There is currently no evidence-based treatment for the smallest babies with malaria The CALINA study tested a new ratio and dose of Coartem® (artemether- lumefantrine) to account for metabolic differences in babies under 5 kg The CALINA trial indicated that the new formulation has good efficacy and safety, and the data have been submitted for regulatory review Basel, April 24, 2024 – Novartis and Medicines for Malaria Venture (MMV) announce positive data from their phase II/III CALINA study, demonstrating that a novel formulation of Coartem® (artemether-lumefantrine) developed for babies weighing less than 5kg with malaria has the required pharmacokinetic profile and good efficacy and safety.

目前还没有针对最小的疟疾婴儿的循证治疗方法CALINA研究测试了一种新的比例和剂量的Coartem®（蒿甲醚-苯芴醇），以解释5公斤以下婴儿的代谢差异CALINA试验表明，新配方具有良好的疗效和安全性，数据已提交2024年4月24日巴塞尔监管审查-诺华和疟疾药物风险投资公司（MMV）宣布其II/III期CALINA研究的阳性数据，表明为体重小于5公斤的疟疾婴儿开发的Coartem®（蒿甲醚-苯芴醇）新配方具有所需的药代动力学特征和良好的疗效和安全性。（笑声）。

The trial was conducted in several African countries. The data, which will be presented this week at the Multilateral Initiative on Malaria (MIM Society) 8th Pan-African Malaria Conference in Kigali, have been submitted for regulatory review. Malaria exerts a massive burden on public health across the world, particularly in Africa1.

该试验在几个非洲国家进行。这些数据将于本周在基加利举行的多边疟疾倡议（MIM协会）第八届泛非疟疾会议上公布，并已提交监管审查。疟疾对全世界的公共卫生造成巨大负担，特别是在非洲1。

Huge strides have been made in recent decades in the treatment of malaria. However, to date, little data has been generated in the smallest children – babies less than 5 kg. “We are pleased with the positive outcomes from our CALINA study and to be one step closer to bringing an effective malaria treatment to all age groups, including vulnerable newborn babies,' said Shreeram Aradhye, President, Development and Chief Medical Officer at Novartis.

近几十年来，疟疾的治疗取得了巨大进展。然而，迄今为止，最小的儿童（小于5公斤的婴儿）的数据很少。“我们对CALINA研究的积极成果感到高兴，并且离为所有年龄组（包括脆弱的新生儿）提供有效的疟疾治疗又近了一步，”诺华公司发展总裁兼首席医疗官Shreeram Aradhye说。

“We have been committed to the fight against malaria for more than two decades, and this successful trial represents another milestone towards ensuring that all people have access to an appropriate antimalarial therapy.” The CALINA study is led by Novartis, with the scientific and financial support of Medicine.

“20多年来，我们一直致力于抗击疟疾，这项成功的试验标志着确保所有人都能获得适当的抗疟治疗的另一个里程碑。”CALINA研究由诺华牵头，并得到医学的科学和财政支持。