Core Viewpoint - The approval and launch of the domestic nine-valent HPV vaccine "Xinkening®9" marks a significant milestone for China's biopharmaceutical industry, breaking the global monopoly of high-priced imported HPV vaccines and establishing China as the second country after the United States capable of independently supplying such vaccines [2][9]. Group 1: Vaccine Development and Approval - The nine-valent HPV vaccine was developed through a collaboration between Xiamen University, Xiang'an Innovation Laboratory, and Wantai Biological Pharmacy, taking 18 years from inception to approval [2]. - The vaccine covers nine HPV types (6, 11, 16, 18, 31, 33, 45, 52, 58) and utilizes an innovative E. coli expression platform, which has reduced production costs and validated safety and efficacy through key clinical trials [2][3]. Group 2: Clinical Trials and Efficacy - Since 2019, five clinical trials have been conducted across China, enrolling over 11,000 healthy volunteers aged 9 to 45, providing robust research data [2]. - The vaccine shows comparable protection rates against HPV16/18-related lesions to imported vaccines and over 98% protection against persistent infections from other high-risk types [3]. Group 3: Market Position and Pricing - The pricing of "Xinkening®9" is set at 499 yuan per dose, approximately 40% of the price of imported vaccines, which were previously monopolized by Merck & Co. at around 1300 yuan per dose [3][9]. - The vaccine has received WHO PQ certification and has gained market access in over 20 countries, being included in immunization programs in four countries, thus positioning it as a "Chinese solution" in global public health [3][9]. Group 4: Industry Context and Future Outlook - The global market for HPV vaccines is projected to grow at an annual rate of 8%, potentially reaching nearly $10 billion by 2027, driven by the increasing inclusion of vaccines in national immunization programs [8]. - The successful launch of "Xinkening®9" exemplifies China's capability in biopharmaceutical innovation and is expected to enhance the competitiveness of Chinese companies in the international market while contributing to global cervical cancer prevention efforts [9].

Core Insights - The first domestically produced nine-valent HPV vaccine "Xinkening 9" by Wantai Biological has been priced at 499 yuan per dose, approximately 40% of the price of imported counterparts [1] - The vaccine was developed in collaboration with Xiamen University and has undergone 18 years of research, with an investment of around 1 billion yuan by 2025 [1] - The approval of "Xinkening 9" marks a significant milestone in the domestic HPV vaccine market, previously dominated by Merck's "Gardasil 9" [1][2] Pricing and Market Impact - The full vaccination cost for the imported vaccine is nearly 4000 yuan, while the domestic vaccine reduces this to about 1500 yuan, and for ages 9-17, the cost is only 998 yuan for two doses [1] - The approval of "Xinkening 9" is expected to enhance HPV vaccination rates in China, which currently stands at 27.43% for the first dose among women aged 9-45, compared to 67% in Western countries [3] Marketing and Distribution Strategy - The company plans to implement a new marketing strategy that combines regional grid management, digital management, and personalized services to cater to different demographics and healthcare resources [3] - Wantai Biological is actively pursuing WHO PQ certification for the nine-valent HPV vaccine and aims to expedite its international market entry based on its previous successes with its bivalent HPV vaccine [3] Financial Performance - Wantai Biological reported a revenue of 2.245 billion yuan for 2024, a decline of 59.25% year-on-year, with a net profit of 106 million yuan, down 91.49%, marking a five-year low [5] - In the first quarter of 2025, the company reported a net loss of 52.78 million yuan, a significant drop from a profit of 126 million yuan in the same period the previous year [5] Competitive Landscape - The nine-valent HPV vaccine market is becoming increasingly competitive, with several domestic companies like Watson Bio, Kangla Weishi, and Ruike Bio also preparing to launch their products [4]

