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 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of its lyophilized Haemophilus influenzae type b conjugate vaccine, indicating progress in its vaccine development pipeline [1] Group 1: Company Developments - The company's subsidiary, Hualan Biological Vaccine Co., Ltd., has been granted a clinical trial approval notice for the lyophilized Haemophilus influenzae type b conjugate vaccine [1] - The clinical trial application was accepted on May 21, 2025, and meets the requirements for drug registration [1] - The vaccine aims to prevent invasive infections caused by Haemophilus influenzae type b, including meningitis, pneumonia, sepsis, cellulitis, arthritis, and epiglottitis [1]

Core Viewpoint - Hualan Biological's subsidiary has received approval for a clinical trial of a new vaccine, indicating progress in its vaccine development pipeline [2] Group 1: Company Announcement - Hualan Biological announced on August 13 that its subsidiary, Hualan Biological Vaccine Co., Ltd., received a clinical trial approval notice from the National Medical Products Administration [2] - The approved clinical trial is for a "lyophilized type b Haemophilus influenzae conjugate vaccine" [2]

格隆汇8月13日丨华兰生物(002007.SZ)公布，2025年8月12日，华兰生物工程股份有限公司控股子公司 华兰生物疫苗股份有限公司(以下称"疫苗公司")收到国家药品监督管理局下发的《药物临床试验批准通 知书》(通知书编号：2025LP02051)，由疫苗公司申报的"冻干b型流感嗜血杆菌结合疫苗"临床试验申请 获得批准：经审查，2025年5月21日受理的冻干b型流感嗜血杆菌结合疫苗符合药品注册的有关要求，同 意开展预防由b型流感嗜血杆菌引起的侵袭性感染(包括脑膜炎、肺炎、败血症、蜂窝织炎、关节炎、会 厌炎等)的临床试验。疫苗公司将按照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。 疫苗公司研发的Hib疫苗系以纯化的Hib荚膜多糖与破伤风类毒素蛋白结合而成，采用冻干剂型，预期可 在接种后诱导针对Hib的免疫答应，对接种者提供保护作用。此外，疫苗公司正在研发以组分百白破为 基础的联合疫苗，Hib疫苗为其中的组成部分，作为未获批上市的单苗需累积一定的临床数据，完成Hib 单价疫苗的申报上市，并支持未来以组分百白破为基础的联合疫苗的注册申报。 ...

证券代码：002007 证券简称：华兰生物 公告编号：2025-032 华兰生物工程股份有限公司 关于公司控股子公司取得药物临床试验批准通知书的公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整，没 有虚假记载、误导性陈述或重大遗漏。 2025年8月12日，华兰生物工程股份有限公司（以下简称"公司"）控股子公 司华兰生物疫苗股份有限公司（以下称"疫苗公司"）收到国家药品监督管理局 下发的《药物临床试验批准通知书》（通知书编号：2025LP02051），由疫苗公司 申报的"冻干b型流感嗜血杆菌结合疫苗"临床试验申请获得批准：经审查，2025 年5月21日受理的冻干b型流感嗜血杆菌结合疫苗符合药品注册的有关要求，同意 开展预防由b型流感嗜血杆菌引起的侵袭性感染(包括脑膜炎、肺炎、败血症、蜂 窝织炎、关节炎、会厌炎等)的临床试验。疫苗公司将按照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。 流感嗜血杆菌为革兰氏阴性杆菌，是儿童急性下呼吸道感染最主要的病原菌 之一，分为有荚膜型和无荚膜型，两者均可引发感染。无荚膜型菌株常可引发中 耳炎和鼻窦炎等疾病。主要由鼻咽部定植细菌在邻近部位传播所致；继发 ...

华兰生物公告，控股子公司华兰疫苗申报的"冻干b型流感嗜血杆菌结合疫苗"临床试验申请获得国家药 品监督管理局批准。该疫苗用于预防由b型流感嗜血杆菌引起的侵袭性感染，包括脑膜炎、肺炎、败血 症等。疫苗公司将尽快开展相关临床试验工作。 ...

从资金流向上来看，当日生物制品板块主力资金净流出7.15亿元，游资资金净流入1.03亿元，散户资金净 流入6.12亿元。生物制品板块个股资金流向见下表： 证券之星消息，8月12日生物制品板块较上一交易日下跌0.65%，科兴制药领跌。当日上证指数报收于 3665.92，上涨0.5%。深证成指报收于11351.63，上涨0.53%。生物制品板块个股涨跌见下表： | 代码 | 名称 | 收盘价 | 涨跌幅 | 成交量(手) | 成交额(元) | | | --- | --- | --- | --- | --- | --- | --- | | 600211 | 西藏药业 | 48.04 | 10.01% | 17.50万 | | 8.33亿 | | 300357 | 我武生物 | 26.60 | 2.19% | 11.16万 | | 2.91亿 | | 002007 | 华兰生物 | 17.06 | 1.73% | 36.57万 | | 6.30亿 | | 301080 | 百普赛斯 | 54.16 | 0.86% | 2.12万 | | 1.14亿 | | 002581 | ST未名 | 7.27 | 0.83% | ...

