Workflow
BIOCAUSE HEILEN PHARMA(301211)
icon
Search documents
2月3日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-03 10:11
Group 1 - Fulin Precision's subsidiary Jiangxi Shenghua invested 270 million yuan to establish a joint venture for a 500,000-ton ferrous oxalate project, with a total investment of 1.5 billion yuan expected to be completed by September 30, 2026 [1] - Xuguang Electronics plans to raise up to 1 billion yuan through a private placement to fund high-voltage vacuum arc extinguishing chamber expansion and other projects [2] - Minexplosion Optoelectronics intends to acquire 100% equity of Xiazhi Precision, with the transaction subject to shareholder and regulatory approvals [3] Group 2 - Shangluo Electronics' controlling shareholder plans to reduce his stake by up to 3% due to personal financial needs [4] - Babi Food reported a 1.3% decline in net profit for 2025, despite an 11.22% increase in revenue [5] - Pengding Holdings' subsidiary acquired industrial land in Huai'an for 66.14 million yuan [6] Group 3 - Zhuoyue New Energy's net profit for 2025 increased by 14.16%, despite a 17.43% decline in revenue [7] - Zhongyuan Media's net profit grew by 30.99% in 2025, with revenue decreasing by 5.13% [8] - Huangshan Tourism plans to invest approximately 530 million yuan in a hotel project with a 24-month construction period [9] Group 4 - *ST Jinling's restructuring plan was approved by the court, which may improve the company's financial situation [11] - Jichuan Pharmaceutical's subsidiary paid 80 million yuan for exclusive commercialization rights of a drug [12] - Pilin Bio's subsidiary received a notice for the acceptance of a drug supplement application [13] Group 5 - Nepe Mining terminated its investment in Swiss Veritas Resources AG due to changes in conditions [14] - Jinhui Wine announced a cash dividend of 0.20 yuan per share for the first three quarters of 2025 [15] - Hualan Biological's clinical trial for a new drug received approval for an additional indication [16] Group 6 - Industrial Fulian reported a total of 247 million yuan spent on share buybacks as of January 31, 2026 [17] - Yitong Century was pre-selected for a 107 million yuan project with China Tower [18] - Wanfeng Co. noted uncertainty in future price changes for disperse dyes [19] Group 7 - Bibet's clinical trial application for a new drug was approved by the National Medical Products Administration [21] - Chengbang Co. signed new project contracts worth 40.03 million yuan in Q4 2025 [22] - *ST Hengji received a court ruling for a performance compensation of 175 million yuan [23] Group 8 - Jihua Group is planning a change in control, leading to continued stock suspension [24] - Ningbo Port expects a container throughput of 5.03 million TEUs in January 2026, a 9.5% increase [25] - Hengli Petrochemical's actual controller increased his stake by 3.3 million shares [26] Group 9 - Hongfuhan signed a sales contract worth 480 million yuan with Guangdong Quanxiang [27] - All New Good's shareholder lifted a judicial freeze on 4.36% of the company's shares [28] - Changchun High-tech's subsidiary's clinical trial application for a new drug was accepted [29] Group 10 - Xingqi Eye Medicine's clinical trial for a new drug entered the first/second phase [31] - Hanma Technology reported a 140.04% increase in new energy heavy truck production in January 2026 [32] - Hengfeng Paper plans to invest 349 million yuan in a new green printing project [33] Group 11 - Zhifei Biological's mRNA vaccine for shingles received clinical trial approval [34] - Yutong Bus reported a 15.35% decrease in production in January 2026 [35] - StarNet Ruijie plans to sign a lease contract with an affiliate for a total rent of up to 110 million yuan [36] Group 12 - Hacheng Bonda's director completed a 0.97% share reduction [37] - Hendi Pharmaceutical's application for a new drug was approved [38] - Xinhua Medical's subsidiary received a medical device registration certificate [40] Group 13 - Yaokang Bio reported a 31.49% increase in net profit for 2025 [41] - Gaotie Electric reported a 14.02% increase in net profit for 2025 [42]
亨迪药业:盐酸埃克替尼获上市申请批准
Jin Rong Jie· 2026-02-03 08:17
亨迪药业公告,近日收到国家药品监督管理局核准签发的关于盐酸埃克替尼的《化学 原料药上市申请 批准通知书》(证书编号:2026YS00095)。盐酸埃克替尼是我国自主研发的EGFR酪氨酸激酶抑制剂 类靶向药,主要用于治疗表皮生长因子受体(EGFR)基因存在敏感突变的局部晚期或转移性非小细胞 肺癌,也可用于既往化疗失败的晚期非小细胞肺癌患者的治疗。 ...
