人民财讯7月31日电，鲁抗医药（600789）7月31日晚间公告，公司控股子公司赛特公司收到国家药品监 督管理局颁发的关于盐酸伐地那非片的药品注册证书，该药品是按照新注册分类4类获批的仿制药，视 为通过仿制药质量和疗效一致性评价。该药品适用于治疗男性阴茎勃起功能障碍。 ...

格隆汇7月31日丨鲁抗医药(600789.SH)公布，公司控股子公司山东鲁抗医药集团赛特有限责任公司（简 称"赛特公司"）收到国家药品监督管理局颁发的关于盐酸伐地那非片（简称"该药品"）的《药品注册证 书》（批件号：2025S02296），该药品是按照新注册分类4类获批的仿制药，视为通过仿制药质量和疗 效一致性评价。 盐酸伐地那非片是一种磷酸二酯酶抑制剂药物，伐地那非通过抑制人体阴茎海绵体内降解环鸟苷酸 （cGMP）的磷酸二酯酶5型（PDE5），增加性刺激作用下海绵体局部内源性的一氧化氮的释放，使得 平滑肌松弛，增加人体阴茎海绵体血流，从而增强性刺激的自然反应。本品适用于治疗男性阴茎勃起功 能障碍。 ...

Group 1 - The core viewpoint of the news is that Shandong Lukang Pharmaceutical Co., Ltd. has shown a mixed financial performance in the latest quarter, with a decline in total revenue but an increase in net profit [1] - As of July 30, 2025, the company's stock price closed at 10.59 yuan, down 1.3%, with a turnover rate of 7.03% and a trading volume of 631,900 hands, amounting to 672 million yuan [1] - The company's latest quarterly report indicates total operating revenue of 1.674 billion yuan, a year-on-year decrease of 6.95%, while net profit attributable to shareholders reached 78.5976 million yuan, a year-on-year increase of 16.77% [1] Group 2 - The company has a current ratio of 1.279, a quick ratio of 0.862, and a debt-to-asset ratio of 54.65% [1] - Shandong Lukang Pharmaceutical has made investments in 17 enterprises and participated in 5,000 bidding projects, showcasing its active engagement in the market [2] - The company holds 187 trademark registrations and 240 patents, along with 313 administrative licenses, indicating a strong intellectual property portfolio [2]

Market Overview - The Shanghai Composite Index rose by 0.12% on July 28, with 15 sectors experiencing gains, led by defense and non-bank financials, which increased by 1.86% and 1.51% respectively. The pharmaceutical and biological sector ranked third in terms of gains [1] - Conversely, the coal and steel sectors saw declines of 2.60% and 1.41% respectively [1] Fund Flow Analysis - The main funds in the two markets experienced a net outflow of 18.575 billion yuan, with 8 sectors seeing net inflows. The electronics sector led with a net inflow of 3.655 billion yuan and a daily increase of 1.10%, followed by the communications sector with a net inflow of 2.848 billion yuan and a daily increase of 1.24% [1] - In contrast, 23 sectors faced net outflows, with the computer sector leading at a net outflow of 6.892 billion yuan, followed by the non-ferrous metals sector with a net outflow of 3.254 billion yuan [1] Pharmaceutical and Biological Sector Performance - The pharmaceutical and biological sector increased by 1.47% with a net inflow of 314 million yuan. Out of 474 stocks in this sector, 265 rose, 9 hit the daily limit up, while 191 fell, with 2 hitting the daily limit down [2] - Notably, 178 stocks in this sector experienced net inflows, with 8 stocks seeing inflows exceeding 100 million yuan. The top stock for net inflow was Heng Rui Medicine, with an inflow of 1.256 billion yuan, followed by Lu Kang Medicine and Zhong Sheng Pharmaceutical with inflows of 181 million yuan and 169 million yuan respectively [2] Top Gainers in Pharmaceutical Sector - The top gainers in the pharmaceutical sector included: - Heng Rui Medicine: +10.00% with a turnover rate of 2.56% and a main fund flow of 1.255 billion yuan - Lu Kang Medicine: +4.30% with a turnover rate of 15.05% and a main fund flow of 181 million yuan - Zhong Sheng Pharmaceutical: +7.88% with a turnover rate of 11.59% and a main fund flow of 169 million yuan [3] Top Losers in Pharmaceutical Sector - The top losers in the pharmaceutical sector included: - Changshan Pharmaceutical: -0.28% with a main fund outflow of 122.818 million yuan - Shenzhou Cell: -1.14% with a main fund outflow of 102.235 million yuan - WuXi AppTec: +3.08% with a main fund outflow of 94.187 million yuan [4]

