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、准确性和完整性依法承担法律责任。 2025年12月22日，前沿生物药业（南京）股份有限公司（以下简称"公司"）向国家药品监督管理局提交 了公司自主研发的一款靶向补体系统凝集素途径关键蛋白MASP-2靶点的siRNA药物（产品代码： FB7013）临床试验申请，2025年12月31日，公司收到国家药品监督管理局核准签发的受理通知书， FB7013的临床试验申请获得受理。现就相关信息公告如下： FB7013在健康食蟹猴中对靶蛋白具有强效且持久的抑制作用，单次皮下注射FB7013对血清MASP-2蛋 白的最大敲降幅度〉95%，且维持时间长，在给药后105天蛋白敲降幅度仍大于90%，预期在临床阶段 有望实现每3-6个月给药一针，有望提升患者的用药依从性。 FB7013在食蟹猴IgA肾病模型中显示出明确的疗效，且试验观察期间，安全性良好。在食蟹猴IgA肾病 模型中，FB7013单次皮下注射给药后，尿总蛋白肌酐比值（uPCR）和尿总蛋白（uTP）呈剂量依赖地 持续显著降低，肾小球滤过率（eGFR）呈剂量依赖地持续升高；高 ...

Core Viewpoint - Rebio Biotech, established in 2007, is attempting to go public in Hong Kong after previously withdrawing its application for the Sci-Tech Innovation Board in 2020. Despite being recognized as a leader in the small nucleic acid drug sector, the company has yet to commercialize any self-developed drugs, relying heavily on financing and technology licensing for revenue [1][3]. Financial Performance - Rebio Biotech reported a revenue of RMB 44,000 in 2023, which is projected to increase to RMB 1.43 billion in 2024. However, net losses for the same periods were RMB 4.37 billion and RMB 2.81 billion, respectively, leading to a cumulative loss exceeding RMB 7 billion over two years [4][5]. - The company's total assets fluctuated from approximately RMB 7.16 billion in 2023 to RMB 10 billion in 2025, while total liabilities increased from RMB 6 billion to RMB 9.42 billion during the same period [5][6]. Funding and Financing - From 2015 to 2025, Rebio Biotech raised a total of RMB 1.829 billion from various investors, including Hillhouse Capital and CICC Capital. However, the company's valuation has been volatile, dropping from RMB 48.7 billion in 2024 to RMB 35.8 billion in 2025 [8][9]. - The company has been utilizing a combination of financing and business development (BD) partnerships to maintain operations, with significant contributions from collaborations, such as a deal with Qilu Pharmaceutical worth over RMB 700 million [9][11]. Research and Development - Rebio Biotech has developed a large pipeline of siRNA drugs, with six self-developed drug assets in clinical trials targeting various diseases. However, the company's resource allocation for core product development has been low, with only 19.1% to 25.9% of total R&D spending directed towards core products from 2023 to 2025 [12][14]. - The company has not established its own production facilities, relying on outsourcing for clinical sample production, which poses a challenge in the competitive landscape [16]. Market Position and Competition - The global small nucleic acid drug market is projected to grow from USD 2.7 billion in 2019 to USD 46 billion by 2033, with Rebio Biotech's core product, RBD4059, being the first siRNA drug for thrombotic diseases in clinical development. However, it faces competition from other companies that have advanced further in clinical trials [13][14].