格隆汇12月12日丨百奥泰(688177.SH)公布，公司于近日收到了欧洲药品管理局（以下简称"EMA"）的 通知，Gotenfia®（BAT2506，戈利木单抗注射液）获得EMA人用药品委员会（以下简称"CHMP"）积 极意见。CHMP建议欧盟委员会（EC）批准Gotenfia®上市，用于治疗类风湿关节炎，幼年特发性关节 炎，银屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 ...

二、 药品其他相关情况 百奥泰生物制药股份有限公司 自愿披露关于 Gotenfia ®（戈利木单抗注射液）获欧 洲药品管理局人用药品委员会积极意见的公告 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 了欧洲药品管理局（以下简称"EMA"）的通知，Gotenfia®（BAT2506，戈利木 单抗注射液）获得EMA人用药品委员会（以下简称"CHMP"）积极意见。 CHMP建议欧盟委员会（EC）批准Gotenfia®上市，用于治疗类风湿关节炎，幼 年特发性关节炎，银屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 现将相关情况公告如下： 一、 药品相关情况 （四） 适应症：类风湿关节炎，幼年特发性关节炎，银屑病关节炎，中轴 型脊柱关节炎，溃疡性结肠炎 证券代码：688177 证券简称： 百奥泰 公告编号：2025-069 BAT2506 是百奥泰根据中国国家药品监督管理局（以下简称"NMPA"）、 美国食品药品监督管理局（以下简称"FDA"）、EMA 生物类似药 ...

BAT2506(戈利木单抗注射液)的原研药为美国强生公司的Simponi® (欣普尼®)。根据强生公司2024年年 度报告，Simponi®2024年在全球的销售额为21.90亿美元。 BAT2506是百奥泰根据中国国家药品监督管理局(以下简称"NMPA")、美国食品药品监督管理局(以下简 称"FDA")、EMA生物类似药相关指导原则开发的戈利木单抗生物类似药。戈利木单抗是靶向TNF-α的 抗体，能够以高亲和力特异性地结合可溶性及跨膜的人TNF-α，阻断TNF-α与其受体TNFR结合，从而 抑制TNF-α的活性。 智通财经APP讯，百奥泰(688177.SH)发布公告，公司于近日收到了欧洲药品管理局(以下简称"EMA")的 通知，Gotenfia®(BAT2506，戈利木单抗注射液)获得EMA人用药品委员会(以下简称"CHMP")积极意 见。 CHMP建议欧盟委员会(EC)批准Gotenfia®上市，用于治疗类风湿关节炎，幼年特发性关节炎，银 屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 ...

格隆汇12月12日丨百奥泰(688177.SH)公布，公司于近日收到了欧洲药品管理局（以下简称"EMA"）的 通知，Gotenfia®（BAT2506，戈利木单抗注射液）获得EMA人用药品委员会（以下简称"CHMP"）积 极意见。CHMP建议欧盟委员会（EC）批准Gotenfia®上市，用于治疗类风湿关节炎，幼年特发性关节 炎，银屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 ...

格隆汇12月12日丨百奥泰(688177.SH)公布，公司于近日收到了欧洲药品管理局（以下简称"EMA"）的 通知，Gotenfia（BAT2506，戈利木单抗注射液）获得EMA人用药品委员会（以下简称"CHMP"）积极 意见。CHMP建议欧盟委员会（EC）批准Gotenfia上市，用于治疗类风湿关节炎，幼年特发性关节炎， 银屑病关节炎，中轴型脊柱关节炎，溃疡性结肠炎。 （原标题：百奥泰(688177.SH)：Gotenfia®（戈利木单抗注射液）获欧洲药品管理局人用药品委员会积 极意见） ...

百奥泰公告，近日收到欧洲药品管理局（EMA）的通知，Gotenfia®（BAT2506，戈利木单抗注射液） 获得EMA人用药品委员会（CHMP）积极意见。CHMP建议欧盟委员会（EC）批准Gotenfia®上市，用 于治疗类风湿关节炎、幼年特发性关节炎、银屑病关节炎、中轴型脊柱关节炎、溃疡性结肠炎。 ...

机构持仓方面，截止2025年9月30日，百奥泰十大流通股东中，香港中央结算有限公司位居第十大流通 股东，持股602.47万股，为新进股东。 12月2日，百奥泰盘中下跌2.01%，截至13:30，报24.35元/股，成交2271.70万元，换手率0.22%，总市值 100.83亿元。 责任编辑：小浪快报 资金流向方面，主力资金净流出150.19万元，大单买入65.34万元，占比2.88%，卖出215.54万元，占比 9.49%。 百奥泰所属申万行业为：医药生物-生物制品-其他生物制品。所属概念板块包括：创新药、抗癌治癌、 融资融券、生物医药、中盘等。 截至9月30日，百奥泰股东户数9397.00，较上期减少0.89%；人均流通股44065股，较上期增加0.89%。 2025年1月-9月，百奥泰实现营业收入6.84亿元，同比增长17.57%；归母净利润-2.24亿元，同比增长 38.72%。 百奥泰今年以来股价涨25.64%，近5个交易日跌2.60%，近20日跌8.25%，近60日跌29.87%。 资料显示，百奥泰生物制药股份有限公司位于广东省广州市国际生物岛螺旋二路18号，成立日期2003年 7月28日，上市日 ...

