来那帕韦：为何这款重磅HIV药物的新获批仿制药将无法在最需要的地区获得
摘要
美国原研药生产商已确认，全球最好的HIV预防药物之一的一种廉价仿制药，至少在26个国家将无法惠及患者。来那帕韦是唯一一种每年注射两次的暴露前预防用药，其首个仿制版本于本周获得美国食品药品监督管理局（FDA）批准。该仿制药由印度公司瑞迪博士实验室（Dr Reddy’s Laboratories）生产，预计每年费用仅为40美元（30英镑；36欧元），仅为美国生产商吉利德科学公司（Gilead Sciences）生产的原研版本标价28218美元的一小部分。1 然而，由于吉利德设定的条件，包括一些HIV疫情日益严重的国家在内的26个中等收入国家和 territories 将无法购买这款新仿制药。吉利德于2024年10月与si
English
A cheap, generic version of one of the world’s best HIV prevention drugs will be out of reach for patients in at least 26 countries, the US manufacturer of the original drug has confirmed.The first generic version of lenacapavir—the only twice-a-year injectable pre-exposure prophylaxis—was approved by the US Food and Drug Administration this week.Made by the Indian company Dr Reddy’s Laboratories, this generic version is expected to cost just $40 (£30; €36) a year, a fraction of the $28 218 list price of the branded version made by the US manufacturer Gilead Sciences.1 However, 26 middle income countries and territories, including some with growing HIV epidemics, will be unable to buy the new generic because of conditions set out by Gilead.Gilead struck an agreement in October 2024 with si