深圳康泰生物制品股份有限公司 2025 年第三季度报告 1 深圳康泰生物制品股份有限公司 2025 年第三季度报告 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。 重要内容提示： 深圳康泰生物制品股份有限公司 2025 年第三季度报告 证券代码：300601 证券简称：康泰生物 公告编号：2025-074 债券代码：123119 债券简称：康泰转 2 1.董事会、监事会及董事、监事、高级管理人员保证季度报告的真实、准确、完整，不存在虚假记 载、误导性陈述或重大遗漏，并承担个别和连带的法律责任。 2.公司负责人、主管会计工作负责人及会计机构负责人(会计主管人员)声明：保证季度报告中财务 信息的真实、准确、完整。 3.第三季度财务会计报告是否经过审计 □是 否 一、主要财务数据 （一） 主要会计数据和财务指标 公司是否需追溯调整或重述以前年度会计数据 □是 否 | | 本报告期 | 本报告期比上年同期 | 年初至报告期末 年初至报告期末 | | | --- | --- | --- | --- | --- | | | | 增减 | 比上年同期增减 | | | 营业收 ...

Core Viewpoint - The domestic vaccine industry is experiencing significant pressure due to economic downturns, declining birth rates, reduced vaccination willingness, and intensified market competition, leading to frequent executive changes among companies [1][3]. Group 1: Executive Changes - Sun Wanfeng has resigned from his position as employee representative director and vice president of Baike Bio, but will continue as assistant to the chairman [1]. - There are rumors of changes in the management of Kangtai Bio, but the company has confirmed that Vice President Yu Bing remains in his position [1]. - Frequent executive turnover is noted in the domestic vaccine industry, with several companies undergoing leadership changes since late 2024 [3]. Group 2: Financial Performance - In the first half of 2025, only 5 out of 10 listed vaccine companies in A-shares reported revenue growth, with only 3 achieving positive net profit growth [3]. - Baike Bio reported a revenue of 284.9 million yuan with a net loss of 73.57 million yuan, marking a year-on-year revenue decline of 53.93% and a net profit decline of 153.47% [4]. - Kangtai Bio's revenue was 1.392 billion yuan with a net profit of 37.53 million yuan, showing a revenue growth of 15.81% but a significant net profit decline of 77.30% [4]. Group 3: Market Competition - The HPV vaccine market is experiencing aggressive price competition, with prices for the bivalent HPV vaccine dropping below 100 yuan, and the lowest price recorded at 27.5 yuan per dose [5]. - The flu vaccine market is also seeing price reductions, with prices for quadrivalent flu vaccines dropping from 128 yuan to 88 yuan per dose [6]. - The pneumococcal vaccine market is highly competitive, with Pfizer withdrawing from the market due to intense competition from domestic products [6]. Group 4: Growth Opportunities - Despite the challenges, there are structural growth opportunities in the vaccine market, exemplified by Olin Bio's adsorbed tetanus vaccine, which achieved a revenue growth of 35.17% in the first half of 2025 [7].

Core Viewpoint - 康泰生物's stock price has experienced a decline in 2023, with a year-to-date drop of 4.57% and a significant decrease in net profit despite revenue growth [2][3]. Company Overview - 康泰生物, established on September 8, 1992, and listed on February 7, 2017, is based in Shenzhen, Guangdong Province, and specializes in the research, production, and sales of human vaccines [2]. - The company's revenue composition includes 93.70% from non-immunization program vaccines, 3.71% from immunization program vaccines, and 2.59% from other sources [2]. Financial Performance - For the first half of 2025, 康泰生物 reported a revenue of 1.392 billion yuan, reflecting a year-on-year growth of 15.81%, while the net profit attributable to shareholders was 37.53 million yuan, a decrease of 77.30% compared to the previous period [2]. - Cumulatively, 康泰生物 has distributed 1.765 billion yuan in dividends since its A-share listing, with 525 million yuan distributed over the last three years [3]. Stock Market Activity - As of October 23, 康泰生物's stock price was 16.28 yuan per share, with a market capitalization of 18.184 billion yuan. The stock saw a trading volume of 85.54 million yuan and a turnover rate of 0.58% [1]. - The stock has seen a net outflow of 15.19 million yuan in principal funds, with large orders accounting for 11.40% of purchases and 29.16% of sales [1]. Shareholder Structure - As of June 30, 2025, 康泰生物 had 61,500 shareholders, a decrease of 1.84% from the previous period, with an average of 14,634 circulating shares per shareholder, an increase of 3.48% [2]. - Major shareholders include 易方达创业板ETF, 招商国证生物医药指数A, and 南方中证500ETF, with notable changes in their holdings [3].

Core Insights - The respiratory syncytial virus (RSV) is currently in an epidemic phase in China, with a significant number of children being hospitalized, including cases in the ICU [1] - There is no specific treatment for RSV in infants, making prevention crucial, and several companies are developing RSV-related drugs [1][2] - The global market for passive immunization agents for RSV prevention in infants is projected to grow at a compound annual growth rate (CAGR) of 78.4% from 2024 to 2028, reaching 2.99 billion yuan [2] Drug Development Landscape - Three monoclonal antibodies (mAbs) for RSV have been approved globally: Palivizumab, Nirsevimab, and Clonabivimab, with Nirsevimab being the first long-acting mAb approved in China [3] - Six additional mAbs are in clinical trials, with TNM-001 from Zhuhai Tenomab Pharmaceutical progressing to Phase III trials [3] Vaccine Development - There are 188 RSV vaccines in development globally, with three approved: GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mRESVIA, none of which are available in China yet [4] - Several Chinese companies, including Chengdu Huarenkang and Beijing Kexing Zhongwei, are actively developing RSV vaccines, with some in Phase III clinical trials [4] Innovative Drug Research - Currently, there are no approved specific treatments for RSV, but notable progress is being made in small molecule drug development [6] - Aikobaf's Qiruisuo is the first targeted RSV fusion protein inhibitor to complete Phase III trials and is recognized as a breakthrough therapy in China [6] - Shionogi's oral antiviral S-337395 is in Phase II trials and has shown promising results in reducing viral load [6] Future Outlook - The ongoing development of vaccines, monoclonal antibodies, and therapeutic drugs is expected to lead to more effective prevention and treatment options for RSV [7]

