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 ...

百奥泰公告，公司近日收到BAT2506(戈利木单抗)注射液生物制品许可申请(BLA)获得美国食品药品监 督管理局(美国FDA)受理的通知。该药物为戈利木单抗生物类似药，原研药为美国强生公司的Simponi (欣普尼 )，2024年全球销售额为21.9亿美元。百奥泰已与多家公司合作，开展BAT2506(戈利木单抗)注 射液在多个地区的商业化进程。药品上市许可申请已获得中国NMPA、美国FDA、欧洲EMA、巴西 ANVISA受理。 ...

Investment Rating - The report does not explicitly state an investment rating for the medical device sector, but it highlights positive developments and opportunities for investment in high-end medical devices and domestic medical equipment companies. Core Insights - The medical and biological sector saw a weekly increase of 1.2%, outperforming the Wind All A index (-1.17%) and the CSI 300 index (-1.37%) during the week of March 31 to April 3, 2025. Key performers included offline pharmacies (4.15%), chemical preparations (3.92%), and medical consumables (1.66%) [2][7]. - A new policy from the National Medical Products Administration aims to support innovation in high-end medical devices, including surgical robots and AI medical devices, through ten key measures that enhance the regulatory framework and promote international standards [2][12]. - The acceleration of centralized procurement for large medical devices in regions like Guangxi is expected to benefit domestic medical equipment companies, allowing them to capture a larger market share as the industry recovers [2][12]. Market Weekly Review - The medical and biological sector increased by 1.2%, with offline pharmacies leading the gains at 4.15%, followed by chemical preparations at 3.92% and medical consumables at 1.66%. Conversely, medical research outsourcing (-3.19%), medical devices (-1.48%), and hospitals (-0.15%) experienced declines [2][7]. - The top three gaining stocks were Duorui Pharmaceutical (56.3%), Weisi Medical (31.8%), and Hasanlian (31.3%), while the largest declines were seen in Dongfang Biological (-11.1%), Dongfang Ocean (-9.2%), and Nengte Technology (-9.1%) [2][10]. Industry News and Key Company Announcements - The National Medical Products Administration is seeking opinions on measures to optimize lifecycle regulation for high-end medical devices, which includes support for innovation and the application of new technologies in healthcare [2][12]. - Guangxi's public resource trading center announced the initiation of centralized procurement for large medical devices for 2025, encouraging participation from both government and non-government medical institutions [2][12]. - Amgen announced FDA approval for a new indication of its CD19 antibody Inebilizumab, targeting a rare autoimmune disease with a patient population of approximately 20,000 to 40,000 in the U.S. and EU [2][12].