全球健康医疗动态汇编第 99 期 51 04 Policy Situations Compiled by Jielu Yu and Andi Sun International | Global Biomanufacturing Training Hub Established in Korea Following the successful implementation of a global mRNA vaccine technology transfer hub in South Africa, the World Health Organization announced that a global biomanufacturing training hub will be established in the Republic of Korea on February 23rd. Aided by the WHO Academy, a comprehensive curriculum including technical, hands-on training around operational and manufacturing practice requirements will be provided by the hub. The purpose is to promote skill building and technology transfer in low and middle income countries in order to strengthen their biomanufacturing capabilities. With a stronger public health system and bio-industry field, LMICs will be more prepared during future pandemics. In addition, there is focus on strengthening the regulatory system and building a “network of regional centers of interest” globally to advise countries with weaker regulatory systems. Recipient countries of the technology transfer hubs are prioritized by countries that already have some biomanufacturing infrastructure and but not yet have mRNA technology. The five new countries that will receive support from both the South Africa and Korea hubs include Bangladesh, Indonesia, Pakistan, Serbia and Viet Nam based on expert opinion that these countries have the capacity to advance to the production stage. WHO will announce other recipient countries in the coming months. https://www.who.int/news/item/23-02-2022-moving-forward-on-goal-to-boost-localpharmaceutical-production-who-establishes-global-biomanufacturing-training-hub-inrepublic-of-korea

全球健康医疗动态汇编第 99 期 52 International | Humanitarian Aid during Crisis in Ukraine WHO has expressed deep concern for the health of the Ukrainian people and emphasizes the need to maintain functional health systems to deliver essential care. Health facilities, workers, supplies, and related humanitarian aid should not be targeted. In addition to supplies prepositioned in health facilities, the WHO Director-General further released $3.5 million from the WHO Contingency Fund for Emergencies on February 24th to buy and deliver trauma and medical supplies to those impacted by war. The United Nations General Assembly met on February 28th for an Emergency Special Session on the fighting in Ukraine. The UN General Assembly condemned Russia’s invasion of Ukraine, warned of the dire consequences the military attacks can bring for regionally and globally, and called for all parties to return to diplomatic measures. The General Assembly also assured Ukraine’s president of UN’s support. The UN has already provided humanitarian assistance to some 3 million people and allocated $20 million from the Central Emergency Response Fund. It is estimated that 12 million inside Ukraine and more than 4 million refugees will require protection and assistance in the coming months. Due to the military conflicts, civilians have been severely and negatively impacted by the destruction of public service provision, civilian infrastructure, residential housing, and other basic services. Access to healthcare has also been limited. On March 1st, the UN released an official emergency appeal to seek $1.7 billion to support delivery of humanitarian aid to people in Ukraine and refugees in neighboring countries. Of that sum, a preliminary $550.6 million will be used to help host countries of Ukrainian refugees provide emergency relief. $1.1 billion will be focused on supporting Ukrainian residents in the initial 3 months on cash assistance, food security, shelter assistance, water and sanitation, healthcare, and education services. https://www.who.int/news/item/24-02-2022-who-director-general-deeply-concerned-overescalating-health-crisis-in-ukraine

全球健康医疗动态汇编第 99 期 53 https://reliefweb.int/report/ukraine/united-nations-stands-people-ukraine-secretary-generaltells-general-assembly https://www.unhcr.org/news/press/2022/3/621e0aa74/un-seeks-us17-billion-humanitarianneeds-soar-ukraine-neighbouring-countries.html International | COVID-19 Global Action Plan The WHO had set a goal of achieving a vaccination rate of 70% of people in every country across all income levels by September 2022, yet current rates are well below the target, leaving the global community vulnerable to new variants and waves of infection. Analysis demonstrates the disparity in vaccination rates along the countries’ economic well-being, with nearly 80% of people vaccinated in upper, middle, and high-income countries while only less than 11% are in low-income countries. To contribute in addressing this issue, the United States launched the Global Action Plan on February 14th to build on previous COVAX efforts. There are six main lines of effort. One goal includes administering more vaccinations, which consists of increasing supply of shots and also safe, efficient delivery methods to ensure quality. Another is strengthening the supply chain for both vaccines and critical supplies. The third approach is to tailor public health messages to local audiences to push back against misinformation leading to vaccine hesitancy. Other efforts include providing support to healthcare workers, increasing access to medical treatments, and increasing global health security for future emergencies through financing pandemic preparedness and response capacity. https://www.state.gov/secretary-antony-j-blinken-at-a-virtual-covid-19-global-action-meeting/

