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 ...

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]

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]

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： ...

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].

Core Viewpoint - Hendi Pharmaceutical has issued a profit warning for 2025, predicting a more than 90% drop in core profits, highlighting its reliance on ibuprofen raw materials and the challenges it faces in the market [1][15]. Financial Performance - The company expects a significant decline in net profit for 2025, estimating a range of 31 million to 39 million yuan, a year-on-year decrease of 57.40% to 66.14% [1][15]. - The projected non-recurring net profit for 2025 is estimated to be between 5.5 million and 8.2 million yuan, reflecting a year-on-year reduction of 88.76% to 92.46% [1][15]. - Total revenue for 2024 is projected at approximately 445.86 million yuan, a decrease of 32.75% compared to 2023 [3]. Business Dependency - Hendi Pharmaceutical primarily engages in the research, production, and sales of chemical raw materials and formulations, with a significant reliance on raw material revenue, which constitutes nearly 80% of its income [2][17]. - The company is the largest supplier of ibuprofen in China and the second largest globally [2][17]. Market Conditions - The global ibuprofen market is experiencing an imbalance in supply and demand, leading to a continuous decline in prices, which has significantly impacted the company's gross margin [1][15]. - Since 2020, the supply of ibuprofen raw materials in China has exceeded daily demand, contributing to a saturated market and declining prices [5][21]. Strategic Changes - The company has terminated its plan to expand ibuprofen production by 5,000 tons and is shifting focus towards formulation and CDMO (Contract Development and Manufacturing Organization) services [1][15][25]. - The company aims to enhance its market competitiveness through technological upgrades and by increasing research and development investments in new products [27]. Shareholder Actions - Major shareholders have begun to reduce their stakes in the company, which may indicate a lack of confidence in the company's short-term recovery prospects [1][14][29]. - Three shareholders plan to collectively reduce their holdings by up to 2.33% of the company's total shares [29].

Group 1 - The core point of the article is that Hendi Pharmaceutical (301211) reported its shareholder count as of January 9, 2026, which stands at 21,066 households [1]

Core Viewpoint - Hendi Pharmaceutical (301211.SZ) is currently experiencing a decline in stock price, with a closing price of 13.20 yuan and a market capitalization of 5.512 billion yuan, indicating it is in a state of share price drop since its IPO [1] Group 1: IPO Details - Hendi Pharmaceutical was listed on the Shenzhen Stock Exchange's ChiNext board on December 22, 2021, with an initial public offering (IPO) of 60 million shares at a price of 25.80 yuan per share [1] - The total funds raised from the IPO amounted to 1.548 billion yuan, with a net amount of 1.401 billion yuan, exceeding the originally planned fundraising by 210 million yuan [1] - The company initially aimed to raise 1.19 billion yuan for various projects, including the production of 5,000 tons of ibuprofen raw materials and 1,200 tons of other raw materials [1] Group 2: Financial Announcements - On May 24, 2023, Hendi Pharmaceutical announced a stock bonus plan, proposing to increase the share capital by 2 shares for every 10 shares held, along with a pre-tax dividend of 4 yuan [2] - On August 1, 2025, the company announced another stock bonus plan, proposing to increase the share capital by 4.5 shares for every 10 shares held [3]