Core Viewpoint - WanTai Biologics has officially launched its nine-valent HPV vaccine "Xinkening®9" at a price of 499 yuan per dose, significantly undercutting the imported vaccine price and marking the end of the "high-price era" for HPV vaccines in China [1][6]. Pricing and Market Impact - The imported nine-valent HPV vaccine "Gardasil 9" is priced at approximately 1318 yuan per dose, with a total cost of nearly 4000 yuan for three doses, while "Xinkening®9" costs about 1497 yuan for three doses [1]. - "Xinkening®9" is the only HPV vaccine approved for a two-dose regimen for ages 9-17, reducing the cost for this age group to 998 yuan, thereby enhancing accessibility and compliance [1]. Historical Context and Market Dynamics - Prior to the launch of "Xinkening®9", the nine-valent HPV vaccine market in China was monopolized by Merck's "Gardasil 9," which faced a dramatic shift from high demand and scarcity to excess inventory [2]. - In 2023, the batch issuance of "Gardasil 9" reached 36.55 million doses, a year-on-year increase of 136.16%, making Merck the highest-grossing multinational pharmaceutical company in China that year [2]. Sales Performance and Challenges - Merck's global sales of the HPV vaccine in 2024 were $8.583 billion, a 3% decline year-on-year, primarily due to weak performance in the Chinese market [3]. - To address high inventory levels, Merck announced a suspension of supply to China starting in early 2025, expected to last until at least mid-2025 [3]. Financial Performance of WanTai Biologics - WanTai Biologics reported a 59.25% year-on-year decline in revenue for 2024, totaling 2.245 billion yuan, with a net profit drop of 91.49% to 106 million yuan [3]. - The company faced significant challenges due to a price collapse in its two-valent vaccine, leading to a drastic reduction in government procurement prices [3]. Market Potential and Future Outlook - The potential market for HPV vaccines in China is substantial, with 70%-80% of the 300 million women aged 9-45 yet to be vaccinated [4]. - National Investment Securities predicts that WanTai's nine-valent HPV vaccine could reach a sales peak of 22.8 billion yuan, with projected revenues of 3.17 billion yuan, 11.4 billion yuan, and 28.63 billion yuan for 2025-2027 [4]. Competitive Landscape - Several domestic pharmaceutical companies are in the late clinical stages of developing their own nine-valent HPV vaccines, creating a competitive environment for WanTai [5]. - WanTai has initiated a Phase III clinical trial for a male indication, but competitors like Kanglaite have already started their trials earlier [5]. International Expansion - WanTai aims to become a leading global vaccine supplier by 2030, with plans to have 3 to 5 WHO pre-qualified products [5]. - Competitors are also pursuing international markets, with Kanglaite planning to submit for approval in Indonesia and Ruike Biologics exploring the Middle East [5]. Industry Trends - The World Health Organization has warned that global HPV vaccine supply may exceed demand from 2025 to 2030, potentially leading to a price war and industry reshuffling [5]. - The WHO's recommendation for a single-dose HPV vaccination regimen could further intensify market competition [5].

6月5日上午，一位上海万泰九价HPV疫苗代理商在见过厂商后，告诉长江商报记者："现在价格还没公 布，他们也没拿到产品说明书。" 此前，万泰生物的王牌产品是二价HPV疫苗，依靠二价HPV疫苗，万泰生物曾实现年度百亿元营收、47 亿元净利。不过，随着竞品相继出现，万泰生物疫苗销量及收入出现滑坡，业绩也断崖式下滑。 随着首个国产九价HPV疫苗获批上市，万泰生物的经营业绩有望修复。目前，其九价HPV疫苗累计已完 成研发投入约10亿元。 首个国产九价HPV疫苗获批上市 6月4日盘后，万泰生物发布公告，公司全资子公司厦门万泰沧海生物技术有限公司申报的九价人乳头瘤 病毒疫苗（大肠埃希菌）（商品名称：馨可宁9）近日获批上市。同时该子公司通过九价HPV疫苗上市 前的首次药品GMP符合性检查。 万泰生物表示，公司本次获批上市的九价HPV疫苗适用于9—45岁女性，其中9—17岁可采用二剂次接种 程序（0、6月），18—45岁采用三剂次接种程序（0、1和6月）。该疫苗覆盖HPV16/18/31/33/45/52/58 七种高危型和HPV6/11两种低危型，可预防上述型别人乳头瘤病毒感染引起的相关疾病。 长江商报消息 全国首个！全球第 ...

