大容量注射剂

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陕西省药品监督管理局关于西安京西双鹤药业有限公司等药品生产企业药品GMP符合性检查结果的通告
Zhong Guo Zhi Liang Xin Wen Wang· 2025-09-28 09:11
Core Viewpoint - The article reports on the compliance inspection results of five pharmaceutical manufacturing companies in Xi'an, China, conducted by the Shaanxi Provincial Drug Supervision Administration, confirming their adherence to drug production quality management standards [2] Group 1: Company Inspection Results - Xi'an Jingxi Shuanghe Pharmaceutical Co., Ltd. passed the inspection for large-volume injection and washing agents, with the inspection conducted from July 7 to July 11, 2025 [2] - Shaanxi Jiuzhou Pharmaceutical Co., Ltd. passed the inspection for oral solid preparations, specifically Olaparib tablets (150mg), from August 5 to August 8, 2025 [2] - Xi'an Yuanda Detian Pharmaceutical Co., Ltd. passed the inspection for lyophilized powder injections and entrusted production of injection use Yanhuning, from July 15 to July 18, 2025 [2] - Xi'an Hanfeng Pharmaceutical Co., Ltd. passed the inspection for tablets and hard capsules, with the inspection date on September 23, 2025 [2] Group 2: Inspection Scope and Compliance - The inspections covered various production lines and workshops, ensuring compliance with the Drug Production Quality Management Standards [2] - The inspections were conducted in accordance with multiple regulatory frameworks, including the Drug Administration Law and related management measures [2]
聚焦创新驱动,辰欣药业延伸发展“触角”
Qi Lu Wan Bao Wang· 2025-09-15 05:13
Core Insights - Chenxin Pharmaceutical is a comprehensive pharmaceutical enterprise engaged in R&D, production, and sales, listed on the Shanghai Stock Exchange in September 2017 [1] - The company has established a strong production capacity, leading in both large-volume and small-volume injection production in China [1][3] - R&D innovation is a core strategic focus, with significant investment in technology and collaboration with over 30 research institutions [4] Group 1: Company Overview - Chenxin Pharmaceutical has over 5,000 employees and offers more than 400 specifications of various dosage forms [1] - The company has completed an industrial layout with four major production bases and five industrial parks [3] - R&D personnel exceed 600, with over 70% holding advanced degrees, and R&D investment accounts for approximately 10% of revenue [3] Group 2: R&D and Innovation - The company invests nearly 400 million yuan annually in R&D innovation, establishing a solid foundation for technological competitiveness [4] - Chenxin focuses on high-end generic drugs, OTC external medications, innovative drugs, and special medical foods, creating a virtuous cycle of production and development [4][5] - Future goals include advancing 1-2 new Class 1 drugs into clinical Phase I each year and launching one Class 1 drug within five years [5] Group 3: Production and Technology - Production is the foundational aspect of Chenxin, emphasizing large-scale capacity, intelligent manufacturing, and standardized quality control [6] - The company integrates advanced technologies such as big data and AI into its manufacturing processes, aiming for a smart manufacturing benchmark in the pharmaceutical industry [6] - Annual investments of no less than 300 million yuan will be directed towards technological upgrades and automation [6] Group 4: Marketing and Industry Chain - The marketing system effectively translates the company's internal value into market results, covering hospitals, grassroots medical institutions, and retail terminals [8] - Chenxin aims to enhance its competitive advantage by integrating raw materials and formulations, ensuring product quality and supply chain stability [8] - The company is exploring new paths in health management and elder care services, expanding its business boundaries [8]
云南省药品监督管理局关于药品GMP符合性检查结果的通告(2025年 第34号)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-09-03 08:39
Core Points - The announcement details the results of GMP compliance inspections conducted on 12 pharmaceutical manufacturing companies in Yunnan Province from May to August 2025 [2]. Group 1: Inspection Results - All inspected companies received a "compliant" rating, indicating they met the required standards for Good Manufacturing Practice (GMP) [2]. - The inspections covered various products, including large-volume injections, traditional Chinese medicine pieces, and small-volume injections [2]. - Specific companies inspected include: - Kunming Nanjing Pharmaceutical Co., Ltd. for large-volume injections [2]. - Kunming Pharmaceutical Group Co., Ltd. for lyophilized powder injections [2]. - Yunnan Youjin Traditional Chinese Medicine Technology Co., Ltd. for traditional Chinese medicine pieces [2]. - China Medical Science Institute for Sabin strain inactivated polio vaccine production [2]. Group 2: Inspection Timeline - Inspections were conducted between June 17 and August 7, 2025, with results announced in July and August 2025 [2]. - The inspection periods varied by company, with some inspections lasting several days [2].
