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复星医药(02196.HK):复宏汉霖”斯鲁利单抗注射液“药品注册申请获受理
Ge Long Hui· 2025-12-12 11:51
格隆汇12月12日丨复星医药(02196.HK)公告,近日,上海复星医药(集团)股份有限公司控股子公司上海 复宏汉霖生物技术股份有限公司及其控股子公司就斯鲁利单抗注射液(中国境内商品名:汉斯状®;以 下简称"该药品")新增适应症(即联合含铂化疗新辅助,在手术后辅助治疗,用于PD-L1阳性的、可手术 切除的胃癌患者)的药品注册申请获国家药品监督管理局受理,并已获纳入优先审评程序。 该药品为集团(即公司及控股子公司/单位,下同)自主研发的创新型抗PD-1单抗。截至本公告日期(即 2025年12月12日,下同),该药品已于中国、欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西亚、新 加坡及印度等国家/地区获批上市,其中中国境内已获批适应症包括联合化疗一线治疗鳞状非小细胞肺 癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq- NSCLC); 此外,该药品相关适应症已获美国、欧盟、瑞士及韩国等国家/地区的药品监管部门授予孤儿药资格认 定,且该药品用于联合化疗新辅助/辅助治疗胃癌已于2025年11月被国家药监局药品审评中心纳入突破 性治疗药物程序;另有以该药品 ...
复星医药:控股子公司酮洛芬贴剂获准开展临床试验
人民财讯12月12日电,复星医药(600196)12月12日公告,控股子公司上海复宏汉霖生物技术股份有限 公司及其控股子公司就斯鲁利单抗注射液新增适应症(即联合含铂化疗新辅助,在手术后辅助治疗,用 于PD-L1阳性的、可手术切除的胃癌患者)的药品注册申请获国家药监局受理,并已获纳入优先审评程 序。公司同日公告,控股子公司朝晖药业收到国家药监局关于同意酮洛芬贴剂开展临床试验的批准。朝 晖药业拟于条件具备后开展该药品的Ⅲ期临床试验。该药品系化学药物。拟主要用于部分疾病及症状的 镇痛﹑消炎。 ...
复星医药(600196.SH):斯鲁利单抗注射液新增适应症药品注册申请获受理
智通财经网· 2025-12-12 09:49
该药品为集团自主研发的创新型抗PD-1单抗。截至本公告日期(即2025年12月12日,下同),该药品已于 中国、欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西亚、新加坡及印度等国家/地区获批上市,其 中中国境内已获批适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES- SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC);此外,该药品相关适应症已获美 国、欧盟、瑞士及韩国等国家/地区的药品监管部门授予孤儿药资格认定,且该药品用于联合化疗新辅 助/辅助治疗胃癌已于2025年11月被国家药监局药品审评中心纳入突破性治疗药物程序;另有以该药品为 核心的多项联合疗法正在全球多个国家和地区开展临床试验,覆盖肺癌、食管癌、头颈鳞癌、结直肠癌 和胃癌等适应症。 智通财经APP讯,复星医药(600196.SH)发布公告,近日,公司控股子公司上海复宏汉霖生物技术股份 有限公司及其控股子公司就斯鲁利单抗注射液(中国境内1商品名:汉斯状®;以下简称"该药品")新增适 应症(即联合含铂化疗新辅助,在手术后辅助治疗,用于PD-L1阳性的、可手术切除的胃癌患者)的药品 注册申 ...
复星医药:斯鲁利单抗注射液新增适应症药品注册申请获受理
Zhi Tong Cai Jing· 2025-12-12 09:47
该药品为集团自主研发的创新型抗PD-1单抗。截至本公告日期(即2025年12月12日,下同),该药品已于 中国、欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西亚、新加坡及印度等国家/地区获批上市,其 中中国境内已获批适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES- SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC);此外,该药品相关适应症已获美 国、欧盟、瑞士及韩国等国家/地区的药品监管部门授予孤儿药资格认定,且该药品用于联合化疗新辅 助/辅助治疗胃癌已于2025年11月被国家药监局药品审评中心纳入突破性治疗药物程序;另有以该药品为 核心的多项联合疗法正在全球多个国家和地区开展临床试验,覆盖肺癌、食管癌、头颈鳞癌、结直肠癌 和胃癌等适应症。 复星医药(600196)(600196.SH)发布公告,近日,公司控股子公司上海复宏汉霖生物技术股份有限公 司及其控股子公司就斯鲁利单抗注射液(中国境内1商品名:汉斯状;以下简称"该药品")新增适应症(即联 合含铂化疗新辅助,在手术后辅助治疗,用于PD-L1阳性的、可手术切除的胃癌患者)的药品注册申请 获 ...
