| 证券代码：300601 | 证券简称：康泰生物 | 公告编号：2024-079 | | --- | --- | --- | | 债券代码：123119 | 债券简称：康泰转 2 | | 深圳康泰生物制品股份有限公司 经查询国家药品监督管理局网站，目前国内已上市麻腮风联合减毒活疫苗的 厂家包括上海生物制品研究所有限责任公司、北京生物制品研究所有限责任公司。 二、Ⅰ期临床试验相关情况 麻腮风联合减毒活疫苗Ⅰ期临床试验采取随机、盲态、阳性对照试验设计， 旨在评价其在8月龄及以上健康人群中的安全性和初步免疫原性。 三、对公司的影响 本次麻腮风联合减毒活疫苗开启Ⅰ期临床试验并成功完成首例受试者入组， 表明该产品研发取得了阶段性进展，公司将积极推动该产品的临床研究，若该疫 一、药物主要信息 名称 剂型 规格 注册分类 临床试验分期 麻腮风联合减毒 活疫苗 注射剂 复溶后每瓶 0.5ml,每 1 次人用剂量 0.5ml 预防用生物制品第 2.2 类 Ⅰ期临床试验 关于麻腮风联合减毒活疫苗开启Ⅰ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 ...

一、药品基本情况 | 证券代码：300601 | 证券简称：康泰生物 | 公告编号：2024-078 | | --- | --- | --- | | 债券代码：123119 | 债券简称：康泰转 2 | | 深圳康泰生物制品股份有限公司 关于四价流感病毒裂解疫苗申请生产注册获得受理的公告 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"）研发的四价流感病毒 裂解疫苗申请生产注册近日获得国家药品监督管理局出具的《受理通知书》，受 理号：CXSS2400126。现将相关情况公告如下： 本次生产注册获得受理的四价流感病毒裂解疫苗适用于 3 岁及以上人群，可 刺激机体产生抗流感病毒的免疫力，用于预防疫苗相关型别的流感病毒引起的流 行性感冒。流行性感冒（也称流感）是由流感病毒引起的急性呼吸道传染病,接 种流感疫苗是预防流感疾病及流感大爆发最有效和最经济的措施。 2024 年 11 月 22 日 重大影响，如未来该疫苗获批上市销售，将对公司经营业绩产生积极的影响。四 价流感病毒裂解疫苗审评审批进度及结果具有一定的不确定性。公司 ...

| 证券代码：300601 | 证券简称：康泰生物 | 公告编号：2024-077 | | --- | --- | --- | | 债券代码：123119 | 债券简称：康泰转 2 | | 深圳康泰生物制品股份有限公司 关于二价肠道病毒灭活疫苗（Vero 细胞）、四价肠道病 毒灭活疫苗（Vero 细胞）临床试验申请获得受理及终止重 组肠道病毒 71 型疫苗（汉逊酵母）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。 一、公司二价肠道病毒灭活疫苗（Vero细胞）、四价肠道病毒灭活疫苗（Vero 细胞）临床试验申请获得受理相关情况 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"）近日收到国家药品监督管理局签发 的受理通知书，同意受理民海生物研发的二价肠道病毒灭活疫苗（Vero细胞）、 四价肠道病毒灭活疫苗（Vero细胞）的临床试验申请。 （一）受理通知书主要内容 产品名称：二价肠道病毒灭活疫苗（Vero细胞）、四价肠道病毒灭活疫苗（Vero 细胞） 根据《中华人民共和国行政许可法》第三十二条 ...

股 票 研 究 公 司 更 新 报 告 证 券 研 究 报 告 国泰君安版权所有发送给上海东方财富金融数据服务有限公司.东财接收研报邮箱.ybjieshou@eastmoney.com p1 ——2024 年三季报点评 业绩环比改善，国际化稳步拓展 康泰生物(300601) [Table_Industry] 医药/必需消费 | --- | --- | --- | --- | --- | --- | --- | --- | --- | |----------|-----------------------------------|-----------------------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 赵峻峰 ( 分析师 ) | | | | | | | | | 0755-23976735 | 0755-23976629 | | | | | | | | | dingdan@gtjas.com | zhaojunfeng@gtjas.com ...