科伦药业股价上涨1.18% 子公司入选中国科技50强
Jin Rong Jie· 2025-08-21 14:12
消息面上,科伦博泰生物入选2025年《财富》中国科技50强榜单,成为创新药赛道代表企业。该公司正 推动中国ADC药物跻身全球第一梯队。 资金流向方面,科伦药业当日主力资金净流入2935.72万元,但近五日主力资金整体呈现净流出状态, 累计净流出1.54亿元。 风险提示:股市有风险,投资需谨慎。 科伦药业最新股价报37.76元,较前一交易日上涨1.18%。公司开盘价为37.36元,盘中最高触及38.18 元,最低下探37.03元,全天成交金额达5.22亿元。 科伦药业主要从事大容量注射剂、小容量注射剂、片剂、胶囊剂等药品的研发、生产和销售。公司控股 子公司科伦博泰生物专注于创新生物技术药物及小分子药物的研发,其核心产品芦康沙妥珠单抗是国内 首个完全获批的原创TROP2ADC药物。 ...
海南双成药业股份有限公司关于取得换发的《药品生产许可证》的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-20 19:53
Core Points - The company, Hainan Shuangcheng Pharmaceutical Co., Ltd., has received a renewed Drug Production License from the Hainan Provincial Drug Administration, ensuring its continued operations [1][2][3] - The previous license was set to expire on November 5, 2025, and the new license is valid until August 7, 2030 [1] - The company specializes in the production of small-volume injectables, lyophilized powder injections, raw materials, and large-volume injectables [1] Company Information - Company Name: Hainan Shuangcheng Pharmaceutical Co., Ltd. [1] - Registered Address: No. 16, Xingguo Road, Xiuying District, Haikou City [1] - Legal Representative: Wang Chengdong [1] - Quality Responsible Person: Li Yuan [1] - License Number: Qiong 20150028 [1] - Daily Supervision Management Agency: Hainan Provincial Drug Administration [1] License Details - The new Drug Production License was issued due to the impending expiration of the previous license [1] - The renewal of the license is expected to have no significant impact on the company's production and operations [1]
*ST双成: 海南双成药业股份有限公司关于取得换发的《药品生产许可证》的公告
Zheng Quan Zhi Xing· 2025-08-19 09:14
Core Viewpoint - The company, Hainan Shuangcheng Pharmaceutical Co., Ltd., has successfully obtained a renewed Drug Production License, ensuring its continued operations without significant impact on its business activities [1][2]. Group 1: License Details - The new Drug Production License is valid until August 7, 2030, replacing the previous license that was set to expire on November 5, 2025 [1]. - The company is located at No. 16, Xingguo Road, Xiuying District, Haikou City, with a social credit code of 9146000072122491XG [1]. - The license covers the production of small-volume injections, lyophilized powder injections, raw materials, and large-volume injections [1]. Group 2: Management and Oversight - The legal representative of the company is Wang Chengdong, with Li Jianming as the responsible person and Li Yuan as the quality manager [1]. - The daily supervision and management are conducted by the Hainan Provincial Drug Administration [1].
江苏四环生物股份有限公司 关于完成工商变更登记备案并换发营业执照暨变更办公地址的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-14 08:46
登录新浪财经APP 搜索【信披】查看更多考评等级 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。 江苏四环生物股份有限公司(以下简称"公司")于2025年6月4日召开了第十届董事会第十三次会议,审 议通过了《关于变更注册地址并修订〈公司章程〉的议案》(公告编号:临-2025-38号),上述议案已 经2025年第三次临时股东会审议通过(公告编号:临-2025-46号)。 近日,公司已完成了相关工商变更登记和章程备案手续,并取得了新的《营业执照》,公司变更后的注 册信息如下: 公司名称:江苏四环生物股份有限公司 统一社会信用代码:913202001381477183 类型:股份有限公司(上市) 法定代表人:邱为碧 注册资本:102,955.6222万人民币 成立日期:1992年5月18日 住所:江阴市滨江东路2号41楼05、06座 经营范围:大容量注射剂(含多层共挤膜输液袋)、小容量注射剂(含抗肿瘤药)、片剂(含抗肿瘤 药)、硬胶囊剂、糖浆剂、口服溶液剂、酒剂、原料药、中药提取、二类精神药品的制造;雪域骨宝 (胶囊、片剂)、博尔腾牌乃可菲胶囊、茵曼金牌硒化螺旋藻片 ...