Group 1 - Hangxiao Steel Structure announced that it does not have a "commercial aerospace" business, with its main operations focused on steel structure contracting and related services, and a recent project contributing less than 1% to its 2024 audited revenue [1] - Tianlong Group stated that it has not generated additional revenue from AI tools, which are currently used internally for advertising content creation, and that the overall business operations remain unaffected [1] - Wanxing Technology confirmed that there are no undisclosed significant matters affecting its operations, and its business environment remains stable [2] Group 2 - Yaxing Chemical announced the termination of a share issuance and cash purchase of assets due to market changes and disagreements on asset valuation [2] - Zhejiang Shuculture clarified that its subsidiaries do not engage in GEO business, which has been misreported by media [2] - Luxshare Precision terminated the acquisition of assets from Wintime Technology due to delivery restrictions, with a request for the return of 1.53 billion RMB [3] Group 3 - Jinyu Group reported that its subsidiaries' revenues from specific projects are minimal compared to its overall revenue, with a small contribution from recent contracts [4] - Tongyu Communication highlighted that its stock price has significantly outpaced its fundamentals, indicating potential risks of a price correction [4] - Dongfang Mingzhu noted that the listing process for its investment in Chaoguhuan has uncertainties but currently does not impact its performance [5] Group 4 - Luyin Investment warned of risks associated with its stock price surge, which has increased by 86.92% over the last ten trading days [5] - Puyuan Information stated that its AI software platform is in the early commercialization stage, with limited revenue impact expected [6] - Zhejiang Wenhu Intermediary reported that its GEO business has not yet generated revenue, reflecting uncertainties in market acceptance [6] Group 5 - Xinhua News confirmed that its GEO business lacks a mature profit model and has not generated income [7] - People's Daily stated that it does not engage in GEO business and has not been affected by market rumors [7] - China First Heavy Industries reported minimal involvement in controllable nuclear fusion projects, with no significant revenue generated [8] Group 6 - Xibu Mining announced an increase in copper resources at the Yulong Copper Mine, adding 131.42 million tons of copper metal resources [8] - Jiurui New Materials commenced trial production of a new photoinitiator project, expected to cater to mainstream markets [9] - Tongda Sea indicated that AI-related revenue is low and does not significantly impact overall business performance [10] Group 7 - Zhenai Meijia's stock price has deviated significantly from market indices, prompting caution for investors [11] - Guizhou Moutai approved a new marketing strategy to enhance its sales channels and adapt to consumer demands [12] - Shunhao Co. plans to increase its stake in a subsidiary, reflecting confidence in future business prospects [14] Group 8 - A number of companies, including TCL Technology and Dazhu CNC, forecast significant profit increases for 2025, driven by operational improvements and market demand [19][22] - Long Cable Technology expects a profit increase due to changes in its employee stock plan and market conditions [22] - Jiangsu Electric Power reported a profit increase attributed to higher sales and reduced financial costs [29]

Core Viewpoint - Hendi Pharmaceutical (301211) anticipates a significant decline in performance for 2025, with net profit expected to drop by 57.40% to 66.14% year-on-year, amounting to between 31 million to 39 million yuan [1][3]. Financial Performance Summary - The projected net profit for 2025 is between 31 million and 39 million yuan, a decrease of 57.40% to 66.14% compared to the previous year [1][2]. - The expected non-recurring net profit for 2025 is between 550,000 and 820,000 yuan, reflecting a decline of 88.76% to 92.46% year-on-year [1][2]. - In the first three quarters of 2025, the company reported revenue of 319 million yuan, down 4.52% year-on-year, with a net profit of 20.93 million yuan, a decrease of 71.96% [3]. Market Position and Product Overview - Hendi Pharmaceutical is one of the six major global producers of ibuprofen raw materials and ranks second in domestic production and sales [3]. - The company's main products include ibuprofen, dexibuprofen, and torasemide, with ibuprofen and dexibuprofen being the primary revenue sources [3]. - The revenue share from the raw material drug segment has been consistently high, accounting for 79.88% in 2024, down from 83.65% in 2023 [4]. Sales and Strategy Adjustments - In 2024, the sales volume of ibuprofen decreased by 37.51% to 2,222.35 tons, leading to a revenue drop of 32.75% to 446 million yuan and a net profit of 9.155 million yuan, down 48.02% year-on-year [5]. - The company has adjusted its sales strategy in response to intense international market competition and low pricing for ibuprofen raw materials, resulting in reduced production and sales volumes [6]. - Hendi Pharmaceutical has also terminated its planned expansion project for ibuprofen production, reallocating funds towards research and development and safety upgrades for existing projects [6].