Core Viewpoint - Company plans to adjust the development strategy of BAT3306 (a biosimilar of Pembrolizumab) and terminate the ongoing BAT3306-002 study, with future decisions pending careful evaluation [1][2][3] Development Strategy Adjustment - BAT3306 is currently involved in a Phase I/III study (BAT3306-002) assessing its pharmacokinetics, efficacy, and safety in combination with chemotherapy for stage IV non-small cell lung cancer [2] - The adjustment in development strategy is influenced by recent communications from the FDA and EMA, indicating a reduced necessity for comparative efficacy studies for biosimilars in the approval process [2][3] - Two other companies developing Pembrolizumab biosimilars have also halted their Phase III efficacy studies, opting for submissions based on Phase I and analytical data [2] Financial Implications - The total investment in the BAT3306 project has reached 224 million yuan, with all R&D expenses accounted for in the respective accounting periods, indicating no substantial impact on current or future financial performance [4] - The company has incurred cumulative losses exceeding 1.8 billion yuan since its listing, with only one profitable year in 2021 due to licensing income [5] Revenue and R&D Expenditure - Revenue figures from 2020 to 2024 show fluctuations, with revenues of 185 million yuan, 837 million yuan, 456 million yuan, 705 million yuan, and 743 million yuan respectively, while net profits remained negative [6] - R&D expenses have consistently exceeded revenue, with ratios of R&D expenditure to revenue ranging from 304% to 104.7% over the same period [6] Market Context - Pembrolizumab (Keytruda) is a leading PD-1 inhibitor with over 30 approved indications and sales reaching 25.011 billion USD in 2023, with its key patent expiring in 2028, potentially opening a significant market for biosimilars [4] - The company will continue to monitor regulatory developments and evaluate the future of the BAT3306 project based on the latest policy dynamics [4] Competitive Risks - The company faces risks from centralized procurement policies, as three of its four approved products are biosimilars, which are a major source of revenue [7]

证券代码： 688177 证券简称： 百奥泰 公告编号：2025-040 百奥泰生物制药股份有限公司 关于 BAT2206（乌司奴单抗）注射液获得 美国 FDA 上市批准的公告 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。 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 了美国食品药品监督管理局（以下简称"美国FDA"）签发的关于BAT2206（乌 司奴单抗）注射液（美国商品名称：STARJEMZA）上市批准的通知，现将相 关情况公告如下： 胞因子，能够参与炎症和免疫应答过程，可以与 p40 亚基以高亲和力特异性地 结合，阻断其与细胞表面受体结合，从而破坏 IL-12 和 IL-23 介导的信号传导和 细胞因子的效应。 一、药品相关情况 皮下制剂：45mg/0.5mL、90mg/mL，静脉注射剂：130mg/26mL （五） 适应症：成人适应症：中重度斑块状银屑病（PsO），活动性银屑 病关节炎（PsA），中重度活动性克罗恩病（CD），中重度活动性溃疡性结肠 炎（UC）；儿童适应症：中重度斑块状银屑 ...

Core Viewpoint - Baiotai has received FDA approval for BAT2206 (Ustinumab) injection, indicating a significant milestone for the company in the biopharmaceutical sector [1] Group 1: Product Approval - The FDA has approved BAT2206 (Ustinumab) injection, marketed in the U.S. as STARJEMZA [1] - The drug is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn's disease, and moderate to severe active ulcerative colitis in both adults and children [1] Group 2: Commercialization Efforts - Baiotai is actively pursuing the commercialization of BAT2206 in multiple global regions [1] - The company has submitted marketing authorization applications to the NMPA in China and the EMA in Europe [1]

Policy Developments - The total amount of personal accounts for employee medical insurance mutual aid reached 17.792 billion yuan from January to April 2025, with 133 million participants [2] Drug and Device Approvals - The KRAS G12C inhibitor, Gozai Lese, developed by Jako and Ailis, has been approved for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously received at least one line of systemic therapy [3] - Heng Rui Medicine's innovative drug, Regaglitin Metformin Tablets, has been approved for use in adults with type 2 diabetes to improve blood sugar control [4] Capital Markets - Boyin Hearing announced a B-round financing of several tens of millions, aimed at increasing investment in domestic hearing aid research and development [5] - Lid Health Technology has completed nearly 100 million yuan in angel round financing, with funds allocated for accelerating technology research and product commercialization [6] Major Industry Events - Rongchang Bio plans to place 19 million new H-shares at a price of 42.44 HKD per share, raising approximately 796 million HKD for core product pipeline expansion [7] - Haoyuan Pharmaceutical announced that its shareholder, Zhenjin Investment, has reduced its holdings by approximately 3.2 million shares, accounting for 1.51% of the total share capital [8] - Baiyatai has decided to terminate the BAT3306-002 study, which evaluated the pharmacokinetics, efficacy, and safety of BAT3306 in combination with chemotherapy in IV-stage NSCLC patients, after an investment of 224 million yuan in the project [9]

