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四川汇宇制药股份有限公司关于自愿披露通过美国FDA现场检查的公告
证券代码:688553 证券简称:汇宇制药 公告编号:2026-009 四川汇宇制药股份有限公司 关于自愿披露通过美国FDA现场检查的公告 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、准确性和完整性依法承担法律责任。 四川汇宇制药股份有限公司(以下简称"公司")于2025年10月27日至2025年11月06日接受了来自美国食 品药品监督管理局(以下简称"FDA")的现行药品生产质量管理规范(cGMP)检查和药品批准前检查 (PAI)。近日,公司收到了FDA签发的现场检查报告(EIR),该报告表明FDA 确认本次检查已结 束,公司通过本次cGMP检查和药品批准前检查(PAI),现就相关情况公告如下: 一、FDA现场检查的相关信息 接受检查企业名称:四川汇宇制药股份有限公司 企业生产地址:四川省内江市市中区汉阳路333号3幢 FDA FEI:301450019 检查结论:VAI(Voluntary Action Indicated,自愿采取整改) 二、本次检查涉及产品情况 ■■ 三、对公司的影响及风险提示 本次检查是公司第三次接受美国FDA现场检查,本次检 ...
盛合晶微IPO过会 开普云终止收购南宁泰克
Xin Lang Cai Jing· 2026-02-24 13:04
《科创板日报》2月24日讯 今日科创板晚报主要内容包括:马斯克设想从月球电磁弹射AI卫星;申联生 物拟2.37亿元收购世之源控股权并开展创新药业务;中微半导发布业绩快报,2025年净利润2.85亿元, 同比增长108.05%。 【热点聚焦】 简讯: 广东省委书记黄坤明:最大限度为技术创新和市场探索"松绑" 让低空经济"飞"起来、自动驾驶"跑"起 来、具身智能"用"起来 广东省委书记黄坤明2月24日在广东省高质量发展大会上表示,要充盈营商环境阳光雨露。两业协同发 展必然伴随新产品、新业态、新模式的持续涌现,迫切需要构建开放、包容、稳定的营商环境,呵护新 生事物成长。要以深化改革强化新赛道新领域制度供给,着力破解"老规矩管新质生产力"的问题,最大 限度为技术创新和市场探索"松绑",让低空经济"飞"起来、自动驾驶"跑"起来、具身智能"用"起来,确 保既"放得活"又"管得好"。要以扩大开放走在两业协同发展最前沿,深度融入全球产业分工网络,加快 集聚全球制造资源、服务资源,在高水平"引进来"、高质量"走出去"中擦亮"广东制造"、"广东服务"双 品牌。生态好不好、环境行不行,企业满意度是评判标准。全省各级党委政府将一以贯 ...
汇宇制药通过美国FDA现场检查
Zhi Tong Cai Jing· 2026-02-24 10:07
本次检查是公司第三次接受美国FDA现场检查,本次检查通过表明公司抗肿瘤注射剂、原料药等生产线 在生产管理质量体系、合规运营等方面符合美国FDA的要求,为公司持续拓展美国市场提供了坚实的保 障,对公司未来经营业绩、提高国际市场竞争力带来积极影响,助力公司持续、健康发展。 汇宇制药(688553.SH)发布公告,公司于2025年10月27日至2025年11月06日接受了来自美国食品药品监 督管理局(以下简称"FDA")的现行药品生产质量管理规范(cGMP)检查和药品批准前检查(PAI)。近日, 公司收到了FDA签发的现场检查报告(EIR),该报告表明FDA确认本次检查已结束,公司通过本次cGMP 检查和药品批准前检查(PAI)。 ...
汇宇制药(688553.SH)通过美国FDA现场检查
智通财经网· 2026-02-24 10:04
本次检查是公司第三次接受美国FDA现场检查,本次检查通过表明公司抗肿瘤注射剂、原料药等生产线 在生产管理质量体系、合规运营等方面符合美国FDA的要求,为公司持续拓展美国市场提供了坚实的保 障,对公司未来经营业绩、提高国际市场竞争力带来积极影响,助力公司持续、健康发展。 智通财经APP讯,汇宇制药(688553.SH)发布公告,公司于2025年10月27日至2025年11月06日接受了来自 美国食品药品监督管理局(以下简称"FDA")的现行药品生产质量管理规范(cGMP)检查和药品批准前检查 (PAI)。近日,公司收到了FDA签发的现场检查报告(EIR),该报告表明FDA确认本次检查已结束,公司 通过本次cGMP检查和药品批准前检查(PAI)。 ...
