In June, the U.S. Food and Drug Administration (FDA) approved

六月，美国食品药品监督管理局（FDA）批准了

Gilead Sciences, Inc.'s

吉利德科学公司

GILD

吉利德科学公司

Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the U.S. for people

Yeztugo（lenacapavir）作为暴露前预防（PrEP）药物，用于降低体重至少35公斤的成人和青少年因性行为感染HIV的风险，这使其成为美国首个且唯一一个每年两次的可用选项。

who need or want PrEP

需要或想要PrEP的人

.

。

Data show that ≥99.9% of participants who received Yeztugo in the Phase 3 PURPOSE 1 and PURPOSE 2 trials remained HIV negative.

数据显示，在3期PURPOSE 1和PURPOSE 2试验中，接受Yeztugo的参与者中≥99.9%保持HIV阴性。

The first PrEP medication, which was also developed by Gilead, was approved in the

第一种PrEP药物也是由Gilead公司开发的，于

U.S. in 2012

美国，2012年

.

。

On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion under accelerated review recommending lenacapavir—the company's injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with .

上周五，欧洲药品管理局 (EMA) 人用医药产品委员会 (CHMP) 在加速审查下通过了一项积极意见，推荐使用该公司的注射型HIV-1衣壳抑制剂Lenacapavir，作为暴露前预防（PrEP）用药，以降低成人和青少年因性行为感染HIV-1的风险。

increased HIV-1 acquisition risk

增加的HIV-1获得风险

.

。

Also Read:

另请阅读：

Gilead's Lenacapavir Plan Faces Global Hurdles As It Commits To No-Profit Access for 2 Million

吉利德的Lenacapavir计划面临全球障碍，因其承诺为200万人提供无利润获取途径。

The final European Commission (EC) decision is expected later this year. If approved, lenacapavir will be marketed in the European Union (EU)

预计欧洲委员会 (EC) 的最终决定将在今年晚些时候公布。如果获得批准，lenacapavir 将在欧盟 (EU) 上市。

under the trade name Yeytuo.

商品名为Yeytuo。

If approved, lenacapavir will be granted one additional year of market exclusivity in the EU due to the new indication.

如果获得批准，由于新的适应症，lenacapavir 将在欧盟获得额外一年的市场独占期。

Data from Gilead's Phase 3 PURPOSE 1 and PURPOSE 2 trials supported the positive opinions.

吉利德的三期临床试验PURPOSE 1和PURPOSE 2的数据支持了这些积极的意见。

In the

在

PURPOSE 1 trial

目的1试验

, data at the primary analysis showed that administration of twice-yearly subcutaneous lenacapavir led to zero HIV infections among 2,134 participants, 100% reduction in HIV infections and superiority of prevention of HIV infections when compared with once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF).

，主要分析数据显示，在2134名参与者中，每年两次皮下注射Lenacapavir导致零例HIV感染，与每日一次口服Truvada（恩曲他滨200mg和替诺福韦二吡呋酯300mg；F/TDF）相比，HIV感染减少了100%，并且在预防HIV感染方面表现出优越性。

in cisgender women in sub-Saharan Africa.

在撒哈拉以南非洲的顺性别女性中。

In the

在

PURPOSE 2 trial

目的2试验

, there were two HIV infections among 2,179 participants in the twice-yearly subcutaneous lenacapavir group, demonstrating 99.9% of participants did not acquire HIV infection and superiority of prevention of HIV infections when compared with once-daily oral Truvada among a broad and geographically diverse range of cisgender men and gender-diverse people..

在每年两次皮下注射Lenacapavir的2179名参与者中，有两例HIV感染，这表明99.9%的参与者没有感染HIV，并且在预防HIV感染方面优于每日一次口服Truvada，涵盖了广泛且地理上多样化的顺性别男性和性别多样化人群。

In both trials, lenacapavir demonstrated superiority in preventing HIV infections when compared with background HIV incidence.

在两项试验中，与背景 HIV 发生率相比，lenacapavir 在预防 HIV 感染方面均表现出优越性。

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Needham

尼达姆

upgraded Gilead after positive feedback from a recent physician survey on Yeztugo.

在最近一项针对医生的调查中，Yeztugo获得积极反馈后，吉利德升级了其产品。

Analyst Joseph Stringer says the physician survey has increased confidence in Yeztugo and could be a multi-billion dollar contributor to the top line over the next several years.

分析师约瑟夫·斯金格表示，医生调查增加了对 Yeztugo 的信心，可能会在接下来的几年内为公司带来数十亿美元的收入。

Needham models that the HIV PrEP TAM (actual people on therapy) could grow from approximately 500K to around 900K by 2035.

Needham 模型预测，到 2035 年，HIV PrEP 的实际治疗人数（TAM）可能从约 50 万增长到约 90 万。

The analyst upgraded Gilead from Hold to a Buy rating

分析师将吉利德的评级从持有上调至买入。

with a price forecast of $133

价格预测为133美元

.

。

Doctors predict the HIV prevention (PrEP) market will grow by about 49% by 2030, and Yeztugo could take about 38% of that growth. They favor Yeztugo because it's easier to take than the current treatments.

医生预测，到2030年，HIV预防（PrEP）市场将增长约49%，而Yeztugo可能占据其中约38%的增长。他们更倾向于Yeztugo，因为它比目前的治疗方案更容易服用。

With around 70% of Gilead's revenue coming from its HIV drugs, Yeztugo could become a key driver of the company's future growth.

吉利德约70%的收入来自其HIV药物，Yeztugo可能成为公司未来增长的关键驱动力。

Needham says Yeztugo could generate $4.1 billion in sales by 2030—about 10% more than current expectations—and $6.4 billion by 2035, about 20% above consensus.

Needham表示，Yeztugo到2030年可能实现41亿美元的销售额，比当前预期高出约10%，到2035年将达到64亿美元，比共识预期高出约20%。

Price Action:

价格行为:

GILD stock is up 2.75% at $116.31 at the last check on Friday.

GILD股票在上周五最后一次检查时上涨了2.75%，达到116.31美元。

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Read Next:

接下来读：

HCA Healthcare Eyes $76 Billion Revenue, Aggressive Profit Growth

HCA医疗保健公司预计收入760亿美元，利润增长强劲

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GILD

吉利德科学公司

Gilead Sciences Inc

吉利德科学公司

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