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]

Core Viewpoint - The company, Shandong Lukang Pharmaceutical Co., Ltd., has shown significant growth in sales revenue and net profit during the reporting period, with a notable increase in sales profit margin attributed to product structure changes and asset disposal gains from land recovery [1][12]. Financial Performance - The company's operating revenue for the reporting periods was 562.14 million yuan, 614.67 million yuan, and 623.31 million yuan, while the net profit attributable to shareholders was 138.01 million yuan, 246.17 million yuan, and 394.62 million yuan, respectively [1][2]. - The sales profit margins were recorded at 2.55%, 4.18%, and 6.55% for the respective years, indicating a steady increase [1][3]. Sales Profit Margin Analysis - The increase in sales profit margin is primarily due to changes in product structure, market competition, and cost variations, with the gross profit margin showing a trend of increase followed by stabilization [2][5]. - The gross profit margins for the reporting periods were 22.19%, 24.65%, and 23.96%, reflecting the impact of product mix and cost management [3][5]. Product Segmentation - The company’s human medicine segment showed a steady increase in gross profit margin for formulation drugs, with margins of 33.68%, 38.02%, and 41.46% over the reporting periods, driven by the introduction of high-margin products and improved production efficiency [5][6]. - The raw material drug segment experienced fluctuations in gross profit margins, with rates of 12.53%, 5.46%, and 8.53%, influenced by market competition and cost changes [10][11]. Export and Revenue Matching - The company’s export revenue showed a strong correlation with customs declaration data, with minor discrepancies deemed reasonable due to small sample exports and internal sales classifications [15][16]. - The total export revenue for the reporting periods was 76.71 million yuan, 78.03 million yuan, and 104.08 million yuan, with the export tax refund amounting to 107.34 million yuan, 69.40 million yuan, and 86.95 million yuan, respectively [16][19]. Market and Competitive Landscape - The company’s external sales were diversified across several countries, including the UK, Netherlands, and Egypt, with stable trade and tariff policies that did not adversely affect export operations [19][20]. - The sales expense ratio for the company was significantly lower than that of comparable companies, recorded at 8.45%, 9.40%, and 9.11% over the reporting periods, reflecting efficient cost management strategies [22][23].

和信会计师事务所（特殊普通合伙） 关于山东鲁抗医药股份有限公司 向特定对象发行股票申请文件的 审核问询函的回复 和信综字（2025）第 000348 号 （修订稿） 二〇二五年七月 和信会计师事务所（特殊普通合伙） 关于山东鲁抗医药股份有限公司 向特定对象发行股票申请文件的 审核问询函的回复 和信综字（2025）第 000348 号 上海证券交易所： 贵所于 2025 年 5 月 9 日出具的上证上审（再融资）〔2025〕137 号《关于山东鲁抗 医药股份有限公司向特定对象发行股票申请文件的审核问询函》（以下简称"问询函"） 已收悉，山东鲁抗医药股份有限公司（简称"鲁抗医药"、"发行人"、"公司"）及我们 对问询函所列问题进行了逐项落实、核查，现对问询函问题回复如下： 如无特别说明，本回复中的简称或名词释义与募集说明书（申报稿）中的相同。本 回复中的字体代表以下含义： 请发行人说明：（1）结合产品结构变化、市场竞争情况、成本变化等，说明报告期 内销售净利率显著增长的原因及合理性，变化趋势与同行业可比公司是否存在显著差异 及合理性；（2）报关数据、出口退税情况与境外收入的匹配性；结合出口国家或地区相 关贸易、关 ...

证券代码：600789 证券简称：鲁抗医药 关于山东鲁抗医药股份有限公司 向特定对象发行股票申请文件的 审核问询函的回复 （修订稿） 保荐机构（主承销商） （北京市朝阳区建国门外大街 1 号国贸大厦 2 座 27 层及 28 层） 二〇二五年七月 上海证券交易所： 贵所于 2025 年 5 月 9 日出具的上证上审（再融资）〔2025〕137 号《关于山东鲁抗 医药股份有限公司向特定对象发行股票申请文件的审核问询函》（以下简称"问询函"） 已收悉，山东鲁抗医药股份有限公司（简称"鲁抗医药"、"发行人"、"公司"）、中国国 际金融股份有限公司（简称"保荐机构"、"中金公司"）、和信会计师事务所（特殊普通 合伙）（简称"申报会计师"）、北京市通商律师事务所（简称"发行人律师"）等相关方 对问询函所列问题进行了逐项落实、核查，现对问询函问题回复如下，请予审核。 如无特别说明，本回复中的简称或名词释义与募集说明书（申报稿）中的相同。本 回复中的字体代表以下含义： | 问询函所列问题 | 黑体（不加粗） | | --- | --- | | 对问题的回答 | 宋体（不加粗） | | 对募集说明书等申请文件的修改、补充 | ...