汇宇制药(688553) - 关于自愿披露通过美国FDA现场检查的公告
2026-02-24 09:45
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、准确性和完整性依法承担法律责任。 四川汇宇制药股份有限公司(以下简称"公司")于 2025 年 10 月 27 日至 2025 年 11 月 06 日接受了来自美国食品药品监督管理局(以下简称"FDA") 的现行药品生产质量管理规范(cGMP)检查和药品批准前检查(PAI)。近日, 公司收到了 FDA 签发的现场检查报告(EIR),该报告表明 FDA 确认本次检查 已结束,公司通过本次 cGMP 检查和药品批准前检查(PAI),现就相关情况公 告如下: 一、FDA 现场检查的相关信息 接受检查企业名称:四川汇宇制药股份有限公司 企业生产地址:四川省内江市市中区汉阳路 333 号 3 幢 检查类别:cGMP 检查和药品批准前检查(PAI) 证券代码:688553 证券简称:汇宇制药 公告编号:2026-009 四川汇宇制药股份有限公司 关于自愿披露通过美国 FDA 现场检查的公告 二、本次检查涉及产品情况 | | | •恶性疾病:恶性淋巴瘤:霍奇金淋巴瘤、 | 间(Ⅳ) | | | --- | --- | -- ...
汇宇制药:公司通过美国FDA现场检查
Di Yi Cai Jing· 2026-02-24 09:41
(文章来源:第一财经) 汇宇制药晚间公告,公司于2025年10月27日至2025年11月06日接受了来自美国食品药品监督管理局的现 行药品生产质量管理规范(cGMP)检查和药品批准前检查(PAI)。近日,公司收到了FDA签发的现 场检查报告(EIR),该报告表明FDA确认本次检查已结束,公司通过本次cGMP检查和药品批准前检 查(PAI)。 ...
四川汇宇制药股份有限公司持股5%以上股东被动减持股份结果公告
Group 1 - The major shareholder, Huang Qianyi, held 27,219,439 shares, representing 6.426% of the total share capital before the passive reduction plan [1] - The passive reduction plan was executed due to a court order, resulting in the forced sale of 1,300,000 shares, which are all unrestricted circulating shares [1] - The completion of the passive reduction was confirmed on February 10, 2026, with a total of 1,300,000 shares sold, accounting for 0.307% of the current total shares [2] Group 2 - The reduction was in compliance with relevant laws and regulations, and the actual reduction matched the previously disclosed plan [3] - There were no violations of the reduction plan or other commitments during the process [3]
2月10日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-10 10:19
Group 1 - Baichuan Co., Ltd. announced a recent price increase for some of its main products due to market supply and demand factors, but the sustainability of this price fluctuation remains uncertain, making it difficult to predict the impact on the company's performance [1] - Jincheng Co., Ltd. plans to increase its acquisition of CMH Company by an additional 42.50% stake, which will give it a total ownership of 97.5% and ultimate control over CMH [2] - Xinhang New Materials intends to raise no more than 1 billion yuan through a private placement of A-shares, with the funds allocated for projects including high-performance resin production and a composite materials innovation center [3] Group 2 - SMIC reported a sales revenue of $2.489 billion for Q4 2025, a 4.5% increase quarter-on-quarter, with an annual revenue of $9.327 billion, reflecting a 16.2% year-on-year growth [4] - China Railway Construction recently won 10 major projects, each valued over 1.5 billion yuan, totaling 45.142 billion yuan, which represents 4.23% of the company's audited revenue for 2024 [5] - Shenzhen Airport recorded a passenger throughput of 5.8795 million in January 2026, a year-on-year increase of 2.84% [6] Group 3 - China State Construction reported a new contract total of 399.5 billion yuan in January 2026, marking a 1.8% year-on-year increase [7] - Jindi Group's sales amount in January 2026 decreased by 45.78% year-on-year, with a signed area of 78,000 square meters [8] - Changyuan Power achieved a power generation of 3.971 billion kWh in January 2026, a year-on-year increase of 37.81% [9] Group 4 - Senyuan Electric is expected to win a project from the Southern Power Grid valued at 272 million yuan [10] - Chengyi Pharmaceutical's products are set to be selected for the national centralized procurement of expiring varieties [12] - Xinwufeng reported a 10.71% year-on-year decrease in pig sales volume in January 2026 [13] Group 5 - Shengnong Development's sales revenue in January 2026 increased by 40.48% year-on-year, with chicken sales volume rising by 42.79% [14] - Minglida announced the termination of its investment in a key component manufacturing project due to global economic uncertainties [15] - CITIC Securities reported that its subsidiary, Huaxia Fund, achieved a net profit of 2.396 billion yuan in 2025 [16] Group 6 - Pianzaihuang completed the first subject enrollment for its Phase II clinical trial of PZH2107 [17] - Xinzhou Bang reported a 16.56% year-on-year increase in net profit for 2025 [18] - Ankai Bus produced 761 vehicles in January 2026, a year-on-year increase of 35.65% [19] Group 7 - Weilan Bio plans to acquire a 50% stake in Aidimeng Weilan for 