人民财讯8月7日电，步长制药（603858）8月7日晚间公告，公司控股子公司泸州步长拟与菲律宾公司 GOODFELLOW签署《独家供应协议》，泸州步长拟授权GOODFELLOW作为菲律宾区域内独家代理 商，在目标区域内完成注射用Efparepoetin alfa的注册、相关临床试验、推广、分销及销售事宜。注射用 Efparepoetin alfa适用于治疗正在接受促红细胞生成素治疗的成人透析患者因慢性肾脏病(CKD)引起的贫 血，为治疗用生物制品I类新药，目前已提交上市申请。 ...

Core Viewpoint - The traditional Chinese medicine (TCM) sector is experiencing significant opportunities due to favorable policies and market developments, with a notable surge in stock performance among TCM companies [6][9]. Market Performance - On August 1, the A-share market saw a slight decline, with the Shanghai Composite Index down 0.37%, Shenzhen Component Index down 0.17%, and ChiNext Index down 0.24%. However, over 3,300 stocks rose in the market [1][2]. - The TCM sector led the market with a substantial increase, as evidenced by the 1.78% rise in the Shenwan TCM Index, with several companies, including Weikang Pharmaceutical and Tianmu Pharmaceutical, hitting the daily limit [5][6]. Policy and Industry Developments - The establishment of the Yangtze River Delta TCM Concept Verification and Achievement Transformation Center in Shanghai aims to enhance the commercialization of TCM research and development [6]. - The State Council's 2025 directive emphasizes the protection and utilization of TCM resources, indicating a supportive regulatory environment for the industry [6]. Company Performance - Notable TCM companies reported significant profit growth in the first half of 2025. For instance, Darentang's net profit is expected to reach between 18.4 billion to 20 billion yuan, marking a year-on-year increase of 180% to 204% [9][11]. - Jilin Aodong anticipates a net profit of approximately 12.36 billion to 12.9 billion yuan, reflecting a year-on-year growth of 130% to 140% [9][11]. - Tianmu Pharmaceutical successfully turned a profit during the reporting period, driven by enhanced sales in pharmaceuticals and medical devices [10]. Investment Insights - Analysts suggest that the TCM sector is poised for growth, driven by innovative products and strong brand recognition, particularly in high-value markets [7][8]. - The focus on stable cash flow to support R&D expenditures is expected to be a key strategy for TCM companies moving forward [7].

Group 1 - A total of 19 listed companies have released their semi-annual reports for 2025, with notable net profit figures from companies such as Darentang, Jilin Aodong, and Buchang Pharma [1] - Darentang's net profit is expected to reach between 1.84 billion to 2 billion yuan, representing a year-on-year growth of 180% to 204%, primarily due to the disposal of a 12% stake in its joint venture Tianjin Shike, resulting in a gain of 1.54 billion yuan [1] - Jilin Aodong and Buchang Pharma also reported net profit growth, with both companies achieving year-on-year increases of over 100% [1] Group 2 - Changcheng Securities highlighted Darentang's successful development of "Jingwanhong Skin Factor," which transforms traditional Chinese medicine wisdom into effective skincare ingredients, indicating potential growth in the Chinese herbal skincare market [1] - Tianmu Pharmaceutical has successfully turned losses into profits by enhancing its market presence in pharmaceuticals, health products, and medical devices, leading to significant increases in product sales and overall profitability [1] - Tianmu Pharmaceutical's stock reached the daily limit increase, with notable investment from well-known trader "Xiaoguo Yangjia," who purchased 9.53 million yuan worth of shares [1]

Core Viewpoint - The announcement highlights that Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. has received approval from the Sichuan Provincial Drug Administration to change the production scope of its drug manufacturing license, which is expected to positively impact the company's future operations [1][2]. Group 1: Drug Production License Details - The company Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. has received a license to change its production scope to include therapeutic biological products, specifically the injection of recombinant anti-vascular endothelial growth factor receptor 2 (VEGFR2) human monoclonal antibody, limited to registration and declaration use [1]. - The license number is 川20220555, and it is valid until February 16, 2027 [1]. Group 2: Impact on the Company - The change in the drug production license is beneficial for the company as it optimizes the production structure and helps maintain stable production capacity to meet market demand [2]. - The high-tech and high-risk nature of pharmaceutical products means that the development and production process is lengthy and complex, which may be influenced by various uncertainties [2].

证券日报网讯 7月31日晚间，步长制药发布公告称，公司近日获悉控股子公司四川泸州步长生物制药有 限公司（简称"泸州步长"）获得四川省药品监督管理局许可，同意泸州步长《药品生产许可证》生产范 围的变更。 （编辑 任世碧） ...

证券代码：603858 证券简称：步长制药 公告编号：2025-140 山东步长制药股份有限公司 关于控股子公司药品生产许可证变更的公告 质量负责人：叶宇 生产地址和生产范围：四川省泸州市泸县康乐大道西段 480 号：治疗用生物 制品（仅限注册申报使用）*** 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。 山东步长制药股份有限公司（以下简称"公司"）近日获悉控股子公司四川 泸州步长生物制药有限公司（以下简称"泸州步长"）获得四川省药品监督管理 局许可，同意泸州步长《药品生产许可证》生产范围的变更，其他内容不变，现 将相关情况公告如下： 一、药品生产许可证相关情况 企业名称：四川泸州步长生物制药有限公司 注册地址：四川省泸州市泸县康乐大道西段 480 号 法定代表人：杨春 许可证编号：川 20220555 分类码：AsBs 企业负责人：王舸 有效期至：2027 年 02 月 16 日 二、药品生产许可证副本变更情况 同意该企业增加生产范围：治疗用生物制品（注射用重组抗血管内皮细胞生 1 长因子受体 2（VEGFR2）全人单克隆 ...