亨迪药业(301211.SZ):盐酸埃克替尼获得化学原料药上市申请批准通知书
Ge Long Hui A P P· 2026-02-03 08:08
格隆汇2月3日丨亨迪药业(301211.SZ)公布,近日收到国家药品监督管理局核准签发的关于盐酸埃克替 尼的《化学原料药上市申请批准通知书》。盐酸埃克替尼是我国自主研发的EGFR酪氨酸激酶抑制剂类 靶向药,主要用于治疗表皮生长因子受体(EGFR)基因存在敏感突变的局部晚期或转移性非小细胞肺 癌,也可用于既往化疗失败的晚期非小细胞肺癌患者的治疗。 ...
亨迪药业:盐酸埃克替尼化学原料药上市申请获批准
Zhi Tong Cai Jing· 2026-02-03 08:00
据悉,盐酸埃克替尼是EGFR酪氨酸激酶抑制剂类靶向药,主要用于治疗表皮生长因子受体(EGFR)基因 存在敏感突变的局部晚期或转移性非小细胞肺癌,也可用于既往化疗失败的晚期非小细胞肺癌患者的治 疗。 亨迪药业(301211)(301211.SZ)公告,公司近日收到国家药品监督管理局核准签发的关于盐酸埃克替 尼的《化学原料药上市申请批准通知书》。 ...
亨迪药业(301211.SZ):盐酸埃克替尼化学原料药上市申请获批准
智通财经网· 2026-02-03 07:59
智通财经APP讯,亨迪药业(301211.SZ)公告,公司近日收到国家药品监督管理局核准签发的关于盐酸埃 克替尼的《化学原料药上市申请批准通知书》。 据悉,盐酸埃克替尼是 EGFR酪氨酸激酶抑制剂类靶向药,主要用于治疗表皮生长因子受体(EGFR)基 因存在敏感突变的局部晚期或转移性非小细胞肺癌,也可用于既往化疗失败的晚期非小细胞肺癌患者的 治疗。 ...
亨迪药业(301211) - 关于公司获得化学原料药上市申请批准通知书的公告
2026-02-03 07:50
证券代码:301211 证券简称:亨迪药业 公告编号:2026-003 湖北亨迪药业股份有限公司 关于获得化学原料药上市申请批准通知书的公告 本公司及董事会全体成员保证公告内容真实、准确、完整,不存 在任何虚假记载、误导性陈述或者重大遗漏。 湖北亨迪药业股份有限公司(以下简称"公司")于近日收到国家药品监督 管理局核准签发的关于盐酸埃克替尼(以下简称"药品")的《化学原料药上市 申请批准通知书》(证书编号:2026YS00095)。现将有关情况公告如下: 一、药品的基本情况 药品名称:盐酸埃克替尼 登记号:Y20240000578 规格:10kg/桶 生产企业:湖北亨迪药业股份有限公司 申请事项:境内生产化学原料药上市申请 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品 符合药品注册的有关要求,批准注册。质量标准、标签及生产工艺照所附执行。 二、药品的其他相关情况 盐酸埃克替尼是我国自主研发的 EGFR 酪氨酸激酶抑制剂类靶向药,主要用 于治疗表皮生长因子受体(EGFR)基因存在敏感突变的局部晚期或转移性非小 细胞肺癌,也可用于既往化疗失败的晚期非小细胞肺癌患者的治疗。 公司盐酸埃克替尼原 ...
