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全球首创:国产破伤风新药登上医学顶刊Nature Medicine
生物世界· 2025-07-10 03:24
2025 年 7 月 8 日,北京大学人民医院 王传林 主任医师、 珠海泰诺麦博制药股份有限公 司 王 莞梅 博士作为共同通讯作者,在国际顶尖医学期刊 Nature Medicine 发表了题为: Recombinant monoclonal antibody siltartoxatug versus plasma-derived human tetanus immunoglobulin for tetanus: a randomized, double-blind, active-controlled, phase 3 trial 的临床研究论文。 这项随机、双盲、活性对照的 3 期临床试验结果显示, 全球首创的重组全人源抗破伤风毒素单克隆抗体新药—— 斯泰度塔单抗 ( Siltartoxatug ) ,相比当前 唯一推荐的抗破伤风被动免疫疗法 人破伤风免疫球蛋白 ,可提供更好的短期和长期防护效果。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 破伤风 是一种由破伤风梭菌 ( Clostridium tetani ) 产生的强效神经毒素所引发的危及生命的感染。在世界许多地区,尤其是在低收入国家或疫苗接种计划不完 ...
赛伦生物: 方正证券承销保荐有限责任公司关于上海赛伦生物技术股份有限公司2024年度持续督导跟踪报告
Zheng Quan Zhi Xing· 2025-05-20 08:19
Core Viewpoint - The report outlines the continuous supervision and monitoring responsibilities of the sponsor, Fangzheng Securities, for Shanghai Sailun Biotechnology Co., Ltd. (Sailun Bio) following its initial public offering on the STAR Market, emphasizing compliance with relevant regulations and the company's operational status [1]. Continuous Supervision Work Situation - The sponsor has established and effectively implemented a continuous supervision work system, including a work plan tailored to specific supervisory tasks [2]. - A continuous supervision agreement was signed with Sailun Bio, clarifying the rights and obligations of both parties during the supervision period [2]. - The sponsor conducts regular communication, site visits, and due diligence to understand Sailun Bio's operational conditions [2][3]. - The sponsor ensures that Sailun Bio complies with laws, regulations, and business rules issued by the Shanghai Stock Exchange [2][3]. - The sponsor monitors the company's governance structure and internal control systems, ensuring they are effectively executed [2][3]. Financial Performance - In 2024, Sailun Bio reported a revenue of approximately 194.92 million yuan, a 2.51% increase from 2023 [9]. - The net profit attributable to shareholders was approximately 44.29 million yuan, reflecting a 14.23% increase year-on-year [9]. - The net cash flow from operating activities increased by 53.12% to approximately 50.25 million yuan [9]. - The company's total assets decreased by 0.75% to approximately 1.12 billion yuan, while net assets increased by 0.89% to approximately 1.10 billion yuan [9]. Core Competitiveness - Sailun Bio has developed a strong competitive advantage in the research and production of antivenom and antitoxin products, with proprietary technologies and patents in various critical processes [11][12]. - The company is the sole domestic producer of specific antivenom products, enhancing its market position [11]. - Continuous innovation and improvement in production processes have led to significant advancements in product quality [11][12]. Research and Development Progress - The R&D expenditure accounted for 12.23% of revenue, a decrease of 3.76 percentage points compared to the previous year [16]. - Key R&D projects are progressing steadily, including the development of antivenom for pit viper bites and honeybee venom, with clinical trials and regulatory submissions underway [17]. - The company is also focusing on improving the production processes of existing products, which has yielded significant results [17]. Use of Raised Funds - The company raised approximately 89.38 million yuan from its IPO, with net proceeds of about 78.49 million yuan after deducting issuance costs [18]. - As of December 31, 2024, the company had utilized approximately 235.99 million yuan of the raised funds, maintaining compliance with regulatory requirements regarding fund usage [18].