瑞西奇拜单抗注射液
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金力永磁、广东明珠等公布三季报预告;兴业银锡:控股股东重整计划执行完毕丨公告精选
2 1 Shi Ji Jing Ji Bao Dao· 2025-10-09 13:37
Group 1: Company Performance - Jinli Permanent Magnet expects a net profit of 505 million to 550 million yuan for the first three quarters of 2025, representing a year-on-year increase of 157% to 179% [1] - Guangdong Mingzhu anticipates a net profit of 215 million to 263 million yuan for the first three quarters of 2025, reflecting a significant year-on-year growth of 858.45% to 1,071.44% [2] - Wide Special Materials forecasts a net profit of approximately 248 million yuan for the first three quarters of 2025, indicating a year-on-year increase of around 213.92% [6] Group 2: Product Development and Innovations - Jinli Permanent Magnet has established a division for embodied robot motor rotors, with small batch deliveries of related products expected in the first three quarters of 2025 [1] - Ganfeng Lithium has a complete integrated layout for solid-state batteries and has developed key components, including high-energy density batteries with a range of 320Wh/kg to 550Wh/kg [2] - Xingqi Eye Medicine received clinical trial approval for SQ-129, a new drug for treating diabetic macular edema, with no similar products approved domestically or internationally [4] Group 3: Strategic Investments and Projects - Tianhe Magnetic Materials plans to invest 850 million yuan in high-performance rare earth permanent magnet projects, with total investment expected to reach 900 million yuan [7] - Time Space Technology is planning to acquire control of Shenzhen Jiahe Jingwei Electronic Technology Co., Ltd. through a combination of share issuance and cash payment [9] - The company has initiated a project to enhance production capacity and efficiency in offshore wind power casting, contributing to profitability [6]
A股公告精选 | 金力永磁(300748.SZ)、广东明珠(600382.SH)等公布三季报预告
智通财经网· 2025-10-09 12:18
Group 1 - Jinli Permanent Magnet expects a net profit of 505 million to 550 million yuan for the first three quarters of 2025, representing a year-on-year increase of 157% to 179% [1] - Guangdong Mingzhu anticipates a net profit of 215 million to 263 million yuan for the first three quarters of 2025, with a year-on-year growth of 858.45% to 1,071.44% [1] - Guangda Special Materials forecasts a net profit of approximately 248 million yuan for the first three quarters of 2025, reflecting a year-on-year increase of about 213.92% [2] Group 2 - Taotao Vehicle expects a net profit of 580 million to 620 million yuan for the first three quarters of 2025, indicating a year-on-year growth of 92.46% to 105.73% [2] - Dongfang Wealth has set the initial transfer price at 24.40 yuan per share, which is an 8.9% discount from the closing price [3] - Ganfeng Lithium has established a complete integrated layout for solid-state batteries and possesses commercialization capabilities [3] Group 3 - Huahai Pharmaceutical's subsidiary has received acceptance for the marketing authorization application of a targeted IL-36R antibody, which is the first of its kind developed in China [4][5] - Xingqi Eye Medicine has obtained clinical trial approval for SQ-129, a sustained-release injection for treating diabetic macular edema [6] - Muyuan Foods has raised its forecast for piglet output in 2025 to a range of 12 million to 14.5 million heads [6] Group 4 - Tianhe Magnetic Materials plans to invest 900 million yuan in high-performance rare earth permanent magnet projects [6] - Qianli Technology reported a significant increase in new energy vehicle production, with 4,282 units produced in September 2025, a year-on-year increase of 975.88% [6] - Yongzhen Co. has signed a strategic cooperation agreement with BYD to provide aluminum alloy components for energy storage [6] Group 5 - Xingye Silver Tin's controlling shareholder has completed its restructuring plan without changing the control of the listed company [7] - Jiangxi Copper has experienced significant price increases in its main products, copper cathodes and gold [7] - Saisir has signed a framework agreement with ByteDance's Volcano Engine for collaboration in embodied intelligence [8] Group 6 - Luoyang Molybdenum's production and operational activities remain normal, with no significant fluctuations in production costs or sales [8] - Tongling Nonferrous Metals has reported significant price increases in its main products, copper cathodes and gold, with low processing fees for copper concentrate [8] - New Yisheng has set the initial transfer price at 328 yuan per share, reflecting a 6.6% discount from the closing price [9] Group 7 - Lichong Group has signed a strategic cooperation agreement with Weijing Intelligent to extend its business into humanoid robotics [10] - Poly Development plans to transfer 4.512 billion shares to Poly Group, making it the controlling shareholder [10] - Huajian Group's executives plan to collectively reduce their holdings by 1.05 million shares [10][11]
华海药业(600521.SH)子公司瑞西奇拜单抗注射液上市许可申请获得受理
智通财经网· 2025-10-09 09:35
智通财经APP讯,华海药业(600521.SH)发布公告,近日,公司下属子公司上海华奥泰生物药业股份有 限公司(简称"华奥泰")收到国家药品监督管理局签发的瑞西奇拜单抗(研发代号为:HB0034)注射液境内 生产药品注册上市许可申请的《受理通知书》。申报适应症:用于治疗成人泛发性脓疱型银屑病(GPP) 发作。 目前全球范围内,尚未有国内企业自研的靶向IL-36R抗体获批上市。HB0034作为国内首个自研创新抗 IL-36R抗体,可通过抑制IL-36通路发挥抗炎的生物学效应。根据研究分析结果显示,相比于安慰剂, HB0034单次静脉给药后的第1周GPP发作患者的皮肤脓疱得到明显清除,达到方案预设的主要研究终 点,安全性方面表现良好,未发现新的安全性信号。 ...