股票市场概览:资讯日报:美联储维持利率不变,符合市场普遍预期-20260129
Market Overview - The Federal Reserve maintained the federal funds rate target range at 3.5%-3.75%, aligning with market expectations[9] - The Hang Seng Index closed at 27,827, down 2.58% for the day but up 8.57% year-to-date[3] - The S&P 500 index closed at 6,978, with a slight decrease of 0.01% for the day and a year-to-date increase of 1.94%[3] Stock Performance - Gold prices surged, with spot gold exceeding $5,280 per ounce, marking a monthly increase of over 22%[9] - Semiconductor stocks saw significant gains, with the Philadelphia Semiconductor Index rising by 2.34%[9] - Major tech stocks showed mixed results, with Intel up 11.04% and Microsoft down 6% post-earnings report[9] Sector Highlights - Oil stocks continued to rise, with Shanghai Petrochemical gaining over 5% due to geopolitical tensions driving oil prices up by 3%[9] - New consumer concept stocks performed well, with a snack retail chain soaring 69% on its debut[9] - Airline stocks faced pressure, with China Southern Airlines down 6.83% due to rising operational costs[9] Economic Indicators - The U.S. dollar index fell to 95.51, the lowest since February 2022, contributing to the rise in gold prices[9] - The Japanese yen strengthened, impacting export-related stocks negatively, with Toyota down 3.24%[13] - The Bank of Japan raised its policy rate to 0.75%, the highest in 30 years, indicating a cautious approach to future rate hikes[13]
亨迪药业(301211.SZ):公司通过美国FDA现场检查
Xin Lang Cai Jing· 2026-01-26 09:44
Core Viewpoint - Hendi Pharmaceutical (301211.SZ) successfully passed the FDA's CGMP inspection conducted from November 10 to 14, 2025, confirming compliance with U.S. regulations [1] Group 1 - The company underwent a routine inspection by the FDA, which is part of the current Good Manufacturing Practice (CGMP) regulations [1] - The FDA issued an Establishment Inspection Report (EIR) confirming the completion of the inspection [1] - The inspection was conducted in accordance with the U.S. Federal Regulations Title 21 (21 CFR) [1]
亨迪药业(301211) - 关于公司通过美国FDA现场检查的公告
2026-01-26 08:02
证券代码:301211 证券简称:亨迪药业 公告编号:2026-002 湖北亨迪药业股份有限公司 关于公司通过美国 FDA 现场检查的公告 本公司及董事会全体成员保证公告内容真实、准确、完整, 不存在任何虚假记载、误导性陈述或者重大遗漏。 湖北亨迪药业股份有限公司于 2025 年 11 月 10 日-14 日接受了来自美国食 品药品监督管理局(以下简称"FDA")的 CGMP(现行药品生产质量管理规范) 日常监管的现场检查。近日公司收到 FDA 出具的现场检查报告(EIR, Establishment Inspection Report),按照美国 21CFR 法规(美国联邦法规第 21 章)的规定,FDA 确认本次检查已结束,公司通过本次现场检查。现将相关信 息公告如下: 一、FDA 现场检查的相关信息 二、对公司的影响及风险提示 公司上次通过 FDA 现场检查时间为 2019 年 9 月 26 日。本次检查的通过,表 1 明公司质量体系持续符合美国 FDA 要求,为公司持续拓展国际市场提供了坚实的 保障,提高了公司原料药产品的国际市场竞争力,对提升公司综合竞争力及未来 发展有着积极的推动作用。 公司名称: ...
亨迪药业1月22日获融资买入305.74万元,融资余额1.08亿元
Xin Lang Cai Jing· 2026-01-23 01:39
Group 1 - The core viewpoint of the news is that Hendi Pharmaceutical's stock performance and financial metrics indicate a challenging period, with significant declines in revenue and net profit [1][2]. Group 2 - On January 22, Hendi Pharmaceutical's stock rose by 0.71%, with a trading volume of 52.66 million yuan. The financing buy amount was 3.06 million yuan, while the financing repayment was 4.10 million yuan, resulting in a net financing buy of -1.05 million yuan [1]. - As of January 22, the total balance of margin trading for Hendi Pharmaceutical was 109 million yuan, with a financing balance of 108 million yuan, accounting for 2.03% of the circulating market value, which is below the 10% percentile level over the past year [1]. - On the same day, Hendi Pharmaceutical repaid 2,700 shares in securities lending, with no shares sold, resulting in a securities lending balance of 25,940 yuan, which is above the 90% percentile level over the past year [1]. Group 3 - As of January 9, the number of shareholders of Hendi Pharmaceutical was 21,100, an increase of 2.27%, while the average circulating shares per person decreased by 2.22% to 19,823 shares [2]. - For the period from January to September 2025, Hendi Pharmaceutical reported operating revenue of 319 million yuan, a year-on-year decrease of 4.52%, and a net profit attributable to shareholders of 20.93 million yuan, down 71.96% year-on-year [2]. - Since its A-share listing, Hendi Pharmaceutical has distributed a total of 378 million yuan in dividends, with 306 million yuan distributed over the past three years [2]. - As of September 30, 2025, Hong Kong Central Clearing Limited exited the list of the top ten circulating shareholders of Hendi Pharmaceutical [2].