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].

Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $39.7 million, a significant increase from $6.4 million in Q2 2024, primarily driven by a BARDA contract awarded in June 2024 [20][21] - The company ended Q2 2025 with cash, cash equivalents, and investments of CAD 26.3 million, expecting cash runway into 2026 [21] Business Line Data and Key Metrics Changes - The COVID-19 clinical program faced a second stop work order, but approximately 5,000 participants were already enrolled, allowing the study to continue for those participants [4][5] - Positive Phase 1 results were reported for the norovirus program, with second-generation constructs showing statistically significant increases in blocking antibodies compared to first-generation constructs [8][15] Market Data and Key Metrics Changes - Norovirus is estimated to cause 20% of diarrheal disease globally, representing a significant unmet need and a potential multibillion-dollar market for a safe and effective vaccine [9][10] - The healthcare economic costs of norovirus infection are estimated at $60 billion worldwide and $10 billion in the United States [9] Company Strategy and Development Direction - The company aims to develop innovative vaccine solutions, including oral vaccines for COVID-19 and norovirus, with a focus on transforming global public health [7][12] - The company is actively seeking strategic partnerships and non-dilutive funding options to extend its cash runway and support ongoing clinical programs [21][66] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the COVID-19 trial despite the stop work order, highlighting strong public interest in the oral vaccine platform [5][6] - The company remains in close contact with BARDA and anticipates further details regarding the trial [6][14] Other Important Information - The company is currently listed on the OTCQX market due to NASDAQ suspension for not meeting the $1 minimum bid price requirement, with plans to regain compliance through a reverse stock split [23][24] - A special meeting of stockholders is scheduled to discuss the reverse stock split proposal, which is seen as critical for future partnerships and funding opportunities [25][26] Q&A Session Summary Question: What is the statistical assumption for the COVID trial? - Management confirmed that the study is randomized, with about half of the participants receiving the test construct and the other half receiving a comparator mRNA vaccine [33] Question: What is the impact of the second stop work order on enrollment? - Management indicated that the impact depends on when changes might occur, and they are awaiting more information [35] Question: Is funding necessary before starting the Phase 2b study for norovirus? - Management confirmed that progression to Phase 2b is contingent on securing funding or partnerships [38][41] Question: What is the rationale behind the second stop work order for COVID? - Management stated they have not received specific information regarding the rationale but are in dialogue with BARDA [44] Question: What is the timeline for the Phase 2b study for norovirus? - Management indicated that the timeline is dependent on securing funding, with potential for the study to start in 2025 [39][41] Question: What are the plans for avian flu data publication? - Management stated that they intend to report data from avian flu studies in a peer-reviewed journal or conference [53] Question: How will R&D spending be impacted by the stop work order? - Management confirmed that BARDA will continue to fund follow-up studies for the participants already dosed, and they anticipate collecting more than 50% of the original contract [55]

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].

谈及此次获得临床批件的意义，华兰疫苗表示，"冻干Hib疫苗"的获批是公司产品研发战略布局阶段性 的成功，不仅丰富公司产品布局，也是实现公司研发多联多价产品的重要一步，既有利于巩固公司在国 内二类疫苗领域的行业地位，又有利于公司疫苗业务的可持续发展。 审批结论显示，Hib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。 本报讯(记者肖艳青)8月13日晚间，华兰生物（002007）疫苗股份有限公司(以下简称"华兰疫苗 （301207）")公告称，公司近日收到国家药品监督管理局核准签发的关于冻干b型流感嗜血杆菌结合疫 苗(以下简称"Hib疫苗")的《药物临床试验批准通知书》。 ...

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]

证券代码：301207 证券简称：华兰疫苗 公告编号：2025- 华兰生物疫苗股份有限公司 关于冻干b型流感嗜血杆菌结合疫苗获得 二、产品的相关情况 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；继发于血流侵袭的 感染通常由荚膜型菌株引起。有荚膜的菌株根据荚膜多糖的化学成分来进行分类， 迄今已发现 6 种血清型，其中，约 95%的侵袭性流感嗜血杆菌疾病由 b 型引起。 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。 华兰生物疫苗股份有限公司（以下简称"公司"）于近日收到国家药品监督管理 局核准签发的关于冻干b型流感嗜血杆菌结合疫苗（以下简称"Hib疫苗"）的《药物 临床试验批准通知书》。具体情况如下： 一、通知书基本情况 产品名称：冻干b型流感嗜血杆菌结合疫苗 注册分类：预防用生物制品3.3类 申请事项：境内生产药品注册临床试验 申请人：华兰生物疫苗股份有限公司 通知书编号：20 ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of a lyophilized Haemophilus influenzae type b (Hib) conjugate vaccine, which is expected to induce an immune response against Hib and provide protection to recipients [1] Group 1: Vaccine Development - The Hib vaccine is composed of purified Hib polysaccharide combined with tetanus toxoid protein and is presented in a lyophilized form [1] - The company is also developing a combination vaccine based on the DTP (diphtheria, tetanus, and pertussis) components, with the Hib vaccine being one of the components [1] - Vaccine development is described as a complex and rigorous scientific activity, characterized by significant challenges and long timelines [1]

Core Viewpoint - Hualan Vaccine has received approval from the National Medical Products Administration for the clinical trial of its lyophilized Haemophilus influenzae type b (Hib) vaccine, marking a significant step in the company's product development strategy [2] Group 1: Company Developments - The approval of the Hib vaccine is an important milestone for Hualan Vaccine, as it will enrich the company's product line [2] - The Hib vaccine is classified as a Class 3.3 preventive biological product, aimed at preventing invasive infections caused by Haemophilus influenzae type b [2] - The company plans to support future registration applications for combination vaccines based on the Hib vaccine and DTP (Diphtheria, Tetanus, Pertussis) [2] Group 2: Industry Context - The development of vaccines typically involves long research and development cycles, and the company must conduct clinical trials in accordance with national regulations [2] - The company faces potential risks associated with the vaccine development process, including the possibility of research and development failures [2]

Core Insights - The HPV vaccine market in China is experiencing significant growth, with a total of 322 batches approved in the first half of 2023, representing a year-on-year increase of 79.20% [1] - Watson Bio's 2-valent HPV vaccine achieved 414.39 million doses approved, marking a staggering year-on-year growth of 368.42% [1] - The sales of HPV vaccines are contributing positively to the financial performance of related companies, with Watson Bio reporting a net profit of 455 million yuan, an increase of 8.13% year-on-year [1] Group 1: Market Performance - Watson Bio's 2-valent HPV vaccine had a successful first half of 2023, winning government procurement projects for 1.686 million doses [3] - WanTai Bio reported sales of over 10 million doses of its 2-valent HPV vaccine during the same period [3] - The penetration rate of the 2-valent HPV vaccine among eligible women is estimated to be less than 10%, indicating substantial growth potential as health awareness increases [3] Group 2: Competitive Landscape - The market for 2-valent HPV vaccines is primarily driven by women aged 9 to 45, but competition from imported 9-valent vaccines is increasing, particularly in the market for women over 30 [3][4] - Five Chinese manufacturers have entered the clinical phase III trials for 9-valent HPV vaccines, indicating a potential surge in domestic competition [4] Group 3: International Expansion - Domestic vaccine companies are accelerating their international market expansion, with WanTai Bio successfully exporting its 2-valent HPV vaccine to Thailand and obtaining licenses in Cambodia and Ethiopia [5] - Watson Bio is collaborating with Indonesian partners for local production of 2-valent HPV vaccines, laying the groundwork for future cooperation [5] - The expansion into international markets is expected to enhance brand value and increase revenue streams for these companies [6]