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湖南汉森制药股份有限公司关于取得换发《药品生产许可证》的公告
Core Viewpoint - The company has received a renewed Drug Production License from the Hunan Provincial Drug Administration, ensuring its continued operations until November 6, 2030 [1]. Group 1: License Information - The new Drug Production License is valid until November 6, 2030, with the license number 湘20150132 [1]. - The company is authorized to produce a variety of pharmaceutical forms, including large volume injections, small volume injections, tablets, hard capsules, granules, syrups, tinctures, and traditional Chinese medicine preparations [1]. Group 2: Company Impact - The renewal of the Drug Production License is a routine procedure due to the expiration of the previous license, and it does not have a significant impact on the company's performance [1].
汉森制药:公司取得换发的药品生产许可证
Core Points - Company obtained a new drug production license from Hunan Provincial Drug Administration, ensuring continued operations until November 6, 2030 [1] - The new license covers a wide range of products including large volume injections, small volume injections, tablets, hard capsules, granules, syrups, tinctures, mixtures, pills, and second-class psychotropic drugs [1] - The renewal of the license is based on the expiration of the previous one and does not have a significant impact on the company's performance [1]
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
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)
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
Core Insights - Kelong Pharmaceutical's latest stock price is 37.76 yuan, up 1.18% from the previous trading day, with a trading volume of 5.22 billion yuan [1] Company Overview - Kelong Pharmaceutical primarily engages in the research, production, and sales of large-volume injectables, small-volume injectables, tablets, and capsules [1] - The company's subsidiary, Kelong Botai Biotech, focuses on the development of innovative biopharmaceuticals and small molecule drugs, with its core product being the first fully approved original TROP2ADC drug in China, Lukanasatuzumab [1] Recent Developments - Kelong Botai Biotech has been included in the 2025 Fortune China Technology 50 list, representing a leading company in the innovative drug sector [1] - The company is working to position China's ADC drugs among the global top tier [1] Financial Performance - On the day of the report, Kelong Pharmaceutical experienced a net inflow of 29.36 million yuan in main funds, although the overall trend over the past five days shows a net outflow of 154 million yuan [1]
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
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
Core Points - Jiangsu Sihuan Biological Co., Ltd. has changed its registered address and revised its Articles of Association, which were approved by the board and shareholders [1][2] - The company has completed the necessary business registration changes and obtained a new business license [1] - The new registered information includes the company name, unified social credit code, type, legal representative, registered capital, establishment date, and new address [1] Company Information - Company Name: Jiangsu Sihuan Biological Co., Ltd. [1] - Unified Social Credit Code: 913202001381477183 [1] - Type: Joint-stock company (listed) [1] - Legal Representative: Qiu Weibing [1] - Registered Capital: 1,029.556222 million RMB [1] - Establishment Date: May 18, 1992 [1] - New Address: 41st Floor, No. 2 Binhai East Road, Jiangyin City [1] Business Scope - The company manufactures large-volume injectables, small-volume injectables (including anti-tumor drugs), tablets (including anti-tumor drugs), hard capsules, syrups, oral solutions, alcohol preparations, raw materials, and traditional Chinese medicine extracts [1] - It also engages in the manufacturing of pharmaceutical intermediates (excluding chemical hazardous products), medical information consulting, technology transfer services, and various manufacturing and sales activities [1]
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].