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 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].

作 者丨尹华禄 季媛媛 闫硕 编 辑丨曾静娇 张伟贤 刘雪莹 首个国产九价HPV疫苗，获批上市！ 售价多少？工作人员：没办法透露 万泰生物（603392.SH）于今日盘后发布公告称，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。 据了解，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。 据招股书披露，万泰生物系全球第二个、中国首个申请临床试验的国产九价宫颈癌疫苗的公 司。 据悉，该公司于2015年申请临床试验，2017年获得临床试验批件，2019年完成I期临床试验， 并开展二期临床试验，2024年4月发布III期临床试验揭盲结果。从申请到获批历时约10年。 | | 4、核心发明专利获中国、美国、欧洲、印度授权。 | | --- | --- | | | 1、全球第二个、中国首个申请临床试验的国产九价宫颈癌疫苗 | | | ● 2015年申请临床试验,2017年获得临床试验批件,2019 | | | 年完成Ⅰ期临床试验,并开展二期临床试验。 | | | . ...

HPV感染是重要的公共卫生问题之一，不仅威胁着女性的健康，同样也对男性构成了不容忽视的影响。 据世界卫生组织（WHO）统计，我国宫颈癌2020年新发病例约11万，死亡人数约5.9万。相当于每5分 钟有一名女性被诊断为宫颈癌，每9分钟有一名女性因宫颈癌离世。而这也让我国成为全球仅次于印度 的第二大宫颈癌疾病负担国。 国外多项研究表明，相比仅限于女性接种，不分性别的接种策略能更显著降低HPV感染率，减少筛查和 治疗成本，并在更短时间内实现消除宫颈癌的目标。 华克勤教授指出，对于公众而言，HPV疫苗常被误认为是针对宫颈癌的疫苗，实际上它是一种针对人乳 头瘤病毒的疫苗。HPV的感染并不局限于性别，男性和女性均有可能感染。社会上对于男性感染HPV的 认知可能尚不充分。然而，对于男性而言，一旦感染HPV，同样可能引发一系列疾病。 "据统计，约90%的男性在其一生中至少会感染一次HPV。感染情况可能是一次性的，也可能是持续性 的。持续性感染的后果相对更为严重，可能引发与HPV高度相关的疾病，例如肛门癌或男性生殖器 癌。"华克勤教授指出，约88%的肛门癌与HPV的持续感染有关。生殖器疣的情况亦然，大约90%的病 例与HPV感 ...

2003年11月，宫颈癌晚期的梅艳芳在红磡体育馆唱了八夜，竭力在《夕阳之歌》末尾喊出ByeBye，一个 月后猝然离世，享年40岁。 "所有宫颈癌患者的死亡是不必要的。" 但它产能有限，跨国批签发手续复杂，2017年到2018年，默沙东的四价和九价HPV疫苗才借智飞生物 的代理在中国姗姗上市，一度成为"疫苗茅"，排号动辄需要两年，打了上针可能没有下针，喂肥了一大 批黄牛党和诈骗犯。 这本该是个医学技术创新带动全民幸福的故事。可 没承想，默沙东联合澳洲和中国的科学家们历时 25 年 研制出的疫苗，费了 11年 进入中国，却在这 个全球宫颈癌高发大国卖 了 7年 就哑火。 在今年的2月4号，默沙东宣布暂停向中国市场供应HPV疫苗——并非美国人又想卡我们的脖子，而是单 纯因为卖不动了。而在代理商智飞的仓库里， 囤积的HPV疫苗一度高达4千万支。 相比狂犬病3个月就能看出疯没疯，高危型HPV病毒像颗地雷，感染后可能自行消失，也可能在20年后 突然爆发。 可以说，在感染HPV的概率上，有过性行为的人首次实现了男女平等。 梅艳芳去世3年后，2006年，美国医药巨头默沙东研制出世界首款HPV四价疫苗，可预防4种常见的 HPV ...