九价HPV疫苗已经"飞入寻常百姓家"，默沙东与其国内代理商 智飞生物都在承受销售压力。不再稀缺的九价苗，万泰生物能 卖动吗？ 作者：张英 刘晓诺 封图：图虫创意 6月5日，万泰生物（603392.SH）的股价一字涨停，截至当日收盘，总市值为991亿元，距离千亿 市值仅一步之遥。 6月4日，万泰生物公告其申报的九价人乳头瘤病毒（HPV）疫苗（商品名称：馨可宁9）获批上 市，适用于9—45岁女性。 这是获批上市的首款国产九价HPV疫苗，也是全球第二款九价HPV疫苗。此前，在全球范围内， 九价HPV疫苗仅有默沙东（NYSE:MRK）的佳达修9。 万泰生物是国产HPV疫苗龙头，曾靠其研发的首支国产二价HPV疫苗馨可宁获得超百亿元收入。 如今二价苗营收不佳，业绩已连续下滑两年。有分析师认为，九价疫苗或可成为万泰生物业绩核心 驱动力。 万泰生物尚未公布九价HPV疫苗的价格，不过曾称该疫苗具有生产成本低、价格实惠等优势。默 沙东的佳达修9在中国的定价是每针1300元左右。 不过，九价HPV疫苗已经"飞入寻常百姓家"，默沙东与其国内代理商智飞生物（300122.SZ）都在 承受销售压力。不再稀缺的九价苗，万泰生物还能卖动吗？ ...

【6月4日多家医药企业有新动态，涉及疫苗获批、药品事件及股份减持等】 6月4日，万泰生物公告，其全资子公司厦门万泰沧海生物技术有限公司申报的九价人乳头瘤病毒疫苗获 批上市。这是我国第一款、全球第二款九价HPV疫苗，此前全球仅默沙东的佳达修9一款九价HPV疫苗 上市。不过，默沙东九价HPV疫苗接种表现下滑，国产疫苗上市后，其价格及竞争格局或生变。 同 日，阿斯利康宣布英飞凡获中国国家药监局批准，可单药用于特定局限期小细胞肺癌成人患者治疗。临 床试验显示，该疗法可延长患者生存期，作为"首个且唯一"免疫疗法，有望提升市场份额。 近期受关 注的康方生物"仅供临床研究使用"抗肿瘤药品流向患者事件，6月4日有了进展。康方生物称，重庆销售 人员伪造材料骗取若干药物，公司正配合监管调查，责任认定待监管给出。该事件暴露公司销售合规管 理漏洞，或影响品牌形象和市场信任。 6月4日，百克生物公告收到重组带状疱疹疫苗《药物临床试验 批准通知书》，接种对象为40岁及以上成人，可预防带状疱疹。若该疫苗上市，有助于公司优化结构和 提升盈利能力。 也是6月4日，科兴制药公告，控股股东深圳科益医药控股有限公司拟减持不超598.92万 股，即不 ...

2025.06. 05 【今日推荐】 特朗普全面暂停12个国家的公民进入美国 当地时间6月4日，根据美国白宫发布的一份声明，美国总统特朗普全面暂停12个国家的公民以移民 和非移民身份进入美国，这些国家分别是阿富汗、缅甸、乍得、刚果共和国、赤道几内亚、厄立特里 亚、海地、伊朗、利比亚、索马里、苏丹和也门。此外，特朗普还宣布对另外七个国家的公民实施部 分限制入境措施，这七个国家是布隆迪、古巴、老挝、塞拉利昂、多哥、土库曼斯坦和委内瑞拉。该 禁令和相关限制措施包含若干豁免情形，包括美国永久居民、阿富汗特别移民签证持有者、外交人 员、运动员，以及持有未被该命令波及国家护照的双重国籍人士。 美国宣布将对哈佛大学国际学生实行签证限制 美国白宫4日发布公告，宣布将对哈佛大学国际学生实行签证限制。 云南大理州洱源县发生5.0级地震 当地已启动Ⅲ级应急响应 据中国地震台网正式测定，6月5日4时31分在云南大理州洱源县发生5.0级地震，震源深度10公里， 距洱源县城约18公里，震中附近村庄震感强烈。地震发生后，洱源县人民政府启动抗震救灾Ⅲ级应 急响应，云南消防大理支队、洱源大队已赶赴震中，目前暂未收到人员伤亡报告。 越南国会通过 ...

