华兰生物工程股份有限公司 2025 年半年度报告全文 华兰生物工程股份有限公司 2025 年半年度报告 华兰生物工程股份有限公司 2025 年半年度报告全文 第一节 重要提示、目录和释义 公司董事会、监事会及董事、监事、高级管理人员保证半年度报告内容 的真实、准确、完整，不存在虚假记载、误导性陈述或者重大遗漏，并承担 个别和连带的法律责任。 公司负责人安康、主管会计工作负责人谢军民及会计机构负责人(会计主 管人员)李萍声明：保证本半年度报告中财务报告的真实、准确、完整。 所有董事均已出席了审议本次半年报的董事会会议。 公司已在本报告中详细描述可能存在的相关风险，敬请查阅本报告第三节 管理层讨论与分析第十项：公司面临的风险和应对措施。 公司经本次董事会审议通过的利润分配预案为：以 1,827,456,666 为基 数，向全体股东每 10 股派发现金红利 5 元（含税），送红股 0 股（含税）， 不以公积金转增股本。 2 1 【2025 年 8 月】 华兰生物工程股份有限公司 2025 年半年度报告全文 | 释义项 | 指 | 释义内容 | | --- | --- | --- | | 公司、本公司、股份公司 | ...

天眼查工商信息显示，8月14日，华兰基因工程有限公司发生工商变更，注册资本由2亿人民币增至3亿 人民币，增幅50%。 该公司成立于2013年6月，法定代表人为安康，经营范围为生物制品的研究、开发、生产、销售，技术 转让，检验检测，代理加工服务；生物医药技术咨询，货物或技术进出口。股东信息显示，该公司由安 康、华兰生物（002007）分别持股60%、40%。 ...

Core Viewpoint - The announcement details the lifting of restrictions on a significant number of shares of Hualan Biological Engineering Co., Ltd., allowing for the circulation of 459 million shares, which accounts for 76.37% of the company's total share capital, effective from August 18, 2025 [2][5][23]. Group 1: Share Circulation Details - The restricted shares being released are part of the shares issued before the initial public offering (IPO) [2]. - The total number of shareholders involved in this release is two: Hualan Biological Engineering Co., Ltd. and Hong Kong Kecang Co., Ltd. [2][24]. - The total number of shares being released is 459,000,000, which represents 76.37% of the total share capital of the company [5][25]. Group 2: Share Capital Structure - As of the announcement date, the total share capital of the company is 601,027,500 shares, with 141,648,150 shares being unrestricted, accounting for 23.57% of the total [5]. - The company underwent a capital increase through a stock dividend distribution, resulting in an increase in total share capital from 400,010,000 shares to 600,015,000 shares [4]. Group 3: Compliance and Commitments - The shareholders lifting the restrictions have fulfilled their commitments made during the IPO process, ensuring compliance with relevant regulations [22]. - The commitments include not transferring or managing the shares for a specified period and adhering to regulations regarding share reduction [6][11]. Group 4: Clinical Trial Approval - Hualan Biological has received approval for clinical trials of its freeze-dried Hib vaccine, which is a significant step in its product development strategy [33]. - The vaccine aims to provide protection against invasive infections caused by Haemophilus influenzae type b, which is a major pathogen in children [34].

Industry Overview - On August 14, the medical device industry experienced a decline of 2.45% with a net outflow of 1.74 billion yuan in principal funds [1] - Among the component stocks, 13 increased while 87 decreased [1] Major Fund Outflows - The companies with the highest net outflows of principal funds included: - Kehua Bio (29.96 million yuan) - Baolait (29.32 million yuan) - Shangrong Medical (28.74 million yuan) - Weisi Medical (26.93 million yuan) - ST Kelly (26.25 million yuan) [1] Notable Stock Performance - Key stocks with significant movements included: - Sainuo Medical: Latest price 30.43, up 3.05%, with a net inflow of 164 million yuan (7.25% of total) [1] - Botao Bio: Latest price 45.13, up 19.99%, with a net inflow of 543.74 thousand yuan (12.47% of total) [1] - Yuyue Medical: Latest price 35.67, down 0.17%, with a net inflow of 49.30 thousand yuan (12.91% of total) [1] - Kefu Medical: Latest price 40.58, up 6.99%, with a net inflow of 470.40 thousand yuan (14.3% of total) [1] - Huatai Medical: Latest price 290.99, down 2.03%, with a net inflow of 297.47 thousand yuan (9.99% of total) [1] - Aohua Endoscopy: Latest price 49.14, down 7.79%, with a net inflow of 2363.53 thousand yuan (10.09% of total) [1] - Meihua Medical: Latest price 20.94, up 3.05%, with a net inflow of 2316.72 thousand yuan (4.81% of total) [1] - Wanfu Bio: Latest price 24.28, down 0.92%, with a net inflow of 184.26 thousand yuan (5.48% of total) [1] - Zhijiang Bio: Latest price 25.24, up 4.87%, with a net inflow of 1420.31 thousand yuan (5.07% of total) [1] - Mairande: Latest price 51.64, up 1.06%, with a net inflow of 1335.64 thousand yuan (2.42% of total) [1]

