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武田独家锁定巴西登革热疫苗 15亿雷亚尔合同,中资医疗企业需关注ANVISA准入窗口

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Takeda bets on Brazil to expand dengue vaccine sales

武田制药6月与巴西卫生部签署两年1800万剂Qdenga疫苗供应合同,价值15亿雷亚尔,成为巴西唯一登革热疫苗供应商。厄尔尼诺降雨预期推高下半年病例,中资医疗企业可关注疫苗冷链、分销及ANVISA注册合作机会。

为什么值得关注

武田独家锁定巴西15亿雷亚尔登革热疫苗合同,ANVISA监管下中资医疗冷链与分销企业面临准入窗口收窄。

武田制药(Takeda)6月与巴西卫生部签署新合同,将在未来两年内供应1800万剂Qdenga登革热疫苗,合同价值15亿雷亚尔。该公司在德国生产该疫苗,并称如有需要可交付更大数量。由于厄尔尼诺现象预计给巴西南部和东南部带来更多降雨,下半年登革热病例预计增加。目前武田是巴西唯一拥有该疾病疫苗的制药公司,而Butantan研究所疫苗因不良反应被暂停、Fiocruz技术转让合作被拒、赛诺菲因需求不足停产,市场格局高度集中。对在巴中资医疗、冷链物流及分销企业而言,该合同意味着ANVISA监管下的疫苗准入与供应链合作窗口正在收窄。

武田制药(Takeda)于6月与巴西卫生部签署新合同,将在未来两年内供应1800万剂Qdenga登革热疫苗,合同价值15亿雷亚尔。该公司在德国生产该疫苗,并表示如有需要有能力交付更大数量。2024年至2027年间,武田预计在巴西交付3360万剂疫苗。Takeda Brasil首席执行官Rodrigo Rodriguez表示:“如有必要,我们有生产能力根据卫生部和私人市场的需求增加产量。”他于去年4月接任该职位。目前武田是唯一拥有该疾病疫苗的制药公司。6月,巴西卫生部在收到多起不良反应报告后暂停了Butantan研究所开发的疫苗的接种。六个月前,该部拒绝了武田与Oswaldo Cruz基金会(Fiocruz)关于在巴西转让技术和开发Qdenga的合作。2025年,赛诺菲(Sanofi)宣布因需求不足停止生产其疫苗。由于厄尔尼诺现象预计将给巴西南部和东南部地区带来更多降雨,预计下半年登革热病例将增加。

对在巴中资企业而言,底稿未涉及中资企业直接影响,但通过疫苗供应链与监管机制间接传导。首先,ANVISA(巴西卫生监管局)是疫苗注册与进口许可的核心监管机构,武田疫苗在德国生产后进入巴西,涉及ANVISA的进口审批与批次放行,中资冷链物流、医药分销企业若参与SUS(巴西公共卫生系统)供应链,需关注ANVISA对疫苗存储运输的合规要求。其次,巴西卫生部暂停Butantan疫苗、拒绝Fiocruz技术转让合作,意味着短期内公立市场对武田的依赖度上升,私人市场疫苗采购也可能向武田集中,中资医疗贸易商若从事疫苗或相关医疗器械进口,需评估与武田的分销合作可能性及ANVISA注册周期。第三,武田巴西业务增长迅速,2025财年制药收入增长20%,过去五年翻了一番,巴西是其第五大重要市场,仅次于美国、日本、中国和德国。中资医药企业若计划进入巴西,可关注ANVISA对创新药的审批节奏,以及武田在巴西每年推出近一个新产品的战略是否带来本地临床试验合作机会。武田目前在该国约有15项临床研究正在开发中,巴西人口由不同族裔群体组成,研究成本低于其他国家,并且拥有强大的研究中心。

CBI观察:底稿显示,武田是当前巴西唯一登革热疫苗供应商,合同金额15亿雷亚尔,2024-2027年预计交付3360万剂。数据表明,武田2025财年营收290亿美元,研发投入约45亿美元,疫苗研发历时20年、超过19项临床试验、超过28000名参与者。CBI认为,巴西登革热疫苗市场短期内难以出现第二家供应商,Butantan疫苗暂停、Fiocruz合作被拒、赛诺菲停产三重因素叠加,使武田在公立和私立市场的议价能力显著增强。对中资企业而言,直接进入疫苗生产环节门槛极高,但在冷链物流、临床试验服务、ANVISA注册咨询等配套环节存在合作空间。CBI同时提示,巴西卫生部对疫苗安全事件的反应速度较快,Butantan疫苗因不良反应被暂停即为先例,中资企业若参与疫苗相关业务,需将药物警戒和合规风控置于首位。

