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Takeda宣布与Biological E. 开展“印度制造”疫苗生产合作

加速骨痛热症疫苗供应

– 新的战略合作伙伴关系将提升疫苗生产能力,以支持骨痛热症疫苗的全球供应,扩大武田制药 (Takeda)在疫苗生产领域的足迹。

– 到 2030 年,该战略合作伙伴关系将每年供应多达 5000 万剂疫苗,以满足全球公共卫生需求。

– 骨痛热症是全球性的公共卫生威胁,为帮助减轻疾病负担,武田制药 (Takeda)不断努力扩大骨痛热症疫苗的供应能力。

新加坡2024年2月27日 /新闻稿网 - Xinwengao.com/ — Takeda武田制药(TSE:4502/NYSE:TAK今日宣布与印度领先的疫苗和生物制品公司 Biological E. Limited 建立战略合作伙伴关系,共同生产武田旗下的骨痛热症疫苗 TAK-003。骨痛热症近年被广泛认为是全球公共卫生威胁之一,而此次合作不仅标志着全球抗击骨痛热症的关键步骤,同时也与世界卫生组织(WHO)所制定的 “于2030年实现骨痛热症零致死率[i].” 的特定疾病目标一致。

武田与Biological E.的合作将大大提高骨痛热症疫苗的生产能力,确保疫苗在全球的可持续供应。Biological E. 将扩大产能,其年产量将可达到每年 5000 万剂,从而加快武田制药在为来十年内实现年产 1 亿剂的目标。

特伦甘纳邦 (Telangana) 首席部长 Sri Anumula Revanth Reddy,在特伦甘纳邦政府组织的地区生命科学与医疗保健论坛 BioAsia 2024 上宣布了双方的合作关系。他在发言中指出:"我们很高兴武田制药和Biological E.合作生产骨痛热症疫苗的设施将落户特伦甘纳邦(Telangana)的海德拉巴(Hyderabad)。特伦甘纳邦为生命科学,特别是疫苗和生物制剂的研发和制造提供了良好的环境。我很高兴这个工厂能加速疫苗在印度及其他骨痛热症流行国家及地区的供应。"

甘纳邦工业和商业部长 Sri Duddilla Sridhar Babu 指出:"透过武田制药的技术专长和Biological E.的制造能力,将有助于提高骨痛热症疫苗的可及性和可负担性,为印度的医疗保健的韧力和未来准备做出贡献。我们很高兴能支持这次结合科学、政府和产业的合作,推动和扩大创新,实现全民健康覆盖。"

武田制药全球疫苗事业部总裁、医学博士Gary Dubin表示:“武田骨痛热症项目的长期目标是为那些可能受益于免疫接种的高危人群提供TAK-003疫苗。在过去一年里,我们不仅成功在私营市场推出TAK-003,最近更在一部分公共项目中推出TAK-003,同时与各界合作伙伴一起为加强对公共卫生健康的维护。今日,我们很自豪地宣布与 Biological E. Limited 正式成为战略生产合作伙伴。该公司在疫苗生产方面拥有深厚的专业知识,并长期支持世界各地的公共卫生项目。通过大幅提高 TAK-003 多剂量瓶的生产能力,不仅能支持全球骨痛热症防治工作,同时也能为更多骨痛热症流行国家提供长期的疫苗供应。”

作为传播速度最快的蚊媒病毒性疾病,目前全球约有一半人口正面临患上骨痛热症的风险[ii]。在印度和东南亚地区,有 13 亿人生活在骨痛热症流行地区,而其中泰国、印度和印度尼西亚则是骨痛热症疫情最严重的国家[iii]。最近,世卫组织免疫战略咨询专家(Strategic Advisory Group of Experts,简称SAGE)建议,在骨痛热症高负担和传播度较高的地区使用武田制药的骨痛热症疫苗,以加强对公共卫生健康的维护。

武田制药印度和东南亚多国组织负责人Dion Warren表示:“这一战略合作再次印证了武田为全球民众提供有效保护健康疫苗的决心,也体现了公司为在亚洲加强合作伙伴关系所作的努力。随着疫苗在泰国、印度尼西亚以及最近在马来西亚获得批准,我们对未来充满信心。我们相信骨痛热症综合防控机制将可有效改善印度、东南亚以及其他地区无数人民的生活。”

