Core Insights - The company has signed a licensing and commercialization agreement with Intas Pharmaceuticals Ltd. for the exclusive commercialization rights of BAT2506 (Golimumab) injection in the U.S. market [1] - The company received a milestone payment of $5.4 million from Intas, after deducting $600,000 for corporate income tax, resulting in a net amount of approximately RMB 38.36 million [1] - This payment will enhance the company's cash reserves, supporting future pipeline research and internationalization strategies [1]

Group 1 - Dematech won a 900 million yuan overseas smart logistics project from a well-known e-commerce giant in Latin America, focusing on intelligent logistics cross-belt sorting systems and related services [1] - Kang En Bei received approval for the registration of short-term financing bonds and medium-term notes, with a total registration amount of 1 billion yuan, valid for two years [1][2] - Zhi Xiang Jin Tai's GR1803 injection for systemic lupus erythematosus clinical trial has been approved by the National Medical Products Administration [2] Group 2 - Jin Da Wei's subsidiary received approval for a veterinary drug product, pyridone, valid from September 3, 2025, to September 2, 2030 [4] - Fu Li Wang's subsidiary plans to invest 500 million yuan in a high-end wire material project, focusing on high-strength prestressed steel strands for various applications [5] - He Li Biological's subsidiary's Class III medical device registration application has been accepted, focusing on natural bone repair materials [12] Group 3 - Lin Yang Energy won a 244 million yuan metering equipment project from Southern Power Grid, expected to positively impact its 2025 and 2026 performance [20] - Sanxia Water plans to absorb its wholly-owned subsidiary, Chongqing Changdian United Energy, with all assets and liabilities to be inherited by Sanxia Water [13] - Tian Cheng Technology canceled the use of 91 million yuan of raised funds for permanent working capital, ensuring no impact on the normal operation of investment projects [24] Group 4 - Baosteel received approval to publicly issue bonds totaling 20 billion yuan to professional investors, valid for 24 months [52] - Tian Kang Biological reported a 10.15% year-on-year increase in pig sales in August, with a total of 263,800 pigs sold [53] - Xinjiang Construction won multiple major projects totaling 4.506 billion yuan, including a 2.4 billion yuan photovoltaic hydrogen synthesis project [18]

证券代码： 688177 证券简称： 百奥泰 公告编号：2025-061 百奥泰生物制药股份有限公司 自愿披露关于 Qletli®（阿达木单抗注射液）获得 英国 MHRA 上市批准的公告 现将相关情况公告如下： 一、 药品相关情况 （一） 药品名称：阿达木单抗注射液 （二） 商品名称：Qletli® （三） 剂型规格： 预充式注射器注射液：40mg/0.8mL （四） 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 二、 药品其他相关情况 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。 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 ...

Core Viewpoint - Company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Qletli (BAT1406), a biosimilar of adalimumab, which is expected to enhance the company's international market presence and positively impact long-term operational performance [1] Group 1 - Qletli (BAT1406) is a fully human monoclonal antibody developed by the company, expressed in CHO cells, that specifically binds to and neutralizes TNF-α, blocking its inflammatory effects [1] - The approval allows the company to expand its product offerings in the UK market, thereby increasing its international influence [1] - The drug is indicated for various adult conditions including rheumatoid arthritis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, among others [1] Group 2 - Pediatric indications for Qletli include juvenile idiopathic arthritis, pediatric plaque psoriasis, and pediatric Crohn's disease [1] - The approval is expected to have a positive impact on the company's long-term business performance [1]

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]

Core Viewpoint - The company Baiotai (688177.SH) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its product Qletli (BAT1406, Adalimumab injection) [1] Group 1: Product Development - Qletli is a biosimilar of Adalimumab developed independently by the company, expressed in CHO cells as a recombinant fully human monoclonal antibody [1] - The mechanism of action involves specific 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] Group 2: Market Impact - With the approval from the UK MHRA, the company can now sell Qletli in the UK, expanding its overseas product offerings [1] - This approval is expected to enhance the company's international influence and positively impact its long-term operational performance [1]

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]