全球健康医疗动态汇编第 99 期 54 Pfizer’s COVID-19 Pill, Paxlovid, Approved in China On February 12th, the China’s Food and Drug Administration issued an announcement that, in accordance with the Special Examination and Approval Procedures for Innovative Medical Products, Pfizer's new coronavirus nematevir/ritonavir treatment, Paxlovid, was conditionally approved for registration on February 11th. Paxlovid is an oral small molecule novel coronavirus drug, which is a potent SARS-CoV-2 3CLpro protease inhibitor combination of nirmatrelvir plus ritonavir. It is used to treat mild to moderate COVID-19 patients with high risk factors for progression to severe disease, such as advanced age, chronic kidney disease, diabetes, cardiovascular disease, and chronic lung disease. Paxlovid was first authorized for use in the United States by an emergency use authorization at the end of December 2021. As of now, Paxlovid has been approved for listing or authorized for emergency use in many countries and regions around the world, including the United Kingdom, Israel, and Canada. On November 5th, 2021, Pfizer announced the interim analysis of the Phase II/III study of Paxlovid, showing that Paxlovid reduced the risk of hospitalization or death from COVID-19 by 89%. In January of this year, Pfizer said that Paxlovid proved to be effective against the new Omicron variant in in vitro trials. Pfizer has entered into a licensing agreement with the international organization Medicines Patent Pool (MPP), to allow licensed generic companies to manufacture and supply Paxlovid to 95 low- and middle-income countries. Pfizer will not collect royalties on drug sales in low-income countries and will waive royalties on drug sales in all countries covered by the agreement. This initiative will cover 53% of the world's population. https://www.nmpa.gov.cn/yaowen/ypjgyw/20220212085753142.html https://www.bjnews.com.cn/detail/164464986514159.html

全球健康医疗动态汇编第 99 期 55 Administrative Measures on Mutual Recognition of Medical Institutions In Effect Starting March The Chinese National Health Commission, National Medical Insurance Administration, State Administration of Traditional Chinese Medicine, and Health Bureau of the Logistics Support Department of the Central Military Commission jointly issued the "Administrative Measures for the Mutual Recognition of Inspection and Test Results in Medical Institutions" to promote mutual recognition of inspection and test results between different medical institutions. These administrative measures distribute the responsibility to relevant departments and emphasizes that medical institutions should follow the principle of "guaranteeing quality and safety” as the bottom line in patient care. When carrying out examinations for mutual recognition, institutions must promise quality control, strive to reduce the burden on patients, put meeting the needs of diagnosis and treatment as a fundamental goal, and take specialist consultations as the golden standard. According to experts, work around mutual inspection on treatment plans has been ongoing since 2006. Prior to this, Beijing, Tianjin, Hebei, Shandong, Jiangsu, Yunnan, Henan and other places have taken the lead in implementing such measures regionally by province. Previously, reaching a mutual consensus between provincial and municipal medical institutions around treatment plans was difficult due to time constraints and resource limitations, such as when diagnosing unclear or critical illnesses and during emergency situations. Another instance would be when patients are receiving care across regional locations but medical records and test results cannot be transferred between institutions. Mutual recognition of inspection among different medical institutions will help improve the use of available medical resources, reduce medical expenses, increase diagnosis and treatment efficiency, and better the quality of life and treatment experience for more patients. http://health.china.com.cn/2022-02/24/content_41885397.htm http://www.legaldaily.com.cn/index/content/2022-03/02/content_8680791.htm

