证券代码：603392 证券简称：万泰生物 公告编号：2025-036 北京万泰生物药业股份有限公司 关于冻干水痘减毒活疫苗（VZV-7D）启动 III 期临床试验并完成首例受试者入组的公告 水痘是由水痘-带状疱疹病毒（Varicella-Zoster Virus，VZV）感染引起的具 有高度传染性的儿童期出疹性疾病，通过飞沫或接触传染，在全球范围内传播。 人群普遍易感，主要常见于儿童，以全身性丘疹、水疱和结痂为主要临床特征， 并发症以皮肤继发性细菌感染为主，严重者可引发肺炎或脑炎等，免疫力低下人 群对水痘病毒普遍易感，易感儿童接触后90%发病。在初次感染水痘且痊愈后， 水痘-带状疱疹病毒会潜伏在感觉神经节中，具有终生潜伏特性，当VZV的特异 性免疫力下降时，病毒可被再次激活，表现为带状疱疹（俗称缠腰龙、蛇缠腰） 公司研发的冻干水痘减毒活疫苗（VZV-7D）接种后可刺激机体产生抗水痘- 带状疱疹病毒（Varicella-Zoster Virus，VZV）的免疫力，用于预防水痘。本品使 用的毒株为用反向遗传学技术构建出毒力基因ORF7表达缺陷的重组水痘-带状 疱疹病毒株，本毒株既不感染皮肤引发水痘，也不潜伏神经 ...

Group 1 - The price of the imported Merck nine-valent HPV vaccine has significantly decreased in several cities, with promotional offers reducing the effective price to around 700 yuan per dose from the original price of 1320 yuan [1][2] - The market for the nine-valent HPV vaccine has shifted dramatically, with the once exclusive Merck vaccine facing competition from domestic manufacturers, leading to a more accessible supply [2][4] - The inventory pressure on Zhifei Biological, the agent for Merck's vaccine, is evident, with a 14.8% year-on-year decline in the batch issuance of the nine-valent vaccine and a staggering 95.49% drop for the four-valent vaccine [3] Group 2 - The approval of the domestic nine-valent HPV vaccine "Xinkening 9" by Wantai Biological has disrupted the market, with a potential price point around 700 yuan, effectively halving the original price of the imported vaccine [4] - Other domestic companies, including Kanglaisheng, Watson Bio, and Shanghai Bowei, are also nearing the launch of their nine-valent HPV vaccines, which is expected to reignite price competition in the market [5] - The anticipated release of more domestic nine-valent vaccines marks the beginning of a trend towards greater affordability and accessibility in the HPV vaccine market [5]

Core Viewpoint - The article discusses the challenges faced by Zhifei Biological, particularly in the sales of the nine-valent HPV vaccine, amid increasing competition and declining performance metrics [1][4][8]. Group 1: Sales and Market Challenges - Zhifei Biological has experienced severe sales difficulties with the nine-valent HPV vaccine, leading to significant inventory issues and delayed payments, resulting in a drastic decline in performance over the past year [1][4]. - The company reported a revenue of 26 billion yuan in 2025, a 50% decrease year-on-year, and a net profit of 2 billion yuan, down 75% from the previous year [8]. - The introduction of a competing nine-valent HPV vaccine by Wantai Biological has intensified market competition, prompting Zhifei to initiate promotional activities to boost sales [3][29]. Group 2: Inventory and Financial Management - As of the first quarter of 2025, Zhifei's accounts receivable decreased from 16.3 billion yuan to 14.6 billion yuan, indicating ongoing efforts to manage financial pressures [14]. - The company is focusing on "de-stocking, collecting payments, and reducing liabilities" as core strategies to mitigate operational risks [12]. - Inventory issues are compounded by a significant amount of unsold products, with a large portion being imported vaccines, leading to increased financial strain [17][18]. Group 3: Strategic Responses - Zhifei Biological has outlined three main strategies to address market challenges: enhancing communication with partners, adjusting promotional policies, and strengthening risk control measures [10][11]. - The company has initiated a large-scale promotional campaign, including free vaccination offers, to stimulate demand and improve vaccination rates [2][5]. - Despite these efforts, there are concerns about the effectiveness of their promotional strategies, particularly in reaching target demographics and adapting to market needs [20][21]. Group 4: Competitive Landscape - The competitive landscape is shifting, with Wantai Biological's entry into the market expected to create additional pressure on Zhifei, which has already been struggling with sales [26][30]. - Experts suggest that the market for the nine-valent HPV vaccine may face challenges due to a saturated customer base, as many potential recipients have already completed their vaccinations [30][31]. - The pricing strategy of Wantai Biological is anticipated to be significantly lower than that of imported vaccines, potentially affecting Zhifei's market share [27][32].