Investment Rating - The report does not explicitly provide an investment rating for the gynecological drug industry in China. Core Insights - The biopharmaceutical industry in China is experiencing structural optimization, valuation recovery, and confidence rebuilding, particularly in the Hong Kong market, where the 18A system supports enterprise value discovery [2][3]. - Gynecological drug companies are characterized by specialized positioning and differentiated competition, focusing on areas such as traditional Chinese medicine, innovative treatments for gynecological tumors, and hormone drugs, showcasing strong professional images and commercialization capabilities [2][3]. Summary by Sections Capital Market Performance of China's Biopharmaceutical Sector - The A-share market has shifted from a focus on scale to sustainable development, while the Hong Kong market has attracted international capital through the 18A system, leading to a gradual rebuilding of long-term confidence in the biopharmaceutical sector [3][25]. - The A-share biopharmaceutical sector has seen a total fundraising amount of 787 billion yuan from January to October 2025, with a peak of 2,451 billion yuan in 2021, indicating a transition from a capital overheating phase to a rational development phase [13][18]. - In the Hong Kong market, the total fundraising amount reached 789 billion HKD from January to October 2025, with a peak of 1,833 billion HKD in 2020, reflecting a significant improvement in the financing environment [27][28]. Market Position Assessment of Chinese Gynecological Drug Companies - The competitive landscape of gynecological drug companies is marked by a focus on specialized fields such as innovative gynecological tumor drugs and hormone treatments, with companies establishing differentiated competitive advantages [40]. - Qianjin Pharmaceutical is recognized as a leading player in the gynecological drug market, with a strong market presence in oral gynecological inflammation traditional Chinese medicine [40]. - Heng Rui Pharmaceutical is noted for its robust pipeline in gynecological tumor treatments, with eight drugs in development as of 2024 [40]. - Xianju Pharmaceutical specializes in hormone treatments, with a focus on steroid drugs, establishing a strong professional image in the gynecological field [40]. Introduction to Representative Listed Chinese Gynecological Drug Companies - Qianjin Pharmaceutical has a significant market share of 25.8% in oral gynecological inflammation traditional Chinese medicine, demonstrating strong sales performance even in challenging market conditions [45]. - Heng Rui Pharmaceutical's research and development pipeline includes multiple innovative treatments for gynecological tumors, indicating a solid commitment to this therapeutic area [52][53]. - Xianju Pharmaceutical leverages its expertise in steroid drugs to maintain a competitive edge in the gynecological drug market, with a focus on cost-effective production and high-quality formulations [58][61].

Group 1 - The core viewpoint of the news is that Baiotai's stock has experienced fluctuations, with a current price of 24.77 CNY per share, reflecting a year-to-date increase of 27.81% but a decline of 20.02% over the past 60 days [1] - As of November 28, Baiotai's market capitalization stands at 10.257 billion CNY, with a trading volume of 20.3261 million CNY and a turnover rate of 0.20% [1] - The company primarily engages in the research and production of innovative drugs and biosimilars, with 91.90% of its revenue coming from drug sales [1] Group 2 - As of September 30, 2025, Baiotai reported a revenue of 684 million CNY, marking a year-on-year growth of 17.57%, while the net profit attributable to shareholders was -224 million CNY, reflecting a 38.72% increase in losses [2] - The number of shareholders decreased by 0.89% to 9,397, while the average circulating shares per person increased by 0.89% to 44,065 shares [2] - The company is categorized under the pharmaceutical and biological industry, specifically in the bioproducts sector, and is involved in concepts such as innovative drugs and cancer treatment [1]

Core Viewpoint - 百奥泰 reported a revenue of 684 million yuan for the first three quarters of 2025, representing a year-on-year growth of 17.57%, while the net loss narrowed to 224 million yuan, indicating improved financial performance [1] Group 1: Financial Performance - The company achieved a revenue of 684 million yuan in the first three quarters, marking a 17.57% increase year-on-year [1] - The net loss for the same period was 224 million yuan, showing a reduction in losses compared to the previous year [1] Group 2: Product Development and Approvals - Several products have been approved for sale, including Adalimumab and Tocilizumab in China and other regions, and Bevacizumab in multiple countries [1] - BAT1806 (Tocilizumab) and BAT2206 (Ustekinumab) have been approved in Europe, with sales managed by partners [2][3] - The company is advancing its innovative drug pipeline, with BAT5906 and BAT4406F expected to submit applications for market approval soon [2][3] Group 3: Market Expansion and Strategy - The company is preparing for participation in centralized procurement, optimizing production capacity and supply chain to enhance competitiveness [2] - New guidelines in the EU and the US for biosimilars are expected to lower R&D costs, providing a competitive advantage for the company [2] Group 4: Clinical Trials and Research - BAT6026 is currently in Phase II clinical trials for atopic dermatitis, while BAT8008 is set to begin Phase III trials for cervical cancer and HER2-negative breast cancer in mid-2026 [3] - Ongoing clinical research for BAT8008 in combination with BAT1308 has shown positive efficacy signals, leading to an expansion of the sample size [3] - BAT7111 is in Phase I dose escalation studies, progressing smoothly with three doses explored [3]