Results from the phase IIb study, EMBRACE, demonstrate that N6LS, a bNAb administered every four months, effectively maintained undetectable viral load when combined with long-acting cabotegravir

EMBRACE 二期研究结果显示，每四个月给药一次的广泛中和抗体 N6LS 与长效卡博特韦联合使用时，能有效维持病毒载量在检测不到的水平。

Results add to the growing body of evidence that N6LS is a potent antiviral that can function as a component of a complete antiretroviral regimen

结果增加了越来越多的证据，表明N6LS是一种有效的抗病毒药物，可以作为完整抗逆转录病毒治疗方案的一部分发挥作用。

EMBRACE study to continue investigating a combination of N6LS dosed at six months with cabotegravir long-acting (CAB-LA)

EMBRACE研究将继续调查每六个月给药一次的N6LS与长效卡博特韦（CAB-LA）的组合。

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders

GSK plc（LSE/NYSE：GSK）宣布，其全球专业的HIV公司ViiV Healthcare，由GSK控股，辉瑞和盐野义为股东。

,

，

today announced positive findings from the company’s EMBRACE phase IIb study.

今天宣布了公司EMBRACE IIb期研究的积极结果。

The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants.

研究发现，每四个月给药一次的 N6LS（VH3810109 或 VH109）与每月一次的长效卡博特韦（CAB LA）联合使用时，能够成功抑制已稳定接受治疗的 HIV 感染者的病毒水平。该药物也受到参与者的良好耐受。

These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S.

这些结果今天在美国旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上公布。

Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said

ViiV Healthcare研发部门负责人金伯利·史密斯医学博士、公共卫生硕士表示

: 'As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with

：“作为长效注射创新的领导者，我们正在建立在患者和医生对我们的积极体验之上，

Cabenuva

卡贝努瓦

and pioneering the next generation of long-acting treatment options. The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.”.

并开创下一代长效治疗方案。EMBRACE研究显示，VH109是一种CD4结合的广谱中和抗体，每四个月与卡博特韦联合使用，六个月后显示出高效性且耐受性良好。我们期待继续开发VH109，作为未来超长效治疗方案的一部分。

Results from the EMBRACE study

EMBRACE研究的结果

1

1

at the six-month primary endpoint showed that 96% of participants receiving VH109 60 mg/kg intravenously (IV) and 88% receiving VH109 3000 mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB-LA.

在六个月的主要终点时显示，接受静脉注射（IV）60 mg/kg VH109的参与者中有96%、接受皮下注射（SC）3000 mg VH109与rHuPH20的参与者中有88%维持了HIV-1 RNA水平低于50拷贝/mL，而标准治疗组为96%。VH109每四个月在两个组中施用一次，并与每月一次的CAB-LA联合使用。

Confirmed virologic failure was observed in two participants from each VH109 group..

确认病毒学失败发生在每个VH109组的两名参与者中。

Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six.

总体而言，4% 的 IV 组和 6% 的 SC 组 HIV-1 RNA 水平达到 50 拷贝/mL 或更高，而在标准护理组中，六个月时的测量结果为零。

VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema).

VH109总体耐受性良好，尽管皮下注射时输注部位反应更为频繁，发生率为14%，而静脉注射则未出现。与研究药物相关的不良事件在静脉注射组中占64%，皮下注射组中占65%，其中皮下注射组有16%的参与者经历了3-4级不良事件（红斑）。

No participants in the IV group experienced a grade 3-4 adverse event..

静脉注射组的参与者均未经历3-4级不良事件。

Based on the favourable results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB-LA for further evaluation in an EMBRACE part two trial.

基于试验中看到的有利结果，ViiV Healthcare 将在 EMBRACE 第二阶段试验中进一步评估 VH109 的六个月静脉注射制剂与 CAB-LA 的组合。

About

关于

Cabenuva

卡贝努瓦

(cabotegravir + rilpivirine)

（卡博特韦 + 利匹韦林）

Cabenuva

卡贝努瓦

is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine..

适用于成人和12岁及以上且体重至少35公斤的青少年，作为治疗HIV-1感染的完整方案，用于替代当前的抗逆转录病毒治疗方案，适用于那些在稳定的抗逆转录病毒治疗方案下病毒学抑制（HIV-1 RNA <50拷贝/毫升）的患者，且无治疗失败史，同时对卡博特韦或利匹韦林无已知或疑似耐药性。

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine..

完整的治疗方案结合了由ViiV Healthcare开发的整合酶链转移抑制剂（INSTI）卡博特韦和由Janssen Sciences Ireland Unlimited Company开发的非核苷逆转录酶抑制剂（NNRTI）利匹韦林。利匹韦林片在美国已获批准，与卡博特韦联合使用时，适用于短期治疗HIV-1感染，针对12岁及以上且体重至少35公斤的成人和青少年，这些患者在稳定的治疗方案下病毒学上受到抑制（HIV-1 RNA小于50拷贝/毫升），没有治疗失败史，并且对卡博特韦或利匹韦林均无已知或怀疑的耐药性。

INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying..

整合酶抑制剂通过阻止病毒DNA整合到人体免疫细胞（T细胞）的遗传物质中，从而抑制HIV的复制。这一步骤在HIV复制周期中至关重要，也是导致慢性疾病形成的关键。利匹韦林是一种非核苷类逆转录酶抑制剂，通过干扰一种叫做逆转录酶的酶起作用，从而阻止病毒的增殖。

Please consult the full

请查阅完整内容

Prescribing Information

处方信息

.

。

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

商标由ViiV Healthcare集团旗下的公司拥有或授权使用。

About ViiV Healthcare

关于ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012.

ViiV Healthcare 是一家全球专业的艾滋病公司，由葛兰素史克（GSK，伦敦证交所：GSK）和辉瑞（Pfizer，纽约证交所：PFE）于2009年11月成立，致力于为艾滋病毒感染者以及可能受益于艾滋病预防的人们提供治疗和护理的进步。盐野义制药于2012年10月成为ViiV的股东。

The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. .

该公司的目标是比任何公司都更深入、更广泛地关注艾滋病和艾滋病，并采取新的方法，为艾滋病的治疗和预防提供有效且创新的药物，同时支持受艾滋病影响的社区。如需了解更多关于该公司、其管理层、产品组合、研发管线和承诺的信息，请访问 viivhealthcare.com。

About GSK

关于GSK

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性声明的警示性声明

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2024..

GSK提醒投资者，GSK所做的任何前瞻性声明或预测，包括本公告中所做的声明或预测，均受可能导致实际结果与预测结果存在重大差异的风险和不确定性影响。这些因素包括但不限于GSK 2024年Form 20-F年度报告中第3.D项“风险因素”中描述的内容。

References

参考文献

Taiwo, B

泰沃，B

et al.

等人

VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA

VH3810109 (N6LS) 在病毒学抑制的成人中的疗效与安全性：EMBRACE 研究。于 2025 年 3 月 9-12 日在美国加利福尼亚州旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上发表。