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盛合晶微IPO过会 开普云终止收购南宁泰克
Xin Lang Cai Jing· 2026-02-24 13:04
《科创板日报》2月24日讯 今日科创板晚报主要内容包括:马斯克设想从月球电磁弹射AI卫星;申联生 物拟2.37亿元收购世之源控股权并开展创新药业务;中微半导发布业绩快报,2025年净利润2.85亿元, 同比增长108.05%。 【热点聚焦】 简讯: 广东省委书记黄坤明:最大限度为技术创新和市场探索"松绑" 让低空经济"飞"起来、自动驾驶"跑"起 来、具身智能"用"起来 广东省委书记黄坤明2月24日在广东省高质量发展大会上表示,要充盈营商环境阳光雨露。两业协同发 展必然伴随新产品、新业态、新模式的持续涌现,迫切需要构建开放、包容、稳定的营商环境,呵护新 生事物成长。要以深化改革强化新赛道新领域制度供给,着力破解"老规矩管新质生产力"的问题,最大 限度为技术创新和市场探索"松绑",让低空经济"飞"起来、自动驾驶"跑"起来、具身智能"用"起来,确 保既"放得活"又"管得好"。要以扩大开放走在两业协同发展最前沿,深度融入全球产业分工网络,加快 集聚全球制造资源、服务资源,在高水平"引进来"、高质量"走出去"中擦亮"广东制造"、"广东服务"双 品牌。生态好不好、环境行不行,企业满意度是评判标准。全省各级党委政府将一以贯 ...
百奥泰(688177) - 百奥泰 关于达尔扑拜单抗注射液(BAT4406F)上市许可申请获得受理的公告
2026-02-24 10:15
证券代码:688177 证券简称:百奥泰 公告编号:2026-011 百奥泰生物制药股份有限公司 关于达尔扑拜单抗注射液(BAT4406F) 上市许可申请获得受理的公告 剂型:注射剂 规格:100mg/5mL 申请事项:境内生产药品注册上市许可 受理号:CXSS2600022 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 到国家药品监督管理局(以下简称"国家药监局")核准签发的关于公司在研 药品达尔扑拜单抗注射液(以下简称"BAT4406F")药品上市许可申请的《受 理通知书》。 BAT4406F 经审评审批通过后可获发药品批准证书并可投入生产、销售, 因为审评审批的办结时间无法预估,本次获得药品上市许可申请受理通知书 对公司近期业绩不会产生影响。 一、 《受理通知书》基本情况 药品名称:达尔扑拜单抗注射液 注册分类:治疗用生物制品 1 类 适应症:本品适用于抗水通道蛋白 4(AQP4)抗体阳性的视神经脊髓炎 谱系疾病(NMOSD)成人患者的治疗。 结论 ...
百奥泰(688177.SH):达尔扑拜单抗注射液(BAT4406F)上市许可申请获得受理
Ge Long Hui A P P· 2026-02-24 10:14
BAT4406F 为依据公司抗体 Fc 工程平台开发的新一代糖基优化的全人源抗CD20 抗体,具有 ADCC 增 强功能,不仅仅特异性与靶细胞B 细胞及前体细胞表面的 CD20 分子结合,还可以高亲和与 NK 自然杀 伤性细胞,诱发ADCC(抗体依赖的细胞介导的细胞毒性作用)等生物学效应,从而达到清除B细胞的目 的。 截至本公告披露日,BAT4406F 针对微小病变肾病/局灶节段性肾小球硬化(MCD/FSGS)适应症的一项 II/III 期注册临床研究正在全国多家三甲医院进行招募,该研究是我国首个针对该适应症的注册研究。 格隆汇2月24日丨百奥泰(688177.SH)公布,百奥泰生物制药股份有限公司于近日收到国家药品监督管理 局核准签发的关于公司在研药品达尔扑拜单抗注射液药品上市许可申请的《受理通知书》。 BAT4406F 经审评审批通过后可获发药品批准证书并可投入生产、销售,因为审评审批的办结时间无法 预估,本次获得药品上市许可申请受理通知书对公司近期业绩不会产生影响。 ...