证券代码：603392 证券简称：万泰生物 公告编号：2025-035 北京万泰生物药业股份有限公司 关于使用部分闲置募集资金 进行现金管理的进展公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性 陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： 履行的审议程序：北京万泰生物药业股份有限公司（以下简称"公司"） 于2025年1月14日召开第六届董事会第六次会议、第六届监事会第六次会议， 审议通过了《关于使用部分闲置募集资金进行现金管理的议案》，同意公司 使用最高额度不超过人民币15亿元（含）的暂时闲置非公开发行股票募集资 金适时投资安全性高、流动性好的保本型产品，单项产品期限最长不超过12 个月。该额度自公司董事会审议通过之日起12个月内有效，可由公司及全资 子公司共同循环滚动使用。具体内容详见公司于指定信息披露媒体披露的 《北京万泰生物药业股份有限公司关于使用部分闲置募集资金进行现金管 理的公告》（公告编号：2025-004）。 一、本次现金管理概况 （一）现金管理目的 鉴于公司募投项目均有一定的实施周期，为提高募集资金的使用效率和资金 效益，公司在确保不 ...

Core Viewpoint - The company has approved the use of idle fundraising for cash management, allowing investment in safe, liquid principal-protected products up to a maximum of RMB 1.5 billion [2][11]. Group 1: Cash Management Overview - The company plans to use idle funds from its non-public stock issuance to invest in principal-protected financial products, enhancing the efficiency and returns of the raised funds while ensuring no impact on ongoing projects [4][9]. - The cash management will involve a maximum of RMB 800 million in a structured deposit product from Hangzhou Bank, with a term of 364 days [6][10]. Group 2: Financial Product Redemption - The company redeemed a structured deposit product from Hangzhou Bank worth RMB 50 million, receiving the principal and a return of RMB 585,900 on June 6, 2025 [3]. Group 3: Financial Situation and Impact - As of March 31, 2025, the company's cash reserves were RMB 1,874.59 million, with the cash management investment representing 4.27% of total cash, indicating minimal impact on financial health [11]. - The use of idle funds for cash management is expected to improve fund utilization efficiency and generate returns for shareholders without affecting the company's operational projects [11].

Group 1: HPV Vaccine Market Overview - The HPV vaccine market in China grew from 940 million yuan in 2017 to 13.56 billion yuan in 2020, with a compound annual growth rate (CAGR) of 143.43% [1] - The global HPV vaccine market is expected to achieve a CAGR of 20.04% from 2020 to 2025, potentially reaching 16.8 billion USD by 2031 [2] Group 2: Policy and Market Drivers - The Chinese government is promoting inclusive development and prioritizing children's welfare, which includes enhancing HPV vaccination efforts among eligible girls [1] - The demand for HPV vaccines is anticipated to accelerate due to policy support and the rapid growth of domestic vaccine companies [2] Group 3: Company Developments - Wantai Biological Pharmacy's subsidiary, Xiamen Wantai Canghai, has received approval from the National Medical Products Administration for its nine-valent HPV vaccine, making it the first in China and the second globally [3] - Watson Bio's subsidiary, Shanghai Zerun, is advancing its phase III clinical trials for a nine-valent HPV vaccine, currently in the data analysis and clinical research report writing phase [3]

证券代码：603392 证券简称：万泰生物 公告编号：2025-034 北京万泰生物药业股份有限公司 关于使用部分闲置募集资金进行现金管理 到期赎回并继续进行现金管理的公告 （一）现金管理目的 鉴于公司募投项目均有较长的实施周期，为提高募集资金的使用效率和资金 效益，公司在确保不影响募集资金投资项目建设和募集资金使用的情况下，使用 部分闲置募集资金投资保本型理财产品，有利于提高募集资金的使用效率，增加 公司收益，保证股东利益最大化。 （二）资金来源 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性 陈述或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示： 履行的审议程序：北京万泰生物药业股份有限公司（以下简称"公司"） 于2025年1月14日召开第六届董事会第六次会议、第六届监事会第六次会议，审 议通过了《关于使用部分闲置募集资金进行现金管理的议案》，同意公司使用最 高额度不超过人民币15亿元（含）的暂时闲置非公开发行股票募集资金适时投资 安全性高、流动性好的保本型产品，单项产品期限最长不超过12个月。该额度自 公司董事会审议通过之日起12个月内有效，可由公司及全资子公 ...