经审慎考虑，公司认为目前正在开展的 BAT3306-002 研究对于 BAT3306 在 证券代码： 688177 证券简称： 百奥泰 公告编号：2025-039 百奥泰生物制药股份有限公司 关于调整 BAT3306（帕博利珠单抗）开发策略的公告 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。 经百奥泰生物制药股份有限公司（以下简称"百奥泰"或"公司"）对药品监督 管理政策动态等因素的审慎评估，计划调整 BAT3306（帕博利珠单抗）的开发 策略，终止 BAT3306 正在开展的 BAT3306-002 研究（一项评价 BAT3306 联合 化疗与可瑞达®联合化疗在 IV 期非小细胞肺癌受试者中的药代动力学、有效性 和安全性的多中心、随机、双盲 I/III 期研究）。 一、 BAT3306 开发策略调整原因 BAT3306 是公司开发的帕博利珠单抗（Keytruda®）生物类似药，目前正在 开展的 BAT3306-002 研究是一项评价 BAT3306 联合化疗与 Keytruda®联合化疗 在 IV 期非小细胞肺癌受试者 ...

Company Overview - Company has four listed products: Geleli (Adalimumab), Pubexi (Bevacizumab), Shuili (Tocilizumab), and Betanin (Citrulline Bevacizumab), all of which are currently sold in China. Betanin started sales this year [2] - Two products, Tofidence (Tocilizumab) and Avzivi (Bevacizumab), have been approved in Europe and the US. Tofidence is expected to start sales in the US in the second half of this year after a transfer of rights to Organon [2] Market Impact and Strategy - The company's chairman stated that Trump's proposed drug price reduction measures will not negatively impact the overseas sales of its biosimilars, as the company has established extensive global connections [2][3] - The company’s total production capacity has reached 66,500L, ranking among the top in the country, and it has covered over 92 countries and regions with its Bevacizumab product [2] Regulatory Environment - Recent US policies are favorable for biosimilars, including the FDA's cancellation of interchangeability study requirements and a shift in payment policies towards biosimilars [2] - The company has not observed any specific impacts from FDA personnel changes on new drug approvals [4] Sales and Revenue Projections - The company anticipates that by 2027, four products will be sold overseas, with multiple products expected to be launched domestically, aiming to improve sales revenue [5] - The company expects to submit for approval of a new production line for Bevacizumab this summer, with a projected US market launch next year [5] Clinical Development - The clinical research for BT8006, targeting platinum-resistant ovarian cancer, is set to begin this month in China, with plans for global clinical trials [6] - The company is also working on a subcutaneous formulation of Tocilizumab, with clinical research completed and awaiting further development [8] Financial Performance - In Q1 2025, the company reported a main revenue of 207 million yuan, a year-on-year increase of 27.83%, and a net profit of -93.33 million yuan, an increase of 21.54% [11] - The company has a debt ratio of 73.79% and a gross profit margin of 76.99% [11] Investment Outlook - Recent ratings from three institutions have all been "buy," with a target price of 25.00 yuan [12] - The company is considering project financing for global clinical trials if necessary, and it is actively managing expenses to improve cash flow [11][12]

