香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性或完整性亦不發表 任何聲明，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴該等內容而引致之任何損失承擔任何 責任。 山東新華製藥股份有限公司 Shandong Xinhua Pharmaceutical Company Limited （於中華人民共和國註冊成立之股份有限公司） （股份代碼：00719） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條作出。 山 東 新 華 製 藥 股 份 有 限 公 司 （ 「 本 公 司 」 ） 將 於 2025 年 11 月 26 日 在 巨 潮 資 訊 網 （http://www.cninfo.com.cn）刊登的本公司《關於獲得利丙雙卡因乳膏藥品註冊證書的公告》, 茲載列有關文檔之中文版，以供參閱。 承董事會命 山東新華製藥股份有限公司 賀同慶 董事長 中國 淄博 2025年11月25日 於本公告日期，本公司董事會之成員如下： 非執行董事： 徐 列先生 張成勇先生 1 证券代码：000756 证券简称：新华制药 公告编号：2025-67 山东新 ...

Market Overview - The Shanghai Composite Index closed at 3870.02 points, above the six-month moving average, with a gain of 0.87% [1] - The total trading volume of A-shares reached 182.62 billion yuan [1] Stocks Breaking the Six-Month Line - A total of 290 A-shares have surpassed the six-month moving average today [1] - Notable stocks with significant deviation rates include: - Xunxing Co., Ltd. (002098) with a deviation rate of 9.03% and a daily increase of 10.04% [1] - Meino Energy (001299) with a deviation rate of 8.16% and a daily increase of 9.98% [1] - Laimu Co., Ltd. (603633) with a deviation rate of 7.83% and a daily increase of 8.70% [1] Detailed Stock Performance - The following stocks have notable performance metrics: - Xunxing Co., Ltd. (002098): Latest price 10.08 yuan, half-year line 9.24 yuan, turnover rate 3.52% [1] - Meino Energy (001299): Latest price 13.00 yuan, half-year line 12.02 yuan, turnover rate 6.41% [1] - Laimu Co., Ltd. (603633): Latest price 10.87 yuan, half-year line 10.08 yuan, turnover rate 7.02% [1] - Other stocks with significant performance include: - Xinhua Pharmaceutical (000756) with a daily increase of 10.00% and a deviation rate of 6.41% [1] - Tonghe Technology (300491) with a daily increase of 7.25% and a deviation rate of 6.40% [1]

Group 1 - The demand for flu-related medications is rising significantly as the flu season approaches, with several stocks in the sector experiencing price surges [1] - Notable stocks that have reached their daily limit include Jindike, Peking University Medicine, and Te Yi Pharmaceutical, among others [1] - Data from Alibaba Health indicates a more than 500% week-on-week increase in the number of people purchasing antiviral flu medications, with Mabalosavir showing a remarkable over 600% increase [1] Group 2 - Experts warn that the H3N2 strain circulating this year is different from previous years, leading to lower immunity in the population and increased transmission risk [2] - The flu virus is known to undergo antigenic drift, but current strains are still within seasonal levels and do not indicate a stronger evolution of the virus [2] Group 3 - Companies are actively ensuring the supply of flu medications and vaccines in response to rising demand [3] - Dongyang Sunshine, a major supplier of Oseltamivir, reports comprehensive coverage of its products across hospitals, pharmacies, and online platforms, maintaining sufficient inventory [3] - Hualan Biological has noted a significant increase in demand for flu vaccines since October, with plans to enhance market supply and ensure timely delivery through cold chain logistics [3]

Core Viewpoint - Xinhua Pharmaceutical (SZ000756) experienced a trading halt with a price of 17.16 yuan, marking a 10% increase and a total market capitalization of 11.837 billion yuan, driven by recent drug approvals, innovation in drug development, and improved cash flow [1] Group 1: Company Developments - Xinhua Pharmaceutical has recently obtained registration certificates for several drugs, including Fumaric Acid Vorinostat, Alendronate Sodium, and Fumaric Acid Bisoprolol, enhancing its product line in cardiovascular and digestive system treatments [1] - The company received clinical trial approval for its first-class innovative drug LXH-1211 tablets, indicating significant progress in its drug development efforts, which lays a foundation for long-term growth [1] - The net cash flow from operating activities for Q3 2025 increased by 26.65% year-on-year, reflecting improved financial management and boosting market confidence in the company [1] Group 2: Industry Context - The pharmaceutical industry remains a focal point for market attention, with innovative drug development being a critical direction for industry growth [1] - Companies within the pharmaceutical sector that have made research breakthroughs have seen active stock performance, suggesting that Xinhua Pharmaceutical's recent innovations may attract market investment [1] - Technical indicators suggest that the stock price may break through key resistance levels, potentially drawing in more investors and contributing to the stock's trading halt [1]

Core Insights - The flu season has arrived earlier than expected, leading to increased activity in flu-related stocks in the A-share market [1] - Significant sales increases have been reported for antiviral medications, with Oseltamivir sales up 237% and Mabalaosavir up 180% in the past week [1] Stock Performance - Notable stock movements include: - Yipinhong (一品红) up 13% - Hendi Pharmaceutical (亨迪药业) up nearly 11% - Special One Pharmaceutical (特一药业) and Guangji Pharmaceutical (广济药业) both hitting the 10% daily limit up - Other companies like Hainan Haiyao (海南海药) and Peking University Pharmaceutical (北大医药) also saw significant gains [1][2] - The overall market sentiment is positive, with many flu-related stocks experiencing substantial year-to-date increases, such as: - Yipinhong with a year-to-date increase of 225.09% - Hainan Haiyao with a 75.37% increase [2] Consumer Behavior - Data from Alibaba Health indicates a marked increase in the attention and purchase volume of flu medications over the past two weeks, with a more than 500% week-on-week growth in the number of buyers for antiviral drugs [1] - Mabalaosavir has shown exceptional performance, with a 600% increase in the number of buyers compared to the previous period, reflecting heightened consumer awareness regarding flu prevention and treatment [1]

