Fangsheng Pharmaceutical(603998)
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突发!方盛制药原料药生产转移检查不合格
Shen Zhen Shang Bao· 2026-01-11 14:42
Core Viewpoint - Fangsheng Pharmaceutical (603998) announced that its new production line for the active pharmaceutical ingredient (API) Indobufen does not meet regulatory requirements following an inspection by the Hunan Provincial Drug Administration [1] Group 1: Inspection Results - The inspection conducted on November 2025 revealed that the production line for Indobufen at the new facility in Hunan Wancheng Economic Development Zone was found non-compliant due to outdated standards used in the production of intermediate 1 [1] - The company received a GMP compliance inspection notice, indicating that the production address is being changed from 789 Lushong Road, Changsha, Hunan, to 368 Huanglong Road, Wancheng Economic Development Zone [1] Group 2: Current Status and Future Plans - Indobufen API was approved for market launch in June 2024, and the company is currently in the pre-market preparation stage, with no sales yet [1] - The company has addressed the issues identified during the inspection and plans to reapply for inspection promptly [1] Group 3: Market and Regulatory Environment - The pharmaceutical products are characterized by high technology, high risk, and high added value, making future sales subject to market changes and regulatory factors, which introduces uncertainty [1] - On January 9, it was noted that the Hunan Securities Regulatory Bureau issued a warning letter to the accounting firm involved in the audit of Fangsheng Pharmaceutical's 2024 annual report due to multiple violations [2]
1月11日上市公司晚间公告速递:13天11板嘉美包装核查完成复牌,德福科技终止收购卢森堡铜箔100%股权
Xin Lang Cai Jing· 2026-01-11 14:02
Group 1: Stock Trading and Corporate Actions - Jia Mei Packaging's stock will resume trading on January 12, 2026, after a price increase of 230.48% from December 17, 2025, to January 6, 2026, which led to a temporary suspension for investigation [1] - Yanjiang Co. continues to suspend its stock trading due to uncertainties related to a potential major asset restructuring, with a trading plan expected to be disclosed by January 19, 2026 [1] - Shangluo Electronics' application for issuing convertible bonds has been accepted by the Shenzhen Stock Exchange [4] - Xianle Health plans to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and capital strength [4] - Hangyu Technology plans to sell up to 752,800 repurchased shares to supplement working capital [4] Group 2: Mergers and Acquisitions - Defu Technology has terminated its acquisition of 100% of Luxembourg Copper Foil due to additional restrictions imposed by the Luxembourg Ministry of Economy [2] - Defu Technology intends to acquire at least 51% of Huiru Technology through cash purchase and capital increase, with Huiru becoming a subsidiary post-transaction [3] Group 3: Financial Performance and Forecasts - Dechang Co. expects a net profit decrease of 51% to 61% for 2025, with automotive parts business growth offset by challenges in the home appliance sector [7] - Hebang Bio anticipates a net loss for 2025 due to asset impairment provisions [8] - Qu Mei Home expects negative profit figures for 2025, with a reported loss of approximately 66.93 million yuan for the first nine months of 2025 [9] - Jinzhongzi Liquor forecasts a net loss for 2025, although the loss is expected to narrow compared to the previous year [10] - Sichuang Electronics predicts a net loss of 265 million to 340 million yuan for 2025, attributed to competitive pressures and delayed customer orders [11] - Wansheng Co. anticipates a net loss for 2025 [12] - Weiyuan Co. expects a net loss for 2025 [13] - Kosen Technology forecasts a net loss for 2025 due to market demand fluctuations and strategic adjustments [13] - Zhongheng Group predicts a net loss for 2025 [13] - Xiantan Co. reported a chicken product sales revenue of 530 million yuan in December 2025, a year-on-year increase of 9.41% [13] Group 4: Shareholder Actions - Huate Gas shareholders plan to reduce their holdings by up to 2% through block trades between February 4 and April 30, 2026 [14] - Meidike's shareholder intends to reduce holdings by up to 1% through centralized bidding [14]
