[Table_Reportdate] 2025年08月26日 [Table_invest] 买入（维持） 报告原因：业绩点评 [贝达药业 Table_NewTitle]（300558）：营收稳健增长，商 业化产品不断丰富 ——公司简评报告 [table_main] 投资要点 [盈利预测与估值简表 Table_profits] | | 2022A | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 2377 | 2456 | 2892 | 3611 | 4228 | 5082 | | 增长率（%） | 5.82% | 3.35% | 17.74% | 24.87% | 17.08% | 20.21% | | 归母净利润（百万元） | 145 | 348 | 403 | 471 | 589 | 747 | | 增长率（%） | -62.04% | 139.33% | 15.67% | 17.08% | 24.91% | 26.90% | | EPS（元/股） | 0 ...

证券代码：300558 证券简称：贝达药业 公告编号：2025-056 贝达药业股份有限公司 一、药品基本情况 恩沙替尼是一种新型强效、高选择性的新一代 ALK 抑制剂，是公司和控股子 公司 Xcovery Holdings, Inc.共同开发的自主创新药。2020 年 11 月，恩沙替尼"适 用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的 ALK 阳性的局部 晚期或转移性 NSCLC 患者的治疗"（即二线适应症）获得 NMPA 批准上市；2022 年 3 月，恩沙替尼"拟用于 ALK 阳性的局部晚期或转移性 NSCLC 患者的治疗" （新增一线适应症）获得 NMPA 批准。2023 年 12 月，恩沙替尼纳入《国家基本 批准上市。2025 年 2 月，恩沙替尼一线适应症欧洲上市申报程序正式启动。2025 年 6 月，澳门药物监督管理局批准盐酸恩沙替尼胶囊上市。具体情况详见公司披 露在巨潮资讯网（http://www.cninfo.com.cn）上的相关公告（公告编号：2020-135、 二、对公司的影响及风险提示 恩沙替尼术后辅助临床试验期中数据的阳性结果是公司集中资源、聚焦开发 的重要成果，显示 ...

金融界8月24日消息，有投资者在互动平台向贝达药业提问："请问董秘，请介绍一下公司在研的双抗产 品项目进展如何？" 针对上述提问，贝达药业回应称："您好！MCLA-129是一款针对表皮生长因子受体（EGFR）和细胞间 质上皮转化因子（c-Met）双靶点的双特异性抗体，可同时阻断EGFR和c-Met的信号传导，抑制肿瘤的 生长和存活。MCLA-129目前有单药和联用的多项适应症临床研究，今年1月，注射用MCLA-129 I/II期 研究进入了平行队列扩展的II期研究阶段并完成首例受试者入组，目标适应症为野生型结直肠癌；今年 7月，MCLA-129在肺癌领域开展的一项关于驱动基因阳性以及MET扩增相关的II期研究完成首例患者入 组；此外，MCLA-129与贝福替尼联用的药物临床试验正在推进中，MCLA-129与恩沙替尼联用的药物 临床试验申请于近日获得NMPA受理。上述临床研究若有重大进展节点公司会及时公开披露。谢 谢！"责任编辑：钟离 ...

Core Viewpoint - The company plans to produce the active pharmaceutical ingredient (API) Ensartinib domestically and will export it, while the formulation will be contracted to the US CDMO company Catalent, indicating minimal potential impact from tariffs on the export of Ensartinib [1] Group 1 - The company will produce Ensartinib's API domestically before exporting it [1] - The formulation of Ensartinib will be outsourced to Catalent, a US-based CDMO [1] - The company is monitoring tariff policies and is prepared to respond to any changes [1]

Core Viewpoint - Beida Pharmaceutical's stock price has shown a slight decline, while the company focuses on the development and production of innovative anti-tumor drugs, particularly targeting lung and breast cancer treatments [1] Company Overview - Beida Pharmaceutical's stock price as of August 8, 2025, is 67.35 yuan, down 0.12% from the previous trading day [1] - The trading volume for the day was 102,400 lots, with a transaction amount of 685 million yuan, and a price fluctuation of 4.30% [1] - The company has received FDA approval for its self-developed drug, Ensartinib, which is set to launch in the North American market in 2024 [1] Research and Development Focus - Beida Pharmaceutical is optimizing its R&D pipeline by concentrating resources on core projects [1] - The company has chosen to independently manage the North American sales of Ensartinib to build its international commercial capabilities [1] - The company’s board secretary indicated that this move will help accumulate essential overseas commercialization experience for the future [1] Financial Flow - On the day of reporting, Beida Pharmaceutical experienced a net outflow of 41.97 million yuan in principal funds, with a cumulative net outflow of 230 million yuan over the past five days [1]