Investment Rating - The investment rating for the company is "Outperform the Market" [3][10][14] Core Views - The company's revenue improved quarter-on-quarter, but profit is under short-term pressure due to factors such as market destocking, increased stock incentive amortization expenses, and rising fixed asset depreciation costs [1][5] - The company achieved a total revenue of 2.018 billion yuan in the first three quarters of 2024, a year-on-year decrease of 18.1%, with a net profit attributable to the parent company of 351 million yuan, down 49.6% year-on-year [1][5] - The company is actively promoting the commercialization of its new products, including the human diploid rabies vaccine and the varicella live attenuated vaccine, which are expected to contribute to revenue growth [2][10] Summary by Sections Revenue and Profitability - In Q1, Q2, and Q3 of 2024, the company achieved revenues of 452 million, 750 million, and 816 million yuan respectively, with Q3 showing a positive year-on-year growth of 11.2% [1][5] - The gross profit margin for the first three quarters of 2024 was 83.4%, a decrease of 2.6 percentage points year-on-year [2][8] - The overall expense ratio for the period was 61.7%, an increase of 6.0 percentage points year-on-year, but is expected to improve as revenue scales recover [2][8] Product Development and Internationalization - The company has made significant progress in the commercialization of its human diploid rabies vaccine, which was approved for sale in September 2023, generating sales of 117 million yuan by June 2024 [2][10] - The company is also advancing the varicella live attenuated vaccine, which received its drug registration certificate in April 2024 [2] - Internationally, the company has signed agency or technology transfer agreements for key products with partners in countries such as Bangladesh, Nigeria, Sri Lanka, and Yemen [2][10] Financial Forecasts - The revenue forecasts for 2024, 2025, and 2026 are adjusted to 3.034 billion, 3.879 billion, and 4.614 billion yuan respectively, with net profits expected to be 610 million, 807 million, and 997 million yuan [10][12] - The current stock price corresponds to a price-to-earnings ratio (PE) of 35, 26, and 21 times for the years 2024, 2025, and 2026 respectively [10][12]

Investment Rating - The report maintains a "Buy" rating for the company [2] Core Views - The company's performance is under short-term pressure, but there is a rapid growth in batch approvals [4] - The company is actively expanding its overseas market presence, which is expected to become a new growth point [6] - The R&D pipeline is progressing well, with multiple products making significant advancements [7] - The company has adjusted its profit forecast due to various market challenges but remains optimistic about future growth [8] Summary by Sections Financial Performance - In the first three quarters of 2024, the company achieved revenue of 2.018 billion yuan (down 18.11% year-on-year) and a net profit of 351 million yuan (down 49.63% year-on-year) [5] - The third quarter of 2024 saw a revenue of 816 million yuan (up 11.21% year-on-year, up 8.76% quarter-on-quarter) and a net profit of 186 million yuan (down 0.46% year-on-year, up 66.94% quarter-on-quarter) [5] Market Expansion - The company has signed a sales contract for a 13-valent pneumonia vaccine with a partner in Indonesia and successfully exported the first batch [6] - Collaborations with multiple countries for various vaccines are in place, indicating a strong international strategy [6] R&D Progress - R&D expenses reached 312 million yuan in the first three quarters, accounting for 15.45% of revenue [7] - Several products are in various stages of clinical trials, including a polio vaccine and a combined vaccine for whooping cough [7] Investment Recommendations - The company is expected to generate revenues of 3.123 billion, 3.860 billion, and 4.499 billion yuan for 2024, 2025, and 2026 respectively, with corresponding net profits of 560 million, 821 million, and 999 million yuan [8] - The company’s diverse product range and the introduction of new products are anticipated to contribute positively to future performance [8]

