证券代码：300601 证券简称：康泰生物 公告编号：2025-085 债券代码：123119 债券简称：康泰转 2 五联疫苗Ⅲ期临床试验采用随机、盲法、阳性对照设计，旨在评价其在 2 月龄及以上健康人群的安全性和免疫原性。 深圳康泰生物制品股份有限公司 关于五联疫苗开启Ⅲ期临床试验的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、 误导性陈述或重大遗漏。 深圳康泰生物制品股份有限公司（以下简称"公司"）全资子公司北京民海 生物科技有限公司（以下简称"民海生物"）研发的吸附无细胞百白破灭活脊髓 灰质炎和b型流感嗜血杆菌联合疫苗（以下简称"五联疫苗"）已完成Ⅲ期临床 试验准备工作，正式开启Ⅲ期临床试验，并于今日成功完成首例受试者入组。现 将相关情况公告如下： 一、药物基本信息 | 名称 | | | 剂型 | 规格 | | 注册分类 | 临床试验分期 | | --- | --- | --- | --- | --- | --- | --- | --- | | 吸附无细胞百白破灭活 | b | 型流感 | 注射剂 | 本品为两个包材 包装。每 | 1 次人 | 预防用生物制 | Ⅲ期临床 ...

Investment Rating - The industry investment rating is maintained at "Overweight" [2][9] Core Insights - The vaccine industry is experiencing a transition from scale expansion to innovation-driven growth, facing short-term pain due to supply-demand imbalance and homogenized competition, but the long-term outlook remains positive driven by policy, demand, and technology [9][28] - Recent clinical trial approvals for innovative vaccines by companies like Zhifei Biological, Kangtai Biological, Wantai Biological, and CanSino indicate significant advancements in the field, particularly in addressing emerging infectious diseases and specific patient populations [4][8] Summary by Sections Industry Performance - The vaccine sector has seen a relative decline, with a 12-month absolute return of -14% and a relative return of -28% compared to the CSI 300 index [4][5] - The vaccine index closed at 11,363.86, down 0.87% last week, while the overall pharmaceutical sector saw a slight decline of 0.14% [5][11] Market Review - The vaccine sector's performance has been lagging, with a cumulative decline of 10.1% since the beginning of 2025, indicating a challenging market environment [5][11] - Notable companies in the vaccine sector include Liaoning Chengda, Hualan Biological, and Kangtai Biological, which have shown better performance compared to others like Kanghua Biological and CanSino [6][11] Valuation - The vaccine sector's price-to-earnings (PE) ratio is 92.32X, reflecting a decrease of 0.74X week-on-week, while the price-to-book (PB) ratio stands at 1.79X, also showing a slight decline [7][11] - The PE ratio is at the 56.20% percentile since 2013, while the PB ratio is at the 1.36% percentile, indicating a relatively high valuation compared to historical data [7][11] Investment Recommendations - The vaccine industry is under pressure, with companies focusing on pipeline adjustments and innovation to enhance competitiveness. Long-term prospects hinge on innovation and international expansion [8][9] - Companies with strong research and development capabilities and differentiated product offerings, such as CanSino and Kanghua Biological, are recommended for investment [9][28]

Core Viewpoint - The company, Kangtai Biological (300601), has indicated that its revenue from immunization program vaccines has historically been relatively low compared to its overall revenue, with a specific focus on the distinction between immunization program vaccines and non-immunization program vaccines [1] Group 1: Revenue Breakdown - The company's revenue from immunization program vaccines for the year 2024 is reported to be 61.08 million yuan, which constitutes only 2.3% of the total operating revenue for that period [1]

Core Viewpoint - Shenzhen Kangtai Biological Products Co., Ltd. has received approval from the National Medical Products Administration for its recombinant hepatitis B vaccine (60μg) to conduct clinical trials aimed at preventing HBsAg reversion in patients with functional cure of chronic hepatitis B [1][2]. Group 1: Clinical Development - The approved 60μg hepatitis B vaccine works by inducing high levels of hepatitis B surface antibodies, establishing long-lasting immune memory to help maintain a sustained functional cure state in patients who have cleared the hepatitis B surface antigen [1]. - The vaccine is positioned as a global innovative strategy to maintain sustained cure in chronic hepatitis B patients after discontinuation of treatment [1]. Group 2: Market Potential - The global market for hepatitis B treatment is projected to reach 124.6 billion yuan by 2030, with approximately 300 million chronic hepatitis B infected individuals worldwide [1]. - In China, there are about 75 million chronic hepatitis B infected individuals, and the domestic market for hepatitis B treatment is expected to exceed 70 billion yuan by 2030 [1]. - There is a significant unmet clinical need in hepatitis B treatment, with a lack of strategies to consolidate long-term efficacy and reduce the risk of reversion [1]. Group 3: Company Background - Kangtai Biological was established in 1992 to undertake the mission of introducing recombinant hepatitis B vaccine technology to China [2]. - The 60μg hepatitis B vaccine, launched in 2010, is a global innovative product, and the recent approval marks a significant step for the company to cover the entire cycle of hepatitis B "prevention + treatment + reversion prevention" needs [2]. - This development is expected to provide greater hope for hepatitis B patients and support the company's goal of becoming a global innovator in biopharmaceuticals [2].

证券日报网讯12月17日，康泰生物（300601）在互动平台回答投资者提问时表示，公司目前销售费用率 维持在行业平均水平，目前公司自身销售团队及服务团队合计已有千余人，团队多年来积累了丰富的销 售经验，现已覆盖全国31个省、自治区、直辖市。公司主要客户是疾病预防控制中心，疾病预防控制中 心为事业单位，具有良好的信誉及履约能力，应收账款回收的风险较小。公司非常重视对应收账款的风 险管理，重视产品销售事前的风险控制、事中的履约跟进以及事后的有效沟通，强化回款考核，持续加 强应收账款管理。 ...

（文章来源：证券日报） 证券日报网讯 12月17日，康泰生物在互动平台回答投资者提问时表示，公司股东人数请详见定期报告 的相关内容。 ...

Core Viewpoint - The company announced that its recombinant hepatitis B vaccine (yeast) (60μg) has received approval from the National Medical Products Administration for clinical trials aimed at preventing HBsAg reversion in patients with chronic hepatitis B who have achieved functional (clinical) cure [1] Group 1 - The vaccine is now approved for a new target population, specifically for individuals aged 16 to 64 who have clinically cured chronic hepatitis B [1] - The clinical trial will focus on preventing the reversion of HBsAg in this specific group [1]

智通财经APP讯，康泰生物(300601.SZ)公告，公司研发的重组乙型肝炎疫苗(酿酒酵母)(60μg)新增适用 人群项目于今日获得国家药品监督管理局出具的《药物临床试验批准通知书》，本品符合药品注册的有 关要求，批准本品在慢性乙型肝炎功能性(临床)治愈人群中开展预防HBsAg复阳的临床试验。 ...

康泰生物（300601）(300601.SZ)公告，公司研发的重组乙型肝炎疫苗(酿酒酵母)(60μg)新增适用人群项 目于今日获得国家药品监督管理局出具的《药物临床试验批准通知书》，本品符合药品注册的有关要 求，批准本品在慢性乙型肝炎功能性(临床)治愈人群中开展预防HBsAg复阳的临床试验。 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for its recombinant hepatitis B vaccine (yeast) to conduct clinical trials in a new target population [1] Group 1 - The vaccine is specifically approved for use in patients with chronic hepatitis B who have achieved functional (clinical) cure [1] - The approval is in accordance with the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China [1] - The clinical trial aims to prevent the recurrence of HBsAg positivity in the specified population [1]