全球健康医疗动态汇编第 99 期 56 Update on Shanghai’s “Convenient Medical Services” Digitalization Plan 2.0 Eight departments, including the Shanghai Municipal Health Commission, jointly established and issued the "Shanghai ‘Convenient Medical Service’ Digitalization Work Plan 2.0" recently. The plan lists seven applicable scenarios around digital medical technology, including the use of artificial intelligence to triage and guidance to achieve accurate medical treatment for patients, guide patients to appropriate hospital locations, control and alleviate hospital congestion and overcrowding in spaces, electronically process and charge medical bills, manage post-diagnosis and follow-up procedures for patients with chronic diseases, ensure proper medication through the blockchain technology of preparing and delivering traditional Chinese medicine, and enable one-click emergency calls to improve mobilization of medical assistance. The plan has selected 19 locations as pilots, with pilot tasks scheduled to be completed by the end of June 2022 and a goal of citywide implementation by the end of September. This 2.0 work plan demonstrates increased innovation and insight on the basis of the first version of the digitalization plan. According to Wu Jinglei, Director of Shanghai’s Municipal Health Commission, "Digitalization Plan 1.0" focused on addressing issues surrounding"difficulty in seeking medical care, excessive waiting times, and a lack of humanization during services." Thus launches the construction of the seven applicable scenarios as listed above for the second version of the plan. Actively proposed by the city, the “‘Convenient Medical Service’ Digitalization Work Plan 2.0" is an important measure for Shanghai's development and also reflects transformations in China’s health information systems in recent years. https://ww.shanghai.gov.cn/gwk/search/content/7aa19db8864a41a39d111039617a49a7 http://www.gov.cn/xinwen/2021-07/16/content_5625406.htm

全球健康医疗动态汇编第 99 期 57 05 智库学界评论 1. 张锋团队赢得“基因魔剪”专利之争 2 月 28 日，美国专利和商标局（USPTO）裁定 CRISPR-Cas9 基因编辑技术专利 属于美国哈佛和麻省理工学院博德研究所的张锋团队。根据该决定，加州大学不再具 有 CRISPR-Cas9 基因编辑技术的专利，博德研究所则拥有在真核细胞中使用 CRISPR 的专利。这一决定结束了长达数年的 CRISPR 专利纷争。 CRISPR-Cas9 是第三代基因编辑技术，短短几年内风靡全球，是现有基因编辑和 基因修饰里面效率最高、最简便、成本最低、最容易上手的技术之一，成为当今最主 流的基因编辑系统。 2012 年 8 月 17 日，加州大学伯克利分校化学家詹妮弗·杜德纳和德国马普感染生 物学研究所教授埃玛纽埃勒·沙尔庞捷在一篇里程碑式的论文中概述了这项技术，成功 解析了 CRISPR-Cas9 基因编辑的工作原理，这两位女科学家因此分享了 2020 年的诺 贝尔化学奖。 2013 年 2 月 15 日，张锋团队在美国《科学》杂志发表论文称，他们首次在体外 将 CRISPR-Cas9 基因编辑技术对小鼠和人类细胞的特定基因完成了精确的切割，意味 着将该技术改进并应用于哺乳动物和人类细胞。 然而此后，以詹妮弗·杜德纳和埃玛纽埃勒·沙尔庞捷为代表的加州大学和维也纳 大学研究团队（CVC 团队）和以张锋为代表的博德研究所团队，就 CRISPR 专利所有 权展开了争夺战。专利之争的关键是 CRISPR-Cas9 在治疗人类疾病中对真核细胞（在 动物、植物和真菌中发现的具有明确细胞核的细胞）进行编辑的能力，因为真核细胞 才是开发人类药物的关键。 USPTO 于 2014 年授予了张锋团队 CRISPR 系统应用于真核细胞的专利，而来自 CVC 团队的上诉也在 2016 年被法院悉数驳回。2017 年，USPTO 认定双方的权利要求 不存在冲突，并裁定张锋团队的成就是一项可单独申请专利的发明，结束了最初的法 律纠纷。 此次，USPTO 在听取了辩论并审查了实验室笔记中的数据后，做出了裁决：张锋