复星医药(600196.SH):控股子公司药品斯鲁利单抗注射液注册申请获受理
Ge Long Hui A P P· 2025-12-12 09:41
Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a new indication of the drug Surulitinib Injection, which is now included in the priority review process [1] Group 1 - The new indication is for the use of Surulitinib Injection in combination with platinum-based chemotherapy as neoadjuvant therapy and postoperative adjuvant treatment for PD-L1 positive, resectable gastric cancer patients [1] - Surulitinib is an innovative anti-PD-1 monoclonal antibody independently developed by the group [1]
IVD巨头共识下注肿瘤早筛
Century Securities· 2025-11-24 12:21
Investment Rating - The report does not explicitly state an investment rating for the industry [2] Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 6.88% from November 17 to November 21, underperforming compared to the Wind All A index (-5.13%) and the CSI 300 index (-3.77%) [3][8] - All sub-sectors within the industry reported losses, with raw materials (-8.6%), offline pharmacies (-8.58%), and other biological products (-7.99%) leading the decline [3][8] - Major companies in the IVD sector are increasingly investing in cancer early screening, with Abbott announcing a $21 billion acquisition of Exact Sciences and Roche entering a partnership with Freenome valued at over $200 million [3][12] - Flu activity is on the rise, with the percentage of flu-like illness cases reported in southern provinces reaching 6.7%, up from 5.5% the previous week, and higher than the same period in previous years [3][11] Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector fell by 6.88%, underperforming the broader market indices [8] - All sub-sectors declined, with raw materials and offline pharmacies showing the largest drops [8] - Individual stock performances varied, with Hainan Haiyao increasing by 23.8% while Jindike fell by 25.5% [11] Industry News and Key Company Announcements Important Industry Events - The report highlights the increase in flu cases in both southern and northern provinces, surpassing levels from previous years [11] Industry News - GE HealthCare announced a $2.3 billion acquisition of Intelerad, indicating a focus on cloud and AI solutions in healthcare [12] - Significant acquisitions and partnerships in the cancer diagnostics space were noted, including Abbott's acquisition of Exact Sciences and Roche's collaboration with Freenome [12][15] Company Announcements - Various companies announced significant developments, including clinical trial approvals and new drug applications, reflecting ongoing innovation in the sector [15][16]
复星医药:控股子公司斯鲁利单抗注射液已被纳入突破性治疗药物程序
Cai Jing Wang· 2025-11-21 05:43
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received breakthrough therapy designation for its independently developed Sru Li Anti-Inflammatory Injection for use in combination chemotherapy for gastric cancer [1] Company Summary - The drug is an innovative anti-PD-1 monoclonal antibody developed by Fosun Pharma [1] - As of November 20, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - In China, the approved indications include first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - Multiple combination therapies involving this drug are currently undergoing clinical trials in various countries, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1]
上证早知道|人民币对日元汇率,创阶段新高!ST中迪,22个连续涨停!大基金减持拓荆科技!“铀业第一股”来了!
Industry Events - The 2025 China 5G + Industrial Internet Conference will be held from November 21 to 23 in Wuhan, focusing on the integration of 5G, AI, big data, and industrial internet technologies [2] - The China Rare Earth Society's 2025 Academic Annual Meeting will take place on November 21 in Xiamen, discussing advancements in rare earth research and applications [2] - Huawei will release breakthrough AI technology on November 21, aiming to increase the utilization rate of computing resources from the industry average of 30%-40% to 70% [2] - Foxconn will showcase new products in collaboration with Nvidia during the Hon Hai Technology Day on November 21 [2] Company News - Walmart announced its transition from the New York Stock Exchange to Nasdaq, with trading expected to begin on December 9 [12] - Tuojing Technology's major shareholder plans to reduce its stake by up to 843.49 million shares, representing 3% of the total share capital, from December 12, 2025, to March 11, 2026 [12] - Qianyuan High-Tech received a takeover offer from China Seed Group for 20% of its total shares at a price of 11.85 yuan per share, totaling an estimated 2.245 billion yuan [12] - Fosun Pharma's subsidiary has received breakthrough therapy designation for its independently developed drug for gastric cancer, marking a significant milestone in treatment options [12] - *ST Weihai signed a construction contract worth 313 million yuan, which is expected to positively impact the company's future performance [12][13] Market Trends - Multiple new energy-themed ETFs have attracted significant capital inflows, with the Huatai-PineBridge CSI Battery Theme ETF seeing a net subscription of 1.696 billion yuan since the fourth quarter began [16] - Institutional investors are focusing on rebalancing their portfolios as the year-end approaches, with an emphasis on sectors like cyclical stocks and consumer goods [8][7] Supply and Demand Insights - Tungsten prices continue to rise due to favorable supply and demand dynamics, with prices for various tungsten products increasing by approximately 6% compared to the first half of November [10] - The overall price of tungsten products has surged over 120% this year, driven by increased demand from industries such as photovoltaics and automotive [10]