Investment Rating - The investment rating for the company is "Accumulate - A" with a 12-month target price of 23.79 CNY [4][8] Core Views - The company's Q3 performance shows improvement with a single-quarter revenue of 816 million CNY, a year-on-year increase of 11.21% and a quarter-on-quarter increase of 8.76% [1] - The launch of the new rabies vaccine is expected to drive revenue growth, with 904,900 doses sold in the first half of 2024, generating 117 million CNY in sales [3][7] - The company maintains a strong pipeline of nearly 30 projects under development, indicating a commitment to innovation and future growth [3][6] Financial Performance Summary - For the first three quarters of 2024, the company reported a revenue of 2.018 billion CNY, a year-on-year decrease of 18.11%, and a net profit of 351 million CNY, down 49.63% [1] - The gross margin for the first three quarters was 83.45%, a decrease of 2.60 percentage points year-on-year, while the net margin was 17.40%, down 10.89 percentage points year-on-year [2] - The company’s R&D expense ratio was 15.45%, reflecting a year-on-year increase of 0.90 percentage points [2] Market Expansion and Strategic Initiatives - The company has established partnerships in over ten countries for the registration and commercialization of various vaccines, including the 13-valent and 23-valent pneumonia vaccines [7] - A strategic cooperation memorandum was signed with AstraZeneca to explore comprehensive collaboration in the vaccine field [7] - The company’s internationalization efforts are expected to enhance its competitive position in the market [7]

债券代码：123119 债券简称：康泰转 2 四价流感病毒裂解疫苗适用于 3 岁及以上人群，可刺激机体产生抗流感病毒 的免疫力，用于预防疫苗相关型别的流感病毒引起的流行性感冒。流行性感冒（也 称流感）是由流感病毒引起的急性呼吸道传染病,接种流感疫苗是预防流感疾病 及流感大爆发最有效和最经济的措施。 经查询国家药品监督管理局网站，目前国内已上市的四价流感病毒裂解疫苗 的厂家包括华兰生物疫苗股份有限公司、江苏金迪克生物技术股份有限公司、长 春生物制品研究所有限责任公司、北京科兴生物制品有限公司、武汉生物制品研 究所有限责任公司、上海生物制品研究所有限责任公司和深圳赛诺菲巴斯德生物 制品有限公司等。 证券代码：300601 证券简称：康泰生物 公告编号：2024-076 深圳康泰生物制品股份有限公司 关于收到四价流感病毒裂解疫苗 Ⅰ期和Ⅲ期临床试验总结报告的提示性公告 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"）近日收到四价流感病 毒裂解疫苗Ⅰ期和Ⅲ期临床试验总结报告，公司研发的四价流感病毒裂解疫苗临 床研究阶段工 ...

