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Usymro (一款参照喜达诺乌司奴单抗开发的生物类似药)获欧盟委员会上市批准
Xin Lang Cai Jing· 2025-08-27 08:26
Core Viewpoint - Baotai Biopharmaceutical Co., Ltd. has received approval from the European Commission for Usymro®, a biosimilar drug for treating moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe active Crohn's disease in adults and children, marking a significant milestone for the company [2][3] Company Overview - Baotai is a global biopharmaceutical company based in Guangzhou, China, focused on developing innovative drugs and biosimilars for various diseases, including cancer and autoimmune disorders [2][3] - The company has successfully launched multiple drugs, including Adalimumab and Tocilizumab, in various markets, establishing itself as a leader in antibody drug development [3] Recent Developments - The approval of Usymro® follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025, highlighting the company's commitment to advancing its biosimilar pipeline [2] - In October 2024, Baotai signed a licensing and commercialization agreement with Gilead Sciences for BAT2206, another biosimilar, covering markets in the EU, UK, Switzerland, and other regions [2]
医药生物行业周报:业绩密集披露,关注超预期标的-20250822
BOHAI SECURITIES· 2025-08-22 13:12
Investment Rating - The report maintains an "Optimistic" rating for the industry [7][71]. Core Insights - The report highlights the intensive disclosure of company performances, with a focus on companies that exceed expectations. It emphasizes the upcoming World Lung Cancer Conference (WCLC) and the importance of monitoring related company data [6][70]. - The report notes a significant increase in the medical device sector and mentions the approval of new treatments by regulatory bodies, indicating a positive trend in the pharmaceutical and medical device industries [2][16]. Industry News - The National Healthcare Security Administration issued a temporary management method for disease-based payment, which includes budget management and payment standards [16]. - Semaglutide received FDA approval for treating MASH, showcasing advancements in drug approvals [16]. Company Announcements - **Hengrui Medicine** reported a revenue of approximately 15.76 billion yuan for the first half of 2025, a year-on-year increase of 15.88%, and a net profit of approximately 4.45 billion yuan, up 29.67% [25]. - **Baili Tianheng** announced a significant drop in revenue but received breakthrough therapy designation from the FDA for its drug targeting advanced non-small cell lung cancer [28]. - **Rongchang Bio** received breakthrough therapy designation for its drug RC148 for non-small cell lung cancer and signed a licensing agreement [29]. - **Baiyao Tai** reported a revenue of approximately 441.89 million yuan, a year-on-year increase of 9.84%, and received EMA approval for Usymro® [30]. Market Review - The Shanghai Composite Index rose by 2.85%, while the pharmaceutical and biological sector increased by 1.85% during the week of August 15-21, 2025 [5][59]. - The industry’s price-to-earnings ratio (TTM) was reported at 31.23 times, with a valuation premium of 154% compared to the CSI 300 index [5][63]. Weekly Strategy - The report suggests focusing on companies with performance exceeding expectations during the earnings disclosure period and highlights the potential benefits from policy support for innovative drugs and medical devices [6][70].
百奥泰与STADA就托珠单抗注射液签署商业化协议,首付及里程碑款最高至1.36亿欧元
Cai Jing Wang· 2025-08-22 05:42
STADA 为一家历史悠久的欧洲优质医药企业,总部位于德国,公司专注于三大支柱战略,包括消费者 健康、仿制药和特药。STADA 在全球范围超过 100 个国家销售其产品。 在 2024 财年 中 ,STADA 实现了 40.59 亿欧元的集团销售额,经调整的息税折旧摊销前利润 (EBITDA)为 8.86 亿欧元。STADA 在全球拥有约 11,649 名员工。 STADA 与公司及控股子公司不存 在关联关系。 (企业公告) 据悉, BAT1806(托珠单抗)是百奥泰根据中国 NMPA、美国 FDA、欧洲 EMA生物类似药相关指导原 则开发的托珠单抗注射液,是一款靶向白介素-6 受体(IL-6R)的重组人源化单克隆抗体,可与可溶性 及膜结合型 IL-6 受体(sIL-6R和 mIL-6R)特异性结合,并抑制由 sIL-6R 和 mIL-6R 介导的信号传导。 截至本公告披露日,BAT1806(托珠单抗)已获得中国 NMPA、美国 FDA、欧洲 EMA的上市批准,中 国商品名为施瑞立,美国商品名为 TOFIDENCE。 近日,百奥泰发布关于与STADA就BAT1806(托珠单抗)注射液签署授权许可与商业化协议的 ...
