贝达药业股份有限公司 2025 年半年度报告全文 +贝达药业股份有限公司 2025 年半年度报告 【披露时间】 1 | 第一节 | 重要提示、目录和释义 | 1 | | --- | --- | --- | | 第二节 | 公司简介和主要财务指标 | 4 | | 第三节 | 管理层讨论与分析 | 6 | | 第四节 | 公司治理、环境和社会 | 35 | | 第五节 | 重要事项 | 37 | | 第六节 | 股份变动及股东情况 | 41 | | 第七节 | 债券相关情况 | 46 | | 第八节 | 财务报告 | 47 | 贝达药业股份有限公司 2025 年半年度报告全文 第一节 重要提示、目录和释义 公司董事会、监事会及董事、监事、高级管理人员保证半年度报告内容的 真实、准确、完整，不存在虚假记载、误导性陈述或者重大遗漏，并承担个别 和连带的法律责任。 公司负责人丁列明、主管会计工作负责人范建勋及会计机构负责人(会计 主管人员)王铁奇声明：保证本半年度报告中财务报告的真实、准确、完整。 所有董事均已出席了审议本次半年报的董事会会议。 本报告中所涉及的未来计划、发展战略等前瞻性描述不构成公司对投资者 的实质承 ...

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The upcoming World Conference on Lung Cancer (WCLC) is expected to showcase significant advancements in innovative drugs, generating new business development expectations [1] - The A-share pharmaceutical index has increased by 3% this week and 25% year-to-date, outperforming the CSI 300 by 0.7% and 18.2% respectively [4][9] - The report highlights the strong performance of the pharmaceutical sector, particularly in innovative drugs, research services, and CXO [10][11] Industry Trends - The WCLC will take place from September 6 to September 9, 2025, in Barcelona, featuring over 1,500 presentations, with a significant number from Chinese researchers [17][18] - Chinese innovation is prominently represented, with over 400 submissions, indicating a shift towards the commercialization of innovative drugs [18][19] Stock Performance - Notable stock performances include a 69% increase for Sainuo Medical and a 94% increase for Paig Biological in the H-share market [4][9] - The report provides a detailed overview of stock performance, highlighting both top gainers and losers in the pharmaceutical sector [9][13] Recommendations - The report suggests a focus on specific sub-sectors, ranking them as follows: innovative drugs > research services > CXO > traditional Chinese medicine > medical devices > pharmacies [10] - Specific stock recommendations include companies like Bory Pharmaceutical, Singlera Genomics, and Innovent Biologics based on various therapeutic angles [11][12]

（文章来源：证券日报） 证券日报网讯贝达药业8月14日在互动平台回答投资者提问时表示，根据交易所的减持披露规定，公司 大股东减持首发前股份和公司董事、高级管理人员减持股份都需要通知上市公司并发布减持预披露公 告，2025年初至今，公司无相关的减持预披露公告发布。 ...

证券日报网讯贝达药业（300558）8月14日在互动平台回答投资者提问时表示，公司高度重视创新发 展，通过自主研发和战略合作，目前已有8款产品处于商业化阶段，为营业收入的稳定增长打下扎实基 础，在研管线则涵盖肺癌、乳腺癌等多个肿瘤领域。在自主创新的同时，公司通过构建创新生态圈，以 孵化、投资、赋能等多种方式与合作伙伴协同发展，发挥企业自身优势，加快创新成果的转化，将协同 创新、高效创新落在实处，也为行业发展提供了借鉴案例。面对企业的未来发展挑战，公司将持续优 化"四驾马车"发展战略，加快推进在研项目进度，充分释放商业化能力，实现公司健康稳定发展。 ...

随着中国居民健康意识不断增强，我国生物医药产业保持高速增长势头，相关上市公司业绩也水涨船 高。 据Wind数据统计，截至1月16日记者发稿，深市共有14家医疗保健企业（以Wind一级行业分类标准划 分）披露了2023年业绩预告。其中，12家净利润预计实现正增长，占比85.71%。康泰生物、贝达药 业、川宁生物暂列净利润增长榜单前三位，预计分别增长（以上限计算）815.86%、154.43%和 140.57%。 2023年中央经济工作会议提出，打造生物制造、商业航天、低空经济等若干战略性新兴产业，开辟量 子、生命科学等未来产业新赛道，广泛应用数智技术、绿色技术，加快传统产业转型升级。 在此背景下，生物医药产业迎来发展黄金期，"高成长"已然成为其鲜明标签，一众优秀企业代表不断涌 现。 例如，川宁生物1月15日晚间发布业绩预告称，2023年公司预计实现归属于上市公司股东的净利润9亿元 至9.9亿元，同比增长118.7%至140.57%；预计实现扣除非经常性损益后的净利润为9亿元至9.9亿元，同 比增长101.51%至121.66%。 贝达药业2023年年度业绩预告显示，公司预计实现归属于上市公司股东净利润3.20亿 ...