Financial Performance - The company's revenue for Q3 2024 was ¥816,136,339.32, an increase of 11.21% compared to the same period last year[2]. - The net profit attributable to shareholders for Q3 2024 was ¥185,759,262.79, a decrease of 0.46% year-on-year, but a 66.94% increase quarter-on-quarter[3]. - The net profit for the first three quarters of 2024 was ¥351,095,608.08, representing a decline of 49.63% compared to the same period last year[2]. - The basic earnings per share for Q3 2024 was ¥0.16, down 5.88% from the previous year[2]. - Total operating revenue for the current period is CNY 2,018,201,664.48, a decrease of 18.06% compared to CNY 2,464,464,778.62 in the previous period[18]. - Net profit for the current period is CNY 351,075,774.02, a decline of 49.6% compared to CNY 697,050,864.48 in the previous period[19]. - The company reported a basic and diluted earnings per share of CNY 0.31, down from CNY 0.62 in the previous period[20]. Cash Flow and Liquidity - The company's cash flow from operating activities for the first three quarters was ¥236,205,250.86, down 62.25% year-on-year[2]. - Net cash flow from operating activities decreased by 62.25% to ¥236,205,250.86, due to reduced sales collections and increased raw material purchases[10]. - The company reported a net decrease in cash and cash equivalents of ¥998,247,579.40, a significant decline of 6995.64% compared to the previous year[10]. - The company's cash and cash equivalents decreased to CNY 190,632,300.70 from CNY 1,195,582,446.07, indicating a significant reduction in liquidity[15]. - Cash inflow from operating activities totaled CNY 2,027,717,804.92, compared to CNY 2,300,307,228.26 in the previous period, reflecting a decrease of 11.8%[21]. - The total cash and cash equivalents at the end of the period were 172,078,219.70 CNY, down from 1,008,585,794.05 CNY at the end of the previous year[22]. - The company reported a total cash outflow of 1,791,512,554.06 CNY from operating activities, compared to 1,674,535,201.33 CNY in the previous year[22]. Assets and Liabilities - Total assets at the end of Q3 2024 were ¥14,515,539,714.49, a decrease of 3.78% from the end of the previous year[2]. - As of September 30, 2024, the total assets of Shenzhen Kangtai Biological Products Co., Ltd. amounted to CNY 14,515,539,714.49, a decrease from CNY 15,085,358,535.27 at the beginning of the period[15]. - The company's total liabilities decreased to CNY 8,664,915,448.75 from CNY 9,689,354,681.20, indicating a reduction of about 10.6%[16]. - The total current liabilities increased to CNY 1,488,856,324.15 from CNY 1,645,656,417.71, showing a decrease of approximately 9.6%[16]. - The company’s total liabilities decreased to CNY 4,806,051,505.11 from CNY 5,543,673,229.15, a reduction of 13.3%[19]. Shareholder Information - Total number of common shareholders at the end of the reporting period was 65,682, with the top ten shareholders holding significant stakes[11]. - The largest shareholder, Du Weimin, holds 25.50% of shares, totaling 284,775,143 shares[11]. - The company reported a decrease in restricted shares from 241,737,629 to 235,537,028, a reduction of about 2.5%[14]. Expenses and Investments - Management expenses increased by 42.76% to ¥244,620,221.51 due to higher depreciation expenses from asset capitalization[9]. - Financial expenses rose significantly by 1067.12% to ¥18,294,027.92, primarily due to a decrease in interest income[9]. - Other income decreased by 48.20% to ¥61,279,404.53, attributed to lower government subsidies received[9]. - Investment income fell by 71.63% to ¥481,740.54, resulting from reduced returns on bank wealth management products[9]. - Research and development expenses for the current period were CNY 311,770,025.07, a decrease of 13.0% from CNY 358,500,265.94 in the previous period[19]. - Sales expenses decreased to CNY 671,404,158.08, down 20.6% from CNY 845,517,600.10 in the previous period[19]. Borrowings and Financing Activities - The company's short-term borrowings increased by 159.28% to ¥155,678,905.79 due to new borrowings during the period[8]. - The company paid 611,535,953.51 CNY in debt repayment, significantly higher than 132,131,074.14 CNY in the same quarter last year[22]. - Net cash flow from financing activities decreased by 193.91% to -¥676,404,914.41, primarily due to bank loan repayments and cash dividend distributions[10]. Other Information - The company received government subsidies amounting to ¥61,761,069.23 for the year-to-date, contributing positively to the financial results[4]. - The company did not undergo an audit for the third quarter report[23]. - The company has not adopted the new accounting standards for the current year[23].

| | | 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"）和兰州百灵生物技术 有限公司研发的四价流感病毒裂解疫苗（MDCK细胞）近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》，根据《中华人民共和国药品管理法》《中 华人民共和国疫苗管理法》及有关规定，经审查，本品符合药品注册的有关要求， 同意本品进行临床试验。现将相关情况公告如下： 一、药物主要信息 | 四价流感病毒裂解疫苗 | 注射剂 | 0.5ml/支 | 预防用生物制 | 2024LP02258 | | --- | --- | --- | --- | --- | | 名称 （MDCK 细胞） | 剂型 | 规格 | 注册分类 品第 2.2 类 | 通知书编号 | 证券代码：300601 证券简称：康泰生物 公告编号：2024-074 深圳康泰生物制品股份有限公司 关于公司四价流感病毒裂解疫苗（MDCK 细胞） 获得药物临床试验批准通知书的公告 公司将根据药物临床试验批准通知书的要求，尽快开展相关临床试验工作。 该文件有效期为获得批准之日起 3 ...