华海药业:子公司瑞西奇拜单抗注射液上市许可申请获受理
Di Yi Cai Jing· 2025-10-09 09:15
华海药业公告,公司下属子公司上海华奥泰生物药业股份有限公司收到国家药品监督管理局签发的瑞西 奇拜单抗(研发代号为:HB0034)注射液境内生产药品注册上市许可申请的《受理通知书》。该药品 用于治疗成人泛发性脓疱型银屑病(GPP)发作。目前全球范围内,尚未有国内企业自研的靶向IL-36R 抗体获批上市。HB0034作为国内首个自研创新抗IL-36R抗体,可通过抑制IL-36通路发挥抗炎的生物学 效应。根据研究分析结果显示,相比于安慰剂,HB0034单次静脉给药后的第1周GPP发作患者的皮肤脓 疱得到明显清除,达到方案预设的主要研究终点,安全性方面表现良好,未发现新的安全性信号。 ...
华海药业:子公司瑞西奇拜单抗注射液上市许可申请获得受理
Zheng Quan Shi Bao Wang· 2025-10-09 08:53
Core Viewpoint - Huahai Pharmaceutical (600521) announced that its subsidiary, Huaotai, received the acceptance notice for the drug registration application of HB0034 injection from the National Medical Products Administration, which is intended for the treatment of adult generalized pustular psoriasis (GPP) flare-ups [1] Company Summary - Huahai Pharmaceutical's subsidiary, Huaotai, is advancing in the pharmaceutical market with the development of HB0034 injection [1] - The drug is specifically aimed at treating a significant dermatological condition, indicating potential market demand and therapeutic relevance [1] Industry Summary - The approval process for new drug applications is critical in the pharmaceutical industry, reflecting regulatory compliance and the potential for market entry [1] - The treatment of generalized pustular psoriasis represents a niche but important segment within dermatological therapies, highlighting ongoing innovation in this area [1]
浙江华海药业股份有限公司关于下属子公司产品被纳入优先审评品种名单的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-08-18 23:54
登录新浪财经APP 搜索【信披】查看更多考评等级 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、准确性和完整性承担个别及连带责任。 近日,根据国家药品监督管理局药品审评中心(以下简称"CDE")发布的公示信息,浙江华海药业股份 有限公司(以下简称"华海药业"或"公司")下属子公司上海华奥泰生物药业股份有限公司(以下简 称"华奥泰")自主研发的瑞西奇拜单抗(研发代号为:HB0034)注射液被纳入优先审评审批程序的品 种名单。根据《国家药监局关于发布突破性治疗药物审评工作程序(试行)等三个文件的公告》(2020 年第82号)有关要求,CDE对纳入优先审评审批程序的药品上市许可申请,按注册申请受理时间顺序优 先配置资源进行审评。现将相关情况公告如下: 一、药物基本情况 药物名称:瑞西奇拜单抗注射液 剂型:注射剂 拟定适应症:用于治疗成人泛发性脓疱型银屑病(GPP)发作 注册分类:治疗用生物制品1类 申请人:上海华奥泰生物药业股份有限公司 优先审评理由:本品符合《药品注册管理办法》和《国家药监局关于发布突破性治疗药物审评工作程序 (试行)等三个文件的公告》(20 ...
华海药业:治疗用生物制品1类产品瑞西奇拜单抗注射液被纳入优先审评品种名单
Mei Ri Jing Ji Xin Wen· 2025-08-18 09:19
每经AI快讯,8月18日,华海药业(600521.SH)公告称,公司下属子公司华奥泰自主研发的瑞西奇拜单抗 (研发代号为:HB0034)注射液被纳入优先审评审批程序的品种名单。该药物用于治疗成人泛发性脓 疱型银屑病(GPP)发作,属于治疗用生物制品1类。目前全球范围内,尚未有国内企业自研的靶向IL- 36R抗体获批上市。HB0034作为国内首个自研创新抗IL-36R抗体,可通过抑制IL-36通路发挥抗炎的生 物学效应。 ...