Semaglutide(Yichang Humanwell)

9月5日，世界卫生组织（WHO）发布了更新版的《基本药物清单》（EML）和《儿童基本药物清单》（EMLc），新增了针对多种类型癌症以及伴有肥胖等并发症的糖尿病的治疗方法。此外，还新增了用于治疗囊性纤维化、银屑病、血友病和血液相关疾病的药物。 世界卫生组织（WHO）的药品示范清单于1977年推出，其主要目的是促进发展中国家获得更多药品的机会。如今，这些清单已成为全球范围内在药品选择和全民覆盖方面做出决策时的可靠政策工具。 世界卫生组织（WHO）关于基本药物遴选与使用的专家委员会审查了59份申请，其中包括31项新增药物或药物类别的提案。最终，有20种新药物被纳入“基本药物清单”（EML），15种被纳入“儿童基本药物清单”（EMLc），同时7种已列入清单的药物也获得了新的使用适应症。更新后的清单共包含523种适用于成人的基本药物和374种适用于儿童的基本药物，这些药物均符合最紧迫的公共卫生需求。 癌症是全球第二大死亡原因，每年导致近1000万人死亡，占非传染性疾病导致的过早死亡人数的近三分之一。过去十年间，癌症治疗一直是世界卫生组织（WHO）专家委员会（EML）的重点关注领域。如今，抗癌药物占监管机构批准的新药总数的约一半，专家委员会采用严格的标准，仅推荐那些能带来最大临床益处的疗法。因此，获批的抗癌药物数量很少——只有那些被证明能够将患者生存期延长至少4到6个月的药物才会被纳入推荐名单。 共有7项申请涉及25种抗癌药物接受了评估。作为减少癌症治疗不平等现象的更广泛努力的一部分，委员会建议增加对PD-1/PD-L1免疫检查点抑制剂的获取途径。这类免疫治疗药物能够帮助身体的免疫系统更有效地识别和攻击癌细胞。帕博利珠单抗被纳入欧洲药品管理局（EMA）的指南中，作为转移性宫颈癌、转移性结直肠癌和转移性非小细胞肺癌的一线治疗药物。对于转移性非小细胞肺癌，阿替利珠单抗（atezolizumab）和西米普利单抗（cemiplimab）也被列为替代治疗方案。 委员会还审议了几项专家推荐的策略，这些策略旨在提高癌症治疗的可及性和可负担性。委员会支持基于证据的临床和卫生系统策略，包括剂量优化方法，以改善治疗的可及性。委员会强调，虽然卫生系统改革需要时间和政府行动，但临床策略可以立即实施，从而更快地带来益处，尤其是在资源有限的环境中。 用于治疗糖尿病和肥胖症的药物 糖尿病和肥胖是当今世界面临的两大最紧迫的健康挑战。2022年，全球有超过8亿人患有糖尿病，其中一半人未得到治疗。与此同时，全球有超过10亿人受到肥胖的影响，尤其是在低收入和中等收入国家，肥胖率的上升速度尤为迅速。这两种疾病密切相关，可能导致严重的健康问题，包括心脏病和肾衰竭。 世界卫生组织专家委员会审查了大量科学证据，这些证据表明一类名为胰高血糖素样肽-1（GLP-1）受体激动剂的药物能够帮助2型糖尿病患者（尤其是同时患有心脏病或肾脏疾病的患者），通过改善血糖控制、降低心脏病和肾脏并发症的风险、促进体重减轻，甚至降低早死风险来改善患者的生活质量。 GLP-1受体激动剂（包括司美格鲁肽、度拉鲁肽和利拉鲁肽）以及GLP-1/葡萄糖依赖性胰岛素促泌多肽（GIP）双重受体激动剂（替尔泊肽）已被纳入欧洲药品管理局（EMA）的药品指南（EML）中。这些药物被用于治疗患有2型糖尿病且伴有已确诊的心血管疾病或慢性肾脏疾病以及肥胖症（定义为体重指数BMI≥30 kg/m²）的成人患者。这为各国提供了明确的指导，帮助确定哪些患者最能从这些疗法中获益。 像semaglutide和tirzepatide这样的药物价格过高，限制了人们获得这些治疗的机会。优先考虑最需要这些药物的人群，鼓励仿制药竞争以降低价格，并将这些治疗方法引入初级保健服务（尤其是在服务不足的地区），是扩大用药范围和改善健康结果的关键。世界卫生组织将继续关注相关进展，支持公平的定价策略，并帮助各国提高人们获得这些改变生命的治疗手段的机会。

London: The World Health Organization has added GLP-1 drugs to treat diabetes to its essential medicines list, alongside treatments for cystic fibrosis and cancer, and said it hopes this will improve global access to the costly drugs. The list, consisting of 523 medicines for adults and 374 for children, is a catalogue of the drugs the WHO believes should be available in all functioning health systems. In the past including a drug, for instance, HIV treatments in the early 2000s, has helped to ensure access for people in poorer countries. "Rather than letting price be a disqualifying factor, the committee views inclusion in the essential medicines list as a potential catalyst for access," Dr Lorenzo Moja, head of the WHO secretariat overseeing the list, told Reuters. The expert committee added the active ingredients in Novo Nordisk's Ozempic and Eli Lilly 's Mounjaro to the list, to treat type 2 diabetes in conjunction with established cardiovascular disease, chronic kidney disease or obesity. The drugs were initially developed for diabetes but have also become hugely popular weight-loss drugs, under different brand names. The WHO stopped short of adding them to treat obesity alone, as it also did in 2023. The committee said this decision provided clear guidance on which patients would most benefit from the therapies. "High prices of medicines like semaglutide and tirzepatide are limiting access to these medicines," the WHO statement added, saying that encouraging generic drugmakers to produce the product would also help when patents begin to expire on the drugs next year. A spokesperson for Novo Nordisk said the company was committed to supporting broader access to its treatments. Several companies are already working on generic copies of the drugs. Eli Lilly said it too was committed to increasing access, but that off-patent or generic copies of drugs "may be better candidates to meet patient needs and offer cost savings in lower resource settings". Globally, more than 800 million people worldwide were living with diabetes in 2022, the WHO said. There are also more than 1 billion people with obesity. Earlier this year, a WHO memo said it would recommend the use of the drugs for obesity, a separate step to adding them to the essential list. The list also includes Vertex Pharmaceuticals' combination therapy for cystic fibrosis, Trikafta or Kaftrio. Activists have criticised its high price and lack of accessibility for years. The drugmaker declined to comment on the list. It also includes Merck's top-selling cancer immunotherapy drug, Keytruda, for the treatment of cervical cancers, colorectal cancers, and non-small cell lung cancers that have spread, or metastasised and it recommended strategies to increase access. Merck said it was committed to reaching patients in need. The WHO also added rapid-acting insulin analogues, also made by Novo Nordisk and Eli Lilly, among others, to the list for treating type 1, type 2 and gestational diabetes.