11月20日这些公告有看头
Di Yi Cai Jing Zi Xun· 2025-11-20 15:24
Major Announcements - EVE Energy signed a procurement framework agreement with Smoore International for the continuous supply of battery cells and other products as raw materials, with actual amounts to be determined by future orders [3] - ST Huami's stock is under "double risk" warning due to an audit report expressing inability to provide an opinion for the 2024 financial report, with a recovery of 1.567 billion yuan in occupied funds [4] - Wuzhou Transportation received a regulatory warning for accounting irregularities and failure to fulfill integrity checks for executives, leading to inaccurate financial disclosures [5] - Wenfeng Co. announced that its vice president is under investigation, but this will not significantly impact the company's operations [6] - Fosun Pharma's subsidiary has had its drug included in the breakthrough therapy designation program for gastric cancer treatment, marking a significant development in its product pipeline [7][8] - Shandong Steel's subsidiary is applying for bankruptcy liquidation, which is expected to increase the parent company's net profit by 15.88 million yuan [9] - Zhouming Technology established a new subsidiary, Shenzhen Zhixian Robotics Co., with a registered capital of 50 million yuan [10] Share Buybacks and Holdings - Spring Airlines conducted its first share buyback, acquiring 35,800 shares for a total of 1.9997 million yuan [11] - Donghua Software's controlling shareholder reduced his stake by 1%, selling 10.9832 million shares [12] - Changshu Bank's executives plan to increase their holdings by at least 550,000 shares over the next six months [13] Major Contracts - Nanfeng Co. won contracts worth 45.7 million yuan and 47.17 million yuan for HVAC systems, with delivery scheduled for 2027 [14] - Huakang Clean announced a pre-bid win for a purification system project at Keqiao Future Medical Center, with a bid price of 176 million yuan [15][16] - Qinglong Pipe Industry secured a contract worth 294 million yuan for a pipe procurement project, expected to impact its performance from 2026 to 2030 [17] - China Nuclear Engineering signed new contracts totaling 123.84 billion yuan as of October, with cumulative revenue of 81.334 billion yuan [18]
11月20日这些公告有看头
第一财经· 2025-11-20 14:48
Core Viewpoint - The article summarizes important announcements from various companies, providing insights for investors regarding partnerships, financial performance, and regulatory actions. Group 1: Partnerships and Agreements - EVE Energy signed a procurement framework agreement with Smoore International for the continuous supply of battery cells and other products, with the actual amounts to be determined by future orders [4] Group 2: Financial Performance and Risks - ST Huami's stock is under "double risk" warning due to an inability to express an opinion on its 2024 financial report, with 1.567 billion yuan of occupied funds recovered [5] - Shandong Steel's subsidiary Metallurgical Ecology is applying for bankruptcy liquidation, which is expected to increase the parent company's net profit by 158.8 million yuan [9] Group 3: Regulatory Actions - Wuzhou Transportation received a regulatory warning for accounting irregularities and failure to fulfill integrity checks for executives, leading to inaccurate financial disclosures [6] - Wenkang's vice president is under investigation, but the company states that this will not significantly impact its operations [7] Group 4: New Projects and Contracts - Nanfeng Co. won contracts worth 45.7 million yuan and 47.17 million yuan for HVAC systems, expected to positively impact future financial performance [14] - Huakang Clean announced a pre-bid win for a purification system project at Keqiao Future Medical Center, with a bid of 176 million yuan [16] - Qinglong Pipe Industry secured a contract worth 294 million yuan for pipe procurement, which represents 10.43% of its audited revenue for 2024 [17] - China Nuclear Engineering signed new contracts totaling 123.84 billion yuan as of October 2025, with revenue of 81.334 billion yuan [18] Group 5: Share Buybacks and Holdings - Spring Airlines conducted its first share buyback, acquiring 35,800 shares for a total of 1.9997 million yuan [11] - Donghua Software's controlling shareholder reduced his stake by 1%, now holding 10.90% of the company [12] - Changshu Bank's executives plan to increase their holdings by at least 550,000 shares over the next six months [13]