证券代码：300601 证券简称：康泰生物 公告编号：2025-071 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 2025 年第三季度可转换公司债券转股情况公告 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。 （三）可转债转股期限及转股价格 特别提示： 1、"康泰转2"（债券代码：123119）转股期限为2022年1月21日至2027年7 月14日，目前最新转股价格为人民币15.73元/股。 2、2025年第三季度，共有91张"康泰转2"完成转股（票面金额共计9,100 元人民币），合计转为574股"康泰生物"股票（股票代码：300601）。 3、截至2025年第三季度末，公司剩余可转债为19,989,952张，剩余票面总 金额为1,998,995,200元人民币。 根据《深圳证券交易所创业板股票上市规则》和《深圳证券交易所上市公司 自律监管指引第15号——可转换公司债券》的有关规定，深圳康泰生物制品股份 有限公司（以下简称"公司"）现将2025年第三季度可转换公司债券（以下简称 "可转债"）转股及公司总股本变化情况公告如下： ...

Core Viewpoint - The company has established a comprehensive product pipeline targeting the growing adult immunization market, with a focus on various vaccines that have already been approved or are in development [1] Product Pipeline Summary - The company has already launched several vaccines, including: - Hepatitis B vaccine (20μg, 60μg) - 23-valent pneumococcal polysaccharide vaccine - Freeze-dried human rabies vaccine (human diploid cells) - Varicella live attenuated vaccine (for individuals aged 13 and above) [1] - The company is also developing additional adult vaccines, which include: - Quadrivalent influenza virus split vaccine - Adsorbed tetanus vaccine - 24-valent pneumococcal polysaccharide conjugate vaccine - Shingles vaccine - Respiratory syncytial virus (RSV) vaccine - Klebsiella pneumoniae vaccine - 60μg recombinant hepatitis B vaccine aimed at preventing recurrence in functionally cured hepatitis B patients [1]

Core Viewpoint - 康泰生物 has terminated its licensing agreement with AstraZeneca for the development, production, and commercialization of the ChAdOx1 adenovirus vector COVID-19 vaccine due to significant changes in domestic and international market conditions and vaccine strains [1] Group 1 - 康泰生物 signed a licensing agreement with AstraZeneca UK Limited on August 20, 2020, granting exclusive rights for the COVID-19 vaccine in mainland China [1] - The decision to terminate the licensing agreement was made after mutual consultation between both parties [1] - A termination agreement has been signed, which nullifies all rights and obligations under the original licensing agreement effective immediately upon signing [1]

Core Viewpoint - 康泰生物 has terminated its licensing agreement with AstraZeneca for the development, production, and commercialization of the ChAdOx1 adenovirus vector COVID-19 vaccine due to significant changes in the domestic and international market environment and vaccine strains [1] Group 1 - 康泰生物 signed a licensing agreement with AstraZeneca UK Limited on August 20, 2020, granting exclusive rights for the COVID-19 vaccine in mainland China [1] - The decision to terminate the licensing agreement was made after friendly consultations between both parties [1] - A termination agreement has been signed, which nullifies all rights and obligations under the original licensing agreement effective from the date of signing [1]

Core Viewpoint - The company has terminated the licensing agreement with AstraZeneca for the development, production, and commercialization of the ChAdOx1 adenovirus vector COVID-19 vaccine due to significant changes in the COVID-19 vaccine strains and market environment [1][2] Group 1 - The licensing agreement was originally signed on August 20, 2020, allowing AstraZeneca to exclusively authorize the company to develop, produce, and commercialize the vaccine in mainland China [1] - The decision to terminate the collaboration was made after careful consideration of the changes in the COVID-19 vaccine strains, market conditions, and the company's resource allocation [2] - The termination of the agreement is aligned with the company's development strategy and is not expected to have a significant impact on its production operations, core business activities, or financial status [2]

Core Viewpoint - The company has decided to terminate the licensing agreement with AstraZeneca for the development, production, and commercialization of the ChAdOx1 adenovirus vector COVID-19 vaccine due to significant changes in the COVID-19 vaccine strains and market environment [1] Group 1: Licensing Agreement Details - On August 20, 2020, the company signed a licensing agreement with AstraZeneca, granting exclusive rights to develop, produce, and commercialize the COVID-19 vaccine in mainland China [1] - The termination of the licensing agreement was mutually agreed upon after careful consideration of changes in the COVID-19 vaccine landscape and the company's resource allocation [1] Group 2: Impact on the Company - The termination of the licensing agreement is deemed a prudent decision aligned with the company's development strategy [1] - The company asserts that this decision will not have a significant impact on its production operations, core business activities, or financial status [1] - There are no concerns regarding the protection of the interests of the company and its shareholders, particularly minority shareholders [1]