China's medical regulators recently approved two foreign drugs, bringing new hope to patients with Alzheimer's disease and groups at risk for HIV/AIDS.
中国医疗监管机构最近批准了两种外国药物,为阿尔茨海默病患者和艾滋病高危人群带来了新的希望。
The National Medical Products Administration announced last week that it had granted market approval for the injected drug Leqembi, developed by Tokyo-based pharmaceutical company Eisai, to treat minor dementia and cognitive dysfunction triggered by Alzheimer's.
美国国家医疗产品管理局上周宣布,已批准注射药物Leqembi上市,该药物由制药公司卫材(Eisai)开发,用于治疗阿尔茨海默氏症引发的轻微痴呆和认知功能障碍,该公司总部位于东京。
The Economic Observer, a Beijing-based news outlet, reported that China is the third country to approve the drug, after the United States in July and Japan in September. The drug targets amyloid betaprotein, widely believed to be associated with neurotoxicity and Alzheimer's.
总部位于北京的新闻媒体《经济观察报》报道称,继美国7月和日本9月批准该药物后,中国是第三个批准该药物的国家。该药物针对的是淀粉样β蛋白,人们普遍认为该蛋白与神经毒性和阿尔茨海默病有关。
The pharmaceutical company added that current drugs on the market only target symptoms and have a hard time dealing with the root cause. During a global clinical trial, taking the drug was shown to reverse the progression for about 60 percent of early-stage patients and help them improve cognitive impairments, the company said.
该制药公司补充说,目前市场上的药物只能针对症状,很难解决根本原因。该公司表示,在一项全球临床试验中,服用该药物可以逆转约60%的早期患者的病情进展,并帮助他们改善认知障碍。
Eisai set the price at 2,508 yuan ($350) per 2-milliliter dose, or about 180,000 yuan annually for a patient weighing 60 kilograms.
卫材将价格定为每2毫升剂量2,508元,对于体重60公斤的患者来说,每年费用约为18万元。
According to the Economic Observer, the drug was priced at 3,328 yuan per dose during a trial in Boao Hope City, a pilot medical zone in Hainan province, which allows drugs approved elsewhere to be used for real-world clinical trials in China. The first batch of 200 doses has been used up, the report said.
据经济观察报报道,该药在海南省医疗试点博鳌希望城进行试验时的售价为每剂3328元,允许在其他地方批准的药物在中国进行真实临床试验。报道称,第一批200剂已经用完。
China has 9.83 million people with Alzheimer's, and the disease is the fifth-largest cause of death in the country, according to an annual report on the disease released last year. Meanwhile, the diagnosis and treatment rate is low, and awareness among the general public is inefficient, the report said.
根据去年发布的阿尔茨海默病年度报告,中国有983万阿尔茨海默病患者,该病是中国第五大死亡原因。并且诊疗率低,公众了解度有限。
Separately, Descovy, a tablet developed by US-based pharmaceutical company Gilead, has been approved by the NMPA for pre-exposure prophylaxis, or PrEP, to lower the risk of HIV infection due to high-risk sexual activities. Previously, the drug had been approved to treat HIV infections in adults.
另外,美国吉利德制药公司开发的片剂Descovy已获得国家药监局批准用于暴露前预防(PrEP),以降低因高危性活动而感染艾滋病毒的风险。此前,该药物已被批准用于治疗成人艾滋病毒感染。
The NMPA said that clinical trials showed that Descovy had effectiveness as a PrEP drug no worse than Truvada, the first PrEP drug approved in China, and that it displayed very low side effects.
国家药监局表示,临床试验表明,德可维作为PrEP药物的有效性并不比中国首个获批的PrEP药物Truvada差,而且副作用非常低。
"Groups with a high risk of HIV exposure can take this drug regularly to help maintain a certain density of the drug in the blood to prevent HIV infections," said Wang Hui, chief expert of the HIV/AIDS center at Shenzhen Third People's Hospital, adding that the drug offers a new choice for those involved in high-risk sexual activities, such as those engaging in unprotected homosexual sex, sex with unfixed partners, or prostitution.
深圳市第三人民医院艾滋病中心首席专家王辉表示,艾滋病暴露高风险人群可以定期服用这种药物,帮助维持血液中一定的药物浓度,预防艾滋病毒感染。该药物为那些从事高风险性活动的人提供了新的选择,例如进行无保护措施的同性恋群体以及与不固定伴侣发生性行为或卖淫的人。
Sexual activity is a major means of HIV transmission among adults. As of late 2022, China has 1.2 million people living with HIV, according to the Chinese Center for Disease Control and Prevention.
性活动是成人中艾滋病毒传播的主要途径。根据中国疾病预防控制中心的数据,截至2022年底,中国有120万艾滋病毒感染者。
The World Health Organization said oral PrEP is highly effective in preventing HIV when used as directed, and recommends people at substantial risk of HIV infection be offered PrEP drugs as an additional choice as part of comprehensive prevention.
世界卫生组织表示,按照指示口服PrEP对预防HIV非常有效,并建议向HIV感染高风险人群提供PrEP药物,以助力全面预防艾滋病。
However, awareness and prevalence of PrEP in China are relatively low compared with developed countries. Based on a study published in the Chinese Journal of Epidemiology in 2020, only 56 percent of some 600 interviewed men who have sex with men said they were aware of the method, and just 10.6 percent said they were absolutely willing to use it.
但与发达国家相比,我国PrEP的知晓率和普及率较低。根据2020年《中国流行病学杂志》发表的一项研究,在约600名接受采访的男男性接触者中,只有56%的人表示他们知道这种方法,只有10.6%的人表示他们非常愿意使用这种方法预防感染艾滋病。