原料药生产转移检查不符合要求 方盛制药:不会对生产经营产生实质性影响
Zheng Quan Shi Bao Wang· 2026-01-11 13:13
Group 1 - The core announcement from Fangsheng Pharmaceutical indicates that the company received a non-compliance notice from the Hunan Provincial Drug Administration regarding the GMP compliance check for its raw material drug production, specifically for Indobufen. However, the company asserts that this will not have a substantial impact on its production and operations [2] - The compliance check was conducted in November 2025, focusing on the production address change for Indobufen from Changsha to the new facility in Wangcheng Economic Development Zone. The non-compliance was primarily due to outdated standards used in the production of an intermediate [2] - Fangsheng Pharmaceutical is currently preparing for the market launch of Indobufen, which was approved for production in June 2024, and has already initiated corrective actions in response to the compliance issues [2] Group 2 - The company announced a special dividend plan for 2025, with a cash dividend of 0.15 yuan per share, totaling approximately 65.86 million yuan, to be distributed on January 16, 2025. This marks the 18th dividend distribution since the company's listing, with a total payout of around 755 million yuan [4] - Fangsheng Pharmaceutical has been consistently increasing its R&D investments and expanding its product pipeline, particularly in the field of traditional Chinese medicine innovation. The successful approval of a key product, Yao Xue Qu Feng Zhi Tong Granules, signifies a major breakthrough in its R&D efforts [4] - The company has developed a diverse range of products over the past five years, including raw materials, tablets, injections, and complex formulations, focusing on chronic disease areas such as orthopedics, cardiovascular, gynecology, pediatrics, and digestive diseases [5] Group 3 - Fangsheng Pharmaceutical has received clinical trial approval for several innovative traditional Chinese medicine products, including Yiqi Xiaoliu Granules and Ziying Granules, and is conducting multiple clinical trials for other projects [6] - The company is also advancing its chemical drug development projects, with Indobufen having received a drug registration certificate, and other products like Bisoprolol Amlodipine Tablets and Silodosin Tablets currently under review for market approval [6]
方盛制药(603998) - 方盛制药2025年特别分红权益分派实施公告
2026-01-11 12:45
湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 证券代码:603998 证券简称:方盛制药 公告编号:2026-002 湖南方盛制药股份有限公司 2025年特别分红权益分派实施公告 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。 重要内容提示: 每股分配比例 A 股每股现金红利0.15元 相关日期 | 股份类别 | 股权登记日 | 最后交易日 | 除权(息)日 | 现金红利发放日 | | --- | --- | --- | --- | --- | | A股 | 2026/1/15 | - | 2026/1/16 | 2026/1/16 | 差异化分红送转: 否 一、 通过分配方案的股东会届次和日期 公司2025 年 5 月 20 日召开的2024年年度股东大会审议通过了 《关于提请股东大会授权董事会制定并执行公司 2025 年中期现金 分红方案的议案》,授权董事会办理中期利润分配相关事宜;2026 年 1 月 4 日,公司召开的第六届董事会 2026 年第一次临时会议审 ...
方盛制药(603998) - 方盛制药关于公司原料药生产转移检查情况的公告
2026-01-11 12:30
湖南方盛制药股份有限公司 HUNANFANGSHENG PHARMACEUTICAL CO., LTD. 证券代码:603998 证券简称:方盛制药 公告编号:2026-003 近日,湖南方盛制药股份有限公司(以下简称"公司")收 到湖南省药品监督管理局(以下简称"药监局")签发的《药品 GMP 符合性检查告知书》。2025 年 11 月,药监局对公司位于湖 南望城经济开发区铜官镇循环经济工业基地内的生产地址进行 了检查,检查范围为原料药(吲哚布芬);原料药车间(101 车 间)D 区、F 区与 E 区吲哚布芬生产线。经检查,结论为不符合 要求(主要系因在中间体 1 的生产中依据的标准未更新到最新版 本导致)。 公司吲哚布芬原料药于 2024 年 6 月获批上市,本次符合性 检查为申请将生产地址由湖南省长沙市麓松路 789 号变更至湖 南望城经济开发区铜官镇循环经济工业基地内黄龙路 368 号。 公司吲哚布芬原料药及制剂当前处于上市前准备阶段,尚未 正式投放市场销售,本次检查不会对公司的生产经营产生实质性 影响。公司已针对检查中发现的问题进行了整改和完善,并将尽 快重新申请检查。 医药产品因高科技、高风险、高 ...
晚间公告丨1月11日这些公告有看头
Di Yi Cai Jing· 2026-01-11 10:40
