the chairman of the supervisory board at Fangda Carbon New Material Technology Co., Ltd. and has no stock ownership in the company [3] - Ms. Li Xin meets all qualifications required by relevant laws and regulations, including the Company Law and the Shenzhen Stock Exchange listing rules [3]