百奥泰:达尔扑拜单抗注射液(BAT4406F)上市许可申请获得受理
Jin Rong Jie· 2026-02-24 09:57
百奥泰公告,公司于近日收到国家药品监督管理局核准签发的关于公司在研药品达尔扑拜单抗注射液 (BAT4406F)药品上市许可申请的《受理通知书》。该药品适用于抗水通道蛋白4(AQP4)抗体阳性 的视神经脊髓炎谱系疾病(NMOSD)成人患者的治疗。 ...
百奥泰:达尔扑拜单抗注射液(BAT4406F)上市许可申请获得受理
Ge Long Hui· 2026-02-24 09:56
BAT4406F 经审评审批通过后可获发药品批准证书并可投入生产、销售,因为审评审批的办结时间无法 预估,本次获得药品上市许可申请受理通知书对公司近期业绩不会产生影响。 截至本公告披露日,BAT4406F 针对微小病变肾病/局灶节段性肾小球硬化(MCD/FSGS)适应症的一项 II/III 期注册临床研究正在全国多家三甲医院进行招募,该研究是我国首个针对该适应症的注册研究。 格隆汇2月24日丨百奥泰(688177.SH)公布,百奥泰生物制药股份有限公司于近日收到国家药品监督管理 局核准签发的关于公司在研药品达尔扑拜单抗注射液药品上市许可申请的《受理通知书》。 BAT4406F 为依据公司抗体 Fc 工程平台开发的新一代糖基优化的全人源抗CD20 抗体,具有 ADCC 增 强功能,不仅仅特异性与靶细胞B 细胞及前体细胞表面的 CD20 分子结合,还可以高亲和与 NK 自然杀 伤性细胞,诱发ADCC(抗体依赖的细胞介导的细胞毒性作用)等生物学效应,从而达到清除B细胞的目 的。 ...
财信证券晨会纪要-20260213
Caixin Securities· 2026-02-13 09:49
Group 1: Market Overview - The overall A-share market showed a slight increase, with the Wind All A Index rising by 0.46% to 6833.88 points, while the Shanghai Composite Index increased by 0.05% to 4134.02 points [6][7] - The ChiNext Index rose by 1.32% to 3328.06 points, and the Sci-Tech 50 Index increased by 1.78% to 1480.99 points, indicating a strong performance in the hard technology sector [6][7] - The trading volume in the market was 21,607.71 billion, an increase of 1,597.27 billion compared to the previous trading day, with 2,107 companies rising and 3,273 companies falling [7] Group 2: Economic Insights - In January, the U.S. non-farm payrolls increased by 130,000, surpassing the expected increase of 70,000, while the unemployment rate stood at 4.3%, slightly better than the expected 4.4% [14] - The average hourly wage increased by 3.7% year-on-year, indicating a stable wage growth environment [14] Group 3: Industry Dynamics - The smart watch and wristband market in China is projected to grow by 13.1% in 2025, with total sales reaching 64.5 million units [24] - Huawei leads the adult smart watch market with a 24.5% share, experiencing a 46.8% year-on-year increase, while Apple holds a 16.5% market share, benefiting from new product launches [25] Group 4: Company Updates - Baiotai (688177.SH) received approval from the European Medicines Agency (EMA) for its Gotenfia injection, which is expected to enhance the company's international market presence [28][30] - Northeast Securities (000686.SZ) has been approved by the China Securities Regulatory Commission to establish a subsidiary in Hong Kong with an investment of 500 million HKD [31] - Huazhong Securities (600909.SH) also received approval for a capital increase of 500 million HKD to its wholly-owned subsidiary in Hong Kong [32] Group 5: Local Economic Policies - Hunan Province announced a subsidy policy for the 2026 Spring Festival, offering up to 1,500 yuan for home appliances and 500 yuan for digital products under the old-for-new program [36][37]
上证早知道|300857,110亿元采购服务器;两公司收购资产停牌
Company News - Xiamen Airport plans to acquire 100% equity of Zhaoxiang Technology from its controlling shareholder for a cash consideration of 1.193 billion yuan. Zhaoxiang Technology is a comprehensive service provider for civil aviation with capabilities in consulting, research and development, design, implementation, and operation and maintenance [12] - Crystal Material plans to invest 600 million yuan to establish a key materials comprehensive base for the integrated circuit manufacturing industry chain in Pengshan Economic Development Zone, Sichuan. The project is expected to achieve an annual output value of approximately 600 million yuan upon reaching full production [12] - Weitang Industrial signed a strategic cooperation framework agreement with Amphenol (Changzhou) Connection Systems Co., Ltd. on February 12 [12] - Baotai received a marketing approval notice from the European Medicines Agency for Gotenfia (BAT2506), which is used to treat rheumatoid arthritis and ulcerative colitis [13] - Penghui Energy plans to invest 1.2 billion yuan in the construction