Core Viewpoint - Hualan Biological Vaccine Co., Ltd. has received implied approval for clinical trials of its "Lyophilized Haemophilus influenzae type b Conjugate Vaccine" aimed at preventing invasive diseases caused by Haemophilus influenzae type b [1] Company Overview - Hualan Biological Vaccine Co., Ltd. was established in 2005 and is located in Xinxiang City, primarily engaged in the pharmaceutical manufacturing industry [1] - The company has a registered capital of 601.0275 million RMB and a paid-in capital of 360 million RMB [1] - Hualan Biological has made investments in 2 companies and participated in 980 bidding projects, holding 41 patents and 138 administrative licenses [1] Shareholder Information - Major shareholders include Hualan Biological Engineering Co., Ltd. with a 75% stake, Kecang Co., Ltd. with 10%, Henan Huaying Enterprise Management Consulting Partnership (Limited Partnership) with 9%, and Xinxiang Chenyi Qiming Management Consulting Partnership (Limited Partnership) with 6% [1]

Group 1 - The company, Hualan Biological Engineering Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of its "lyophilized type b Haemophilus influenzae conjugate vaccine" [1] - The vaccine aims to prevent invasive infections caused by type b Haemophilus influenzae, including meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis [2] - The Hib vaccine is developed using purified Hib capsular polysaccharide combined with tetanus toxoid protein, and it is expected to induce an immune response against Hib [2] Group 2 - The company is also developing a combination vaccine based on the DTP (diphtheria, tetanus, and pertussis) vaccine, with the Hib vaccine as one of its components [2] - Following the approval of the clinical trial, the company must conduct clinical trials and obtain further approval from the National Medical Products Administration before the vaccine can be marketed [3] - The drug development process is lengthy and involves multiple stages, which may be affected by uncertainties [3]

Core Viewpoint - The company has received approval for clinical trials of its "lyophilized Haemophilus influenzae type b (Hib) conjugate vaccine," which is aimed at preventing invasive infections caused by Hib bacteria [1][2]. Group 1: Clinical Trial Approval - The company's subsidiary, Hualan Biological Vaccine Co., Ltd., has obtained the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for the Hib vaccine [1]. - The clinical trial application for the vaccine was accepted on May 21, 2025, and has met the requirements for drug registration [1]. - The vaccine is intended to prevent invasive infections such as meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis caused by Hib [1]. Group 2: Vaccine Development - The Hib vaccine is developed using purified Hib capsular polysaccharide combined with tetanus toxoid protein, and it is in a lyophilized form [2]. - The vaccine is expected to induce an immune response against Hib, providing protection to the vaccinated individuals [2]. - The company is also developing a combination vaccine based on the DTP (diphtheria, tetanus, and pertussis) framework, with the Hib vaccine as one of its components [2].

（文章来源：证券日报） 证券日报网讯 8月13日晚间，华兰疫苗发布关于部分首次公开发行前已发行股份上市流通的提示性公告 称，本次上市流通的限售股为公司部分首次公开发行前已发行股份；本次解除限售股东户数共计2户， 为华兰生物工程股份有限公司和科康有限公司，解除限售的股份数量共计459，000，000股，占公司总 股本的76.37%。本次解除限售的股份上市流通日期为2025年8月18日（星期一）。 ...

Core Points - The company Hualan Biological announced the approval of a clinical trial for its "lyophilized Haemophilus influenzae type b conjugate vaccine" by the National Medical Products Administration [2] - The clinical trial aims to prevent invasive infections caused by Haemophilus influenzae type b, including meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis [2] - The approval was granted following the review of the application submitted on May 21, 2025, confirming that it meets the requirements for drug registration [2] Summary by Categories Company Developments - Hualan Biological's subsidiary, Hualan Biological Vaccine Co., Ltd., received a clinical trial approval notification for its vaccine [2] - The company is expected to commence the clinical trial work promptly in accordance with the approval notification [2] Industry Implications - The approval of the vaccine is significant for addressing public health concerns related to invasive infections caused by Haemophilus influenzae type b [2] - This development may enhance the company's position in the vaccine market and contribute to advancements in preventive healthcare [2]

核查意见 部分首次公开发行前已发行股份上市流通的核查意见 华泰联合证券有限责任公司（以下简称"华泰联合证券"或"保荐人"）作为华 兰生物疫苗股份有限公司（以下简称"华兰疫苗"或"公司"）首次公开发行股票并 在创业板上市持续督导阶段的保荐人，根据《证券发行上市保荐业务管理办法》 《深圳证券交易所创业板股票上市规则》《深圳证券交易所上市公司自律监管指 引第 2 号——创业板上市公司规范运作》及《深圳证券交易所上市公司自律监管 指引第 13 号——保荐业务》等规定，对华兰疫苗部分首次公开发行前已发行股 份上市流通事项进行了审慎核查，并出具核查意见如下： 一、首次公开发行前已发行股份概况 经深圳证券交易所《关于华兰生物疫苗股份有限公司人民币普通股股票在创 业板上市的通知》（深证上[2022]154 号）同意，公司首次公开发行人民币普通 股（A 股）股票 40,010,000 股，并于 2022 年 2 月 18 日在深圳证券交易所创业板 上市交易。公司首次公开发行股票前总股本为 360,000,000 股，首次公开发行完 成后，公司总股本为 400,010,000 股。 东每 10 股转增 5 股，共计 200,00 ...