Core Viewpoint - The company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar drug Qletli® (BAT1406, Adalimumab injection) [1] Group 1: Product Approval - Qletli® is a biosimilar of Adalimumab developed by the company, expressed in CHO cells as a recombinant fully human monoclonal antibody [1] - The drug works by specifically binding to TNF-α, neutralizing its biological function, and blocking its interaction with cell surface TNF-α receptors, thereby inhibiting the inflammatory effects of TNF-α [1] - The approval allows the company to expand its product offerings in the UK market, enhancing its international influence and potentially positively impacting long-term operational performance [1] Group 2: Indications - Adult indications for Qletli® include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, spondyloarthritis related to enthesitis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis [1] - Pediatric indications include polyarticular juvenile idiopathic arthritis, spondyloarthritis related to enthesitis, pediatric plaque psoriasis, pediatric Crohn's disease, pediatric ulcerative colitis, and pediatric uveitis [1]

Core Viewpoint - Company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar drug Qletli® (BAT1406, Adalimumab injection) [1] Group 1: Product Development - BAT1406 is a biosimilar of Adalimumab developed independently by the company, expressed in CHO cells as a recombinant fully human monoclonal antibody [1] - The drug works by specifically binding to TNF-α and neutralizing its biological function, blocking its interaction with cell surface TNF-α receptors, thereby inhibiting the inflammatory effects of TNF-α [1] Group 2: Market Impact - With the approval from the UK MHRA, Qletli® can now be marketed and sold in the UK, further expanding the company's overseas product offerings [1] - This approval is expected to enhance the company's international influence and may have a positive impact on its long-term operational performance [1]

BAT1406是百奥泰自主研发的阿达木单抗生物类似药，是由CHO细胞表达的重组全人源单克隆抗体，通 过与TNF-α特异性结合并中和其生物学功能，阻断其与细胞表面TNF-α受体的相互作用，从而阻断TNF- α的致炎作用。Qletli获得英国MHRA上市批准后可在英国进行销售，公司海外销售产品品类得到进一步 扩充，将进一步提升公司产品的国际影响力，有望对公司长期经营业绩产生积极影响。 百奥泰(688177.SH)发布公告，公司于近日收到了英国药品和健康产品管理局(简称"英国MHRA")签发的 关于Qletli(BAT1406，阿达木单抗注射液)上市批准通知。 ...

成人适应症：类风湿关节炎、多关节型幼年特发性关节炎、与附着点炎症相关的关节炎、强直性脊柱 炎、无强直性脊柱炎影像学证据的中轴型脊柱关节炎、银屑病关节炎、银屑病、化脓性汗腺炎、克罗恩 病、溃疡性结肠炎、葡萄膜炎；儿童适应症：多关节型幼年特发性关节炎、与附着点炎症相关的关节 炎、儿童斑块状银屑病、儿童克罗恩病、儿童溃疡性结肠炎、儿童葡萄膜炎。 BAT1406是百奥泰自主研发的阿达木单抗生物类似药，是由CHO细胞表达的重组全人源单克隆抗体，通 过与TNF-α特异性结合并中和其生物学功能，阻断其与细胞表面TNF-α受体的相互作用，从而阻断TNF- α的致炎作用。Qletli®获得英国MHRA上市批准后可在英国进行销售，公司海外销售产品品类得到进一 步扩充，将进一步提升公司产品的国际影响力，有望对公司长期经营业绩产生积极影响。 格隆汇9月10日丨百奥泰(688177.SH)公布，公司于近日收到了英国药品和健康产品管理局（称"英国 MHRA"）签发的关于Qletli®（BAT1406，阿达木单抗注射液）上市批准通知。 ...

Core Viewpoint - The company, Baiotai (688177.SH), has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Qletli® (BAT1406, Adalimumab injection), which is expected to positively impact the company's long-term operational performance [1] Group 1 - The approval allows Qletli® to be sold in the UK, expanding the company's overseas product offerings [1] - The marketing authorization signifies a strategic milestone for the company in enhancing its market presence [1] - The introduction of Qletli® is anticipated to contribute positively to the company's revenue growth [1]

Group 1 - The company will hold a collective performance briefing for the innovative drug industry on September 16, 2025, from 15:00 to 17:00 [1][2] - The briefing will be conducted via video recording and online interaction at the Shanghai Stock Exchange Roadshow Center [2][3] - Investors can submit questions from September 9 to September 15, 2025, before 16:00, through the Roadshow Center website or via the company's email [3][4] Group 2 - Key personnel attending the briefing include the Chairman and General Manager, LI SHENGFENG, and other board members and executives [2] - The company aims to address common investor concerns regarding its operational results and financial indicators for the first half of 2025 during the briefing [2][3] - After the briefing, investors can access the main content and updates through the Shanghai Stock Exchange Roadshow Center [4]