of a battery production project in Yicheng District, Zhumadian City, with an additional investment of 2.1 billion yuan for a 120Ah cell production project in Zhengyang County, Henan [13] Industry Insights - The National Development and Reform Commission, along with financial regulators and the Civil Aviation Administration, released implementation opinions to promote the high-quality development of low-altitude insurance. By 2027, a mandatory insurance system for unmanned aerial vehicles is expected to be established, with a diverse range of low-altitude insurance products to meet various application scenarios [7] - Peking University announced the development of the world's first large-scale quantum communication network based on integrated optical quantum chips, which has strong market demand. The global Ethernet optical module market is expected to continue growing rapidly, driven by strong demand for AI infrastructure [9] - ViDi Technology's performance exceeded expectations, with a sales forecast of $13.25 billion to $13.75 billion for 2026, significantly above market expectations. The global market for power and liquid cooling solutions is anticipated to continue growing due to increasing demand in AI infrastructure [10]
百奥泰生物制药股份有限公司关于GotenfiaR(戈利木单抗注射液)获欧洲EMA上市批准的公告
登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码:688177 证券简称:百奥泰 公告编号:2026-010 百奥泰生物制药股份有限公司 关于GotenfiaR(戈利木单抗注射液)获欧洲EMA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")于近日收到欧洲药品管理局(以下简 称"EMA")签发的关于GotenfiaR(BAT2506,戈利木单抗注射液)上市批准通知。 GotenfiaR作为百奥泰又一个获得EMA上市批准的产品,将进一步拓展公司国际化市场,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。已上市竞品和其他潜在竞品可能会拥有先行者 优势,GotenfiaR可能在未来面临激烈的市场竞争。 考虑到医药产品具有高科技、高风险、高附加值的特点,药品的前期研发以及产品从研制、临床试验报 批到投产的周期长,易受到技术、审批、政策等多方面因素的影响,未来产品市场竞争形势均存在诸多 不确定性,敬请广大投资者谨慎决策,注意投资风险,公 ...
2月12日晚间重要公告一览
Xi Niu Cai Jing· 2026-02-12 10:18
Group 1 - Fuda Alloy's controlling shareholder Wang Dawu plans to reduce his stake by up to 3% of the company's total shares, amounting to a maximum of 406.34 million shares, due to personal funding needs [1] - ST Songfa's subsidiary signed contracts for the construction of 17 vessels, with a total contract value between 1.6 billion to 1.8 billion USD [2] - Pairui Co. signed a technical cooperation agreement with a university to develop large-capacity power semiconductor devices and related power electronic modules, effective for three years [3] Group 2 - Shuangliang Energy indirectly participates in commercial aerospace projects, supplying heat exchangers for SpaceX's fuel production system, with orders totaling approximately 1.39 million CNY [4] - Hangya Technology plans to issue convertible bonds to raise up to 600 million CNY for various projects, including an intelligent manufacturing base in Malaysia [5] - Yuhua Development is publicly selling assets with a base price of 251 million CNY for residential properties [6] Group 3 - Penghui Energy plans to invest 2.1 billion CNY in a new battery production project in Zhengyang County, Henan Province, focusing on high-performance battery products [7] - Haige Communication's shareholder Yang Haizhou intends to reduce his stake by up to 0.1624% of the company's total shares [8] - Yaoshi Technology's controlling shareholder pledged 5.13% of shares to repay loans, with a pledge period from February 10, 2026, to February 2, 2027 [9][10] Group 4 - Hanyu Pharmaceutical received FDA approval for its drug Acetate Glatiramer Injection, used for treating relapsing multiple sclerosis [11] - Baiyao Tai's GoliMab Injection received EMA approval for various indications, including rheumatoid arthritis and ulcerative colitis [12] - Jiangxi Tungsten Equipment plans to issue A-shares to raise up to 1.882 billion CNY for acquisitions [13] Group 5 - Hesong New Materials expects to recognize asset impairment provisions between 23.6 million to 28.5 million CNY for 2025 [14] - ST Meichen's