证券日报网讯 12月16日，华兰生物发布公告称，近日参股公司华兰基因工程有限公司收到国家药品监 督管理局签发的帕博利珠单抗注射液境内生产药品注册临床试验申请《受理通知书》（受理号： CXSL2501079）。 （文章来源：证券日报） ...

Group 1 - The core point of the article is that Hualan Biological (002007.SZ) announced that its subsidiary, Hualan Gene Engineering Co., Ltd., received a clinical trial application acceptance notice from the National Medical Products Administration for the domestic production of Pembrolizumab injection [1] - Pembrolizumab is a biosimilar drug developed by the company, targeting multiple cancers including melanoma, non-small cell lung cancer, esophageal cancer, and head and neck squamous cell carcinoma [1] - The original product of Pembrolizumab, marketed as Keytruda, was developed by Merck and is one of the first PD-1 inhibitors approved globally, recognized for its clinical value across various significant tumor indications [1] Group 2 - Pembrolizumab is a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1), which plays a crucial role in immune checkpoint regulation [2] - The drug works by blocking the interaction between PD-1 and its ligands PD-L1/PD-L2, thereby restoring T cell anti-tumor activity and enhancing the immune system's ability to combat tumors [2] - As an immune checkpoint inhibitor, Pembrolizumab has become a standard treatment for various advanced malignancies, revolutionizing the landscape of cancer treatment [2] - Currently, there are no similar drugs approved for marketing in China, aside from the original product [2]

Core Viewpoint - Hualan Biological (002007.SZ) announced that its subsidiary, Hualan Gene Engineering Co., Ltd., received a clinical trial application acceptance notice from the National Medical Products Administration for the domestic production of the drug Pembrolizumab injection [1] Group 1: Drug Development - The Pembrolizumab injection developed by the company is a biosimilar drug [1] - The original product of Pembrolizumab (brand name: Keytruda) was developed by Merck & Co. and is one of the first PD-1 inhibitors approved globally [1] - Pembrolizumab has been approved for multiple significant cancer indications, including non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, esophageal cancer, liver cancer, gastric cancer, and colorectal cancer [1] Group 2: Mechanism of Action - Pembrolizumab is a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) [1] - PD-1 is a critical immune checkpoint protein on the surface of immune T cells, which tumor cells can activate to suppress T cell immune activity, leading to immune evasion [1] - Pembrolizumab works by blocking the binding of PD-1 to its ligands PD-L1/PD-L2, restoring T cell tumor-killing function and enhancing the immune system's ability to combat tumors [1] Group 3: Market Impact - As an immune checkpoint inhibitor, Pembrolizumab has become one of the standard treatment options for various advanced malignancies, revolutionizing the landscape of cancer treatment [1]

华兰生物公告，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帕博利珠单 抗注射液境内生产药品注册临床试验申请《受理通知书》（受理号：CXSL2501079）。药品名称为帕 博利珠单抗注射液，申请事项为境内生产药品注册临床试验，注册分类为治疗用生物制品3.3类，规格 为100mg（4ml）/瓶，药品适应症为黑色素瘤、非小细胞肺癌、食管癌、头颈部鳞状细胞癌等。 ...

证券代码：002007 证券简称：华兰生物 公告编号：2025-047 华兰生物工程股份有限公司 关于参股公司收到药品注册临床试验受理通知书的公告 注 册 分 类：治疗用生物制品 3.3 类 规 格：100mg（4ml）/瓶 药品适应症：黑色素瘤、非小细胞肺癌、食管癌、头颈部鳞状细胞癌等。 申 请 人：华兰基因工程有限公司 结 论：根据《中华人民共和国行政许可法》第三十二条的规定，经审 查，决定予以受理。 二、药品相关情况简介 公司研发的帕博利珠单抗注射液为生物类似药。帕博利珠单抗原研产品（商 品名：可瑞达®，Keytruda®）由默沙东公司开发，是全球首个获批上市的 PD-1 抑制剂之一，已在全球范围内获批用于包括非小细胞肺癌、黑色素瘤、头颈部鳞 状细胞癌、食管癌、肝癌、胃癌、结直肠癌等在内的数十个重要肿瘤适应症，临 床价值得到广泛认可。 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没 有虚假记载、误导性陈述或重大遗漏。 近日，华兰生物工程股份有限公司（以下简称"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帕博利 珠单抗注射液境内生产药品注册临床试 ...

Group 1 - Unicom Guowei has established a Central Research Institute focusing on the development of edge AI chips for applications in autonomous driving, embodied robots, and low-altitude flying vehicles [2] - The research will also include new types of storage devices based on two-dimensional materials and high-performance special sensor chips [2] - Aerospace Electronics plans to increase its investment in Aerospace Long March Rocket Technology Co., Ltd. by 728 million yuan, maintaining the existing shareholding structure [3] Group 2 - Aerospace Rainbow successfully completed the first flight test of its self-developed Rainbow-7 high-altitude, high-speed, long-endurance drone, achieving all preset parameters [4] - The project is still in the research and testing phase, with further rigorous testing and validation required before mass production [4] Group 3 - Changchun High-tech's subsidiary signed an exclusive licensing agreement for the GenSci098 injection project, potentially earning up to 1.365 billion USD in milestone payments [5] - The agreement includes an initial payment of 120 million USD and additional milestone payments related to development and commercialization [5] Group 4 - TCL Technology plans to acquire a 10.7656% stake in Shenzhen Huaxing Semiconductor for 6.045 billion yuan, increasing its ownership from 84.2105% to 94.9761% [26] - This acquisition aims to enhance TCL's competitiveness and profitability in the semiconductor display industry [26] Group 5 - Zhongmin Resources announced the successful ignition of its Tsumeb smelting plant's multi-metal comprehensive recycling project, with an annual processing capacity of 80,000 tons [11] - The project will produce various products, including germanium ingots and zinc ingots, with a design capacity of 33 tons/year for germanium [11] Group 6 - Xinhua Insurance reported a 16% year-on-year increase in original insurance premium income, totaling 188.85 billion yuan from January to November 2025 [43] - This growth reflects the company's strong performance in the insurance market [43]

（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）。 ...

一周观点 总量研究 本周观点 | 总量研究 2 | | --- | | 本周观点 2 | | 重点报告 2 | | 行业研究 4 | | 本周观点 4 | | 重点报告 5 | | 公司研究 6 | | 重点报告 6 | | 重点报告摘要 7 | | 总量研究 7 | | 行业研究 10 | | 公司研究 12 | | 领域 | 一周观点 | 分析师 | | --- | --- | --- | | | 新一轮政策部署护航，A 股跨年行情可期。一方面，未来国内经济政策有望持续发力，经济增 | | | | 长有望保持在合理区间，进一步夯实资本市场繁荣发展的基础；另一方面，政策红利释放，有 | | | 策略 | 望提振市场信心，进一步吸引各类资金积极流入；此外，历史来看，"十三五"和"十四五" | 张宇生 | | | 开局之年 A 股市场均有不错的表现，历史上开局之年的积极表现有望在 2026 年得到延续。 | | | | 本周国内权益市场指数普遍上涨，创业板指上涨 1.86%,周期主题基金表现占优，消费、医药 | | | 金工 | 主题基金净值回调。国内市场新成立基金 39 只，合计发行份额为 365.89 亿份 ...

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 ...

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 ...