步长制药（603858）公告，控股子公司四川泸州步长生物制药有限公司获得四川省药品监督管理局许 可，同意其《药品生产许可证》生产范围的变更。变更内容为增加生产范围：治疗用生物制品(注射用 重组抗血管内皮细胞生长因子受体2(VEGFR2)全人单克隆抗体)，其他内容不变。此次变更有利于公司 优化生产结构，满足市场需求，对未来的经营产生积极影响。 ...

Core Insights - Shandong Buchang Pharmaceutical has been recognized as an "Advanced Intelligent Factory" by the Shandong Provincial Department of Industry and Information Technology for its systematic intelligent manufacturing practices [1][2] - The factory integrates traditional Chinese medicine with modern technology through a comprehensive digital transformation across five major processes and 14 scenarios, promoting a shift towards new productive forces in the Chinese medicine industry [1] Company Developments - Buchang Pharmaceutical has achieved several technological breakthroughs addressing key pain points in intelligent manufacturing of traditional Chinese medicine, including precise material delivery, continuous production, and intelligent drying technologies [1] - The implementation of these technologies has resulted in a 40% reduction in energy consumption and a doubling of production efficiency [1] - The factory's annual production capacity for its core product, Xinxin Granules, has surpassed 5 billion bags, serving over 10 million patients daily [1] Industry Impact - The establishment of a digital traceability system covering 350 nodes for Chinese medicinal herb cultivation, along with 345 standardized planting techniques, has led to over 5,000 farmers experiencing an annual income increase of more than 30% [1] - The intelligent factory currently holds 473 patents and focuses on intelligent equipment, continuous pharmaceutical production, resource conservation, and green engineering to promote the inheritance and innovation of traditional Chinese medicine [1][2]

证券代码：603858 证券简称：步长制药 公告编号：2025-139 山东步长制药股份有限公司 关于控股股东股份质押的公告 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。 重要内容提示： 一、上市公司股份质押 山东步长制药股份有限公司（以下简称"公司"）于 2025 年 7 月 28 日接到 通知，获悉公司控股股东步长（香港）控股有限公司（以下简称"步长（香港）"） 办理了股份质押手续，具体情况如下： 1、本次股份质押基本情况 | 股东名称 | 控股股 | （股） | 为限 | 补充 | 起始日 | 到期日 | 质权人 | 所持 | 司总 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 是否为 | 本次质押数 | 是否 售股 | 是否 质押 | 质押 | 质押 | | 占其 股份 | 占公 股本 | 质押融资资 金用途 | 1 公司控股股东步长（香港）持有本公司股份 490,957,202 股，占公司总 股本的 44.39 ...

Core Viewpoint - The Chinese innovative drug industry is experiencing significant growth in the first half of 2025, driven by policy benefits and international breakthroughs, with leading companies achieving explosive growth due to technological barriers and commercialization capabilities [1]. Company Performance Summaries - **Shuanglu Pharmaceutical**: Expected net profit for H1 2025 is between 100 million and 135 million RMB, a year-on-year increase of 237.95% to 356.24% from 29.59 million RMB in the same period last year, primarily benefiting from financial asset returns and breakthroughs in innovative drug pipelines [3][4]. - **Sino Biopharmaceutical**: Anticipated net profit ranges from 77.03 million to 94.14 million RMB, reflecting a year-on-year increase of 253.54% to 332.10%, driven by strong performance in peptide raw material exports [5][7]. - **Microchip Biotech**: Expected net profit of approximately 30.06 million RMB, representing a 173% increase, attributed to the inclusion of its core product (Sida Benamine) in medical insurance and optimized sales strategies [8][10]. - **Buchang Pharmaceutical**: Projected net profit between 488 million and 708 million RMB, a year-on-year increase of 110.88% to 205.94%, due to increased sales scale and reduced production costs [11][13]. - **Ganli Pharmaceutical**: Expected net profit of 600 million to 640 million RMB, a year-on-year increase of 100.73% to 114.12%, driven by significant revenue growth and refined expense management [15][16]. - **Shanghai Pharmaceuticals**: Anticipated net profit of 4.45 billion RMB, an increase of approximately 52% from the previous year, following the acquisition of a 10% stake in Shanghai Hengrui Medicine [17][18]. - **Liaoning Chengda**: Expected net profit between 689 million and 735 million RMB, a year-on-year increase of 50% to 60%, supported by a dual-driven strategy of healthcare and financial investment [19][21]. - **WuXi AppTec**: Projected net profit of approximately 6.3 billion RMB, a year-on-year increase of about 44.43%, driven by optimized CRDMO business models and significant non-operating gains from stock sales [23][25]. - **Notai Biopharmaceutical**: Expected net profit between 300 million and 330 million RMB, a year-on-year increase of 32.06% to 45.27%, attributed to sales growth in peptide raw materials [27][29]. - **I-Wu Biotech**: Anticipated net profit between 170 million and 180 million RMB, reflecting a year-on-year increase of 13.92% to 23.97%, focusing on allergy disease treatment products [30][31]. Industry Trends - The performance divergence in the innovative drug industry in 2025 indicates a shift from "scale competition" to "technological competition," with companies possessing genuine innovation capabilities and international layouts expected to lead, while those relying on capital operations or policy arbitrage face growth challenges [32].