地舒单抗注射液
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华兰生物:关于参股公司收到药品注册受理通知书的公告
Zheng Quan Ri Bao· 2025-12-15 09:45
(文章来源:证券日报) 证券日报网讯 12月15日,华兰生物发布公告称,近日公司参股公司华兰基因工程有限公司收到国家药 品监督管理局签发的地舒单抗注射液境内生产药品注册上市许可申请《受理通知书》(受理号: CXSS2500138)。 ...
华兰生物(002007.SZ)参股公司地舒单抗注射液药品注册获受理
智通财经网· 2025-12-15 04:32
智通财经APP讯,华兰生物(002007.SZ)发布公告,近日,公司参股公司华兰基因工程有限公司(以下简 称"基因公司")收到国家药品监督管理局签发的地舒单抗注射液境内生产药品注册上市许可申请《受理 通知书》(受理号:CXSS2500138)。 目前国内已有江苏泰康生物医药有限公司、齐鲁制药有限公司、山东博安生物技术股份有限公司、康宁 杰瑞(吉林)生物科技有限公司四家公司的地舒单抗注射液获批上市,若基因公司获批上市,将丰富基因 公司的产品梯队,为基因公司增加新的利润增长点。 地舒单抗是一种人源化单克隆抗体(IgG2型),通过特异性靶向核因子κB受体活化因子配体(RANKL)发 挥作用。RANKL是破骨细胞形成、发挥功能和存活所必需的关键因子。恶性肿瘤骨转移常导致骨溶解 性破坏,引发骨痛、病理性骨折、脊髓压迫、高钙血症等骨相关事件,严重影响患者生活质量和生存预 后。地舒单抗通过抑制RANKL,强效抑制破骨细胞介导的骨吸收和骨破坏,从而有效预防和延迟上述 骨相关事件的发生,是临床重要的肿瘤支持治疗药物。 公司研发的地舒单抗注射液为生物类似药。其原研产品由安进公司开发,已在全球多个国家及地区获批 上市,用于治疗骨质 ...
华兰生物参股公司地舒单抗注射液药品注册获受理
Zhi Tong Cai Jing· 2025-12-15 04:32
智通财经APP讯,华兰生物(002007.SZ)发布公告,近日,公司参股公司华兰基因工程有限公司(以下简 称"基因公司")收到国家药品监督管理局签发的地舒单抗注射液境内生产药品注册上市许可申请《受理 通知书》(受理号:CXSS2500138)。 目前国内已有江苏泰康生物医药有限公司、齐鲁制药有限公司、山东博安生物技术股份有限公司、康宁 杰瑞(吉林)生物科技有限公司四家公司的地舒单抗注射液获批上市,若基因公司获批上市,将丰富基因 公司的产品梯队,为基因公司增加新的利润增长点。 公司研发的地舒单抗注射液为生物类似药。其原研产品由安进公司开发,已在全球多个国家及地区获批 上市,用于治疗骨质疏松症、骨巨细胞瘤等多类骨骼疾病,其疗效与安全性获得了广泛临床验证。 地舒单抗是一种人源化单克隆抗体(IgG2型),通过特异性靶向核因子κB受体活化因子配体(RANKL)发 挥作用。RANKL是破骨细胞形成、发挥功能和存活所必需的关键因子。恶性肿瘤骨转移常导致骨溶解 性破坏,引发骨痛、病理性骨折、脊髓压迫、高钙血症等骨相关事件,严重影响患者生活质量和生存预 后。地舒单抗通过抑制RANKL,强效抑制破骨细胞介导的骨吸收和骨破坏,从而 ...
A股午间公告:东方智造控股股东科翔高新拟转让14.33%公司股份
Ge Long Hui A P P· 2025-12-15 04:14
③华兰生物:近日,公司参股公司华兰基因工程有限公司收到国家药品监督管理局签发的地舒单抗注射 液境内生产药品注册上市许可申请《受理通知书》。 格隆汇12月15日|①东方智造:控股股东科翔高新正在筹划涉及其所持有公司股份转让事宜,拟将持有 占公司总股本约14.33%的股份转让给广西现代物流集团有限公司或其指定主体,该事项可能导致公司 控制权发生变更。公司股票自2025年12月15日开市起停牌,预计停牌时间不超过2个交易日。 ②华侨城A:2025年11月,公司实现合同销售面积8.6万平方米,同比减少61%,环比10月减少5%;合 同销售金额12.0亿元,同比减少65%,环比10月减少8%。2025年1—11月,公司累计实现合同销售面积 107.1万平方米,同比减少31%;合同销售金额157.5亿元,同比减少33%。 ...
华兰生物:参股公司收到药品注册受理通知书
2 1 Shi Ji Jing Ji Bao Dao· 2025-12-15 03:56
南财智讯12月15日电,华兰生物公告称,公司参股公司华兰基因工程有限公司近日收到国家药监局签发 的地舒单抗注射液境内生产药品注册上市许可申请《受理通知书》。规格为120mg(1.7ml)/瓶,申请 人为华兰基因工程有限公司。该药品为治疗用生物制品3.3类。 ...
