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江苏诺泰澳赛诺生物制药股份有限公司关于自愿披露通过药品cGMP现场检查的公告
Group 1 - The company has received the CBPF-GMP certificate from Brazil's National Health Surveillance Agency (ANVISA), confirming compliance with international production quality management standards [1] - The cGMP inspection covered the company's production line for active pharmaceutical ingredients Semaglutide and Liraglutide, marking the third successful overseas compliance check after approvals from the FDA and MFDS [1] - This certification is expected to enhance the company's ability to promote and sell its products in international markets [1] Group 2 - The cGMP inspection took place from April 28 to May 2, 2025, at the company's facility located at 28 Linpu Road, Lianyungang Economic and Technological Development Zone [2] - The inspection concluded that the company meets cGMP standards, which is crucial for exporting active pharmaceutical ingredients [2]
8月5日晚间重要公告一览
Xi Niu Cai Jing· 2025-08-05 10:20
Group 1 - Niuwei Co., Ltd. reported a net profit of 637 million yuan for the first half of 2025, representing a year-on-year increase of 30.47% [1] - The company achieved a total operating revenue of 3.404 billion yuan, up 19.96% year-on-year [1] - Niuwei specializes in the research, manufacturing, and sales of industrial valves [2] Group 2 - Shandong Haohua plans to acquire a 29% stake in Zhongyan Alkali Industry with a total investment of 2.32 billion yuan [2] - The company is involved in the production of soda ash and caustic soda [3] Group 3 - Dongfang Co., Ltd. announced a partnership with Dongfang Import and Export Company to develop overseas marketing business [38] - The company focuses on the research, production, and sales of light commercial vehicles and powertrains [38] Group 4 - Xinyuan Technology reported a net profit of 52.6 million yuan for the first half of 2025, a year-on-year increase of 10.70% [12] - The company achieved an operating revenue of 2.871 billion yuan, up 3.86% year-on-year [12] - Xinyuan provides one-stop custom development and production services for pharmaceutical companies and research institutions [12] Group 5 - Zhuhai Piano announced that its subsidiary won the operating rights project for the Baihuazhai scenic area, with an investment of no less than 400 million yuan over 20 years [21] - The company specializes in the research, manufacturing, and sales of pianos and digital musical instruments [21] Group 6 - Zhenghong Technology reported a sales revenue of 26.02 million yuan from pig sales in July, a year-on-year increase of 288.69% [16] - The company sold 63,000 pigs in total from January to July 2025, with a cumulative sales revenue of 109 million yuan, representing a year-on-year increase of 38.06% [16] - Zhenghong focuses on feed products and pig farming [17] Group 7 - ST Nuotai received the cGMP certification from Brazil's National Health Surveillance Agency for its production facility [15] - The company specializes in the research and development of peptide drugs and small molecule pharmaceuticals [15] Group 8 - Guizhou Moutai has repurchased a total of 3.4517 million shares, accounting for 0.2748% of its total share capital, with a total expenditure of 5.301 billion yuan [48][49] - The company is engaged in the production and sales of Moutai liquor and related products [49]
公司要闻|诺泰生物连云港工厂通过巴西ANVISA cGMP检查
Xin Lang Cai Jing· 2025-08-05 09:35
(来源:诺泰生物) 转自:诺泰生物 近日,诺泰生物连云港工厂获得(PIC/S)成员巴西国家卫生监督局 (ANVISA) 签发的《药品生产质量 管理规范证书》CBPF-GMP证书。本次检查覆盖工厂cGMP系统,产品包括原料药司美格鲁肽及利拉鲁 肽。PIC/S (Pharmaceutical Inspection Co-operation Scheme) 是一个国际组织,旨在促进药品生产质量的 全球统一标准,成员遍布全球,包括欧洲,美洲,亚洲,大洋洲等地区。此次顺利通过将进一步推进公 司产品在海外市场的销售和推广。公司近两年还接受并顺利通过美国FDA飞检及韩国MFDS的官方合规 检查。 BPF-GMP批准证书 司美格鲁肽(Semaglutide)是一款新型的长效胰高糖素样肽-1受体激动剂(GLP-1RA),用于治疗成人 2型糖尿病,以及慢性体重管理(超重且伴有至少一种体重相关疾病(如高血压、2型糖尿病、高胆固 醇)。具有长效控糖,减重效果显著,心血管保护,安全性良好,剂型灵活,使用方便的特点和优势。 2024年6月,增加减肥适应症在我国获批上市,用于通过控制饮食和增加运动量的基础上对成人患者进 行长期体重管理。 ...
中证1000指数样本临时调整 调入万和电气、特发服务等
Xin Hua Cai Jing· 2025-08-05 09:34
(文章来源:新华财经) 根据调整名单,本次中证1000指数样本调入万和电气、特发服务、电气风电,调出ST未名、ST应急、 ST诺泰。 新华财经北京8月5日电据中证指数有限公司网站,根据指数临时调样规则及编制方案,中证指数有限公 司决定调整中证1000指数样本,于2025年8月8日收市后生效。 ...
中证指数公司:中证1000指数样本临时调整 8月8日收市后生效
Xin Lang Cai Jing· 2025-08-05 09:16
中证指数有限公司公告称,决定调整中证1000指数样本,于2025年8月8日收市后生效,调入万和电气、 特发服务、电气风电,调出ST未名、ST应急、ST诺泰。 ...
