本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性 陈述或重大遗漏。 证券代码：000756 证券简称：新华制药 公告编号：2025-66 山东新华制药股份有限公司 关于获得富马酸伏诺拉生化学原料药上市申请批准通知书的公告 近日，山东新华制药股份有限公司（"新华制药"或"本公司"）收到国家药品监督管理局 核准签发的富马酸伏诺拉生（"本品"）《化学原料药上市申请批准通知书》。现将相关情况公告 如下： 一、基本情况 原料药名称：富马酸伏诺拉生 注册分类：化学药品 申请人：山东新华制药股份有限公司 申请事项：境内生产化学原料药上市申请 受理号：CYHS2460214 登记号：Y20230001353 通知书编号：2025YS00988 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，批准生产本品。质量标准、包装标签及生产工艺照所附执行。 二、其他相关信息 2024 年 3 月，新华制药向国家药品监督管理局 CDE 递交富马酸伏诺拉生境内生产化学原料 药上市申请注册申报资料并获受理，2025 年 11 月获得《化学原料药上市申请批准通知书》，审 ...

Core Viewpoint - The approval of fumaric acid volnorasone by the National Medical Products Administration enhances the company's product line and competitiveness, with potential sales in public medical institutions projected at approximately 825 million yuan in 2024 [1] Group 1: Product Approval - The company has received approval for fumaric acid volnorasone, which is primarily used for reflux esophagitis [1] - The application for market registration was submitted in March 2024 and has been accepted [1] Group 2: Market Potential - The product is classified as a Category B item in the medical insurance catalog, indicating its relevance in the healthcare market [1] - The estimated sales revenue for related formulations in Chinese public medical institutions is around 825 million yuan in 2024 [1] Group 3: Competitive Landscape - The approval is expected to enrich the company's product portfolio, thereby enhancing its competitive position in the pharmaceutical market [1] - However, the sales of the drug may be influenced by various factors, including policies and market conditions, leading to uncertainties [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the marketing application of fumaric acid volnorelin, which is primarily used for treating gastroesophageal reflux disease [1] Group 1 - The drug fumaric acid volnorelin has been approved for marketing, indicating a significant milestone for the company [1] - This approval may enhance the company's product portfolio and potentially increase revenue from the treatment of gastroesophageal reflux disease [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the marketing application of fumaric acid volnorasone, which is primarily used for treating gastroesophageal reflux disease [1] Group 1 - The approval signifies a regulatory milestone for the company, potentially enhancing its product portfolio in the pharmaceutical market [1] - Fumaric acid volnorasone is specifically indicated for gastroesophageal reflux disease, indicating a targeted therapeutic application [1]

Core Viewpoint - Xinhua Pharmaceutical (000756) has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, which is primarily used for gastroesophageal reflux disease [1] Group 1 - The approval notification for Fumaric Acid Venlafaxine marks a significant milestone for the company in expanding its product portfolio [1] - The drug is specifically indicated for the treatment of reflux esophagitis, addressing a common gastrointestinal condition [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, which is primarily used for gastroesophageal reflux disease and is included in the 2025 National Basic Medical Insurance Drug List as a Class B drug [1] Company Summary - The company has announced the receipt of the approval notice for Fumaric Acid Venlafaxine, indicating a significant development in its product portfolio [1] - This approval may enhance the company's market position in the pharmaceutical industry, particularly in the treatment of gastroesophageal reflux disease [1] Industry Summary - The inclusion of Fumaric Acid Venlafaxine in the National Basic Medical Insurance Drug List suggests a growing recognition of the drug's importance in treating specific medical conditions [1] - The approval aligns with industry trends towards expanding access to essential medications through insurance coverage [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical has received approval from the National Medical Products Administration for the marketing of fumaric acid volnorex, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [1] Company Summary - Shandong Xinhua Pharmaceutical submitted the registration application for fumaric acid volnorex in March 2024, which was accepted by the National Medical Products Administration [1] - The company received the approval notice for the chemical raw material drug in November 2025, allowing it to commence production [1] Industry Summary - Fumaric acid volnorex is primarily used for treating 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 sales revenue for fumaric acid volnorex-related formulations in Chinese public medical institutions is projected to be approximately RMB 825 million in 2024 [1]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the marketing application of Fumaric Acid Venlafaxine, indicating a significant advancement in its product portfolio and potential revenue growth in the pharmaceutical market [1] Company Summary - Shandong Xinhua Pharmaceutical submitted the registration application for Fumaric Acid Venlafaxine in March 2024, which was accepted by the National Medical Products Administration [1] - The company received the approval notice for the chemical raw material drug in November 2025, allowing it to commence production [1] Industry Summary - Fumaric Acid Venlafaxine is primarily used for treating 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 Venlafaxine-related formulations in Chinese public medical institutions is approximately RMB 825 million in 2024 [1]

Market Performance - On November 13, the Shandong state-owned enterprise reform sector rose by 1.17%, with Furi Shares leading the gains [1] - The Shanghai Composite Index closed at 4029.5, up 0.73%, while the Shenzhen Component Index closed at 13476.52, up 1.78% [1] Top Gainers in Shandong State-Owned Enterprises - Key stocks in the Shandong state-owned enterprise reform sector included: - Qirui Shares (002083) closed at 10.51, up 10.05% with a trading volume of 182,000 shares and a turnover of 191 million yuan [1] - Shida Shenghua (603026) closed at 91.38, up 10.00% with a trading volume of 72,400 shares and a turnover of 655 million yuan [1] - Jiga Development (600807) closed at 3.88, up 9.92% with a trading volume of 561,900 shares and a turnover of 216 million yuan [1] Market Capital Flow - The Shandong state-owned enterprise reform sector experienced a net outflow of 132 million yuan from institutional investors, while retail investors saw a net inflow of 138 million yuan [2] - The top stocks by net inflow from retail investors included: - Qirui Shares (002083) with a net inflow of 64.38 million yuan, accounting for 33.65% of its trading volume [3] - ST Chenming (000488) with a net inflow of 38.29 million yuan, accounting for 29.70% of its trading volume [3] Notable Decliners - Some stocks in the sector faced declines, including: - Shandong High-speed (600350) closed at 9.37, down 1.99% with a trading volume of 97,100 shares and a turnover of 9.13 million yuan [2] - Shandong High-tech (000803) closed at 8.50, down 2.52% with a trading volume of 1,180,500 shares and a turnover of 1.06 billion yuan [2]

Core Viewpoint - The A-share market has seen a significant rise in flu-related stocks due to a noticeable increase in flu activity across China, with most provinces entering the flu epidemic period [1] Group 1: Stock Performance - Hendi Pharmaceutical has increased by over 14%, while Hualan Biological has risen by 11% [1] - Other notable performers include Peking University Pharmaceutical with a 10% increase, and Jinshi Yao with a rise of over 7% [1] - Several companies, including Teva Pharmaceutical, Erkang Pharmaceutical, and others, have also shown gains of over 5% [1] Group 2: Market Context - Recent data from the China CDC indicates that flu virus cases have surpassed other respiratory viruses, marking a significant shift in the current flu season [1] - Since mid-October, sales of related medications, such as Oseltamivir, have increased, with production running continuously [1]