华兰生物(002007.SZ)参股公司收到药品注册受理通知书
Ge Long Hui A P P· 2025-12-15 03:56
目前国内已有江苏泰康生物医药有限公司、齐鲁制药有限公司、山东博安生物技术股份有限公司、康宁 杰瑞(吉林)生物科技有限公司四家公司的地舒单抗注射液获批上市,若基因公司获批上市,将丰富基因 公司的产品梯队,为基因公司增加新的利润增长点。 地舒单抗是一种人源化单克隆抗体(IgG2型),通过特异性靶向核因子κB受体活化因子配体(RANKL)发 挥作用。RANKL是破骨细胞形成、发挥功能和存活所必需的关键因子。恶性肿瘤骨转移常导致骨溶解 性破坏,引发骨痛、病理性骨折、脊髓压迫、高钙血症等骨相关事件,严重影响患者生活质量和生存预 后。地舒单抗通过抑制RANKL,强效抑制破骨细胞介导的骨吸收和骨破坏,从而有效预防和延迟上述 骨相关事件的发生,是临床重要的肿瘤支持治疗药物。 格隆汇12月15日丨华兰生物(002007.SZ)公布,近日,公司参股公司华兰基因工程有限公司(以下简称"基 因公司")收到国家药品监督管理局签发的地舒单抗注射液境内生产药品注册上市许可申请《受理通知 书》(受理号:CXSS2500138)。 公司研发的地舒单抗注射液为生物类似药。其原研产品由安进公司开发,已在全球多个国家及地区获批 上市,用于治疗骨质疏 ...
复星医药拟分拆旗下疫苗平台赴港上市
Guo Ji Jin Rong Bao· 2025-10-29 13:15
Core Viewpoint - Fosun Pharma (600196.SH; 02196.HK) reported a decline in revenue for the first three quarters of 2025, but a significant increase in net profit, driven by its innovative drug segment and plans for the spin-off of its subsidiary, Fosun Antigen, for listing in Hong Kong [1][2][3]. Financial Performance - For the first three quarters of 2025, Fosun Pharma achieved revenue of 29.39 billion yuan, a year-on-year decrease of 4.91% [1][2]. - The net profit attributable to shareholders was 2.52 billion yuan, reflecting a year-on-year increase of 25.5% [1][2]. - Innovative drug revenue exceeded 6.7 billion yuan, marking an 18.09% year-on-year growth [1]. - The net cash flow from operating activities was 3.38 billion yuan [1]. Quarterly Results - In Q3 2025, revenue was 9.88 billion yuan, down 5.46% year-on-year, while net profit was 821 million yuan, up 4.52% [4]. - The decrease in revenue was attributed to the impact of centralized drug procurement policies [4]. - The basic and diluted earnings per share for the first three quarters were 0.95 yuan, a 26.67% increase year-on-year [2]. Research and Development - Fosun Pharma's R&D investment for the first three quarters of 2025 totaled 3.998 billion yuan, a 2.12% increase year-on-year, with R&D expenses of 2.73 billion yuan [4]. - In Q3 2025, R&D expenses were 1.013 billion yuan, a significant increase of 28.81% year-on-year, focusing on high-value pipelines [4]. Spin-off Plans - The company announced plans to spin off its subsidiary, Fosun Antigen, which focuses on vaccine development, for a listing on the Hong Kong Stock Exchange [1][2][8]. - Fosun Pharma has a history of successfully spinning off subsidiaries for financing, including the 2019 IPO of its subsidiary, Fuhong Hanlin, which raised 3.13 billion HKD [8]. Debt and Asset Management - Fosun Pharma is actively managing its debt, with short-term borrowings reaching 17.862 billion yuan and a total interest-bearing debt of 36.994 billion yuan [10]. - The company has been disposing of non-core assets to optimize its asset structure and improve cash flow, including the planned sale of Shanghai Clone for up to 1.256 billion yuan [9].