百奥泰2025年中报简析:营收上升亏损收窄,盈利能力上升
Zheng Quan Zhi Xing· 2025-08-21 22:55
Financial Performance - Company reported total revenue of 442 million yuan, an increase of 9.84% year-on-year [1] - Net profit attributable to shareholders was -125 million yuan, an increase of 47.25% year-on-year [1] - In Q2, total revenue was 235 million yuan, a decrease of 2.23% year-on-year, while net profit was -31.6 million yuan, an increase of 73.19% year-on-year [1] - Gross margin increased by 16.38% to 77.76%, while net margin improved by 51.98% to -28.27% [1] Expense Analysis - Total selling, administrative, and financial expenses amounted to 162 million yuan, accounting for 36.65% of revenue, an increase of 9.96% year-on-year [1] - Sales expenses increased by 18.84% due to higher promotional costs related to domestic sales of specific products [9] - Management expenses rose by 43.7% due to increased transportation losses and depreciation [9] Cash Flow and Investments - Operating cash flow per share was -0.0 yuan, an increase of 98.71% year-on-year, indicating improved cash flow from sales [1][10] - Investment activities generated a net cash flow decrease of 41.42% due to increased purchases of financial products [11] - Financing activities saw a net cash flow decrease of 96.42% due to reduced cash from borrowings and increased debt repayments [11] Asset and Liability Changes - Accounts receivable increased by 37.2% due to higher revenue [3] - Fixed assets increased by 56.6% due to the capitalization of the R&D and marketing center project [5] - Short-term borrowings decreased by 99.86% as the company repaid bank loans [7] Business Model and Historical Performance - Company relies heavily on R&D for its performance, necessitating careful examination of the underlying drivers [13] - Historical financial performance shows a median ROIC of -37.69%, indicating poor investment returns [12] - The company has reported losses in 8 out of 10 years since its listing, raising concerns about its financial sustainability [12]
百奥泰生物制药股份有限公司关于与STADA 就BAT1806(托珠单抗)注射液签署授权许可与商业化协议的公告
Core Viewpoint - The company has signed a licensing and commercialization agreement with STADA for its BAT1806 (Tocilizumab) injection, granting STADA exclusive commercialization rights in several regions, which is expected to positively impact the company's future performance [2][4][14]. Agreement Summary - The agreement allows STADA to commercialize BAT1806 in the EU, Switzerland, the UK, parts of Europe, the MENA region, and CIS countries [2][10]. - The total transaction amount can reach up to €136 million, including an upfront payment of €8.5 million and milestone payments not exceeding €127.5 million, along with a percentage of net sales as revenue sharing [2][11][12]. Agreement Conditions - The agreement will take effect after approval by the company's shareholders and will last for an initial period of 15 years, automatically extending for 2 years unless either party provides written notice to terminate [3][13]. - The company will be responsible for the research, production, and supply of BAT1806, while STADA will handle its commercialization [10][14]. Impact on Company Performance - The signing of this agreement is expected to enhance the company's global commercialization and profitability capabilities [4][15]. - The collaboration is anticipated to leverage international advanced research, production quality control, and commercial promotion, thereby improving the company's core competitiveness [14].
