证券代码：688177 证券简称：百奥泰 公告编号：2025-059 百奥泰生物制药股份有限公司 关于召开2025年第二次临时股东会的通知 本公司董事会及全体董事保证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： 一、 召开会议的基本情况 （一） 股东会类型和届次 2025年第二次临时股东会 （四） 现场会议召开的日期、时间和地点 召开日期时间：2025 年 9 月 15 日 14 点 00 分 召开地点：广州市国际生物岛螺旋二路 18 号会议室 （五） 网络投票的系统、起止日期和投票时间。 网络投票系统：上海证券交易所股东会网络投票系统 网络投票起止时间：自2025 年 9 月 15 日 至2025 年 9 月 15 日 采用上海证券交易所网络投票系统，通过交易系统投票平台的投票时间为股 东会召开当日的交易时间段，即 9:15-9:25,9:30-11:30，13:00-15:00；通过互联网 投票平台的投票时间为股东会召开当日的 9:15-15:00。 股东会召开日期：2025年9月15日 本次股东会采用的网络投票系统：上海证券交 ...

Core Viewpoint - The stock of Baiotai has experienced fluctuations, with a notable decline of 2.01% on August 28, 2023, despite a year-to-date increase of 55.57% [1][2]. Group 1: Stock Performance - As of August 28, 2023, Baiotai's stock price was 30.15 CNY per share, with a total market capitalization of 12.485 billion CNY [1]. - The stock has seen a recent decline of 9.43% over the last five trading days and a 1.76% decrease over the last 20 days, while it has increased by 13.35% over the last 60 days [1]. Group 2: Financial Metrics - For the first half of 2025, Baiotai reported a revenue of 442 million CNY, reflecting a year-on-year growth of 9.84% [2]. - The company recorded a net profit attributable to shareholders of -125 million CNY, which represents a year-on-year increase of 47.25% [2]. Group 3: Company Overview - Baiotai Biopharmaceutical Co., Ltd. was established on July 28, 2003, and went public on February 21, 2020 [1]. - The company's main business involves the research and production of innovative drugs and biosimilars, with 91.90% of its revenue coming from drug sales [1].

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]

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].

Core Viewpoint - Baiyoutai has signed a licensing and commercialization agreement with STADA for BAT1806 (Tocilizumab) injection, granting STADA exclusive commercialization rights in several regions, which is expected to positively impact the company's future performance and enhance its global commercialization and profitability [1][2]. Group 1: Agreement Details - The total amount of upfront and milestone payments 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 double-digit percentage of net sales as revenue sharing [1]. - The agreement covers the commercialization rights in the EU, Switzerland, the UK, parts of other European countries, parts of the Middle East and North Africa (MENA), and some Commonwealth of Independent States (CIS) countries [1]. Group 2: Product Information - BAT1806 (Tocilizumab) is a biosimilar developed by Baiyoutai, targeting the interleukin-6 receptor (IL-6R) and is approved by the NMPA in China, the FDA in the US, and the EMA in Europe [2]. - The product is marketed under the name Shiruili in China and TOFIDENCE in the US [2]. Group 3: STADA Overview - STADA is a well-established European pharmaceutical company headquartered in Germany, focusing on three strategic pillars: consumer health, generics, and specialty pharmaceuticals [2]. - In the fiscal year 2024, STADA achieved a group sales revenue of €4.059 billion, with an adjusted EBITDA of €886 million, and employs approximately 11,649 people globally [2].

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]

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].

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].

Core Viewpoint - The report highlights the financial performance of Baotai Biopharmaceutical Co., Ltd. for the first half of 2025, indicating a growth in revenue but a significant loss in net profit compared to the previous year [1][2]. Financial Summary - Total assets at the end of the reporting period amounted to CNY 2,246.69 million, reflecting a 1.87% increase from the previous year [1]. - The net assets attributable to shareholders decreased by 17.65% to CNY 583.12 million compared to the previous year [1]. - Operating revenue reached CNY 441.89 million, representing a 9.84% increase year-on-year [1]. - 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 same period last year [2]. - The net profit attributable to shareholders was a loss of CNY 124.93 million, compared to a loss of CNY 236.85 million in the previous year [2]. - The net profit after deducting non-recurring gains and losses was a loss of CNY 171.20 million, improving from a loss of CNY 270.33 million year-on-year [2]. - The net cash flow from operating activities was a negative CNY 0.81 million, a significant improvement from a negative CNY 63.26 million in the previous year [2]. - The weighted average return on net assets was -19.35%, an increase of 2.29 percentage points from -21.64% in the previous year [2]. - Basic and diluted earnings per share were both -CNY 0.57, compared to -CNY 0.30 in the previous year [2]. - Research and development expenses accounted for 78.94% of operating revenue, a decrease of 21.12 percentage points [2]. Shareholder Information - As of the end of the reporting period, the total number of shareholders was 9,481 [2]. - Major shareholders include Guangzhou Qixi Group Co., Ltd. with 38.64% ownership and Therabio International Limited with 11.39% ownership [3][4].

Core Viewpoint - The company has signed a licensing and commercialization agreement with STADA for BAT1806 (Tocilizumab) injection, granting STADA exclusive commercialization rights in several regions, which is expected to positively impact the company's future performance [1][2][3] Agreement Summary - The agreement allows STADA to commercialize BAT1806 in the EU, Switzerland, the UK, parts of Europe, the MENA region, and CIS countries [1][2] - 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 double-digit percentage of net sales as revenue sharing [2][6] - The agreement will be effective upon 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 [2][6] Product and Partner Information - BAT1806 is a biosimilar developed according to guidelines from NMPA, FDA, and EMA, targeting the IL-6 receptor [3] - STADA is a well-established European pharmaceutical company with a focus on consumer health, generics, and specialty pharmaceuticals, achieving €4.059 billion in sales and €886 million in adjusted EBITDA in the 2024 fiscal year [3] Impact on Company Performance - The agreement is expected to enhance the company's global commercialization and profitability, leveraging STADA's strengths in research, production quality control, and market promotion [6][7] - The successful execution of this agreement is anticipated to have a positive impact on the company's future operating performance [6][7]