全球健康医疗动态汇编第 99 期 58 团队拥有在真核细胞中使用 CRISPR 基因编辑技术的专利。裁定要点是，CVC 团队没 有证明他们是第一个在动物细胞中使用 CRISPR 的人，其最初论文只是描述了它在细 菌中的用途。 这一裁定意味着，从现在起，从 CVC 获得 CRISPR-Cas9 许可的公司将需要从博德 研究所获得许可。但该裁定同时肯定了 CVC团队是 CRISPR基因编辑技术的关键发明者。 http://www.stdaily.com/guoji/xinwen/202203/4a26fbf42c714eb287ea9113a5 40f548.shtml 2. 孕妇服用欧米伽 -3 可显著降低早产风险 据英国《新科学家》杂志网站 2 月 28 日报道，此前有研究表明，孕妇服用欧米伽 -3 （omega-3）补充剂可显著降低早产风险。在此基础上，南澳大利亚州启动了世界上 首个监测孕妇体内 omega-3 浓度并在不足时给予补充剂来降低胎儿早产的计划。该试 验提供的最新数据表明，体内 omega-3 含量较低的孕妇补充添加剂，可将该地区胎儿 早产的几率降低 14% 左右。 omega-3 存在于鱼类中，已知可保护心脏和大脑健康，有证据表明它们对孕妇非 常重要。如观察性研究表明，孕妇经常吃鱼似乎可以降低胎儿早产的风险。孕期一般 要持续 40 周，早产指孕妇怀孕不满 37 周分娩。 几年前，南澳大利亚健康和医学研究所科学家开展了一项试验，他们随机挑 选 5500 名孕妇，从怀孕 20 周前的任何时间开始，每天服用 1 克鱼油胶囊形式的 omega-3 或安慰剂。结果发现，血液中 omega-3 浓度较低的孕妇如果补充 omega-3 可将胎儿在怀孕 34 周前出生的风险降低 77%；服用安慰剂则对降低早产风险毫无作用。 不过，研究也发现，血液内 omega-3 浓度很高的女性服用补充剂实际上会增加早 产的风险，这表明，这些补充剂只应推荐给血液内 omega-3 浓度较低的孕妇。 有鉴于此，研究人员在南澳大利亚州启动了一项筛查计划，为所有孕妇提供免费 血液检测，以识别和治疗体内 omega-3 浓度低的孕妇。自 2021 年 5 月以来，他们已 经筛查出约 3000 名妇女，约有 17% 的妇女体内 omega-3 浓度较低。早期临床试验结 果显示，向她们提供补充剂可将整个南澳大利亚胎儿的早产率降低 14%。 早产会增加婴儿死亡或出现残疾的风险，但目前几乎没有有效的方法来预防早产。

全球健康医疗动态汇编第 99 期 59 研究人员表示，找到预防早产的方法是妇幼保健领域的最优先事项之一。 http://www.stdaily.com/guoji/xinwen/202203/91c1bddbc2654301964f29032 6ff2375.shtml 3. 利用脐带血干细胞疗法全球首位女性艾滋病 “治愈”者出现 据外媒最新报道，研究人员 15 日在美国科罗拉多州丹佛举行的会议上宣布，科学 家使用一种“神奇的”脐带血移植的突破性治疗法治愈了一名艾滋病病毒（HIV）女性 感染者。这是有史以来第一位接受干细胞移植并使用抗 HIV 细胞的女性，也是第三位 已知的 HIV 功能性治愈的病例。 这名女性现年 64 岁，2013 年被诊断出感染了 HIV，四年后被诊断出患有急性髓 性白血病。她是首批接受使用脐带血的新型移植方法的人之一。在单倍体脐带移植手 术中，她从一个部分匹配的捐赠者那里获得了脐带血来治疗她的癌症。手术时，一位 近亲还为她提供了血液以增强她的免疫系统。该方法增强了一种突变，可阻止 HIV 进 入她的细胞。 自 2017 年 8 月该女性接受移植手术四年多以来，她的白血病得到了缓解。移植三 年后，医生停止了她的艾滋病毒治疗。在她接受脐带血移植后 14 个月，她的血液中就 再也没有 HIV“死灰复燃”的迹象。 美国威尔·康奈尔医学院传染病科副主任、研究团队成员马歇尔·格列斯比博士表 示，使用脐带血的优势在于，它取自国家储存库，科学家可以在那里识别血液中的 HIV 抗药性突变。 然而，目前只在大约 2 万名捐赠者中发现了这种突变，其中大多数是北欧血统。 此次研究中的患者是混血儿，但她仍然是移植的匹配对象，这表明来自不同种族背景 的接受者池子更广。脐带血也不需要像成人捐赠者干细胞那样严格配型。 与治愈前两名患者的骨髓移植中使用的成人干细胞相比，脐带血的可获得性更广 泛，且不需要与接受者进行密切配型。科学家说，只要允许部分匹配就有可能治愈每 年数十名同时感染艾滋病毒和癌症的美国人。