Investment Rating - Investment Rating: Positive [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 3.36%, ranking 6th among 31 primary industries, outperforming the CSI 300 index, which decreased by 0.21% [5][17] - The valuation of the pharmaceutical and biotechnology industry as of June 6, 2025, is 28.24x (TTM, excluding negative values), up from 27.60x in the previous period, indicating an upward trend but still below the average [5][23] - Notable sub-industry performance includes chemical preparations and other biological products, with increases of 5.77% and 4.68% respectively, while offline pharmacies saw a decline of 1.15% [5][17] Industry Review - The report highlights three major investment opportunities: 1) Companies with dual-antibody/multi-antibody technology platforms that have differentiated target design capabilities and clinical advancement efficiency are likely to attract international giants [9] 2) Areas with unmet clinical needs, such as advanced liver cancer and non-small cell lung cancer, are promising for dual-antibody therapy development [9] 3) Potential license-out candidates, as domestic innovative pharmaceutical companies continue to engage in global collaborations [9] Important Industry News - CDE launched the "Star Plan" to encourage the development of pediatric anti-cancer drugs, addressing significant unmet clinical needs in this area [7][32] - Alcon's dry eye medication "Tryptyr" received FDA approval, marking it as the first of its kind globally [39] - Hansoh Pharmaceutical's third-generation EGFR-TKI "Amivantamab" was approved in the UK for first-line treatment of NSCLC, becoming the first domestically developed EGFR-TKI approved overseas [42] - BMS and BioNTech entered a collaboration for the dual-antibody candidate BNT327, with an upfront payment of $1.5 billion and potential milestone payments of $7.6 billion [51] Company Dynamics - Stone Pharmaceutical is negotiating three potential deals totaling $5 billion, involving several products including EGFR ADCs [49] - BMS's "Rotecip" was approved for treating lower-risk myelodysplastic syndromes, marking a significant innovation in this therapeutic area [45] - AbbVie’s JAK inhibitor "Upadacitinib" was approved for treating giant cell arteritis, becoming the first approved treatment for this condition in China [48]

Core Viewpoint - The approval of the first domestic nine-valent HPV vaccine, Xinkening®9, by Wantai Biological Pharmacy, marks a significant breakthrough in China's vaccine industry, challenging Merck's long-standing monopoly in the market [1][26]. Summary by Sections R&D and Product Value - Wantai Biological invested approximately 1 billion yuan over 18 years to develop Xinkening®9, achieving three major breakthroughs in vaccine technology [3][12]. - The vaccine utilizes an innovative E. coli expression system, resulting in higher immunogenicity, cost-effectiveness, and complete proprietary intellectual property [5][6]. Efficacy and Safety - Xinkening®9 can prevent infections from nine HPV types, covering over 90% of HPV-related infections, with proven efficacy and safety comparable to imported vaccines [6][7]. - A head-to-head study published in The Lancet confirmed that both domestic and imported vaccines had a 100% seroconversion rate for neutralizing antibodies [7]. Administration and Accessibility - The vaccine offers flexible dosing schedules: a two-dose regimen for females aged 9-17 and a three-dose regimen for those aged 18-45, making it more accessible compared to imported alternatives [11][12]. Pricing Strategy - The market is keenly awaiting the pricing strategy for Xinkening®9, with current expectations based on the pricing of the only other available nine-valent HPV vaccine, Gardasil®9, which costs around 1300 yuan per dose [13][14]. - Two main pricing strategies are anticipated: an aggressive pricing approach or a price set at 50%-70% of the imported vaccine's cost [14][15]. Market Potential and Growth - If priced between 700 to 800 yuan per dose, Xinkening®9 could balance commercial viability and social responsibility, addressing the significant gap in HPV vaccination rates in China [16][17]. - The global demand for HPV vaccines is robust, with projections estimating Xinkening®9 could reach sales of 22.8 billion yuan [23]. Future Expansion - Wantai Biological plans to expand into the male market and pursue international opportunities, leveraging its WHO pre-certification and existing market access in various countries [25]. - The approval of Xinkening®9 signifies a shift in China's vaccine industry from catching up to leading in core product development [26].

Core Viewpoint - Wantai Biological's 9-valent HPV vaccine has been approved in China, breaking the long-standing foreign monopoly and potentially reversing the company's declining revenue and profit trend [1][2]. Group 1: Company Performance - Wantai Biological's revenue and profit have been declining for several years, with reported revenues of 111.85 billion yuan in 2022, 55.11 billion yuan in 2023, and a projected 22.45 billion yuan in 2024. Net profits were 47.36 billion yuan, 12.48 billion yuan, and 1.06 billion yuan for the same years [4]. - In Q1 2025, the company continued to face challenges, with revenue of 4.01 billion yuan, a year-on-year decline of 46.76%, and a net loss of 0.53 billion yuan, a staggering decline of 141.98% [4]. Group 2: Market Dynamics - The approval of the 9-valent HPV vaccine is expected to boost Wantai's performance in 2025, as it can capture market share from Merck, which currently has the only competing product [8]. - The 9-valent HPV vaccine offers broader protection compared to the 2-valent version, which may enhance its market appeal [8]. Group 3: Competitive Landscape - The domestic HPV vaccine market has become increasingly competitive, with prices for the 2-valent HPV vaccine dropping significantly from 329 yuan to 86 yuan, leading to a substantial revenue decline for Wantai's vaccine segment [6][10]. - The market is expected to see more competitors entering with their own 9-valent HPV vaccines by 2026, which could lead to further price wars and impact Wantai's ability to maintain growth [15][16]. Group 4: Future Outlook - While the approval of the 9-valent HPV vaccine is a positive development for Wantai, the long-term growth outlook remains uncertain due to potential pricing pressures and increased competition from other domestic manufacturers [16].