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关于<\/b> CALINA<\/b> 研究<\/b> <\/p> \n

Swissmedic的批准基于II\/III期CALINA<\/a>研究数据。该研究针对5公斤以下婴儿的代谢特点,探索了Coartem®<\/sup>(蒿甲醚-苯芴醇)的新配比与剂量。该药物适用于治疗体重在2公斤至不足5公斤之间、由恶性疟原虫或包括恶性疟原虫在内的混合感染引起的急性无并发症疟疾的婴幼儿及新生儿。Coartem®<\/sup>在瑞士及部分其他国家的商品名为Riamet®<\/span><\/sup>。<\/p> \n

关于疟疾<\/b> <\/p> \n

疟疾是一种由寄生虫引起、经蚊虫传播的致命性疾病。根据世界卫生组织的最新数据,2023年全球共有2.63亿例疟疾病例,造成597,000人死亡,几乎全部发生在非洲地区。在该地区,5岁以下儿童约占疟疾死亡病例的四分之三[7]<\/sup>。<\/p> \n

关于诺华在疟疾创新领域的贡献<\/b> <\/p> \n

秉承85年全球卫生创新传统,诺华专注于攻克被科学界忽视的疾病,为医疗资源匮乏地区提供创新药物。凭借自2021年以来近4.9亿美元的全球卫生研发投入,诺华建立了业界最大的疟疾及被忽视的热带病防治药物研发管线,包括四种可应对耐药性趋势的新型抗疟药物,其中一种刚刚完成III期临床试验,另有一种有望实现单剂治愈。自1999年以来,诺华已累计提供超过11亿疗程的抗疟药物,绝大部分为以非营利方式供应,其中5亿剂为适合5公斤以上儿童的剂型。<\/p> \n

关于中国对<\/b> Coartem Baby<\/b> 做出的贡献<\/b> <\/p> \n

Coartem Baby是专为婴幼儿定制的Coartem®<\/sup>特殊剂型,这款药物源自诺华与中国之间的突破性合作。1994年,诺华(前身汽巴-嘉基)与中国合作伙伴达成协议,扩大基于青蒿素的新型抗疟药物的研发。青蒿素是从中药材青蒿中提取的化合物[8]<\/sup>。首款基于青蒿素的抗疟疾复方治疗药物(ACT)Coartem®<\/sup>于1999年获得国际许可批准[9]<\/sup>,成为中国首个获得国际专利的药物[10]<\/sup>。自2002年以来,Coartem®<\/sup>已被列入《世界卫生组织基本药物标准清单》,这份优先药物清单指导着联合国机构和许多中低收入国家的采购决策。2015年,中国科学家屠呦呦因其研究成果成为首位获得诺贝尔生理学或医学奖的中国大陆科学家[11]<\/sup>。<\/p> \n

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参考文献<\/b> <\/span> <\/p> <\/td> \n <\/tr> \n

[1].  Eight African countries participated in Swissmedic's Marketing Authorization for Global Health Products (MAGHP) procedure<\/a> for Coartem Baby – Burkina Faso, Cote d'Ivoire, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda  -- and are expected to approve the medicine following approval by Swissmedic. These eight countries account for 47% of estimated cases in 2023, according to the WHO's Global Health Observatory<\/a><\/span> <\/p> <\/td> \n <\/tr> \n

[2].  WHO. Malaria vaccines (RTS,S and R21)<\/a> <\/span> <\/p> <\/td> \n <\/tr> \n

[3].  Reddy, Valentina et al. Global estimates of the number of pregnancies at risk of malaria from 2007 to 2020: a demographic study. The Lancet Global Health, Volume 11, Issue 1, e40 - e47<\/span> <\/p> <\/td> \n <\/tr> \n

[4].  Ceesay SJ et al. Malaria Prevalence among Young Infants in Different Transmission Settings, Africa. Emerg Infect Dis. 2015 Jul;21(7):1114-21. doi: 10.3201\/eid2107.142036. PMID: 26079062; PMCID: PMC4480393.<\/span> <\/p> <\/td> \n <\/tr> \n

[5].  D'Alessandro U, et al. Malaria in infants aged less than six months - is it an area of unmet medical need? Malar J. 2012 Dec 2;11:400. doi: 10.1186\/1475-2875-11-400. PMID: 23198986; PMCID: PMC3529680.<\/span> <\/p> <\/td> \n <\/tr> \n

[6].  Dobbs, et al. Plasmodium malaria and antimalarial antibodies in the first year of life. Parasitology<\/i>. 2016;143(2):129-138. doi:10.1017\/S0031182015001626<\/span> <\/p> <\/td> \n <\/tr> \n

[7].  WHO. Malaria.<\/a><\/span> <\/p> <\/td> \n <\/tr> \n

[8].  Premji ZG. Coartem: the journey to the clinic. Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S3. doi: 10.1186\/1475-2875-8-S1-S3. PMID: 19818170; PMCID: PMC2760238.<\/span> <\/p> <\/td> \n <\/tr> \n

[9].  Ibid<\/span> <\/p> <\/td> \n <\/tr> \n

[10].  Weiyuan C. Ancient Chinese anti-fever cure becomes panacea for malaria. Bull World Health Organ. 2009 Oct;87(10):743-4. doi: 10.2471\/blt.09.051009. PMID: 19876540; PMCID: PMC2755319.<\/span> <\/p> <\/td> \n <\/tr> \n

[11].  Nobelprize.org, "Tu Youyou"<\/a><\/span> <\/p> <\/td> \n <\/tr> \n <\/tbody> \n <\/table> \n<\/div>"]; $("#dvExtra").html(content_array[0]);})();