全球健康医疗动态汇编第 99 期 60 研究人员说，新病例的性别和种族背景，标志着在开发 HIV 治疗方法方面迈出了 重要的一步。 艾滋病的传统治疗方式是骨髓移植，但是对于大多数患者来说，骨髓移植都不是 一个很现实的选择，这种移植具有很高的侵入性和风险，因此通常只提供给用尽了所 有其他选择的癌症患者。 到目前为止，只有两个已知的 HIV 治愈病例。这两名都是男性且都通过骨髓或干 细胞移植治愈了 HIV。但由于骨髓移植取代了他们所有的免疫系统，两人都出现了严重 的副作用，包括移植物抗宿主病，这是一种捐赠者的细胞攻击接受者身体的疾病。 美国威尔·康奈尔医学院的医生徐静梅（音译）说，相比之下，最新病例中的这名 女性在移植后第 17 天出院，没有出现移植物抗宿主病，脐带血和她近亲的干细胞结合 在一起，可能会让她避免很多典型骨髓移植的残酷副作用。 http://www.stdaily.com/guoji/xinwen/202202/ea77b6c41f064b45a6943d5bfb 5fba23.shtml 4. 阿尔茨海默病认知衰退“罪魁祸首”揭示 据 17 日发表在《阿尔茨海默病与痴呆症》杂志上的一项研究，美国耶鲁大学研究 人员开发的先进成像技术帮助他们确认，大脑突触的破坏是阿尔茨海默病患者认知缺 陷的根源。 多年来，科学家们一直认为，脑细胞之间联系的丧失会导致阿尔茨海默氏症相关 症状，包括记忆力丧失，但大脑突触丧失会带来何种影响，其实际证据仅限于对中晚 期疾病患者进行的少量脑活组织检查和尸检。然而，耶鲁大学开发的正电子发射断层 扫描（PET）技术的出现，使研究人员能够观察即使仅患有轻度阿尔茨海默病症状的在 世患者的突触丧失情况。 新的糖蛋白 2A（SV2A）的 PET 成像扫描使科学家能够测量 45 名被诊断为轻至中 度阿尔茨海默病的人的大脑突触的代谢活动。研究人员随后在五个关键领域测量了每 个人的认知表现：言语记忆、语言技能、执行功能、处理速度和视觉空间能力。 他们发现，脑细胞间突触或连接的丧失与认知测试中的糟糕表现密切相关。他们 还发现，与大脑中神经元总体积的丧失相比，突触丧失是认知能力低下的一个更强的

全球健康医疗动态汇编第 99 期 61 指标。 耶鲁阿尔茨海默病研究中心主任、该论文的资深作者克里斯托弗·范·戴克表示， 研究人员现在可以追踪患者随着时间的推移丧失突触的情况，从而更好地了解个体认 知能力下降的发展过程。 论文主要作者当·麦卡说：“这些发现帮助我们了解了这种疾病的神经生物学，可 以成为测试阿尔茨海默氏症新药疗效的重要新生物标记物。” http://www.stdaily.com/guoji/xinwen/202202/06ef26e550f84158ac986e3994f 29cd5.shtml

全球健康医疗动态汇编第 99 期 62 05 Academic comments Compiled by Qiping Zhang 1. Broad Institute Wins CRISPR Patent Case Scientists from the Broad Institute, the University of Harvard and the Massachusetts Institute of Technology (MIT) – referred to collectively as “Broad” hereafter – have won a seven-yearlong patent case relating to the CRISPR-Cas9 genome editing technology. A “revolution” in genomics CRISPR-Cas9 genome editing, a technology that allows scientists to edit the genome by removing, adding or altering genes, has “revolutionized” genomics research over the last decade. The versatility, speed and low-cost of CRISPR-Cas9 has seen its application across the life sciences, advancing fields such as personalized medicine, synthetic biology and climate change, to name a few examples. The technology’s contribution to modern science was recognized in 2020 when Jennifer Doudna, professor of Biochemistry, Biophysics and Structural Biology at University of California (UC) Berkeley and Professor Emmanuelle Charpentier, founding, scientific and managing director of the Max Planck Unit for the Science of Pathogens, were awarded the Nobel Prize in Chemistry. In the short time since its discovery, CRISPR-Cas9 genome editing technology has been harnessed by several biotech start-ups with aspirations to treat or even cure genetic conditions. However, in the shadows of such incredible advancements, a dispute surrounding intellectual property (IP) rights has been lurking.