待观察:第一,巴西卫生部是否会在2025年下半年公布Butantan疫苗不良反应调查结论,以及是否恢复接种或永久暂停;第二,ANVISA是否会在2025年内发布新的疫苗进口或注册便利化措施,影响中资冷链与分销企业的准入成本;第三,武田与Fiocruz的技术转让合作是否会在2026年重启谈判,若重启,中资企业可关注本地化生产带来的供应链配套机会。

CBI 观察编辑判断

底稿显示武田是巴西唯一登革热疫苗供应商,合同价值15亿雷亚尔。CBI认为,Butantan疫苗暂停、Fiocruz合作被拒、赛诺菲停产使武田议价能力增强,中资企业直接竞争疫苗生产不现实,但冷链物流、临床试验服务、ANVISA注册咨询等配套环节存在合作空间。

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信息概要

类型
合作协议
方向
巴西
分类
宏观市场
层级
编辑整理
地点
中资医疗贸易商、冷链物流企业、医药分销商、ANVISA注册咨询机构、临床试验服务商
核验
待核验
对象
在巴中资医疗企业冷链物流与分销商医药投资者
话题
企业动态行业趋势政策

来源信息

来源
Valor International
原文标题
Takeda bets on Brazil to expand dengue vaccine sales
原始语言
英语
原文链接
查看原文 →
编辑
Clara Lin
查看原文(英语

Takeda bets on Brazil to expand dengue vaccine sales

Takeda, the pharmaceutical company responsible for the Qdenga vaccine against dengue fever, signed a new contract with the Ministry of Health in June to supply 18 million doses of the vaccine over the next two years. The pharmaceutical company, which manufactures the vaccine in Germany, said it has the capacity to deliver a larger volume if necessary. There are expectations of an increase in dengue cases in the second half of the year due to El Niño, which is expected to bring more rainfall to Brazil’s South and Southeast regions. Brazil suspends Butantan dengue vaccine, recalls batches MSD bets on technology to expand in animal health Zoetis bets on genomics and vaccines after foot-and-mouth “We have the production capacity to increase output, if necessary, in line with demand from the Ministry of Health and, obviously, the private market,” said Rodrigo Rodriguez, CEO of Takeda Brasil, who took over the position in April last year after joining the pharmaceutical company as a human resources trainee. Between 2024 and 2027, the pharmaceutical company expects to deliver 33.6 million doses in Brazil. The new contract to distribute 18 million doses of the vaccine through the country’s public health system, SUS, was valued at R$1.5 billion. Currently, Takeda is the only pharmaceutical company with a vaccine against the disease. In June, the Ministry of Health halted immunization with the vaccine developed by the Butantan Institute following reports of various adverse reactions. Six months earlier, the ministry had rejected a partnership between Takeda and the Oswaldo Cruz Foundation (Fiocruz) for the transfer of technology and development of Qdenga in Brazil. In 2025, Sanofi announced that it had stopped producing its vaccine due to a lack of demand. Brazil is the fifth most important market for the pharmaceutical company, behind only the U.S., Japan, China, and Germany. The Brazilian operation is one of the company’s fastest-growing. In fiscal year 2025, pharmaceutical revenue grew 20%, and it has doubled over the past five years. The dengue vaccine accounts for a significant share, but the CEO emphasized that other medicines are equally important, including those in the gastroenterology field. Takeda focuses on medicines that require substantial investment in research and development. In fiscal year 2025, the company reported revenue of $29 billion and invested approximately $4.5 billion in research and development. “The vaccine is also an innovative product. We spent 20 years researching and developing it and conducting clinical trials. There have been more than 19 clinical studies, with more than 28,000 participants. Just as the vaccine represents an innovation, we have other products as well,” Rodriguez said. Takeda has recently gone through a restructuring phase involving workforce reductions and a global leadership change following an 18-month transition. The Brazilian executive, who led the Middle East operation for the five years before taking his current position, says the pharmaceutical company is now entering a significant growth phase, including in Brazil, driven by drug approvals from regulatory authorities such as the U.S. Food and Drug Administration (FDA) and Brazil’s Health Regulatory Agency (Anvisa). “We are working with the expectation of launching nearly one [new product] per year in Brazil and introducing between three and five new therapies by 2029,” said the CEO of Takeda Brazil. The medicines will be used to treat cancer, inflammatory diseases, and type 1 narcolepsy, a chronic neurological sleep disorder. In addition, Brazil has come onto the radar for clinical research following the regulation of the law governing the sector in mid-2025. “Brazil has a population made up of different ethnic groups, research costs are lower than in other countries, and it has robust research centers. Takeda currently has around 15 clinical studies under development in the country.”

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