Core Points - The company is holding its second extraordinary general meeting of shareholders in 2025 to ensure the rights of all shareholders and maintain order during the meeting [1][2] - The meeting will include discussions on several key proposals, including changes to the company's registered address and the signing of a licensing agreement for BAT1806 (Tocilizumab) [7][9][11] Meeting Procedures - Attendees must verify their identity upon arrival and sign in to confirm their participation [1][2] - Shareholders and their representatives have the right to speak, inquire, and vote during the meeting, but must register to speak in advance [2][3] - Voting will be conducted through both on-site and online methods, with results announced after the meeting [3][5] Agenda Items - Proposal 1: Change of registered address and amendment of the company's articles of association, with the new address being "18 Spiral Second Road, International Biological Island, Guangzhou" [7][9] - Proposal 2: Signing a licensing and commercialization agreement for BAT1806 (Tocilizumab) with STADA Arzneimittel AG, with a total transaction amount of up to €136 million [10] - Proposal 3: Establishment of a remuneration management system for directors and senior management to enhance corporate governance [11][12]

证券代码：688177 证券简称：百奥泰 公告编号：2025-060 百奥泰生物制药股份有限公司 关于召开 2025 年半年度科创板创新药行业集体 业绩说明会的公告 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： 投资者可于 2025 年 9 月 9 日（星期二）至 9 月 15 日（星期一）16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 IR@bio-thera.com 进行提问。公司将在说明会上对投资者普遍关注的问题进行回 答。 百奥泰生物制药股份有限公司（以下简称"公司"）已于 2025 年 8 月 21 日发 布公司 2025 年半年度报告，为便于广大投资者更全面深入地了解公司 2025 年半 年度经营成果、财务状况，公司计划于 2025 年 9 月 16 日（星期二）15:00-17:00 参与由上海证券交易所主办的 2025 年半年度科创板创新药行业集体业绩说明 会，就投资者关心的问题进行交流。 一、 说明会类型 本次投资者说明会以视频录播结合网络互动召开，公司将针对 ...

2025 年 9 月 15 日 证券代码：688177 证券简称：百奥泰 百奥泰生物制药股份有限公司 2025年第二次临时股东会会议资料 | 2025 年第二次临时股东会会议须知 2 | | | --- | --- | | 年第二次临时股东会会议议程 2025 4 | | | 年第二次临时股东会议案 2025 6 | | | 议案一：关于变更注册地址、修订《公司章程》并办理工商变更登记的议案 | 7 | | 议案二：关于就 BAT1806（托珠单抗）签署授权许可与商业化协议的议案 | 8 | | 议案三：关于制定《董事、高级管理人员薪酬管理制度》的议案 | 9 | 1 目 录 百奥泰生物制药股份有限公司 2025 年第二次临时股东会 百奥泰生物制药股份有限公司 2025 年第二次临时股东会会议须知 四、股东及股东代理人参加股东会依法享有发言权、质询权、表决权等权利。 股东及股东代理人参加股东会应认真履行其法定义务，不得侵犯公司和其他股东 及股东代理人的合法权益，不得扰乱股东会的正常秩序。 五、股东及股东代理人要求在股东会现场会议上发言的，应于股东会召开前 一天向会务组进行登记。会议主持人根据会务组提供的名单和 ...

Group 1 - The core viewpoint of the news is that Baiotai's stock has experienced significant price movements and financial performance indicators, reflecting both market interest and operational results [1][2]. - Baiotai's stock price has increased by 75.49% year-to-date, with a 6.25% rise in the last five trading days, 9.96% in the last 20 days, and 19.00% in the last 60 days [2]. - As of September 2, Baiotai's stock was trading at 34.01 CNY per share, with a total market capitalization of 14.083 billion CNY [1]. Group 2 - Baiotai's main business revenue composition includes 91.90% from drug sales, 6.55% from licensing, 0.90% from contract manufacturing, and 0.65% from technical services [2]. - The company reported a revenue of 442 million CNY for the first half of 2025, representing a year-on-year growth of 9.84%, while the net profit attributable to the parent company was -125 million CNY, showing a 47.25% increase year-on-year [2]. - As of June 30, the number of Baiotai's shareholders increased by 11.20% to 9,481, while the average circulating shares per person decreased by 10.07% to 43,674 shares [2].