Core Viewpoint - Baiotai Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for the clinical trial of BAT7111, a drug intended for the treatment of advanced solid tumors [2][3] Group 1: Clinical Trial Approval - The drug BAT7111 is a PD-1/4-1BB bispecific antibody developed by the company, aimed at treating advanced solid tumors [3] - The clinical trial application for BAT7111 was accepted on February 12, 2025, and has been approved to proceed with clinical trials [2][3] Group 2: Drug Composition and Mechanism - BAT7111 consists of a recombinant humanized anti-PD-1 antibody and a fully human 4-1BB single-domain antibody, which can block the PD-1/PD-L1 immune suppression pathway and activate immune cells [3] - The design of differential affinity for PD-1 antibodies and 4-1BB antibodies aims to enhance safety and potentially improve the efficacy of existing PD-1 therapies [3] Group 3: Clinical Development Insights - According to data from "Clinical Development Success Rates 2011-2020," the typical duration for Phase I/II clinical trials for anti-tumor drugs is about 2 years, with a 48.8% transition rate from Phase I to II and a 24.6% transition rate from Phase II to III [2][5] - The company will analyze trial data to determine the safety and efficacy of the drug, which will inform the progression of subsequent clinical trials [5]

重要内容提示： 百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）于近日收到国 家药品监督管理局（以下简称"国家药监局"）核准签发的《药物临床试验批准通 知书》，公司在研药品注射用BAT7111用于晚期实体瘤的临床试验申请获得批准。 根据《Clinical Development Success Rates2011-2020》公布的数据，通常情况 下对于抗肿瘤药物，一般 I/II 期临床研究阶段持续约 2 年时间，I 期完成进入 II 期的比率约 48.8%，II 期完成进入 III 期的比率约 24.6%，考虑到临床研究周期 长、投入大，过程中不可预测因素较多，临床试验、审评和审批的结果以及时间 都具有一定的不确定性，容易受到一些不确定性因素的影响，敬请广大投资者谨 慎决策，注意防范投资风险。现将相关情况公告如下： 一、 《药物临床试验批准通知书》基本情况 药品名称：注射用 BAT7111 证券代码：688177 证券简称：百奥泰 公告编号：2025-033 百奥泰生物制药股份有限公司 自愿披露关于注射用 BAT7111 获得 药物临床试验批准通知书的公告 本公司董事会及全体董事保证本公告内容不存在 ...

证券代码：688177 证券简称：百奥泰 公告编号：2025-032 百奥泰生物制药股份有限公司 关于选举第三届董事会职工代表董事的公告 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个别及连带责任。 百奥泰生物制药股份有限公司（以下简称"公司"）第二届董事会任期即将届满，根据《中华人民共和国 公司法》（以下简称"《公司法》"）等法律法规和《百奥泰生物制药股份有限公司章程》（以下简 称"《公司章程》"）等制度的规定，公司于2025年4月10日召开职工代表大会，选举杜莹女士（简历详 见附件）为公司第三届董事会职工代表董事，并按照相关规定于2025年4月17日履行完成任前公示程 序，公示期间未收到任何关于选举结果的有效异议，选举结果真实有效。 本次职工代表大会选举产生的职工代表董事将与公司股东大会选举产生的董事共同组成公司第三届董事 会，任期三年，自公司2024年年度股东大会审议通过之日起计算。 杜莹女士的任职资格符合相关法律法规、规范性文件对职工代表董事任职资格的要求，不存在《公司 法》和《公司章程》等规定的不得担任公司董事的情形，未受到 ...