subsidiary is involved in two major lawsuits with a total amount of approximately 31.9 million CNY [15] - China Coal Energy reported a 7.3% year-on-year decline in coal sales for January 2026, with total sales of 20.05 million tons [16] Group 6 - Yida Co. plans to adjust its epoxy propylene derivative project, reducing the total investment from 845 million CNY to 642 million CNY [17] - Fosun Pharma's subsidiary received approval for a clinical trial of HLX15-SC for multiple myeloma treatment [18][19] - Yinfeng Communication's board members and executives have terminated their share reduction plan [20] Group 7 - Huazhong High-tech has waived its preferential purchase rights for a fund, extending the investment period from three to four years [21] - Warner Pharmaceuticals plans to participate in a national drug procurement program, with expected sales of 176 million CNY [22] - Changling Hydraulic announced a tender offer to acquire 12% of its shares at a price of 35.82 CNY per share [23] Group 8 - ST Chuan Zhi's stock may face delisting due to financial data falling below regulatory thresholds [24] - Tian Pharmaceutical and its subsidiaries are participating in a national drug procurement program, with expected sales of 323 million CNY [25] - China Metallurgical Group signed new contracts worth 73.65 billion CNY in January 2026 [26] Group 9 - Torus plans to invest 21.2 million CNY in a venture capital fund focused on artificial intelligence [27] - Shangwei Co. received a government subsidy of 1.764 million CNY, representing 10.79% of its net profit for 2024 [28] - Hanghua Co. reported a 21.97% decline in net profit for 2025, with total revenue of 1.249 billion CNY [29] Group 10 - Huaxia Bank reported a 1.72% decline in net profit for 2025, with total revenue of 91.914 billion CNY [30] - Guotou Fengle plans to transfer 51% of its stake in Hubei Fengle Ecological Fertilizer to optimize management [31] - Huaru Technology is co-investing in a fund with a total commitment of 20 million CNY [32] Group 11 - Jindike reported a loss of 173 million CNY for 2025, despite a 40.13% increase in revenue [33] - Zhenong Co. announced a 0.52% increase in shares held by a major shareholder [34] - Maike Audi plans to recognize asset impairment provisions of approximately 52.55 million CNY [35] Group 12 - Fuan Pharmaceutical's subsidiary is expected to be selected for a national drug procurement program, with projected sales of 680 million CNY [36] - Rundu Co. is participating in a national drug procurement program, with some products expected to be selected [37] - Changqing Co. has postponed its large-scale die-casting project to March 2027 due to customer requirements [38] Group 13 - Pan Asia Micro透 received a patent for a graphene-based automotive headlight defogging device [39] - Luan An Huan Neng reported a 17.1% increase in raw coal production for January 2026, totaling 5 million tons [40] - Guangji Pharmaceutical received a drug registration certificate for Mecobalamin Tablets [41] Group 14 - Ruifeng New Materials announced the resignation of its deputy general manager for personal reasons [42] - Zhiguang Electric's subsidiary signed a procurement contract for energy storage equipment worth 210.4 million CNY [43] - Youyan Powder Materials reported a 19.41% increase in net profit for 2025 [44] Group 15 - Jincheng reported a 22.2% increase in net profit for 2025, with total revenue of 253 million CNY [46]
百奥泰(688177) - 百奥泰 关于Gotenfia(戈利木单抗注射液)获欧洲EMA上市批准的公告
2026-02-12 09:15
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。 证券代码:688177 证券简称:百奥泰 公告编号:2026-010 百奥泰生物制药股份有限公司 关于 Gotenfia ®(戈利木单抗注射液)获欧洲 EMA 上市批准的公告 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。 截至本公告披露日,BAT2506(戈利木单抗注射液)的上市许可申请已获 得 NMPA、FDA、巴西国家卫生监督局受理。BAT2506(戈利木单抗注射液) 的商业化授权合作目前已覆盖 115 个国家和地区,主要包括: 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 欧洲药品管理局(以下简称"EMA")签发的关于Gotenfia®(BAT2 ...