[Current Period Performance Forecast](index=1&type=section&id=Current%20Period%20Performance%20Forecast) The company forecasts a 59.34%-65.98% year-on-year decrease in H1 2025 net profit attributable to shareholders, primarily due to prior year non-recurring gains, while core business profitability shows growth 2025 Semi-Annual Performance Forecast | Metric | 2025 Semi-Annual Forecast (million CNY) | Year-on-Year Change | | :--- | :--- | :--- | | **Net Profit Attributable to Shareholders of the Parent Company** | 102.06 - 121.96 | ↓ 59.34% - 65.98% | | **Net Profit Excluding Non-Recurring Gains/Losses** | 94.88 - 107.68 | ↑ 3.49% - 17.45% | - The performance forecast data represents preliminary calculations by the finance department and has not been audited by a certified public accountant[3](index=3&type=chunk) [Prior Period Operating Performance and Financial Status](index=1&type=section&id=Prior%20Period%20Operating%20Performance%20and%20Financial%20Status) Key financial data for H1 2024, including approximately **300 million CNY** in net profit attributable to shareholders and **92 million CNY** in net profit excluding non-recurring items, serves as the baseline for current period comparisons H1 2024 Operating Performance | Metric (H1 2024) | Amount (million CNY) | | :--- | :--- | | **Net Profit Attributable to Shareholders of the Parent Company** | 299.96 | | **Net Profit Excluding Non-Recurring Gains/Losses** | 91.68 | | **Earnings Per Share** | 0.33 (CNY) | [Key Reasons for Current Period Performance Change](index=1&type=section&id=Key%20Reasons%20for%20Current%20Period%20Performance%20Change) The significant year-on-year decline is primarily due to a substantial **156 million CNY** non-recurring gain from land disposal in the prior year, with core business profit growing after excluding this impact - Non-recurring gains/losses impact: A **156 million CNY** asset disposal gain from the South Plant land transfer in the prior year significantly skewed the net profit base for comparison[6](index=6&type=chunk) - Core business impact: The company achieved increased operating profit year-on-year by strengthening excellent performance management and optimizing production, sales, and supply chain processes for quality and efficiency improvements[6](index=6&type=chunk) [Risk Warning](index=2&type=section&id=Risk%20Warning) The company confirms no significant uncertainties affecting the accuracy of this performance forecast exist as of the announcement date - As of the announcement date, the company confirms no significant uncertainties affecting the accuracy of this performance forecast[7](index=7&type=chunk) [Other Explanatory Notes](index=2&type=section&id=Other%20Explanatory%20Notes) The company reminds investors that this disclosure contains preliminary data, with final financial figures subject to the official 2025 semi-annual report, and advises caution regarding investment risks - This forecast data represents preliminary results, with final accurate figures subject to the company's officially disclosed 2025 semi-annual report[8](index=8&type=chunk)

鲁抗医药（600789）公告，预计2025年半年度实现归属于母公司所有者的净利润1.02亿元-1.22亿元。与 上年同期相比，将减少1.78亿元-1.98亿元，同比减少59.34%-65.98%。预计2025年半年度实现归属于母 公司所有者的扣除非经常性损益的净利润9488万元-1.08亿元。与上年同期相比，将增加320万元-1600万 元，同比增加3.49%-17.45%。 ...