47 million yuan [20] - Ningbo Gaofa intends to establish a wholly-owned subsidiary with an investment of no more than 100 million yuan [21] - Shanghai Airport signed a leasing contract worth approximately 585 million yuan with the Shanghai Airport Group [22] Group 8 - Fosun Pharma's subsidiary received acceptance for a drug registration application [23] - Jindai Home's subsidiary invested in acquiring shares in a North American market company [24] - Huatong Co. reported a 1.45% year-on-year decrease in pig sales revenue in January 2026 [25] Group 9 - Yunnan Energy Investment's Nanchong Wind Power Project has been approved with a total installed capacity of 62,500 kW [28] - Youyan Silicon reported a 10.14% year-on-year decrease in net profit for 2025 [29] - Jinpu Titanium announced a temporary shutdown of its Nanjing Titanium White production due to reduced demand [30] Group 10 - Yipin Hong completed the sale of its stake in Arthrosi for a total of $9.5 billion in upfront payments [31] - Liande Co. stated that its gas turbine business currently has limited supply, with minimal impact on overall performance [32] - Tiens Wind Power signed new contracts worth 870 million yuan in the offshore engineering sector [33] Group 11 - Daqin Railway reported a freight volume of 31.28 million tons in January 2026, a year-on-year increase of 5% [34] - ST Mingcheng successfully dismissed all claims from Beijing Fusheng in a recent court ruling [35] - Zhiyang Innovation is planning to acquire control of Lingming Photon and will continue its stock suspension for up to five trading days [36][37] Group 12 - Fulai New Materials accelerated the commercialization of flexible sensors, preparing for mass production of its third-generation electronic skin products [38] - Minhe Co. reported a 36.89% year-on-year decrease in sales of broiler chicks in January 2026 [39] - Ruiang Gene received government subsidies totaling 2 million yuan [40] Group 13 - Huiyu Pharmaceutical's shareholder was forced to reduce holdings by 0.307% due to a court order [41] - Fuyuan Pharmaceutical's subsidiary obtained a drug registration certificate for a new oral solution [42] - Xuantai Pharmaceutical's product is set to be selected for national procurement [43] Group 14 - Chunqiu Electronics completed the cancellation of 9.1369 million repurchased shares [44] - Jinguang Electric won a bid worth approximately 28.8691 million yuan [45] - Hongda Co. plans to invest approximately 71.43 million yuan in a 110kV power transmission project [46] Group 15 - Nanchao Foods reported a 1.99% year-on-year decrease in revenue for January 2026 [47] - Shisheng Intelligent plans to repurchase shares worth between 17.5 million and 35 million yuan [48]
汇宇制药:股东黄干益被强制减持0.307%
Guo Ji Jin Rong Bao· 2026-02-10 08:07
Core Viewpoint - The company Huayu Pharmaceutical announced that shareholder Huang Ganyi was forced by the Sichuan Anyue County People's Court to sell 1.3 million shares of unrestricted circulating stock, which represents a passive reduction in holdings [1] Group 1: Shareholder Reduction - The reduction period for the shares is from February 9, 2026, to February 10, 2026, and the shares will be sold through centralized bidding [1] - The price range for the reduction is between 19.41 to 19.77 yuan per share, resulting in a total reduction amount of 25.4803 million yuan [1] - The reduced shares account for 0.307% of the company's total share capital [1] Group 2: Shareholding Status Post-Reduction - After the reduction, Huang Ganyi holds 25.9194 million shares, which is 6.119% of the total shares [1] - Previously, Huang Ganyi held 27.2194 million shares, representing 6.426% of the total shares [1] - The passive reduction has been completed [1]
汇宇制药(688553) - 持股5%以上股东被动减持股份结果公告
2026-02-10 08:01
证券代码:688553 证券简称:汇宇制药 公告编号:2026-008 四川汇宇制药股份有限公司 持股 5%以上股东被动减持股份结果公告 本公司董事会、全体董事及相关股东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、准确性和完整性依法承担法律 责任。 重要内容提示: 大股东持有股份的基本情况 本次被动减持计划实施前,四川汇宇制药股份有限公司(以下简称"公司") 股东黄乾益持有公司股份数量为 27,219,439 股,占公司总股本的 6.426%, 上述股份来源于公司首次公开发行前取得的股份,且上述股份已被司法冻 结,全部为无限售流通股。 2026 年 2 月 10 日,公司收到股东黄乾益先生出具的《关于被动减持 股份实施完成的告知函》,股东黄乾益先生通过集中竞价交易方式合计被动 减持所持公司股份 1,300,000 股,占公司目前总股份的 0.307%,本次被动 减持已实施完成。现将有关股份被动减持实施结果公告如下: 1 上述减持主体无一致行动人。 二、减持计划的实施结果 (一)大股东因以下事项披露减持计划实施结果: 其他情形:股份被司法强制执行实施完成 | 股东名称 | 黄 ...