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东北制药:细胞治疗管线获重要进展 DCTY0801注射液临床试验获批
2024年,东北制药通过收购鼎成肽源70%股权,快速切入细胞治疗领域,DCTY0801注射液正是鼎成肽 源管线中进展前列的核心产品之一。其临床获批,标志着东北制药创新药战略取得实质性突破,打破了 公司此前以传统原料药、制剂为主的业务结构局限。 该负责人称,这一成果进一步夯实了公司"双轮驱动"的发展格局。一方面,公司持续巩固在左卡尼汀、 磷霉素等传统优势产品领域的市场地位,该类产品稳定的现金流为创新药研发提供了充足的资金支持; 另一方面,通过DCTY0801注射液等创新管线的推进,公司成功打开新的成长空间,后续将继续加大创 新药研发投入,推动更多管线产品进入临床阶段。 值得关注的是,当前全球细胞治疗市场正处于高速增长期,中国CAR-T细胞治疗市场规模持续扩容,赛 道发展潜力巨大。从细分疾病领域来看,脑胶质瘤是我国最常见的原发性脑肿瘤之一,其中高级别脑胶 质瘤占比较高,患者生存期短、治疗选择少,未满足的临床需求极为突出。 "本次DCTY0801注射液临床试验获批,是该款产品研发进程中的重要里程碑,将进一步加快公司在研 产品的进度,提高公司在肿瘤治疗领域的核心竞争力。"该负责人表示。 中证报中证网讯(记者 宋维东) ...
东北制药破局国际抗生素市场壁垒 国内首家斩获磷霉素氨丁三醇原料药CEP证书
Core Insights - Northeast Pharmaceutical has officially obtained the CEP certificate for its core raw material product, fosfomycin trometamol, from the European Directorate for the Quality of Medicines (EDQM), marking a significant milestone as the first domestic pharmaceutical company to achieve this certification [1][2] - The CEP certificate serves as a "golden key" for entering the European and American markets, indicating that the product meets stringent quality standards that exceed typical international registration requirements [2] - The certification enhances Northeast Pharmaceutical's international brand value and strengthens China's position in the global antibiotic sector [2][3] Market Potential - Fosfomycin trometamol is recognized for its low resistance characteristics and is suitable for treating various infections, making it highly relevant in the context of the global antibiotic resistance crisis [3] - The demand for high-quality antibiotic raw materials in the European market is on the rise, and the CEP certification is expected to boost the market penetration of Northeast Pharmaceutical's products in Europe [3] Competitive Position - Northeast Pharmaceutical has established a robust international registration matrix, with approximately 20 raw material products having passed high-end registrations in various countries, including the EU, Japan, and Russia [4] - The company is a major supplier of vitamin C and holds significant positions in the global supply of fosfomycin and chloramphenicol, maintaining a competitive edge in the international market [4] - The company aims to leverage its CEP registration to enhance its global market share and transition from "product export" to "brand export," thereby gaining greater international respect for Chinese pharmaceuticals [5]
深耕大健康赛道培育全产业链生态
Group 1 - The fourth China (Nanchang) International Health Industry Conference and Expo was inaugurated, showcasing the achievements of Liaoning Fangda Group in the health sector [1] - Liaoning Fangda Group is a diversified large enterprise group with multiple listed companies across various sectors, including pharmaceuticals, and is focusing on enhancing its pharmaceutical business [1][2] - Northeast Pharmaceutical, a subsidiary of Liaoning Fangda Group, is a major supplier of vitamin C and has made significant progress in international certifications, including receiving the CEP certificate for its raw material phosphomycin [2] Group 2 - Liaoning Fangda Group is investing nearly 10 billion yuan to establish Liaoning Fangda General Hospital, which will feature advanced medical technologies and a capacity of 5,000 beds [3] - The hospital aims to set a new benchmark for private hospitals in China by integrating public welfare attributes with private mechanisms and has formed strategic partnerships with top medical institutions [3] - The health industry is identified as a future growth sector, with Liaoning Fangda Group planning to develop a comprehensive health ecosystem through the Fangda Health City project [4]
东北制药净利润实现四连增 布局生物药赛道打造第二成长曲线
Zheng Quan Ri Bao· 2025-04-03 07:08
Core Viewpoint - Northeast Pharmaceutical Group Co., Ltd. has shown continuous improvement in profitability, driven by market expansion and innovation in research and development [2][4]. Financial Performance - In the 2024 annual report, the company reported operating revenue of 7.503 billion yuan, a slight decrease year-on-year; net profit reached 410 million yuan, an increase of 14.34%; and non-net profit was 312 million yuan, up 18.97% [2]. - Both net profit and non-net profit have achieved four consecutive years of growth, reaching the highest levels since 2010 [2]. Dividend Distribution - The company plans to distribute a cash dividend of 1 yuan (including tax) for every 10 shares to all shareholders [3]. Competitive Advantages - Northeast Pharmaceutical is a significant drug production and export base in China, with integrated production bases for raw materials and formulations [4]. - The company has a diverse product line covering ten major series, including vitamins and anti-infection drugs, with products exported to over 100 countries and regions [4]. - The company increased its R&D investment to 149 million yuan, a year-on-year growth of 7.55% [4][5]. Innovation and Product Development - In 2024, the company successfully obtained one innovative drug candidate and approved five generic drugs for production [5]. - The company received approval for raw material drug listings and registered certificates for several new products, enhancing its product portfolio [5]. - The company’s raw materials, such as L-carnitine and vitamin C, received CEP certification from the European Medicines Agency, allowing sales in the EU high-end pharmaceutical market [5]. Export Business - The export business generated revenue of 902 million yuan in 2024, reflecting a year-on-year increase of 26.30%, with a gross margin growth of 5.89% [6]. Strategic Acquisition - The company is expanding into the biopharmaceutical sector by acquiring Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., focusing on cell immunotherapy technology [7][8]. - Dingcheng Peptide Source has developed a complete technical platform for TCR-T and CAR-T cell therapy products targeting various cancers [7]. - This acquisition is expected to enhance the company's competitiveness in the biopharmaceutical field and accelerate the R&D and commercialization of innovative drugs [8].