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 ...

鲁抗医药（600789）公告，近日收到国家药品监督管理局颁发的吉非替尼片《药品注册证书》及吉非替 尼原料药《化学原料药上市申请批准通知书》。吉非替尼是一种表皮生长因子受体酪氨酸激酶抑制剂 (EGFR-TKI)，适用于具有表皮生长因子受体(EGFR)基因敏感突变的局部晚期或转移性非小细胞肺癌 (NSCLC)患者的治疗。国内现有吉非替尼片文号15个，2024年销售额为2.63亿元。公司在吉非替尼片的 研发投入约为1114.91万元，原料药研发投入约为990万元。 ...

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 | ...

证券代码：600789 证券简称：鲁抗医药 公告编号：2025—031 山东鲁抗医药股份有限公司 关于向特定对象发行股票申请文件的 审核问询函回复更新的提示性公告 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。 山东鲁抗医药股份有限公司（以下简称"公司"）于近期收到上海证券交易 所（以下简称"上交所"）出具的《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》（上证上审（再融资）〔2025〕137 号，以下 简称《问询函》），上交所审核机构对公司向特定对象发行股票申请文件进行了 审核，并形成了问询问题。 公司收到《问询函》后，按照要求会同相关中介机构就《问询函》所列问题 进行了认真研究和逐项落实，根据相关要求对《问询函》有关问题进行了说明和 论证，同时对募集说明书等申请文件的部分内容进行了相应补充和修订，具体内 容详见公司于 2025 年 6 月 18 日在上海证券交易所网站（www.sse.com.cn）披露 的《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》等文件。 根据上 ...

Group 1 - The Alzheimer's concept sector rose by 1.80%, leading the gains among concept sectors, with 18 stocks increasing in value [1][2] - Notable gainers included Hotgen Biotech with a 20% limit up, and other companies like Jingxin Pharmaceutical and Haizheng Pharmaceutical also reached their limit up [1][2] - The sector saw a net inflow of 372 million yuan from main funds, with 17 stocks receiving net inflows, and six stocks exceeding 30 million yuan in net inflow [2][3] Group 2 - The top three stocks by net inflow were Haizheng Pharmaceutical (105 million yuan), Jingxin Pharmaceutical (88.79 million yuan), and Hotgen Biotech (79.62 million yuan) [2][3] - The net inflow ratios for leading stocks were 9.03% for Haizheng Pharmaceutical, 7.51% for Jingxin Pharmaceutical, and 8.09% for Hotgen Biotech [3][4] - Stocks with significant declines included Fujilai, Wohua Pharmaceutical, and Wanbangde, with declines of 1.61%, 1.30%, and 1.29% respectively [1][5]

Core Viewpoint - The company is advancing its "党建链" (Party Building Chain) to empower its "产业链" (Industrial Chain) by enhancing collaboration across innovation, industry, talent, and technology chains, aiming for high-quality development [2]. Group 1: Innovation Chain - The company is establishing a new model for collaborative innovation that includes "source innovation → technology development → achievement transformation → industrial application" through party building [2]. - Collaboration with the Chinese Academy of Sciences has led to the development of trans-aconitic acid, with significant contributions to innovation and talent exchange, culminating in a first-class award from Shandong Province for technological invention [2]. - The global first green bio-manufacturing project for trans-aconitic acid is set to commence production in June 2025 [2]. Group 2: R&D Chain - The company is creating a new collaborative model for R&D that focuses on "core technology breakthroughs → drug clinical applications → drug achievement transformation" [3]. - Joint efforts with China Pharmaceutical University and Peking University People's Hospital are enhancing the development of the innovative drug CIGB-814, which is expected to lead new directions in immunotherapy and cell therapy [3]. - The establishment of the "Innovative Drug Evaluation and Repositioning Laboratory" is a key initiative in advancing the research of CIGB-814 [3]. Group 3: Supply Chain - The company is enhancing upstream and downstream collaboration through party building, ensuring the stability and safety of its supply chain [5]. - Partnerships with companies like Sinopharm Holdings and Henan Renhua Biotech are driving sales growth through collaborative efforts [5]. Group 4: Professional Chain - The company is collaborating with various regulatory and research institutions to improve quality and compliance, thereby enhancing operational efficiency [6]. - Engagement with the Shandong Provincial Department of Ecology and Environment is facilitating the effective implementation of ecological policies and advanced technologies [6]. - The integration of party building with professional guidance is fostering a strong foundation for quality improvement and high-quality development [6].

Company Overview - Shandong Lukang Pharmaceutical Co., Ltd. was established on February 15, 1993, and is located at 88 Deyuan Road, Jining High-tech Zone, Shandong Province [18] - The company is listed on the Shanghai Stock Exchange with the stock code 600789, and its actual controller is the State-owned Assets Supervision and Administration Commission of the Shandong Provincial Government [18][19] - As of December 31, 2024, the total share capital of the company is 898,669,632 shares, with 100% being unrestricted shares [19] Issuance Plan - The company plans to issue shares to no more than 35 specific investors, including its controlling shareholder, Hualu Group, which intends to subscribe for 23.81% of the shares, amounting to no more than 64,201,417 shares [2][3][6] - The total amount of funds raised from this issuance is not expected to exceed 1.2 billion yuan (120,000 million yuan) [8] - The final issuance price will be determined based on the average trading price of the company's shares over the 20 trading days prior to the pricing benchmark date, with a minimum price set at 80% of this average [4][5] Industry Context - The global chemical pharmaceuticals market has shown stable growth, increasing from USD 924.8 billion in 2016 to USD 1,104.7 billion in 2022 [20] - The Chinese chemical pharmaceuticals market reached a scale of 801.2 billion yuan in 2016, experiencing fluctuations due to global public health events but is expected to recover starting in 2023 [20] - Chronic diseases, particularly cardiovascular diseases and diabetes, are key focus areas for the company, with significant patient populations and high medical costs associated with these conditions [21][20] Market Trends - The market for cardiovascular drugs in China has maintained growth from 2015 to 2019, with fluctuations from 2020 to 2022 due to public health events [21] - The market for type 2 diabetes treatment drugs in China has experienced volatility from 2018 to 2022 but is projected to grow steadily due to the introduction of innovative diabetes medications and increased awareness of comprehensive health management [21] - The antibiotic market in China has grown from 145 billion yuan in 2016 to 208 billion yuan in 2023, despite regulatory restrictions on antibiotic use [22]