中证1000指数样本临时调整,调入万和电气、特发服务等
Xin Lang Cai Jing· 2025-08-05 09:10
8月5日,据中证指数有限公司网站,根据指数临时调样规则及编制方案,中证指数有限公司决定调整中 证1000指数样本,于2025年8月8日收市后生效。调入万和电气、特发服务、电气风电,调出ST未名、 ST应急、ST诺泰。 ...
ST诺泰(688076)8月5日主力资金净流入1504.98万元
Sou Hu Cai Jing· 2025-08-05 08:45
Core Viewpoint - ST诺泰 (688076) has shown significant financial growth in the first quarter of 2025, with a notable increase in both revenue and net profit, indicating strong operational performance and potential investment opportunities [1][2]. Financial Performance - As of the first quarter of 2025, ST诺泰 reported total revenue of 566 million yuan, representing a year-on-year growth of 58.96% [1]. - The net profit attributable to shareholders reached 153 million yuan, marking a year-on-year increase of 130.10% [1]. - The company's non-recurring net profit was 152 million yuan, with a year-on-year growth of 131.79% [1]. - The liquidity ratios are as follows: current ratio at 1.062, quick ratio at 0.732, and debt-to-asset ratio at 47.86% [1]. Market Activity - On August 5, 2025, ST诺泰's stock closed at 49.25 yuan, up by 2.28%, with a turnover rate of 2.38% and a trading volume of 75,200 lots, amounting to a transaction value of 368 million yuan [1]. - The net inflow of main funds was 15.05 million yuan, accounting for 4.09% of the transaction value, with significant contributions from large orders [1]. Company Background - 江苏诺泰澳赛诺生物制药股份有限公司 was established in 2009 and is located in Lianyungang City, primarily engaged in the pharmaceutical manufacturing industry [2]. - The company has a registered capital of 2.131838 billion yuan and a paid-in capital of 1.5690785 billion yuan [1]. - The legal representative of the company is 童梓权 [1]. Investment and Intellectual Property - The company has made investments in 13 enterprises and participated in 192 bidding projects [2]. - ST诺泰 holds 13 trademark registrations and 123 patents, along with 398 administrative licenses [2].
ST诺泰(688076.SH):司美格鲁肽、利拉鲁肽原料药生产线通过巴西卫生监督局cGMP现场检查
Ge Long Hui A P P· 2025-08-05 08:32
Core Viewpoint - ST诺泰 has received the CBPF-GMP certificate from Brazil's National Health Surveillance Agency (ANVISA), indicating compliance with international production quality standards for its active pharmaceutical ingredients, Semaglutide and Liraglutide [1] Group 1 - The inspection covered the company's cGMP system at its Lianyungang factory, which includes the production lines for Semaglutide and Liraglutide [1] - The company has previously passed compliance checks from the FDA and the MFDS in South Korea, demonstrating its adherence to international regulatory standards [1] - This certification is expected to enhance the company's ability to market and promote its products in overseas markets [1]
ST诺泰(688076) - ST诺泰:关于自愿披露通过药品cGMP现场检查的公告
2025-08-05 08:30
江苏诺泰澳赛诺生物制药股份有限公司 关于自愿披露通过药品 cGMP 现场检查的公告 证券代码:688076 证券简称:ST 诺泰 公告编号:2025-060 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、准确性和完整性承担法律责任。 江苏诺泰澳赛诺生物制药股份有限公司(以下简称"公司")于近日收到 PIC/S 成员巴西国家卫生监督局 (ANVISA) 签发的《药品生产质量管理规范证书》 CBPF-GMP 证书。本次检查覆盖公司连云港工厂 cGMP 系统,产品包括原料药司美 格鲁肽及利拉鲁肽。PIC/S (Pharmaceutical Inspection Co-operation Scheme) 是一个旨在促进药品生产质量全球统一标准的国际组织,成员遍布欧洲、美洲、 亚洲、大洋洲等地区。 一、本次 cGMP 现场检查的相关情况 1、企业名称:江苏诺泰澳赛诺生物制药股份有限公司 2、检查地址:连云港经济技术开发区临浦路 28 号 3、检查内容:为原料药(司美格鲁肽、利拉鲁肽)出口海外开展的 cGMP 现场检查 4、检查时间:2025 年 4 月 28 日至 ...
ST诺泰通过药品cGMP现场检查
Zhi Tong Cai Jing· 2025-08-05 08:27
ST诺泰(688076.SH)发布公告,公司于近日收到PIC/S成员巴西国家卫生监督局(ANVISA)签发的《药品 生产质量管理规范证书》CBPF-GMP证书。本次检查覆盖公司连云港工厂cGMP系统,产品包括原料药 司美格鲁肽及利拉鲁肽。PIC/S(Pharmaceutical Inspection Co-operation Scheme)是一个旨在促进药品生产 质量全球统一标准的国际组织,成员遍布欧洲、美洲、亚洲、大洋洲等地区。 公司本次司美格鲁肽、利拉鲁肽原料药生产线通过巴西卫生监督局cGMP现场检查,是继美国食品药品 监督管理局(FDA)、韩国食品药品安全部(MFDS)后通过的又一海外官方合规检查。标志着公司拥有符 合国际法规市场标准的生产质量管理体系,将进一步推进公司产品在海外市场的销售和推广。 ...