百奥泰: 百奥泰2025年半年度报告
Zheng Quan Zhi Xing· 2025-08-21 05:40
Core Viewpoint - Bio-Thera Solutions, Ltd. reported a revenue increase of 9.84% in the first half of 2025, driven by the sales of its products, including Adalimumab injection and Tocilizumab injection, while also noting a significant reduction in net losses compared to the previous year [3][4][5]. Company Overview and Financial Indicators - Bio-Thera Solutions is a biopharmaceutical company focused on the research and development of innovative drugs and biosimilars, classified under the pharmaceutical manufacturing industry [5]. - The company reported a total revenue of approximately CNY 441.89 million in the first half of 2025, compared to CNY 402.29 million in the same period of the previous year [3][4]. - The total profit for the period was a loss of CNY 124.77 million, an improvement from a loss of CNY 236.85 million in the previous year [3][4]. - The net assets attributable to shareholders decreased by 17.65% to CNY 583.12 million compared to the end of the previous year [3][4]. - The company’s R&D expenditure accounted for 78.94% of its revenue, a decrease of 21.12 percentage points from the previous year [4]. Industry Overview - The global pharmaceutical market has grown from USD 1,324.5 billion in 2019 to USD 1,472.3 billion in 2023, with a projected CAGR of 5.0% reaching USD 2,069.4 billion by 2030 [5]. - The Chinese innovative drug market is also on the rise, with a market size expected to grow from USD 132.5 billion in 2019 to USD 159.2 billion by 2024, reflecting a CAGR of 3.7% [5]. - The oncology treatment sector is the largest in the pharmaceutical industry, with significant growth in antibody-drug conjugates (ADC) and bispecific antibodies, showing annual growth rates of approximately 70% and 125%, respectively [6]. - The autoimmune disease drug market is projected to grow from USD 116.9 billion in 2019 to USD 158.5 billion by 2032, with a CAGR of 6.1% from 2019 to 2023 [7][8]. - Cardiovascular diseases are a major health concern in China, with a significant increase in the incidence of acute coronary syndrome (ACS), leading to a projected growth in percutaneous coronary intervention (PCI) procedures [9]. - The aging population is contributing to an increase in eye diseases, particularly age-related macular degeneration (AMD), with the number of patients expected to rise significantly by 2050 [10].
百奥泰: 百奥泰 2025年半年度报告摘要
Zheng Quan Zhi Xing· 2025-08-21 05:40
百奥泰生物制药股份有限公司2025 年半年度报告摘要 公司代码:688177 公司简称:百奥泰 百奥泰生物制药股份有限公司 百奥泰生物制药股份有限公司2025 年半年度报告摘要 第一节 重要提示 规划,投资者应当到 http://www.sse.com.cn/网站仔细阅读半年度报告全文。 公司已在半年度报告全文中详细阐述公司核心竞争力风险、经营风险、行业风险和宏观环境风险 等因素,敬请查阅公司半年度报告第三节"管理层讨论与分析"之"四、风险因素"。 虚假记载、误导性陈述或重大遗漏,并承担个别和连带的法律责任。 无 □适用 √不适用 第二节 公司基本情况 公司股票简况 公司股票简况 股票种类 股票上市交易所 股票简称 股票代码 变更前股票简称 A股 上海证券交易所科创板 百奥泰 688177 不适用 公司存托凭证简况 □适用 √不适用 百奥泰生物制药股份有限公司2025 年半年度报告摘要 联系人和联系方式 联系人和联系方式 董事会秘书(信息披露境内代 表) 证券事务代表 姓名 鱼丹 宋姗 珊 电话 (8620)32203528 (8620)32203528 办公地址 广州市国际生物岛螺旋二路18号 广州市 国际 ...
