证券代码：603858 证券简称：步长制药 公告编号：2026-012 山东步长制药股份有限公司 关于为公司控股子公司提供担保的公告 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： ● 担保对象及基本情况 （一）担保的基本情况 山东步长制药股份有限公司（以下简称 "公司"）于2026年1月26日与北京银行股份有限公司北京经济技 术开发区分行（以下简称 "北京银行北京经济技术开发区分行"）签订了《最高额保证合同》，为公司 控股子公司北京博源润步医药研发有限公司（以下简称 "博源润步"）与北京银行北京经济技术开发区 分行签订的《综合授信合同》提供3,000万元连带责任保证。 （二）内部决策程序 公司于2025年4月25日召开第五届董事会第二十次（年度）会议，于2025年6月26日召开2024年年度股东 会，审议通过了《关于审议公司及控股子公司2025年度预计新增融资额度及担保额度的议案》，同意 2025年度公司及控股子公司向金融机构申请授信总额不超过人民币69.20亿元的综合融资额度。上述融 资事项如需采用保证或抵 ...

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [2] Core Views - The company reported a significant increase in revenue and has multiple business development (BD) collaborations that are expected to drive future growth [8] - The company has a strong pipeline with clinical advancements in its CDH17 ADC and TCE platform, showcasing its R&D capabilities [8] - Revenue projections for 2025-2027 are estimated at 9.03 billion, 14.31 billion, and 22.72 billion RMB respectively, with a path to profitability expected by 2027 [8] Financial Performance - For the third quarter of 2025, the company achieved a revenue of 465 million RMB, representing a year-on-year growth of 1717.41% [8] - The total revenue for the first three quarters of 2025 reached 566 million RMB, a year-on-year increase of 301.03% [8] - The company's drug sales revenue for the third quarter was 55.32 million RMB, up 120.85% year-on-year, and for the first three quarters, it was 156 million RMB, up 72.10% year-on-year [8] Business Development Collaborations - The company has secured three BD collaborations, including a partnership with Qilu Pharmaceutical for the Agrestin α product, which includes a 380 million RMB upfront payment [8] - Collaborations with Calico and Kalexo involve significant upfront payments and milestone payments, indicating strong commercial potential [8] Clinical Development - The company’s self-developed CDH17 ADC has received approval for clinical trial applications from both the National Medical Products Administration and the FDA [8] - The TCE platform has established a comprehensive antibody library, enhancing its capabilities for targeted cancer therapies [8] Earnings Forecast - Projected revenues for 2025, 2026, and 2027 are 9.03 billion, 14.31 billion, and 22.72 billion RMB respectively, with corresponding net profits expected to be -648 million, -301 million, and 80 million RMB [7][8] - The company is expected to achieve an EPS of -1.62, -0.75, and 0.20 RMB for the years 2025, 2026, and 2027 respectively [7]

Investment Rating - The report maintains an "Outperform" rating for Ascentage Pharma with a target price of HKD 90.70, reflecting a potential upside from the current price of HKD 90.20 [2][24]. Core Insights - Ascentage Pharma reported strong product sales growth, with revenue from product sales reaching RMB 213 million, a 70.5% increase year-on-year, driven by a 93% increase in sales of Olverembatinib [3][15][17]. - The company achieved a gross profit of RMB 212 million with a gross margin of 90.7%, indicating improved operational efficiency [3][15]. - R&D expenses increased by 19% year-on-year to RMB 529 million, reflecting ongoing global clinical trials and the company's commitment to advancing its pipeline [3][18]. Financial Performance - For the first half of 2025, total revenue was RMB 234 million, down 71.6% year-on-year, primarily due to a one-off intellectual property income from Takeda in the previous year [3][15]. - The company recorded a net loss of RMB 591 million during the same period, with cash reserves totaling approximately RMB 3.15 billion [3][15][18]. - The report projects revenues for FY25, FY26, and FY27 to be RMB 730 million, RMB 3.16 billion, and RMB 3.02 billion, respectively, with corresponding net profits of RMB -1.09 billion, RMB 1.39 billion, and RMB 990 million [9][21]. R&D Progress - The approval of Lisaftoclax® for treating CLL/SLL patients was a significant milestone, and the initiation of the GLORA-4 Phase III trial for higher-risk MDS patients is expected to accelerate the drug's market entry [4][16][20]. - Efficacy data presented at the 2025 ASCO meeting showed promising results for Lisaftoclax® in MDS and CMML patients, with an overall response rate of 80% in newly diagnosed patients [20][21]. Market Dynamics - The report highlights the significant unmet medical need in the MDS treatment landscape, particularly for higher-risk patients, where current therapies have limited efficacy [19][20]. - The combination of National Reimbursement Drug List coverage and expanded hospital access has driven sales growth for Olverembatinib, with a 114% increase in sales volume [17][18].

Investment Rating - The report maintains a "Buy" rating for the company [3] Core Views - The company achieved a revenue of 2.131 billion yuan in H1 2025, a year-on-year increase of 4.32%, with a net profit attributable to shareholders of 347 million yuan, up 3.93% year-on-year [1][2] - The sales of patented and new products have significantly increased, contributing to revenue growth, particularly in the sales of new diabetes drug Xinlitin and other therapeutic products [2] - The company has increased its R&D investment to 542 million yuan in H1 2025, a 17.89% increase year-on-year, accounting for 25.43% of revenue [2] Summary by Sections Financial Performance - In Q2 2025, the company reported a revenue growth of 12.30% year-on-year and a net profit growth of 14.55% year-on-year [1] - The company’s revenue forecast for 2025 is 4.495 billion yuan, with a projected net profit of 708 million yuan, reflecting a growth rate of 17.67% [4][10] R&D Progress - Key projects in clinical trials include: - S086 for chronic heart failure, currently in follow-up phase after patient enrollment completion - SAL003, a monoclonal antibody, has completed Phase III clinical research and is expected to submit for market approval within the year [2][3] - The company is advancing multiple pipelines, indicating a strong focus on innovation and product development [3] Valuation Metrics - The projected P/E ratios for 2025, 2026, and 2027 are 81, 70, and 58 respectively, indicating a favorable valuation outlook as the company transitions into a product harvest phase [3][4]

Core Viewpoint - Haichuang Pharmaceutical-U reported significant revenue growth in the first half of 2025, primarily driven by the launch of its first new drug, but still faces challenges in achieving profitability due to competition and ongoing R&D costs [1][2]. Financial Performance - The company achieved revenue of 13.167 million yuan, a year-on-year increase of 11,899.08% [2][3]. - The net profit attributable to shareholders was -61.853 million yuan, a reduction in losses by 38.40% compared to the same period last year [3]. - The company reported a decrease in R&D expenses by 30.96 million yuan, contributing to the reduction in losses [3]. Product Development - The newly launched drug, Dihenzalutamide soft capsule, generated over 10 million yuan in revenue within a month of its approval [1][2]. - The company plans to include Dihenzalutamide in the national medical insurance by 2025 to enhance product accessibility [4]. - Haichuang Pharmaceutical announced the suspension of the HP501 project, which had already invested over 80 million yuan, due to increased competition in the market [5][6]. Market Competition - The Dihenzalutamide soft capsule faces competition from similar androgen receptor inhibitors and generic drugs, with several competitors already in advanced clinical stages [4][7]. - The company noted that the HP501 project was lagging behind competitors, prompting the decision to halt further investment [6][7]. Future Outlook - The company aims to continue advancing other projects, such as HP518, which is in the clinical trial phase for treating metastatic castration-resistant prostate cancer [8].