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]

Group 1 - The innovative drug sector is a key focus in the pharmaceutical industry, with multiple companies successfully obtaining product approvals this year and ongoing business development (BD) projects in China [1] - China's share of global innovative drug BD transactions has been increasing, from 10.8% in 2015 to an estimated 30.6% in 2024, with a significant rise to 52.5% as of August 8 this year [3] - The market size for innovative drugs in China reached 679 billion yuan in 2022, projected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [3] Group 2 - The proportion of innovative drugs in China's pharmaceutical market was 41% in 2022, expected to rise to 50% by 2026 and 51% by 2027 [3] - The pace of domestic innovative drug companies expanding overseas is accelerating, with 81 pharmaceutical and biotech companies involved in innovative drug business, generating over 100 billion yuan in overseas revenue from 2022 to 2024 [3] - Companies like Betta Pharmaceuticals and Rundu Co. have reported significant overseas revenue, with some companies exceeding 70% of their revenue from international markets in the first half of 2025 [3] Group 3 - Investor interest in innovative drugs has surged, with over 2,000 interactions related to "innovative drugs" recorded this year, highlighting companies such as Betta Pharmaceuticals, Rundu Co., and Zhendong Pharmaceutical [3][4] - Betta Pharmaceuticals plans to commercialize its innovative drug, Tarecitinib, which is expected to be approved by June 30, 2025 [4] - Rundu Co. has completed phase IIIb clinical trials for its innovative drug, a heart load test medication, and plans to submit a marketing application by March 2024 [4]

Core Viewpoint - China's innovative pharmaceuticals have transitioned from being followers to key players in global medical innovation, achieving significant breakthroughs in core treatment areas such as metabolic diseases and oncology, with a surge in new drug approvals and international progress [1][3]. Group 1: Market Trends - The attention of A-share investors towards innovative pharmaceuticals has significantly increased this year, with numerous companies actively disclosing their R&D and clinical progress [2]. - The total value of license-out transactions for innovative drugs in China is projected to exceed $60 billion by mid-2025, surpassing the total for 2024, with 16 transactions exceeding $1 billion each [3]. - The market size of China's innovative drugs reached 679 billion yuan in 2022, expected to exceed 1 trillion yuan by 2026 and reach 1.12 trillion yuan by 2027 [6]. Group 2: International Expansion - Chinese innovative drug companies are accelerating their international business, with 81 companies generating over 100 billion yuan in overseas revenue from 2022 to 2024, accounting for more than 14% of their total revenue [7]. - The proportion of China's innovative drug transactions in the global market has increased from 10.8% in 2015 to approximately 52.5% by August 2023 [6]. Group 3: Policy and Financial Support - The Chinese government has implemented policies to support the high-quality development of innovative drugs, significantly reducing the time from drug approval to inclusion in the medical insurance directory from about 5 years to approximately 1 year [8]. - From 2015 to 2024, the financing in China's innovative drug sector exceeded 1.23 trillion yuan, providing strong momentum for industry growth [9]. Group 4: R&D Investment - The number of companies in the pharmaceutical and biotechnology sector has increased from over 220 in 2015 to nearly 500 currently, with R&D investment in the sector exceeding 140 billion yuan in 2024, a fivefold increase since 2015 [9]. - Among the 81 innovative drug companies, R&D investment rose from approximately 8.8 billion yuan in 2015 to over 57.8 billion yuan in 2024, with R&D intensity increasing from 3.29% to 8.04% [9]. Group 5: Company Developments - Companies such as Betta Pharmaceuticals and Rundu Co. have reported significant advancements in their innovative drug pipelines, with Betta's drug expected to be approved by June 2025 and Rundu's drug completing phase III clinical trials [12]. - The stock performance of companies involved in innovative drugs has surged, with some companies experiencing average increases of over 50% since May 1, 2023 [13]. Group 6: Institutional Interest - 13 companies have received significant institutional interest this year, with some experiencing over 30% increase in financing, indicating strong market confidence in innovative drug investments [14]. - Companies like BeiGene and TaiGen Biotechnology are projected to see substantial profit growth in 2025 and 2026, with BeiGene potentially turning profitable this year [15].

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]

8月7日，精准医疗概念上涨0.62%，今日主力资金流出9350.36万元，概念股23只上涨，23只下跌。 来源：金融界 主力资金净流出居前的分别为千红制药（1.87亿元）、塞力医疗（1.39亿元）、智飞生物（1.34亿 元）、贝达药业（1.04亿元）、君实生物-U（7825.06万元）。 序号代码名称最新价涨跌幅主力净流入主力净占比1000710贝瑞基因15.625.262.07亿元16.92%2300289利 德曼9.7720.021.58亿元14.9%3002022科华生物7.959.961.43亿元28.2%4002030达安基因7.262.986009.70万 元9.23%5301293三博脑科54.595.125730.70万元6.83%6688289圣湘生物22.210.142969.10万元 12.2%7300676华大基因53.481.02843.77万元4.28%8300244迪安诊断16.070.062704.34万元4.64%9300832 新产业55.57-0.232373.09万元5.75%10300642透景生命17.151.841917.71万元7.78% ...