最近,《柳叶刀全球健康》杂志(The Lancet Global Health发表了武田制药关键的骨痛热症四价免疫接种三期疗效研究(Phase 3 Tetravalent Immunization against Dengue Efficacy Study ,简称TIDES)的长期探索性结果,表明TAK-003疫苗在接种后的四年半(54个月)内仍具有预防骨痛热症的保护作用。目前,该疫苗已在 30 多个国家获得批准,包括欧盟[iv]、英国[v]、巴西[vi]、阿根廷[vii]、印度尼西亚[viii]、泰国[ix]和马来西亚[x],用于预防任何血清型的骨痛热症。今后,武田制药将继续监测长期数据,并继续在更多国家进行监管申请,满足相关公共卫生需求,让防范胜于治疗。

致编辑

这些突破性研发标志着我们在全球范围内努力抗击骨痛热症所取得的重大进展。武田制药仍致力于开发一种可应对由任何病毒血清型引起的有症状骨痛热症、且安全的骨痛热症疫苗,无论是否曾感染骨痛热症,都能为高危人群提供保护。武田制药将继续与医疗合作伙伴、政府和社区密切合作,确保按照当地法规成功预防骨痛热症

About Takeda

Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.

About TAK-003 (Dengue Tetravalent Vaccine [Live, Attenuated])

TAK-003 is a dengue vaccine that is based on a live-attenuated dengue serotype 2 virus, which provides the genetic “backbone” for all four dengue virus serotypes and is designed to protect against any of these serotypes.[xi]

TAK-003 is currently approved in more than 30 countries including the European Union, the United Kingdom, Brazil, Argentina, Indonesia, Thailand and Malaysia for the prevention of dengue disease. The vaccine should be administered subcutaneously as a 0.5 mL dose at a two-dose (0 and 3 months) schedule according to the approved dosing regimen and in accordance with local recommendations and age guidelines.[xii] 

Approval code: C-ANPROM/MY/DENV/0266

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

[i] World Health Organization, Ending the neglect to attain the Sustainable Development Goals: A road map for neglected tropical diseases 2021–2030. Available at: https://www.who.int/publications/i/item/9789240010352. Accessed: February 2024.

[ii] World Health Organization, Dengue and Severe Dengue. Available at: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue#:~:text=About%20half%20of%20the%20world’s,urban%20and%20semi%2Durban%20areas. Accessed: February 2024.

[iii] World Health Organization, Dengue in South-East Asia. Available at: https://www.who.int/southeastasia/health-topics/dengue-and-severe-dengue. Accessed: February 2024.

[iv] European Medicines Agency, Qdenga. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/qdenga. Accessed: February 2024.

[v] Medicines and Healthcare products Regulatory Agency, Marketing authorisations granted 15 January to 31 January 2023. Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1134336/Marketing_authorisations_granted_15_January_to_31_January_2023.pdf. Accessed February 2024.

[vi] Brazil’s ANVISA approves Takeda’s dengue vaccine Qdenga, Pharmceutical Technology, March 14, 2023. Available at: https://www.pharmaceutical-technology.com/news/brazil-takeda-dengue-vaccine/. Accessed: February 2024.

[vii] Regulator approves dengue vaccine in Argentina, Buenos Aries Herald, April 27, 2023. Available at : https://buenosairesherald.com/society/health/regulator-approves-dengue-vaccine-in-argentina. Accessed February 2024.

[viii] Takeda’s dengue vaccine approved in Indonesia for Use Regardless of Prior Dengue Exposure, August 22, 2022,. Available at: https://www.takeda.com/newsroom/newsreleases/2022/takedas-qdenga-dengue-tetravalent-vaccine-live-attenuated-approved-in-indonesia-for-use-regardless-of-prior-dengue-exposure/. Accessed February 2024.

[ix] Food and Drug Administration Ministry of Public Health, Thailand, May 8, 2023. Available at : https://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/pop-up_drug_ex.aspx?Newcode=U1DR2C1072660000411C. Accessed February 2024.

[x] Media Statement of National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Available at : https://www.npra.gov.my/easyarticles/images/shared/One-Stop%20Centre/Kenyataan-Media-KPK–keputusan-mesyuarat-PBKD-393—Zolgensma-dan-QDenga-v7-09022024.pdf. Accessed February 2024.

[xi] Huang CY-H, et al. Genetic and phenotypic characterization of manufacturing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7: e2243.

[xii] Takeda. TAK-003 Summary of Product Characteristics. Accessed February 2024.

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