7月30日，医疗器械行业下跌0.38%，今日主力资金流出4.36亿元，成分股41只上涨，56只下跌。 主力资金净流出居前的分别为诺唯赞（1345.21万元）、翔宇医疗（1328.4万元）、山东药玻（1264.96 万元）、ST凯利（1228.57万元）、之江生物（1055.64万元）。 序号代码名称最新价涨跌幅主力净流入主力净占比1300869康泰医学20.489.647210.99万元7.05%2300760 迈瑞医疗237.962.655584.03万元1.73%3002432九安医疗39.41.184117.95万元9.47%4600587新华医疗 16.813.382981.82万元5.89%5688050爱博医疗77.471.552538.28万元5.85%6300314戴维医疗 14.652.092318.76万元5.67%7300453三鑫医疗8.851.491781.91万元11.83%8300677英科医疗 33.965.51375.80万元1.21%9688029南微医学84.90.981371.50万元3.24%10300529健帆生物 24.370.911339.14万元2.86% 来 ...

Summary of Key Points from the Conference Call Industry Overview - **Industry Focus**: The conference call primarily discusses the healthcare sector in China, particularly the medical technology (Medtech), in vitro diagnostics (IVD), retail pharmacies, hospitals, vaccines, and insulin markets [1][2]. Core Insights and Arguments Medtech - **Key Areas of Focus**: 1. Progress of capital equipment value-based procurement (VBP) and the trade-in policy [1] 2. Channel destocking trends [1] 3. Import substitution trends post-VBP, including intraocular lenses (IOLs) and IVD [1] - **VBP Impact**: The June bidding value data showed a year-on-year growth rate of 49%, but a month-on-month decline of 3%, indicating lower unit prices due to VBP [10]. IVD Market - **Weak Demand**: The IVD sector continues to face challenges, with a projected 20% year-on-year decline in the CLIA reagent market size for 2025 [19]. - **AmoyDx Performance**: AmoyDx is expected to grow against the trend due to its strong presence in compliant in-hospital sales channels, benefiting from the anti-corruption campaign [21]. Insulin Market - **Domestic Substitution**: The insulin industry has seen significant growth, particularly for insulin analogs from companies like Gan & Lee and THDB, which reported rapid revenue growth in 1Q25 [22]. Retail Pharmacies - **Market Pressure**: Retail pharmacies are under pressure due to strict reimbursement policies and weak consumer spending. However, there is a potential market-clearing trend expected by year-end [31]. Hospitals - **New Product Feedback**: Hospitals are seeing new product introductions, such as the new version of SMILE surgery and new PIOL products, which are expected to drive consumption recovery [1]. Vaccine Market - **Anti-Corruption Campaign**: The ongoing anti-corruption campaign within the CDC system is impacting vaccine demand and distribution channels [1]. Financial Performance and Estimates Earnings Revisions - **Mindray**: Annual earnings estimates revised down by 2.1% to 5.0% for 2025E-27E due to industry headwinds in medical equipment and IVD [2][37]. - **United Imaging**: Revenue and earnings forecasts adjusted down to reflect lower-than-expected bidding data [39]. - **SNIBE**: Earnings estimates revised down by 1.4% to 7.1% for 2025E-27E due to policy headwinds in the IVD sector [40]. Revenue Growth Expectations - **High Growth Companies**: THDB and Gan & Lee are expected to achieve the highest revenue growth due to a low base from VBP renewal in 2Q24 [6]. - **Mindray's Decline**: Mindray's China business is expected to decline by 26% year-on-year in 2Q25 due to IVD weakness [9]. Other Important Insights - **Trade-in Policy Concerns**: The trade-in stimulus fund is expected to run out, leading to a decline in applications and a reduced stimulus effect in the second half of 2025 [10]. - **Market Dynamics**: The healthcare market is experiencing a shift with increasing government support for procurement and a focus on innovative products [47][48]. Conclusion - The healthcare sector in China is facing various challenges, including policy headwinds, weak demand in certain segments, and the impact of ongoing reforms. However, there are also opportunities for growth, particularly in innovative products and domestic substitution trends. Companies like AmoyDx, Gan & Lee, and THDB are positioned to benefit from these trends, while others like Mindray and SNIBE are facing headwinds that may impact their performance in the near term.