辰欣药业遇瓶颈业绩徘徊6年 月内股价翻倍机构现身龙虎榜
Chang Jiang Shang Bao· 2025-07-31 00:00
Core Viewpoint - The stock price of Chenshin Pharmaceutical (603367.SH) has experienced a significant surge, with a cumulative increase of over 100% since July, raising questions about the underlying reasons for this unusual market activity [2][3][9]. Stock Performance - On July 30, Chenshin Pharmaceutical's stock price reached a new high of 28.52 CNY per share, following a series of trading days with a cumulative increase exceeding 20% [2][9]. - The stock has shown a remarkable recovery from a previous downtrend, with a notable increase of 103.42% since the beginning of July [9]. - Prior to this surge, the stock had been in a prolonged period of decline, with a low of 10.30 CNY per share recorded in April 2022 [5][6]. Market Activity - The recent stock fluctuations are attributed to increased institutional interest, with significant buying activity observed. For instance, institutions purchased 1.01 billion CNY worth of shares from July 27 to 29, while selling none [11]. - The company has made two announcements regarding abnormal trading activity, clarifying that there are no undisclosed significant matters affecting the stock price [9][12]. Financial Performance - Chenshin Pharmaceutical has faced challenges in achieving substantial growth, with revenue and net profit fluctuating between 40 billion CNY and 5 billion CNY from 2019 to 2024 [3][13]. - The company has not engaged in significant capital operations since its IPO in 2017, apart from the spin-off of its subsidiary, which is currently seeking to list on the Beijing Stock Exchange [3][12]. - Despite having a stable business model and some market competitiveness, the company's financial performance has not met market expectations, with revenue and net profit showing no significant growth since 2018 [13][14].
江西省药品生产监督检查结果公告(2025年第1号)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-07-25 07:57
Core Viewpoint - The article discusses the results of drug production supervision inspections conducted by the Jiangxi Provincial Drug Supervision Administration from January to June 2025, highlighting compliance and non-compliance among various pharmaceutical companies [2][3][4]. Summary by Category Inspection Results - A total of 23 pharmaceutical companies were inspected during the first half of 2025, with most companies found to be compliant with the Good Manufacturing Practice (GMP) standards [2][3]. - Specific companies such as Jiangxi Ma Kang Pharmaceutical Co., Ltd. and Jiangxi Chengzhi Yongfeng Pharmaceutical Co., Ltd. were noted for their compliance in producing various drug forms including eye drops and traditional Chinese medicine [2][3]. Compliance Details - Companies like Jiangxi Qinfeng Pharmaceutical Co., Ltd. and Jiangxi Yichuan Pharmaceutical Technology Co., Ltd. were recognized for their adherence to GMP during inspections, covering a range of products from small volume injections to tablets [3][4]. - The inspections included checks on production lines for specific drugs, ensuring that companies met the required safety and quality standards [2][3]. Non-Compliance Issues - Some companies faced issues during inspections, although the article primarily focuses on those that complied with regulations [2][3]. - The inspections aimed to ensure that all pharmaceutical products manufactured in the province meet the necessary legal and quality standards [2][3][4].
北陆药业: 公司章程
Zheng Quan Zhi Xing· 2025-05-22 12:26
Group 1 - The company is established as a joint-stock company in accordance with the Company Law and other relevant regulations [2][3] - The registered capital of the company is RMB 491,855,896 [3] - The company was approved by the China Securities Regulatory Commission to issue 17 million shares of ordinary stock to the public in 2009 [2][3] Group 2 - The company's business scope includes the production and sale of large-volume injections, small-volume injections, tablets, granules, and raw materials [4][5] - The company aims to leverage its technological advantages and high-tech talent resources to provide high-quality pharmaceutical products and services [4] Group 3 - The company has a share structure consisting of ordinary shares, with a total of 491,855,896 shares issued [8] - The shares are issued at a par value of RMB 1 per share [8] Group 4 - The company’s shareholders have the right to receive dividends and participate in decision-making processes at the shareholders' meetings [12][13] - Shareholders holding more than 5% of the shares are subject to specific trading restrictions [10][11] Group 5 - The company’s board of directors is responsible for major decisions, and shareholders have the right to request the convening of shareholder meetings under certain conditions [20][23] - The company must disclose information regarding significant transactions and decisions to ensure transparency [42][43]