复星医药今年前三季度创新药收入增长超18%
Xin Jing Bao· 2025-10-29 04:21
Core Insights - Fosun Pharma reported a revenue of 29.393 billion yuan for the first three quarters of 2025, a year-on-year decline of 4.91% [1] - The revenue from innovative drugs exceeded 6.7 billion yuan, showing a growth of 18.09% year-on-year [1] - The net profit attributable to shareholders reached 2.523 billion yuan, an increase of 25.5% year-on-year [1] Innovative Products - The company focuses on core treatment areas such as solid tumors, hematological tumors, and immune inflammation, enhancing its core technology platforms including antibodies, ADCs, cell therapy, and small molecules [1] - The innovative small molecule CDK4/6 inhibitor, Fovetisil Capsules, received approval for an additional indication in China for HR+/HER2- locally advanced or metastatic breast cancer [1] - The self-developed drug, Dushuan Antibody Injection (HLX14), was approved for sale in the US and EU, marking it as the first domestically produced Dushuan antibody approved overseas [1] R&D Investments - Fosun Pharma's R&D investment totaled 3.998 billion yuan in the first three quarters, a year-on-year increase of 2.12%, with R&D expenses amounting to 2.730 billion yuan [2] - In Q3, R&D expenses reached 1.013 billion yuan, up 28.81% year-on-year, primarily invested in innovative platforms including nuclear medicine and cell therapy [2] - The clinical trials for the innovative PD-1 inhibitor, Surulizumab, are progressing smoothly, with a Phase III trial for gastric cancer achieving its primary endpoint [2] New Business Initiatives - In September, Fosun Pharma established a nuclear medicine business platform, Xingrui Jingxuan, aiming to develop integrated diagnostic and therapeutic nuclear medicine products in the pan-tumor field [3]
创新药发力 复星医药前三季度创新药品收入超67亿元
Zheng Quan Ri Bao Wang· 2025-10-28 14:13
Core Viewpoint - Shanghai Fosun Pharmaceutical (Group) Co., Ltd. reported a revenue decline of 4.91% year-on-year for the first three quarters of 2025, totaling CNY 29.393 billion, while innovative drug revenue increased by 18.09% to over CNY 6.7 billion, indicating a strategic focus on innovation-driven growth [1][2]. Group 1: Financial Performance - For the first three quarters of 2025, Fosun Pharmaceutical achieved a total revenue of CNY 29.393 billion, reflecting a year-on-year decrease of 4.91% [1]. - Innovative drug revenue reached over CNY 6.7 billion, marking an 18.09% increase compared to the previous year [1]. Group 2: Innovation and Product Development - In Q3 2025, several self-developed innovative drugs made significant progress in mainstream markets, including the approval of a new indication for the small molecule CDK4/6 inhibitor, Fuzhengning, for specific breast cancer patients in China [2]. - The self-developed Dushuan injection received approval in the U.S. and EU, becoming the first domestically developed Dushuan to be approved overseas, covering all indications previously approved for the original drug [2]. - The CAR-T product, Brexucabtagene autoleucel, had its drug registration application accepted by the National Medical Products Administration in September 2025 for treating adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia [2]. Group 3: Strategic Initiatives - On October 28, 2025, Fosun Pharmaceutical announced plans to spin off its vaccine business platform for a listing on the Hong Kong Stock Exchange to enhance its competitive edge in the vaccine sector [3]. - The company signed a partnership agreement to invest CNY 100 million in a target fund focusing on strategic emerging sectors, including chemical innovation drugs, biopharmaceuticals, high-end medical devices, and traditional Chinese medicine [3]. - Fosun Pharmaceutical is establishing a nuclear medicine platform, Xingrui Jingxuan, to develop integrated diagnostic and therapeutic nuclear medicine products, emphasizing its commitment to innovation and resource optimization [3].
复星医药2025前三季度创新药品收入超67亿元 同比增长18.09%
Xin Hua Cai Jing· 2025-10-28 13:41
Core Insights - Fosun Pharma reported a revenue of 29.393 billion RMB for the first three quarters of 2025, showing a decline compared to the same period last year, but innovative drug revenue grew robustly, exceeding 6.7 billion RMB, a year-on-year increase of 18.09% [2] - The company is focusing on cost reduction, efficiency improvement, and asset lightening, optimizing its asset and financial structure, which resulted in a net cash flow from operating activities of 3.382 billion RMB, up 13.23% year-on-year [2] - Fosun Pharma is advancing its innovation transformation, with new approvals for its proprietary drugs, including a new indication for its CDK4/6 inhibitor and the first domestic desmopressin approved in the US and EU [2][3] Revenue and Financial Performance - For the first three quarters of 2025, Fosun Pharma's total revenue was 29.393 billion RMB, reflecting a decrease from the previous year [2] - Innovative drug revenue reached over 6.7 billion RMB, marking an 18.09% increase year-on-year, indicating a shift towards a more optimized revenue structure [2] - The net cash flow from operating activities was 3.382 billion RMB, representing a 13.23% increase compared to the same period last year [2] Research and Development Progress - R&D investment totaled 3.998 billion RMB in the first three quarters of 2025, a 2.12% increase year-on-year, with R&D expenses amounting to 2.730 billion RMB [4] - In Q3 2025, R&D expenses were 1.013 billion RMB, up 28.81%, primarily focused on innovative platforms including nuclear medicine and cell therapy [4] - The company is developing a high-value pipeline, with significant advancements in PD-1 inhibitors and other innovative drugs, and has established a nuclear medicine platform to integrate diagnosis and treatment in oncology [3][4] Product Development and Approvals - Fosun Pharma's CAR-T product, FKC889, received acceptance for registration in September 2025 for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adults [3] - The company’s innovative PD-1 inhibitor and other drug candidates have reached critical research milestones, with HLX43 receiving orphan drug designation from the FDA [3] - The establishment of the Xingrui Jingxuan nuclear medicine platform indicates a strategic move into integrated oncology treatment solutions [3]