消息面上，11月24日，据中国国家药品监督管理局(NMPA)官网最新显示，山东新华制药股份有限公司 按注册分类4类申报的利丙双卡因乳膏获批上市，视同过评。公开资料显示，利丙双卡因乳膏是利丙双 卡因乳膏是利多卡因和丙胺卡因的复合制剂，主要用于正常完整皮肤的局部麻醉和生殖器粘膜浅表手术 和浸润麻醉的预处理，与传统麻醉药物相比具有便利、安全性高和无依赖性等优点。 山东新华制药股份(00719)涨超4%，截至发稿，涨4.14%，报7.05港元，成交额1935.58万港元。 ...

智通财经APP获悉，山东新华制药股份(00719)涨超4%，截至发稿，涨4.14%，报7.05港元，成交额 1935.58万港元。 消息面上，11月24日，据中国国家药品监督管理局(NMPA)官网最新显示，山东新华制药股份有限公司 按注册分类4类申报的利丙双卡因乳膏获批上市，视同过评。公开资料显示，利丙双卡因乳膏是利丙双 卡因乳膏是利多卡因和丙胺卡因的复合制剂，主要用于正常完整皮肤的局部麻醉和生殖器粘膜浅表手术 和浸润麻醉的预处理，与传统麻醉药物相比具有便利、安全性高和无依赖性等优点。 ...

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the marketing application of fumaric acid volnorelin, which is primarily used for gastroesophageal reflux disease and is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1] Group 1 - The approval of fumaric acid volnorelin will enhance the company's product line [1] - This new product is expected to improve the company's overall competitiveness in the pharmaceutical market [1]

Group 1 - Yongtai Technology's wholly-owned subsidiary has received approval for trial production of a lithium battery additive project with an annual capacity of 5,000 tons, set to begin trial production [1] - Mengke Pharmaceutical has decided to terminate its plan to issue shares to a specific entity due to ongoing disagreements among major shareholders, which could impact the company's stable operations [1] - Anhui Construction's subsidiary has been approved to register and issue debt financing tools totaling 15 billion yuan, including 5 billion yuan in short-term financing notes and 10 billion yuan in medium-term notes [2] Group 2 - Koli'er plans to repurchase shares worth between 10 million and 20 million yuan, with a maximum repurchase price of 20.94 yuan per share, to implement an employee stock ownership plan [2] - Xinhua Pharmaceutical has received approval for the production of fumaric acid volnoral raw materials, which are used to treat gastroesophageal reflux disease [3] - Lianhuan Pharmaceutical has received approval for additional specifications of tadalafil tablets, expanding its product offerings for treating erectile dysfunction and benign prostatic hyperplasia [5] Group 3 - Greenland Holdings reported an increase of 1,834 lawsuits with a total amount of 6.587 billion yuan from October 21 to November 13, 2025 [7] - Lianke Technology plans to invest up to 600 million yuan of idle funds in low-risk financial products [8] - Yinglian Co. signed a strategic procurement contract for 5,000 million square meters of composite aluminum foil with a leading new energy technology company [10] Group 4 - China Eastern Airlines reported a 10.58% year-on-year increase in passenger turnover for October, with a capacity increase of 6.84% [12] - China National Airlines reported an 8.7% year-on-year increase in passenger turnover for October, with domestic and international capacity also showing growth [15] - Oupai Home plans to use 320 million yuan of idle funds to purchase structured deposits with expected annual yields between 0.65% and 2.50% [16] Group 5 - Tianwei Food has submitted H-share issuance application materials to the Hong Kong Stock Exchange, which have been accepted by the China Securities Regulatory Commission [18] - Guizhou Aviation plans to establish a subsidiary focused on the research, production, and market expansion of intelligent automotive components, with initial operating funds of 40 million yuan [20] - Daimai Co. plans to invest 100 million yuan to establish a wholly-owned subsidiary in Shanghai focused on robotics technology [22] Group 6 - Founder Securities has received approval to issue company bonds totaling up to 30 billion yuan [24] - Hengrui Medicine has received clinical trial approvals for multiple drugs, indicating ongoing research and development efforts [26] - Zhaojing Pharmaceutical's product ZG006 has received orphan drug designation from the FDA, providing various benefits for its development in the U.S. market [39]

Core Viewpoint - The approval of fumaric acid volnorasone as a chemical raw material drug by the National Medical Products Administration enhances the company's product line and overall competitiveness in the pharmaceutical market [1][2]. Group 1: Product Approval - The company received the approval notice for fumaric acid volnorasone, with the notification number 2025YS00988 [1]. - The application for the domestic production of fumaric acid volnorasone was submitted in March 2024 and was accepted by the National Medical Products Administration [1]. - The approval for production was granted in November 2025, confirming the product's evaluation conclusion as approved [1]. Group 2: Market Potential - Fumaric acid volnorasone is primarily used for gastroesophageal reflux disease and is classified as a Category B drug in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [1]. - The estimated sales revenue for fumaric acid volnorasone-related formulations in Chinese public medical institutions is approximately RMB 825 million in 2024 [1]. Group 3: Competitive Advantage - The approval of this product will further enrich the company's product line, thereby enhancing its comprehensive competitiveness in the pharmaceutical industry [2].