百奥泰: 百奥泰 关于与STADA就BAT1806(托珠单抗)注射液签署授权许可与商业化协议的公告
Zheng Quan Zhi Xing· 2025-08-21 05:40
证券代码:688177 证券简称:百奥泰 公告编号:2025-058 百奥泰生物制药股份有限公司 关于与 STADA 就 BAT1806(托珠单抗)注射液签 署授权许可与商业化协议的公告 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、准确性和完整性依法承担法律责任。 重要内容提示: ? 协议内容摘要: 本协议的签订预计将对公司未来业绩产生积极影响,有利于提升公司全球商 业化及盈利能力。 ? 协议履行中的重大风险及重大不确定性: 详见本公告之"五、协议履行的风险分析"。 一、 审议程序情况 百奥泰于 2025 年 8 月 20 日召开公司第三届董事会第二次会议,审议通过了 《关于就 BAT1806(托珠单抗)签署授权许可与商业化协议的议案》,本次签 署授权协议事项不属于关联交易和重大资产重组事项,根据《上海证券交易所科 创板股票上市规则》及公司章程等相关规定,本议案尚需提交公司股东会审议。 百奥泰生物制药股份有限公司(以下简称"百奥泰"或"公司")与 STADA Arzneimittel AG (以下简称"STADA")签署授权许可与商业化协议,将公司的 ...
百奥泰: 中国国际金融股份有限公司关于百奥泰生物制药股份有限公司使用部分闲置募集资金暂时补充流动资金的核查意见
Zheng Quan Zhi Xing· 2025-08-21 05:39
中国国际金融股份有限公司 关于百奥泰生物制药股份有限公司使用 部分闲置募集资金暂时补充流动资金的核查意见 中国国际金融股份有限公司(以下简称"中金公司"或"保荐机构")作为 百奥泰生物制药股份有限公司(以下简称"百奥泰"或"公司")首次公开发行 股票并在科创板上市项目的保荐机构,根据《证券发行上市保荐业务管理办法》 《上市公司募集资金监管规则》 《上海证券交易所科创板股票上市规则》 预计募集资金使用 | | | 《科创板 上市公司持续监管办法(试行)》和《上海证券交易所科创板上市公司自律监管 指引第 1 号——规范运作》等有关规定,对百奥泰拟使用部分闲置募集资金暂时 补充流动资金事项进行了核查,具体核查情况如下: 一、募集资金基本情况 经上海证券交易所科创板上市委员会2019年11月20日审核同意,并经中国证 券监督管理委员会2020年1月14日《关于同意百奥泰生物制药股份有限公司首次 公开发行股票注册的批复》(证监许可[2020]92号)注册同意,公司公开发行人 民币普通股6,000万股,发行价格为人民币32.76元/股。募集资金总额为人民币 募集资金到位情况已经由安永华明会计师事务所(特殊普通合伙)审验并 ...
百奥泰上半年营收同比增长9.84%净利大幅减亏1.12亿元
Xin Lang Cai Jing· 2025-08-21 03:10
来源:上海证券报·中国证券网 上证报中国证券网讯 8月20日晚,百奥泰发布了2025年半年报,上半年公司实现营业收入4.42亿元,同比增长9.84%,主要得益于公司积极拓展市场,阿达木单抗注射液(格乐立®)及托珠单抗 报告期内,公司利润总额、净利润和扣非净利润较上年同期分别减少亏损1.12亿元、1.12亿元和9913.69万元,主要原因是本报告期营业收入增长及研发费用减少所致。 报告期内,公司经营活动产生的现金流量净流出额较上年同期减少6244.57万元,主要原因是本报告期销售商品、提供劳务收到的现金增加,以及研发费用减少所致。 公司秉承"创新只为生命"的理念,坚持创新驱动发展战略,致力于开发新一代创新药和生物类似药,用于治疗肿瘤、自身免疫性疾病、心血管疾病、眼科以及其它危及人类生命或健康的重大疾病 截至本报告披露日,公司已有5款上市产品,其中有4款产品获NMPA上市批准,包括:格乐立®(阿达木单抗)、普贝希®(贝伐珠单抗)、施瑞立®(托珠单抗)和贝塔宁®(枸橼酸倍维巴肽);3款产 ...