全球健康医疗动态汇编第 99 期 63 A brief history of the CRISPR patent dispute On June 28 2012, Doudna and Charpentier – alongside colleagues at their respective institutes – published a paper in Science, outlining how they could guide a specific enzyme to make sitespecific DNA cleavages in the genome. Their research was born from Charpentier’s earlier studies of the bacteria Streptococcus pyogenes, where she discovered the molecule tracrRNA, part of the bacteria’s ancient immune system that disarms viruses by cleaving their DNA. After publishing her work in 2011, Charpentier instigated a collaboration with Doudna – an expert in RNA – to further advance the research. The 2012 Science paper – the culmination of their time collaborating on the CRISPR-Cas system – was an in vitro study, i.e., conducted in test tubes. In May 2018, Doudna and colleagues filed a patent application for CRISPR-Cas9. Meanwhile, Professor Feng Zhang, who holds multiple positions across the Broad Institute, Harvard University and MIT, and colleagues had also been conducting research on the CRISPR-Cas system. On January 3, 2013, Zhang published a paper (also in Science), where his team outlined the successful application of CRISPR-Cas9 technology to induce precise edits in human and mouse cells. Prior to that publication, in December 2012, Zhang and colleagues had also filed their first patent application to the U.S. patent office. “It was based on original work that began at the Broad and MIT in early 2011, was further reflected in a January, 2012 federal grant application to the National Institutes of Health and culminated in the manuscript submitted on October 5, 2012 that was published in Science on January 3, 2013 as Cong et al,” a statement from Broad said. When the conflicting applications eventually came to light, a long, legal battle commenced. A number of twists and turns have occurred during this case. In 2014, patent rights were initially granted to Broad. However, this was contested by UC Berkeley, and in 2017 it was concluded that patent filings from both groups were different enough to warrant individual consideration. This dispute has presented challenges for biotech companies wanting to use the technology to develop gene-editing therapies. Some companies – like Editas Medicine – have licensed the technology from the Broad Institute, while others – such as Intellia Therapeutics – have licensed it from the UC Berkeley group. Patent decision made Now, an appeal board of the U.S. Patent and Trademark Office (USPTO) has declared that Zhang and colleagues were the first to invent the use of CRISPR-Cas9 genome editing technology in eukaryotic cells.

全球健康医疗动态汇编第 99 期 64 “In this interference, we determine that The Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (“Broad”) have priority over The Regents of the University of California, University of Vienna and Emmanuelle Charpentier (“CVC”) with respect to Count 1 – a single RNA CRISPR-Cas9 system that functions in eukaryotic cells,” a summary of the 84-page document reads. A statement from the Broad Institute said, “This decision once again confirmed Broad’s patents were properly issued. As the PTAB and U.S. federal courts have repeatedly established, the claims of Broad’s patents to methods for use in eukaryotic cells, such as for genome editing, are patentably distinct and not reasonably expected from results of biochemical ‘test tube’ experiments.” However, UC Berkeley issued a contrasting statement suggesting it may still work to contest the decision: “The University of California is disappointed by the PTAB’s decision and believes the PTAB made a number of errors. CVC is considering various options to challenge this decision,” adding that, “CVC also has issued patents to its foundational CRISPRCas9 systems in over 30 countries worldwide that are not affected by any U.S. interference proceedings.” CRISPR to better humankind This decision may be interpreted as a milestone for some. Clarity surrounding the IP rights will likely simplify future endeavors in developing CRISPR-Cas9-based therapeutics for patients, helping to address unmet clinical need. Just yesterday, Intellia – which was co-founded by Doudna – announced it had dosed its first patient in a clinical trial of NTLA-5001, a novel investigational T cell receptor (TCR)-T cell therapy for the treatment of acute myeloid leukemia, which harnesses CRISPR-Cas9. Prior to that, on February 28, Intellia shared that NTLA-2001 – a CRISPR therapy for the nerve disorder transthyretin (ATTR) amyloidosis – had yielded positive results in a Phase I clinical trial. The patent ruling will require companies that licensed the technology from UC Berkeley – like Intellia – to negotiate those licenses with Broad; the outcome of which, at this stage, is unclear. Responses issued by both UC Berkeley and Broad following the ruling imply that their priorities remain with ensuring that CRISPR can be used to better the planet and humanity. “Since first disclosing their groundbreaking work in 2012, Doudna and Charpentier have each continued to lead the global development and ethical application of CRISPR technology. Their efforts have helped to establish a “CRISPR economy” of new, innovative companies and