第一财经每日早间精选热点新闻，点击「听新闻」，一键收听。 【今日推荐】 特朗普全面暂停12个国家的公民进入美国 当地时间6月4日，根据美国白宫发布的一份声明，美国总统特朗普全面暂停12个国家的公民以移民和非 移民身份进入美国，这些国家分别是阿富汗、缅甸、乍得、刚果共和国、赤道几内亚、厄立特里亚、海 地、伊朗、利比亚、索马里、苏丹和也门。此外，特朗普还宣布对另外七个国家的公民实施部分限制入 境措施，这七个国家是布隆迪、古巴、老挝、塞拉利昂、多哥、土库曼斯坦和委内瑞拉。该禁令和相关 限制措施包含若干豁免情形，包括美国永久居民、阿富汗特别移民签证持有者、外交人员、运动员，以 及持有未被该命令波及国家护照的双重国籍人士。 云南大理州洱源县发生5.0级地震 当地已启动Ⅲ级应急响应 据中国地震台网正式测定，6月5日4时31分在云南大理州洱源县发生5.0级地震，震源深度10公里，距洱 源县城约18公里，震中附近村庄震感强烈。地震发生后，洱源县人民政府启动抗震救灾Ⅲ级应急响应， 云南消防大理支队、洱源大队已赶赴震中，目前暂未收到人员伤亡报告。 越南国会通过法律修正案 取消生育限制 当地时间6月3日下午，越南国会常务委员会通过 ...

丨2025年6月5日星期四丨 6月4日，阿斯利康宣布英飞凡(通用名：度伐利尤单抗)已获中国国家药品监督管理局(NMPA)批准，作 为单药用于在接受铂类药物为基础的放化疗后未出现疾病进展的局限期小细胞肺癌(LS-SCLC)成人患者 的治疗。 点评：局限期小细胞肺癌患者预后极差，只有15-30%的患者在确诊后可活过5年，临床试验结果显示经 度伐利尤单抗单药治疗可显著延长患者的无进展生存期与总生存期，超过一半的患者成功跨越了三年的 生存期。作为目前"首个且唯一"的免疫疗法，英飞凡有望进一步提升市场份额。 NO.3康方生物证实医药代表伪造材料骗取抗癌药物 近期，康方生物"仅供临床研究使用"抗肿瘤药品流向患者，这一事件引发关注。6月4日，康方生物方面 称，该公司重庆销售人员通过伪造研究立项文件及医院伦理批件等材料，以研究者发起的药品上市后临 床研究的名义，从公司骗取了若干药物。康方目前配合相关监督管理部门就此事件开展调查。这起事件 牵涉康方、医药代表、医院、医生及患者各方，进一步的责任认定仍待监管机构给出。 点评：康方生物销售人员伪造材料骗取抗癌药品，尽管是其个人行为，但也暴露出公司在销售合规管理 方面存在漏洞。短期内 ...

HPV16/18/31/33/45/52/58七种高危型和HPV6/11两种低危型，可预防上述型别人乳头瘤病毒感染引起的相关疾 病。 业绩承压的万泰生物（603392）或迎来转机。6月4日晚间，万泰生物发布公告称，公司全资子公司厦门万泰沧 海生物技术有限公司申报的九价人乳头瘤病毒疫苗（大肠埃希菌）（商品名称：馨可宁9）获批上市，这也是 首个获批上市的国产九价HPV疫苗。 同时，万泰生物公告称，厦门万泰沧海生物技术有限公司已通过GMP符合性检查，检查范围包括九价HPV疫 苗生产车间生产线。万泰生物表示，本次药品GMP符合性检查，是九价HPV疫苗上市前的首次药品GMP符合 性检查。 据悉，宫颈癌是女性最常见的恶性肿瘤之一，由高危型HPV持续感染引起。宫颈癌也是目前唯一可有效预防的 癌症，最有效和经济的预防方式就是接种HPV疫苗。万泰生物本次获批的九价HPV疫苗覆盖 在馨可宁9获批上市之前，全球范围内仅有一款九价HPV疫苗上市，为默沙东的佳达修9。佳达修9于2018年在 中国获批，佳达修9适用9－45岁女性，其中9－14岁可采用二剂次接种程序，15－45岁采用三剂次接种程序。 万泰生物本次获批的九价HPV疫苗适用于 ...