百奥泰生物制药股份有限公司 关于选举第三届董事会职工代表董事的公告 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个别及连带责任。 证券代码：688177 证券简称：百奥泰 公告编号：2025-032 杜莹女士的任职资格符合相关法律法规、规范性文件对职工代表董事任职资 格的要求，不存在《公司法》和《公司章程》等规定的不得担任公司董事的情形， 未受到中国证券监督管理委员会的行政处罚或交易所惩戒，不存在上海证券交易 所认定不适合担任上市公司董事的其他情形。 百奥泰生物制药股份有限公司（以下简称"公司"）第二届董事会任期即将 届满，根据《中华人民共和国公司法》（以下简称"《公司法》"）等法律法规和《百 奥泰生物制药股份有限公司章程》（以下简称"《公司章程》"）等制度的规定，公 司于 2025 年 4 月 10 日召开职工代表大会，选举杜莹女士（简历详见附件）为公 司第三届董事会职工代表董事，并按照相关规定于 2025 年 4 月 17 日履行完成任 前公示程序，公示期间未收到任何关于选举结果的有效异议，选举结果真实有效。 本次职工代表大会选举 ...

Summary of Baotai's Conference Call Company Overview - Baotai focuses on the research and development of Antibody-Drug Conjugates (ADC), particularly in the field of oncology, with multiple ADC projects entering clinical stages and plans to present related data at the ASCO conference, indicating the company's R&D strength and future potential in the ADC field [2][3] Key Points and Arguments ADC Development - Baotai is advancing several ADC projects in clinical stages, with a strong emphasis on oncology treatments [2][3] - The company plans to disclose data on HQ monoclonal antibody combined with HQ ADC and PD-1 related data at the ASCO conference, which will provide important references for optimizing treatment plans [4][17] Immunotherapy Focus - The company is concentrating on PD-1 combination therapy strategies, including a clinical trial for cervical cancer and plans to combine it with other immunotherapies for triple-negative breast cancer and non-small cell lung cancer [2][4] - Baotai is exploring new dual-target dual-panel ADCs and other innovative approaches, despite these projects being in early development stages [4][13] Ovarian Cancer Trials - Baotai is conducting a Phase III clinical trial for patients with resistant ovarian cancer in China and plans to initiate global research, aiming to provide treatment options for patients with less than 75% expression [6][10] Market Trends and Future Directions - The company views ADCs and topoisomerase inhibitors as the hottest directions in oncology for the next two years and plans to increase investment in these areas [7][10] - Baotai's R&D pipeline includes PD-1, innovative ADCs, HER2 monoclonal antibodies, and FRP ADCs, primarily in Phase III clinical trials in China [10][19] Financial and Strategic Considerations - The company anticipates high costs for overseas clinical trials of the folate receptor ADC (Ailetan) but is exploring various strategies, including business development opportunities and subsidiary formation, to manage these costs [11][12] - Baotai's financial situation is stable, with product sales and biosimilar revenues supporting part of the R&D expenses [19][21] Additional Important Content - The company is also focusing on dual-specificity antibody ADCs, which can recognize two different targets, enhancing drug selectivity and therapeutic effects [14][15] - Baotai expects to complete the Phase III clinical trial for the 5,906 ophthalmic drug in the first half of this year, marking a significant step towards market entry [20][24] - The company plans to report milestone revenues from biosimilars, which are expected to contribute to stable sales income and cover some R&D costs [22][23]