全球健康医疗动态汇编第 99 期 65 research projects for the betterment of humankind,” UC Berekely said. “Broad believes that all institutions should work together to ensure wide, open access to this transformative technology and will continue to explore how best to make this happen,” the Broad statement concluded. https://www.technologynetworks.com/genomics/news/broad-institute-wins-crispr-patentcase-359160 2. Omega-3 supplements could reduce the number of premature births Giving omega-3 supplements to pregnant women with low levels of this fatty acid could prevent about 14 per cent of early preterm births, according to data from an Australian trial. The finding has inspired a world-first screening and treatment programme for omega-3 deficiencies in pregnant women in South Australia. Omega-3 fatty acids are found in fish and are known to protect heart and brain health, and there is evidence that they are also important in pregnancy. For example, observational studies have shown that eating fish regularly during pregnancy seems to lower the risk of preterm birth. A few years ago, Maria Makrides at the South Australian Health and Medical Research Institute and her colleagues ran a trial in which they randomly assigned 5500 pregnant women to have either 1 gram of omega-3 per day in the form of fish oil capsules or a placebo, starting any time before 20 weeks of gestation. They found that in women who started out with low levels of omega-3 in their blood, supplements of omega-3 fatty acids reduced the risk of birth happening before 34 weeks of gestation by 77 per cent. The placebo had no effect on the risk of such early premature birth. But for women who already had high omega-3 levels, taking the omega-3 supplements actually increased their risk of these preterm births. This suggests that the supplements should only be recommended to pregnant women with low omega-3 levels, although multivitamins containing small omega-3 doses are fine for women who already have high levels, says Makrides. On the back of these results, Makrides has helped launch a screening programme in the state

全球健康医疗动态汇编第 99 期 66 of South Australia that offers free blood tests to all pregnant women to identify and treat those who are low in omega-3. About 3000 women have been screened since May 2021 and so far 17 per cent have been found to have low omega-3 levels. Based on the earlier clinical trial results, Makrides and her team estimate that recommending omega-3 supplements to these women with low omega-3 levels could prevent 1 in 7 early preterm births across South Australia. Currently, there are few effective ways to prevent premature births, which increase the risk of death or disability in babies, says Makrides, who will present the first results of the screening programme at the annual scientific meeting of the Royal College of Pathologists of Australasia on 6 March. “Finding ways to prevent premature birth is one of the highest priorities in maternal and child health,” she says. It isn’t clear why omega-3 fatty acids protect against preterm birth, but there is some evidence that it influences pre-labour changes to the cervix and contractions of the uterus, says Makrides. https://www.newscientist.com/article/2309696-omega-3-supplements-could-reduce-thenumber-of-premature-births/#ixzz7MXNahWmX 3. Breakthrough treatment makes woman 3rd person to be cured of HIV Researchers revealed on Tuesday that an American, described as a middle-aged woman of mixed race, has likely been cured of HIV after undergoing a new transplant procedure using donated umbilical cord blood. The patient, who needed a stem cell transplant for leukemia, reportedly developed a new HIVresistant immune system following a breakthrough procedure in which she was genetically matched with umbilical cord stem cells that contained an HIV-resistant mutation. She was part of a study that began in 2015 designed to monitor outcomes of 25 people with HIV in the U.S. who underwent a transplant, according to the National Institute of Allergy and Infectious Diseases.

全球健康医疗动态汇编第 99 期 67 Dr. Yvonne Bryson, an infectious disease physician at UCLA, who led the study, discussed their team's finding along with the patient's condition at the Conference on Retroviruses and Opportunistic Infections this week. "Today, we reported the third known case of HIV remission and the first woman following a stem cell transplant and using HIV-resistant cells," Bryson said in a press conference. "This case is special for several reasons: First, our participant was a U.S. woman living with HIV of mixed race, who needed a stem cell transplant for treatment of her leukemia. And she would find a more difficult time finding both a genetic match and one with the HIV-resistant mutation to both cure her cancer and potentially her HIV. This is a natural, but rare mutation." Bryson added that while this approach of using genetically-matched umbilical cord blood with HIV-resistant mutation opens the door to more diverse populations and studies, she confirmed there is no current routine screening in place in the U.S. for this mutation. Previously, only two men have been cured of HIV using a bone marrow or stem cell transplant. And while this is the third known case, according to Bryson's team, of HIV remission in an individual who received a stem cell transplant of any kind, experts in the field caution that this method is not ideal for curing the many millions of HIV-positive people around the globe today. Bryson said there could eventually be "approximately at least 50 [people] per year that may benefit from this." In an interview with Community Health Center, Inc., Dr. Anthony Fauci, the leading expert in infectious disease in the U.S., whose work in HIV care and treatment innovation spans four decades, said, "I don't want people to think that now this is something that can be applied to the 36 million people [globally] who are living with HIV." "This person had an underlying disease that required a stem cell transplant. ... It is not practical to think that this is something that's going to be widely available," Fauci added. "It's more of a proof of concept." While there is no practical and applicable cure for HIV on a large scale, there have been incredible strides in HIV treatment over the years that allow individuals to live a normal and healthy life. Known as U=U, or Undetectable=Untransmittable, if an HIV-positive person begins HIV treatment and brings the virus in their body to an undetectable level, the individual cannot transmit the virus to someone as long as they remain on said treatment or medication. https://abcnews.go.com/Health/breakthrough-treatment-makes-woman-3rd-person-cured-hiv/

