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百奥泰(688177) - 百奥泰 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
2025-04-21 08:00
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 ...
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
Shang Hai Zheng Quan Bao· 2025-04-18 23:19
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(688177) - 百奥泰 关于选举公司第三届董事会职工代表董事的公告
2025-04-18 09:46
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 ...
百奥泰20250416
2025-04-16 15:46
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]
太平洋:给予百奥泰买入评级
Zheng Quan Zhi Xing· 2025-04-13 07:19
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]
百奥泰(688177):阿达木单抗持续增长 BAT8006进入III期临床
Xin Lang Cai Jing· 2025-04-13 00:29
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 ...
百奥泰2024年财务表现欠佳,需关注现金流与债务状况
Zheng Quan Zhi Xing· 2025-04-09 22:16
近期百奥泰(688177)发布2024年年报,证券之星财报模型分析如下: 2024年,百奥泰的三费(财务费用、销售费用和管理费用)占总营收的比例显著上升,从2023年的29.47% 增至2024年的38.48%,增幅达30.59%。具体而言,销售费用同比增长39.42%,主要由于市场推广费用 增加;管理费用同比增长5.24%,主要由于职工薪酬增加;财务费用同比增长156.17%,主要由于银行 借款利息费用增加。 盈利能力 公司的毛利率为69.11%,较2023年减少了4.77个百分点。净利率为-68.67%,较2023年减少了22.67个百 分点。这表明公司在扣除所有成本后,产品或服务的附加值较低。 现金流与债务状况 尽管货币资金同比增长76.72%,达到2.9亿元,但公司仍需关注其现金流状况。经营活动产生的现金流 量净额为-0.13元/股,虽然较2023年的-1.11元/股有所改善,但仍为负值。此外,有息负债从2023年的 4.83亿元增至2024年的6.29亿元,增幅为30.24%,有息资产负债率已达28.5%。 营收与利润 百奥泰(688177)在2024年的营业总收入为7.43亿元,较2023年的7. ...
今日37家公司公布年报 第一医药增幅最大





Zheng Quan Shi Bao Wang· 2025-04-09 02:37
| | 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 ...
百奥泰生物制药股份有限公司2024年年度报告摘要
Shang Hai Zheng Quan Bao· 2025-04-08 23:24
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].
百奥泰2024年财报:营收增长但亏损扩大,创新药研发成关键
Jin Rong Jie· 2025-04-08 15:43
2025年4月8日,百奥泰发布2024年年报。报告显示,公司全年营业总收入为7.43亿元,同比增长 5.44%,但归属净利润为-5.10亿元,同比亏损扩大29.34%。尽管公司在创新药研发和全球市场拓展方面 取得了一定进展,但持续的亏损和研发投入的高昂成本仍是其面临的主要挑战。 创新药研发稳步推进,但商业化进程缓慢 百奥泰在2024年持续推进创新药研发,多个产品取得阶段性成果。首款国家1类创新药贝塔宁®(枸橼 酸倍维巴肽注射液)获得NMPA批准上市,为急性冠脉综合征患者提供了新的治疗选择。此外, BAT1706(贝伐珠单抗)和BAT1806(托珠单抗)分别获得EMA和ANVISA的上市批准,实现了中美欧 和巴西四地获批上市。 然而,尽管研发进展顺利,百奥泰的创新药商业化进程仍然缓慢。BAT1806在美国市场的销售表现不 佳,2024年仅贡献110万美元的营收。此外,公司尚未在海外建立自有销售团队,依赖合作伙伴进行市 场推广,这在一定程度上限制了其产品的市场渗透率。 全球市场拓展加速,但盈利能力不足 百奥泰在2024年积极拓展全球市场,与多家国际企业达成授权合作。BAT1706授权Macter Internat ...