Group 1 - The innovative pharmaceutical ETF (560900) has seen a 0.89% increase, marking a four-day rising streak, with the index tracking the innovative drug industry (931152) up by 0.85% [1] - Notable stock performances include Maiwei Biotech (688062) rising over 9%, Tianshili (600535) up 4.76%, and Baotai (688177) increasing by 4.38% [1] - The innovative pharmaceutical ETF has experienced a significant growth of 4 million shares in the last three months, indicating a recovery in market enthusiasm for the pharmaceutical sector [2] Group 2 - The pharmaceutical and biotechnology sector's Q1 2025 financial reports show stable revenue and profit performance, with notable improvements in certain sub-industries [2] - The market sentiment towards the pharmaceutical sector has shifted positively, ending a continuous downtrend since Q1 2024, driven by a systematic valuation increase in the innovative drug sector [2] - Long-term potential exists in China's biomanufacturing, quantum technology, embodied intelligence, and 6G industries, with significant development opportunities across the entire industrial chain [2] Group 3 - Morgan Asset Management is integrating its "Global Vision Investment Technology" product line to assist investors in seizing investment opportunities in quality technology companies globally [2] - Various actively managed funds focus on emerging industry trends, including the Morgan Emerging Power Fund and the Morgan Smart Connectivity Fund, which targets artificial intelligence opportunities [3] - The Morgan Hang Seng Technology ETF and the Morgan Zhongzheng Innovative Pharmaceutical Industry ETF provide passive investment options for technology and innovative pharmaceutical sectors [3]

Group 1 - The A-share market saw a collective decline on May 16, while the Sci-Tech Innovation Pharmaceutical sector rebounded, with the Sci-Tech Innovation Pharmaceutical ETF (588860) rising by 0.16% [1] - Notable stocks in the sector included Maiwei Biotech-U, which increased by over 5%, along with Shouyao Holdings-U, KQ Biotech, Innotec, CanSino, and Baotai, all of which experienced gains [1] - The Sci-Tech Innovation Pharmaceutical ETF closely tracks the Shanghai Stock Exchange Sci-Tech Innovation Board Biopharmaceutical Index, which selects 50 large-cap companies in biopharmaceuticals and related fields to reflect the overall performance of representative companies in the sector [1] Group 2 - According to CMB International, the optimization of centralized procurement policies in mainland China provides hospitals and enterprises with more flexibility and autonomy, benefiting leading prescription drug companies [2] - The anticipated implementation of favorable policies, such as the 2025H2 medical insurance category, is expected to accelerate industry consolidation, with the sector's valuations remaining at historical lows [2] - The recommendation is to focus on innovative drug targets with high growth potential or clear breakeven timelines after short-term sentiment stabilizes [2]

Core Viewpoint - The company is accelerating preparations for the BAT8006 clinical project, with an estimated start for subject enrollment this month [1] Group 1: Clinical Development Plans - The company aims to obtain approval for BAT2206 in major markets (China, the US, and Europe) in the second half of this year and early next year [1] - The unblinding date for the first III phase indication study of BAT5906 for wAMD is set for the end of Q2 2025 [1] - Ongoing clinical trials for DME are in progress, with plans for registration clinical studies targeting CNV and CRVO in the preparatory stage [1] Group 2: Product Development and Collaborations - Development of subcutaneous tocilizumab and collaboration for tocilizumab in Europe are progressing [1] - The company is working to expedite the sales of already approved intravenous administration in Europe [1]

Meeting Overview - The annual general meeting of Baotai Biopharmaceutical Co., Ltd. was held on April 30, 2025, with no resolutions being rejected [2][4] - The meeting was convened by the board of directors and chaired by Chairman Li Shengfeng, complying with relevant laws and regulations [2][3] Attendance - Out of 8 current directors, 7 attended the meeting, while all 3 supervisors and the board secretary were present [3] - All senior management personnel attended the meeting [3] Resolutions Passed - The following resolutions were approved: 1. 2024 Annual Report and Summary [4] 2. 2024 Board of Directors Work Report [4] 3. 2024 Supervisory Board Work Report [5] 4. 2024 Financial Settlement Report [5] 5. 2024 Profit Distribution Plan [5] 6. 2025 Salary Plan for Directors and Senior Management [5] 7. Changes and Amount Adjustments for Certain Fundraising Projects [5] 8. Reappointment of Accounting Firm for 2025 [5] 9. Application for Comprehensive Credit from Financial Institutions [5] 10. Amendments to the Articles of Association and Corporate Governance [6] Board Election - The third board of directors was elected, consisting of 5 non-independent directors and 3 independent directors, with a term of three years starting from the approval date [10][11] - Li Shengfeng was elected as the chairman of the third board of directors [12] Management Appointments - The following senior management appointments were made: - Li Shengfeng as General Manager - Huang Xianming as Deputy General Manager - Yu Dan as Board Secretary - Zhan Xianhong as Chief Financial Officer [15] Legal Compliance - The meeting and voting procedures were verified by Shanghai Fangda (Guangzhou) Law Firm, confirming compliance with relevant laws and regulations [8]