Core Insights - The Chinese pharmaceutical industry is transitioning from "generic" to "innovative" drugs, entering a phase of explosive growth after years of technological accumulation and industry maturation [1][3] - In the first half of this year, China approved 43 innovative drugs, a 59% increase year-on-year, marking a historical high for the same period [1] - Business development (BD) activities have exceeded 50 cases with a total value surpassing $48 billion, indicating strong market interest in domestic innovations [1] Industry Trends - The Chinese innovative drug sector has moved from initial exploration to a mature growth phase, significantly reducing the time gap for drug approval compared to the U.S. from 10 years in 2010 to 3.7 years in 2024 [3] - The industry faces challenges of high homogeneity in drug development, with 29% of all drug applications targeting the top 20 drug development targets [3][4] - Companies are focusing on creating differentiated advantages by targeting unmet clinical needs or developing new products in less explored areas [4] Policy and Capital Support - The Chinese government has introduced a comprehensive support system for innovative drugs, including 16 measures covering research, insurance access, and clinical use [5][6] - Recent regulatory changes have facilitated capital access for innovative drug companies, allowing them to secure funding for research and development [5][6] Globalization and Market Expansion - Chinese pharmaceutical companies are increasingly becoming key contributors to global innovation, with nearly half of the global BD transactions exceeding $50 million involving Chinese firms [2][7] - The trend of "license out" and strategic partnerships is becoming more prevalent as companies seek to expand their international presence [8][9] - The cost advantages in clinical trials in China, where the cost per participant is about one-third of that in the U.S., are enhancing the competitiveness of Chinese biotech firms [9] Technological Innovation - The application of AI technologies is revolutionizing the Chinese innovative drug sector, improving efficiency in drug development and clinical research [9] - Companies are integrating AI into their processes to enhance research efficiency and data value, which is crucial for global competitiveness [9]

Investment Rating - The report assigns an "Accumulate" rating to the company, marking its first coverage [3][8]. Core Insights - The company focuses on the NSCLC small molecule innovative drug sector, possessing both second and third generation ALK-TKIs, with significant advancements in its clinical pipeline [3][17]. - The commercial value of the second generation ALK-TKI is about to be realized, while the third generation ALK-TKI is progressing well in clinical trials [4][60]. - The company has multiple early-stage research projects that have achieved significant milestones, ensuring sustainable development [3][18]. Summary by Sections Section 1: Focus on NSCLC Small Molecule Innovative Drugs - The company specializes in the independent research and development of small molecule innovative drugs, with a pipeline that includes various tumor indications and urgent clinical needs [3][17]. - It is the first domestic company to have both second and third generation ALK-TKIs [3][17]. - As of the 2024 report, the company has 22 proprietary research pipelines, all classified as new drugs [17][18]. Section 2: Commercial Value of ALK-TKIs - The second generation ALK-TKI SY-707 is nearing commercialization, with its NDA accepted by NMPA [4][55]. - The third generation ALK-TKI SY-3505 is the fastest progressing domestic option, with ongoing key clinical trials [4][58]. - The ALK-TKI market in China is dominated by second generation products, which are expected to account for 67.33% of the market by 2024 [60]. Section 3: SY-5007 and RET-TKI Development - SY-5007 is a high-selectivity RET-TKI that is currently in phase III clinical trials, showing promising efficacy and safety [6][22]. - It is the only domestic selective RET-TKI that has entered phase III trials globally, providing a significant competitive edge [6][22]. Section 4: Financial Projections - The company is projected to generate revenues of 0.59 billion, 1.43 billion, and 2.87 billion RMB from 2025 to 2027, with net losses expected to decrease slightly over the same period [7][10]. - The total equity value of the company is estimated at 6.614 billion RMB based on DCF modeling [7][8].

Core Insights - Benda Pharmaceutical reported a revenue of 2.892 billion yuan for 2024, representing a year-on-year growth of 17.74%, with a net profit of 403 million yuan, up 15.67% year-on-year [2] - The company achieved a revenue of 918 million yuan in Q1 2025, marking a 24.71% increase year-on-year, with a net profit of 100 million yuan, a 1.99% increase year-on-year [2] Financial Performance - In 2024, the sales expenses were 1.094 billion yuan, with a sales expense ratio of 37.8%, up 3 percentage points year-on-year; R&D expenses were 502 million yuan, with a R&D expense ratio of 17.4%, down 8.7 percentage points year-on-year [3] - For Q1 2025, sales expenses were 280 million yuan, maintaining a sales expense ratio of 30.53%, while R&D expenses were 113 million yuan, with a R&D expense ratio of 12.35%, down 8.41 percentage points year-on-year [3] Product Development and Market Position - The core product, ALK inhibitor Ensartinib, is experiencing steady growth due to its long usage duration and has been included in the medical insurance directory for first-line treatment of ALK-positive NSCLC [4] - The company is expanding its product portfolio in the lung cancer field and has four candidates in development for EGFR-mutant NSCLC, including MCLA-129 and CFT8919 [4] Future Outlook - The company expects revenues of 3.702 billion yuan, 4.516 billion yuan, and 5.162 billion yuan for 2025, 2026, and 2027 respectively, with net profits adjusted to 661 million yuan and 930 million yuan for 2025 and 2026 [6] - The ongoing commercialization of Ensartinib in overseas markets and the acceptance of BPI-16350's application in China are anticipated to contribute to new revenue streams [5]