Group 1 - Jia Mei Packaging's stock will resume trading on January 12, 2026, after completing a review due to a 230.48% price increase from December 17, 2025, to January 6, 2026 [1] - Yan Jiang Co. continues to suspend trading as it plans to acquire assets, with a disclosure expected by January 19, 2026 [2] - Defu Technology terminated its acquisition of 100% of Luxembourg Copper Foil due to restrictions from the Luxembourg Ministry of Economy, with a refund of €17.4047 million expected [3] Group 2 - Defu Technology plans to acquire at least 51% of Huiru Technology through cash and capital increase, with Huiru focusing on high-performance electrolytic copper foil [4] - Shangluo Electronics' application for issuing convertible bonds has been accepted by the Shenzhen Stock Exchange [5] - Xianle Health intends to issue H-shares and list on the Hong Kong Stock Exchange to enhance its global strategy and capital strength [6] Group 3 - Hangyu Technology plans to sell up to 752,800 repurchased shares to supplement working capital, with a potential cancellation of unsold shares [7] - Fangsheng Pharmaceutical's production facility failed a GMP compliance check, but it will not significantly impact operations [8][9] - East China Pharmaceutical's subsidiary's product has been included in the list of breakthrough therapeutic varieties for severe hypertriglyceridemia [10] Group 4 - Dechang Co. expects a net profit decrease of 51% to 61% for 2025, primarily due to competitive pressures and foreign exchange losses [12] - Hebang Bio anticipates a net loss for 2025 due to asset impairment provisions [13] - Qu Mei Home expects a net loss for 2025, with significant negative figures reported for the first nine months [14] Group 5 - Jinzongzi Wine forecasts a net loss for 2025, although the loss is expected to narrow compared to the previous year [15] - Sichuan Electronics expects a net loss of between 265 million to 340 million yuan for 2025, attributed to market competition and delayed orders [16] - Wansheng Co. anticipates a net loss for 2025 [17] - Weiyuan Co. also expects a net loss for 2025 [19] - Kosen Technology predicts a net loss for 2025 due to low capacity utilization and strategic adjustments [20] - Zhongheng Group expects a net loss for 2025 [21] Group 6 - Xiantan Co. reported a 9.41% year-on-year increase in chicken product sales revenue to 530 million yuan in December 2025 [22] Group 7 - Huate Gas shareholders plan to reduce their holdings by up to 2% through block trades [24] - Meidike shareholders plan to reduce their holdings by up to 1% through market transactions [25]
方盛制药(603998.SH):原料药生产转移检查不符合要求 但不会对生产经营产生实质性影响
Ge Long Hui A P P· 2026-01-11 10:12
公司吲哚布芬原料药于 2024 年6 月获批上市,本次符合性检查为申请将生产地址由湖南省长沙市麓松 路789 号变更至湖南望城经济开发区铜官镇循环经济工业基地内黄龙路368号。公司吲哚布芬原料药及 制剂当前处于上市前准备阶段,尚未正式投放市场销售,本次检查不会对公司的生产经营产生实质性影 响。公司已针对检查中发现的问题进行了整改和完善,并将尽快重新申请检查。 格隆汇1月11日丨方盛制药(603998.SH)公布,近日,公司收到湖南省药品监督管理局(以下简称"药监 局")签发的《药品GMP 符合性检查告知书》。2025 年11 月,药监局对公司位于湖南望城经济开发区铜 官镇循环经济工业基地内的生产地址进行了检查,检查范围为原料药(吲哚布芬);原料药车间(101车 间)D 区、F 区与 E 区吲哚布芬生产线。经检查,结论为不符合要求(主要系因在中间体 1 的生产中依据 的标准未更新到最新版本导致)。 ...
方盛制药:原料药生产转移检查不符合要求
Zhi Tong Cai Jing· 2026-01-11 09:15
方盛制药(603998)(603998.SH)发布公告,近日,公司收到湖南省药品监督管理局签发的《药品GMP 符合性检查告知书》,2025年11月,药监局对公司位于湖南望城经济开发区铜官镇循环经济工业基地内 的生产地址进行了检查,检查范围为原料药(吲哚布芬);原料药车间(101车间)D区、F区与E区吲哚布芬生 产线。经检查,结论为不符合要求(主要系因在中间体1的生产中依据的标准未更新到最新版本导致)。 公司吲哚布芬原料药及制剂当前处于上市前准备阶段,尚未正式投放市场销售,本次检查不会对公司的 生产经营产生实质性影响。公司已针对检查中发现的问题进行了整改和完善,并将尽快重新申请检查。 医药产品因高科技、高风险、高附加值特点,其未来销售受市场变化、政策等诸多因素影响,存在不确 定性。请广大投资者谨慎决策,注意防范投资风险。 ...
方盛制药(603998.SH):原料药生产转移检查不符合要求
智通财经网· 2026-01-11 09:10
公司吲哚布芬原料药及制剂当前处于上市前准备阶段,尚未正式投放市场销售,本次检查不会对公司的 生产经营产生实质性影响。公司已针对检查中发现的问题进行了整改和完善,并将尽快重新申请检查。 医药产品因高科技、高风险、高附加值特点,其未来销售受市场变化、政策等诸多因素影响,存在不确 定性。请广大投资者谨慎决策,注意防范投资风险。 智通财经APP讯,方盛制药(603998.SH)发布公告,近日,公司收到湖南省药品监督管理局签发的《药 品GMP符合性检查告知书》,2025年11月,药监局对公司位于湖南望城经济开发区铜官镇循环经济工 业基地内的生产地址进行了检查,检查范围为原料药(吲哚布芬);原料药车间(101车间)D区、F区与E区吲 哚布芬生产线。经检查,结论为不符合要求(主要系因在中间体1的生产中依据的标准未更新到最新版本 导致)。 ...
方盛制药:吲哚布芬原料药生产检查不合格
Xin Lang Cai Jing· 2026-01-11 08:40
方盛制药公告,公司收到湖南省药品监督管理局的通知,关于公司位于湖南望城经济开发区的新生产地 址的吲哚布芬原料药生产线的检查结果不符合要求,主要原因是中间体1的生产标准未更新到最新版 本。该原料药于2024年6月获批上市,目前尚未正式投放市场,因此此次检查结果不会对公司的生产经 营产生实质性影响。公司已进行整改,并将尽快重新申请检查。 ...