Core Viewpoint - The report highlights the continuous growth of Adalimumab sales and the entry of BAT8006 into Phase III clinical trials, leading to a "Buy" rating for Baiotai [1] Financial Performance - In 2024, Baiotai achieved a revenue of 743 million yuan, a year-on-year increase of 5.44%, primarily driven by the sustained growth of Adalimumab sales [1] - Research and development expenses amounted to 778 million yuan, reflecting a year-on-year increase of 1.17% [1] - The sales expense ratio was 31.71%, up 7.73% year-on-year [1] Product Performance - The self-immune business generated sales of 602 million yuan in 2024, a year-on-year increase of 22.83%, with a gross margin of 78.63% [1] - The oncology business reported sales of 133 million yuan, a decline of 36.29% year-on-year, with a gross margin of 26.09% due to reduced high-margin licensing income [1] International Expansion - Baiotai has secured multiple international licensing agreements for various products, including BAT1806 and BAT1706, to expand its overseas market presence [2][3] - The company has entered into agreements with several partners across different regions, including the U.S., Europe, and emerging markets, to commercialize its products [2][3] Clinical Development - Five products, including BAT8006, are in critical clinical stages, with BAT8006 recently starting a Phase III clinical trial for ovarian cancer [4] - The primary endpoint for the BAT8006 trial is progression-free survival (PFS) [4] Profit Forecast and Investment Rating - The company forecasts revenues of 889 million yuan, 1.342 billion yuan, and 1.790 billion yuan for 2025, 2026, and 2027, respectively, with year-on-year growth rates of 19.59%, 50.97%, and 33.40% [5] - Expected net profits for the same years are projected to be -41.5 million yuan, -10.7 million yuan, and 172 million yuan, with significant growth rates in subsequent years [5] - The report maintains a "Buy" rating based on these projections [5]

事件：2025 年4 月9 日，公司发布2024 年年度报告：全年实现营业收入7.43 亿元，同比增长5.44%，主 要为阿达木单抗销量持续增长；研发费用7.78 亿元，同比增长1.17%；销售费用率31.71%，同比增长 7.73%。 阿达木单抗持续增长，托珠单抗新增境外业务。 分产品看，自免业务持续稳健增长，肿瘤业务收入有所下降。 自身免疫药物：2024 年实现销售收入6.02 亿元，同比增长22.83%，毛利率为78.63%，主要为阿达木单 抗销量持续增长，公司自营团队与国内超过1500 家处方医院及超过1500 家药店已达成合作。同时，托 珠单抗新增境外供货业务，但境外合作商尚处于拓展初期，增额相对较小，毛利相对较低。 抗肿瘤药物：2024 年实现销售收入1.33 亿元，同比下降36.29%，毛利率为26.09%，主要为抗肿瘤药物 较高毛利率的授权许可收入减少，导致抗肿瘤药物整体毛利率降低。 多个品种达成对外授权，进一步拓宽海外市场 公司五款产品BAT1308、BAT3306、BAT5906、BAT4406F 和BAT8006处于III 期临床研究或关键注册临 床研究阶段，其中BAT5906 已完成w ...

Revenue and Profit - The total operating revenue of Baiotai (688177) in 2024 was 743 million yuan, a year-on-year increase of 5.44% compared to 705 million yuan in 2023 [1] - However, the net profit attributable to shareholders decreased from -395 million yuan in 2023 to -510 million yuan in 2024, a decline of 29.34% [1] - The non-recurring net profit also worsened, dropping from -472 million yuan in 2023 to -556 million yuan in 2024, a decrease of 17.76% [1] Quarterly Data - The performance in the fourth quarter of 2024 was particularly weak, with total operating revenue of 162 million yuan, a year-on-year decline of 33.65% [2] - The net profit attributable to shareholders for the fourth quarter was -145 million yuan, a staggering decline of 1073.85% [2] - The non-recurring net profit for the fourth quarter was -151 million yuan, down 189.16% year-on-year [2] Costs and Expenses - In 2024, the proportion of the three expenses (financial, selling, and administrative expenses) to total revenue significantly increased from 29.47% in 2023 to 38.48% in 2024, an increase of 30.59% [3] - Selling expenses rose by 39.42% year-on-year, primarily due to increased marketing costs [3] - Administrative expenses increased by 5.24% year-on-year, mainly due to higher employee compensation [3] - Financial expenses surged by 156.17% year-on-year, largely due to increased bank loan interest costs [3] Profitability - The gross profit margin was 69.11%, a decrease of 4.77 percentage points compared to 2023 [4] - The net profit margin was -68.67%, a reduction of 22.67 percentage points from the previous year [4] - This indicates a low added value of products or services after deducting all costs [4] Cash Flow and Debt Situation - Despite a year-on-year increase of 76.72% in cash and cash equivalents, reaching 290 million yuan, the company still needs to monitor its cash flow situation [5] - The net cash flow from operating activities was -0.13 yuan per share, an improvement from -1.11 yuan per share in 2023, but still negative [5] - Interest-bearing liabilities increased from 483 million yuan in 2023 to 629 million yuan in 2024, a rise of 30.24%, with an interest-bearing asset-liability ratio reaching 28.5% [5] Summary - Overall, Baiotai's financial performance in 2024 was poor, particularly in terms of profit and cash flow [6] - The company needs to closely monitor its cash flow and debt situation to ensure sustainable development in the future [6]

