格隆汇11月25日丨山东新华制药股份(00719.HK)公布，近日，公司收到国家药品监督管理局核准签发的 利丙双卡因乳膏(以下简称"本品")《药品注册证书》。 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， 发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企业应当符合药品生产 质量管理规范要求方可生产销售。 利丙双卡因乳膏是利多卡因和丙胺卡因的复方制剂，用于下列情况的皮肤局部麻醉：1.针穿刺，例如： 置入导管或采血；2.浅层外科手术，例如：生殖器粘膜，在浅层外科手术或浸润麻醉之前；腿部溃疡清 洁/清创术。 相关事件 山东新华制药股份(00719.HK)：获得利丙双卡因乳膏药品注册证书 山东新华制药股份(00719.HK)：获得 富马酸伏诺拉生化学原料药上市申请批准通知书 ...

Core Viewpoint - The A-share market experienced a significant rally on November 25, with the ChiNext Index rising nearly 2%, driven by a surge in flu-related stocks due to an increase in flu activity across the country [1] Group 1: Market Performance - The ChiNext Index saw a nearly 2% increase on November 25, indicating strong market performance [1] - Flu-related stocks, such as Jindike and Xinhua Pharmaceutical, reached their daily limit up, reflecting heightened investor interest [1] Group 2: Flu Activity and Sales Data - National flu activity has rapidly increased in November, with Beijing entering a high incidence period for respiratory infectious diseases [1] - Sales of Oseltamivir surged by 237% over the past week, while sales of Maviral (Sofosbuvir) increased by 180% [1] - Data from Meituan indicates that special flu medications in Beijing have seen a month-on-month growth exceeding 130%, with Maviral growing over 110% and Oseltamivir granules increasing by over 85% [1] Group 3: Investment Opportunities - According to Everbright Securities, the rising flu epidemic is likely to increase public and market attention, leading to a growth in demand for flu prevention and treatment products [1] - Investment opportunities are suggested in flu vaccines, virus testing, cold medications, and special antiviral drugs, as well as blood products as a response to complex epidemic situations [1]

利丙双卡因乳膏是利多卡因和丙胺卡因的复方制剂，用于下列情况的皮肤局部麻醉：1.针穿刺，例如： 置入导管或采血;2.浅层外科手术，例如：生殖器粘膜，在浅层外科手术或浸润麻醉之前;腿部溃疡清洁/ 清创术。 根据相关统计数据，2024年中国公立医疗机构利丙双卡因乳膏销售额约为人民币6.15亿元。 智通财经APP讯，山东新华制药股份(00719)发布公告，近日，山东新华制药股份有限公司(以下简称"新 华制药"或"本公司")收到国家药品监督管理局核准签发的利丙双卡因乳膏(以下简称"本品")《药品注册 证书》。 2024年2月，新华制药向国家药品监督管理局药品审评中心(CDE)递交利丙双卡因乳膏境内生产药品上 市许可注册申报资料并获受理，2025年11月获得《药品注册证书》，审评结论为批准注册。 ...

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。 ...