全球健康医疗动态汇编第 99 期 68 story?id=82907276 4. What is the reason for cognitive decline in Alzheimer’s disease? Technology developed by Yale University confirms that destruction of brain synapses explains cognitive deficits experienced by patients with Alzheimer’s disease For decades, scientists have had to make assumptions about Alzheimer’s disease and what causes cognitive decline. Cognitive decline is at the heart of Alzheimer’s, with those affected becoming increasingly unable to interact with their loved ones as they used to. This issue has a widespread set of social consequences, alienating the individual from their reality and creating a painful, difficult distance. Any identification of what causes cognitive decline can lead to new treatment pathways, which are sorely needed for a range of neurological diseases. Now, a team at Yale have discovered a new link between synapses and Alzheimer’s. PET imaging scan reveals loss of synapses By research being limited to a small number of brain biopsies and post-mortem brain exams conducted on patients with moderate to advanced symptoms, the team had assumed that the loss of connections between brain cells caused Alzheimer’s-related symptoms. However, using advanced image technology known as positron emission tomography (PET) scanning technology has allowed researchers to observe the loss of synapses in living patients with even mild symptoms of Alzheimer’s disease. The new glycoprotein 2A (SV2A) PET imaging scan allowed scientists to measure metabolic activity at the brain synapses of 45 people diagnosed with mild to moderate Alzheimer’s disease. This new scan will provide even more precise picture of the entire scale of Alzheimer’s disease from mild all the way advanced. Measuring 5 key areas researchers explored each patient’s cognitive performance: Verbal memory , Language skills, Executive function, Processing speed and Visual-spatial ability. Through this process the team discovered that the loss of synapses or connections between

全球健康医疗动态汇编第 99 期 69 brain cells was strongly associated with poor performance on cognitive tests along with that, they also observed that synaptic loss was a stronger indicator of poor cognitive performance than the loss of overall volume of neurons in the brain. The importance of understanding cognitive decline Through this research and new technology, Yale researchers are able to track the loss of synapses in patients over time – therefore providing a better understanding of the cognitive decline that follows Alzheimer’s patients. “The findings help us understand the neurobiology of the disease and can be an important new biomarker to test the efficacy of new Alzheimer’s drugs,” said Adam Mecca, assistant professor of psychiatry and lead author of the paper. https://www.openaccessgovernment.org/cognitive-decline-alzheimers/129848/

全球医疗健康动态汇编第 98 期 -69- 《全球健康医疗动态 汇编》 全球健康医疗动态汇 编，对全球公共卫生 事务和医疗健康政策 经济运行整合，并在 每期设置专题，通过 撰写有价值的原创文 章和论文编译对热点 事件进行追踪。以通 过多方面的公共卫生 研究，为全球的健康 协作治理提供多样化 的思路，并为读者提 供更加客观、更具时 效性的咨询和分析 Copyright@2021 发行人、主编 陈定定 执行主编 余卓朋 负责编辑 李 帆 余洁璐 张启平 孙安迪 排版较对 张千惠 张镕怡 广州市天河区谭村路 #348 马赛国际商务中心 2709 室 +86 2037276476 读者反馈： enquiry@intellisia.org 媒体宣传： media@intellisia.org 投资人： support@intellisia.org 本出版物内容版权均属 于海国图智研究院。转 载、摘编请注明“来自海 国图智研究院”。如因 作品内容和版权问题需 要同海国图智研究院联 系的，请于 30 日内进行。