| | 和 | | | | | | | --- | --- | --- | --- | --- | --- | --- | | 601228 | 广州港 | 0.1280 | 96443.07 | -10.63 | 1407293.13 | 6.66 | | 301488 | 豪恩汽 | 1.1000 | 10091.18 | -11.15 | 140893.71 | 17.25 | | | 电 | | | | | | | 001324 | 长青科 | 0.4361 | 6018.00 | -16.41 | 46042.71 | -13.16 | | | 技 | | | | | | | 002535 | 林州重 | 0.1189 | 9534.40 | -18.47 | 168353.14 | -8.38 | | | 机 | | | | | | | 002075 | 沙钢股 | 0.0700 | 16258.29 | -27.75 | 1441626.09 | -7.69 | | | 份 | | | | | | | 002860 | 星帅尔 | 0.4700 | 14369.40 | -29.03 | 207 ...

Core Viewpoint - The company focuses on the development of innovative drugs and biosimilars, with a strong emphasis on oncology, autoimmune diseases, cardiovascular diseases, and ophthalmology, aiming to enhance patient health and expand its market presence globally [3][25]. Company Overview - The company is a biopharmaceutical enterprise dedicated to the research, development, production, and sales of innovative drugs and biosimilars, with a complete independent system for R&D, procurement, production, and commercialization [17]. - The company has four products approved for market in China: Gelerit (Adalimumab), Pubexi (Bevacizumab), Shireli (Tocilizumab), and Betanin (Citrulline Valproate) [21][39]. Product Pipeline - The company has developed several biosimilars, including Gelerit, which is the first approved biosimilar of Adalimumab in China, and has been included in the national medical insurance directory [4][38]. - The company’s product BAT1706 (Bevacizumab) has received approvals from NMPA, FDA, EMA, and ANVISA, making it the first and only domestically developed biosimilar of Bevacizumab to achieve such approvals [5][6][39]. - BAT1806 (Tocilizumab) is the first domestically developed biosimilar of Tocilizumab to receive FDA approval, marking a significant milestone for the company [8][39]. - The company has multiple products in clinical trials, including BAT2206 (Ustekinumab), BAT2506 (Golimumab), and BAT2306 (Secukinumab), with applications submitted to various regulatory bodies [12][13][14]. Industry Overview - The pharmaceutical manufacturing industry is a critical sector for national health, technological innovation, and economic development, with a focus on innovative drug development as a strategic priority [26]. - The global pharmaceutical market has shown stable growth, with the market size increasing from $1,324.5 billion in 2019 to $1,472.3 billion in 2023, and projected to reach $1,766.7 billion by 2026 [28]. - The oncology drug market has seen significant growth, with the global market size increasing from $143.5 billion in 2019 to $228.9 billion in 2023, and expected to reach $419.8 billion by 2030 [29][30]. - The autoimmune disease treatment market is also expanding rapidly, with the global market size projected to grow from $132.3 billion in 2022 to $176.7 billion by 2030 [31]. Market Dynamics - The aging population and increasing healthcare awareness are driving demand for pharmaceutical products, particularly in oncology and autoimmune disease treatments [27][31]. - The company is positioned to benefit from the growing demand for biosimilars and innovative drugs, especially as key patents for several blockbuster drugs are set to expire in the coming years [40].