Core Viewpoint - The collaboration between Qingdao Institute of Bioenergy and Process Research and Shandong Lukang Pharmaceutical has successfully developed a microbial green manufacturing technology for trans-aconitic acid, overcoming production challenges and achieving large-scale production, which has been recognized with a first-class award in Shandong Province for 2024 [1][3][12] Group 1: Production Challenges and Solutions - Trans-aconitic acid is a food additive with significant applications in agriculture, medicine, and chemicals, but traditional production methods face high costs and inefficiencies [3][9] - The research team developed an integrated technology system using industrial Aspergillus niger as a chassis cell, enabling the conversion of starch sugars into trans-aconitic acid through synthetic biology [3][5] - Key challenges addressed include the genetic modification of industrial strains, achieving high-efficiency synthesis, and optimizing fermentation processes for industrial application [5][7] Group 2: Industrial Application and Market Potential - The successful production of trans-aconitic acid opens up new avenues for its use as a biopesticide, particularly in combating root-knot nematodes in agriculture, aligning with national green agriculture initiatives [9][11] - In the chemical industry, trans-aconitic acid is being developed into a bio-based plasticizer, providing a safer alternative to petroleum-based phthalate plasticizers, which are facing regulatory restrictions due to health concerns [11][12] - The technology has garnered attention from various enterprises, leading to successful production demonstrations and positioning trans-aconitic acid as a key bio-based chemical in the upcoming 2024-2027 development plan for fine chemical industries [12]

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a focus on innovative drug companies [2][3]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.82%, outperforming the CSI 300 index (0.82%) and the Wind All A index (1.71%). The market is currently focused on the expectations surrounding semi-annual reports and business development (BD) activities [8][9]. - The launch of the 2025 National Basic Medical Insurance and Commercial Health Insurance innovative drug directory is a significant development. This directory will include high-innovation drugs that provide substantial clinical value and patient benefits, which are not covered by basic medical insurance but recommended for commercial health insurance [3][13]. - The report highlights the importance of the commercial health insurance sector in the payment for innovative drugs, suggesting that the accessibility of high-priced innovative drugs is expected to improve, particularly in the areas of cell and gene therapy [3][13]. Market Weekly Review - The medical research outsourcing sector led the gains with a 9.29% increase, primarily driven by WuXi AppTec's positive semi-annual report announcement. Conversely, offline pharmacies and other biological products experienced declines of -1.29% and -1.55%, respectively [8][9]. - Notable stock performances included Frontier Biotech-U (41.4%), Mediso (38.9%), and Lianhuan Pharmaceutical (38.6%) leading the gains, while ST Unimed (-18.5%), Shenzhou Cell-U (-13.4%), and Shutai Shen (-11.6%) faced significant losses [11][12]. Industry News and Key Company Announcements - The report outlines several key industry events, including the approval of innovative drugs and strategic partnerships among major pharmaceutical companies, which are expected to enhance their market positions and product offerings [13][16][17]. - The report also mentions significant financial forecasts from various companies, indicating strong growth potential in the sector, with some companies projecting net profit increases of over 100% year-on-year [17][18].

药品名称：吉非替尼片 剂型：片剂 包装规格：0.25g 证券代码：600789 证券简称：鲁抗医药 公告编号：2025—032 山东鲁抗医药股份有限公司 关于获得药品注册证书及化学原料药上市申请批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗 漏，并对其内容的真实性、准确性和完整性承担法律责任。 近日，山东鲁抗医药股份有限公司（以下简称"公司"）收到国家药品监督 管理局颁发的关于吉非替尼片《药品注册证书》（证书编号：2025S02063）及吉 非替尼原料药《化学原料药上市申请批准通知书》（通知书编号：2025YS00544）。 现将相关情况公告如下： 一、《药品注册证书》基本信息 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。 三、药品研发及市场情况 批准文号：国药准字 H20254759 药品标准：YBH15512025 注册分类：化学药品 4 类 生产企业：山东鲁抗医药股份有限公司 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，发给药品注册证书。质量标准、说明书、 标签及生产工艺照 ...

Core Viewpoint - LuKang Pharmaceutical (600789) has received the drug registration certificate for Gefitinib tablets and the approval notice for the raw material drug from the National Medical Products Administration, indicating a significant advancement in its oncology product portfolio [1] Company Summary - Gefitinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with sensitive EGFR gene mutations [1] - The company has invested approximately 11.1491 million yuan in the research and development of Gefitinib tablets and about 9.9 million yuan in the raw material drug [1] Industry Summary - There are currently 15 existing drug registration numbers for Gefitinib tablets in China, with projected sales of 263 million yuan in 2024 [1]