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新天地:维格列汀片获批药品注册证书
Zhong Zheng Wang· 2025-07-30 06:36
新天地表示,公司维格列汀片按化学药品4类注册申报,获批后视同通过一致性评价。该药品获批,标 志着该产品符合药品注册的有关要求,公司获得了该药品在国内市场生产、销售的资格,将进一步丰富 公司产品种类,提升市场竞争力。 维格列汀片原研企业为瑞士诺华制药有限公司,国内上市商品名为"佳维乐"。维格列汀片适用于治疗2 型糖尿病。在高血糖期间,维格列汀通过升高肠降血糖素水平,增加胰岛素/胰高血糖素的比率,导致 空腹和餐后肝脏葡萄糖生成量减少,进而降低血糖。 中证报中证网讯(王珞)7月29日,新天地(301277)发布公告称,公司于近日收到国家药品监督管理局 核准签发的《药品注册证书》,药品通用名称为"维格列汀片",该药品的注册分类为化学药品4类,药 品有效期为24个月,批准文号为国药准字H20254948,有效期至2030年7月21日。 ...
新天地:关于获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-07-29 15:12
(文章来源:证券日报) 证券日报网讯 7月29日晚间,新天地发布公告称,公司于近日收到国家药品监督管理局核准签发的《药 品注册证书》,药品名称为维格列汀片。 ...
新天地:获得维格列汀片的药品注册证书
Ge Long Hui· 2025-07-29 09:29
维格列汀片原研企业为瑞士诺华制药有限公司,国内上市商品名为"佳维乐"。维格列汀片适用于治疗2 型糖尿病,主要成分维格列汀是一种选择性二肽-肽酶-4(DPP-4)抑制剂,给药后能快速抑制DPP-4活 性,使空腹和餐后内源性肠降血糖素GLP-1(胰高血糖素样多肽-1)和GIP(葡萄糖依赖性促胰岛素多肽)的 水平升高,进而增加β细胞对葡萄糖的敏感性,促进葡萄糖依赖性胰岛素的分泌。通过增加内源性GLP-1 水平,维格列汀还能够增加α细胞对葡萄糖的敏感性,使葡萄糖水平与胰高血糖素的分泌量契合度提 高。在高血糖期间,维格列汀通过升高肠降血糖素水平,增加胰岛素/胰高血糖素的比率,导致空腹和 餐后肝脏葡萄糖生成量减少,进而降低血糖。 格隆汇7月29日丨新天地(301277.SZ)公布,公司于近日收到国家药品监督管理局核准签发的维格列汀片 的《药品注册证书》。 ...
新天地:获得维格列汀片药品注册证书
人民财讯7月29日电,新天地(301277)7月29日晚间公告,公司于近日收到国家药品监督管理局核准签 发的维格列汀片《药品注册证书》。维格列汀片适用于治疗2型糖尿病。 ...
东北制药经营质量持续向好 布局生物药稳固发展根基
Mei Ri Jing Ji Xin Wen· 2025-04-15 15:39
Core Viewpoint - The pharmaceutical industry in China is undergoing a deep adjustment period with intensified competition in the existing market. Northeast Pharmaceutical (000597) has demonstrated strong profitability and operational resilience despite the complex market environment, as evidenced by its financial performance in 2024 [1][2]. Financial Performance - In 2024, Northeast Pharmaceutical achieved a revenue of 7.503 billion yuan and a net profit attributable to shareholders of 410 million yuan, with year-on-year growth rates of 14.34% and 18.97% respectively. The net cash flow from operating activities was 759 million yuan, reflecting a year-on-year increase of 29.32% [1][2]. Operational Quality Improvement - The overall operational quality of Northeast Pharmaceutical has improved, with a significant reduction in total operating costs compared to the previous year. The sales of its main products continue to maintain strong competitiveness, leading to steady profit growth. The company leveraged its "raw material + formulation" integration advantage to enhance market competitiveness and increased export revenue by 26.30% year-on-year [2]. R&D Innovation - Northeast Pharmaceutical is actively investing in research and development to establish a solid foundation for long-term growth. The company focuses on both generic and innovative drugs, implementing a phased R&D management approach. In 2024, it successfully obtained one innovative drug candidate and received production approval for five generic drugs, while also advancing several new products towards market launch [3][4]. Strategic Acquisition - The company has strategically acquired a 70% stake in Beijing Dingcheng Peptide Source Biotechnology Co., Ltd., positioning itself in the emerging field of cell therapy. Dingcheng Peptide Source has developed a comprehensive technology platform for TCR-T and CAR-T cell therapy products targeting various cancers, with ongoing clinical trials for its products [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].