GSK plc (LSE/NYSE: GSK) announced today that it has licensed its Shigella

GSK plc（LSE/NYSE：GSK）今天宣布，它已经授权其志贺菌属

vaccine candidate,

疫苗候选，

altSonflex1-2-3

altSonflex1-2-3

, to Bharat Biotech International Limited (BBIL). The agreement paves the way for the ongoing development and potential distribution of the vaccine in low-and-middle--income countries where Shigella, the leading bacterial cause of diarrhoea, poses a significant health threat to children under five.

，与巴拉特生物技术国际有限公司（BBIL）达成协议。该协议为继续开发和潜在分发疫苗铺平了道路，特别是在中低收入国家，志贺菌（腹泻的主要细菌原因）对五岁以下儿童构成重大健康威胁。

The Phase 1 clinical trial, and interim statistical analysis conducted to date from Phase 2 trials, has demonstrated promising results and confirmed the achievement of pre-set immunogenicity success criteria. The

第一阶段临床试验，以及迄今为止从第二阶段试验中进行的中期统计分析，已经展示了令人鼓舞的结果，并确认了预设的免疫原性成功标准的达成。

Shigella

志贺菌属

vaccine candidate uses innovative GMMA technology (Generalized Modules for Membrane Antigens), a novel platform discovered and developed by scientists in GSK’s Global Health team that uses tiny particles naturally released from bacteria – called outer membranes vesicles (OMVs) – to deliver antigens that trigger the immune system.

疫苗候选物采用了创新的GMMA技术（广义膜抗原模块），这一新型平台由GSK全球健康团队的科学家发现并开发，利用细菌自然释放的微小颗粒——称为外膜囊泡（OMVs）——来递送触发免疫系统的抗原。

GMMA technology is low-cost and scalable, making it ideal for producing affordable vaccines for low-income countries, while naturally stimulating a strong immune response often without requiring adjuvants, and offering versatility for targeting various bacterial diseases, such as .

GMMA技术成本低、可扩展，非常适合为低收入国家生产负担得起的疫苗，同时能够自然激发强烈的免疫反应，通常无需佐剂，并且具有针对各种细菌疾病的多功能性，例如 。

Shigella

志贺菌属

Thomas Breuer, Chief Global Health Officer, GSK said:

葛兰素史克（GSK）全球健康官托马斯·布罗尔表示：

“With young children in lower-income countries disproportionately impacted by Shigella, the development of a low-cost vaccine is an important goal for global public health. With no licensed vaccines widely available, the development of our

“由于低收入国家的幼儿受到志贺菌的严重影响，开发低成本疫苗成为全球公共卫生的一个重要目标。鉴于目前尚无广泛可用的许可疫苗，我们疫苗的开发至关重要。”

Shigella

志贺菌属

vaccine candidate which has demonstrated promising clinical trial results, fills us with immense pride. We are proud to collaborate with Bharat Biotech, whose expertise in developing and supplying vaccines for infectious diseases, especially as a trusted supplier to Gavi, the Vaccine Alliance, and UNICEF, positions them to further advance this important work.

候选疫苗展现出良好的临床试验结果，令我们充满信心。我们很荣幸与Bharat Biotech合作，该公司在开发和供应传染病疫苗方面的专业能力，尤其是作为全球疫苗免疫联盟（Gavi）和联合国儿童基金会（UNICEF）的可信赖供应商，使他们能够进一步推动这项重要的工作。

This agreement allows us to combine our strengths in science, research, and technology with Bharat Biotech's capacity to develop and deliver vaccines at scale, potentially preventing illness and saving lives around the world.'.

该协议允许我们将我们在科学、研究和技术方面的优势与巴拉特生物技术公司大规模开发和交付疫苗的能力结合起来，有可能预防疾病，拯救全世界的生命。'

The urgent challenge posed by increasing antimicrobial-resistant enteric bacteria including

日益增加的抗微生物药物耐药性肠道细菌所带来的紧迫挑战包括

Shigella

志贺菌属

, highlights the broader impact a Shigella vaccine could have beyond helping to reduce illness and mortality rates. It has the potential to indirectly reduce antibiotic consumption and help to tackle the rise of antimicrobial resistance (AMR)

，强调了志贺氏菌疫苗除了有助于减少疾病和死亡率外，还可能产生的更广泛影响。它有潜力间接减少抗生素的使用，并帮助应对抗菌素耐药性（AMR）的上升。

Following the technology transfer, GSK will collaborate with BBIL on its design of the Phase 3 trial and support BBIL’s efforts to secure external funding. This collaboration builds on GSK’s existing relationship with the Indian Biotech company, following a product transfer and license agreement in 2021 for the world’s first malaria vaccine, RTS,S..

在技术转让之后，GSK将与BBIL合作设计III期试验，并支持BBIL争取外部资金的努力。此次合作建立在GSK与这家印度生物技术公司现有关系的基础上，此前双方于2021年就世界上首款疟疾疫苗RTS,S达成了产品转让和许可协议。

Dr. Krishna Ella, Executive Chairman, Bharat Biotech, said:

巴拉特生物技术公司执行主席克里希纳·埃拉博士说：

“As the market leader in vaccines for diarrhoeal infections—including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi—Bharat Biotech is proud to collaborate partner with GSK with the ambition to develop a Shigella vaccine candidate. Shigellosis continues to be a serious public health concern, particularly among children under the age of five in low- and middle-income countries, where access to timely and effective medical intervention can be limited.

“作为腹泻感染疫苗（包括轮状病毒、伤寒、脊髓灰质炎、非伤寒沙门氏菌、霍乱和副伤寒）的市场领导者，巴拉特生物技术公司很荣幸与GSK合作，致力于开发一种志贺氏菌疫苗候选方案。志贺菌病仍然是一个严重的公共卫生问题，特别是在低收入和中等收入国家，五岁以下儿童获得及时有效医疗干预的机会可能有限。

. The absence of a licensed vaccine, combined with the growing threat of antimicrobial resistance, underscores the urgency of developing effective, and affordable preventive solutions. Bharat Biotech is committed to leveraging its expertise in vaccine development and manufacturing to ensure that, if successful, this innovative vaccine reaches those who need it most.

缺乏获得许可的疫苗，加上抗菌素耐药性威胁的不断增大，突显了开发有效且价格合理的预防解决方案的紧迫性。如果取得成功，巴拉特生物技术公司承诺将利用其在疫苗研发和生产方面的专业知识，确保这款创新型疫苗送到最需要它的人手中。

This licensing agreement reflects our shared commitment to global health equity and positions us to advance .

本许可协议反映了我们对全球健康公平的共同承诺，并使我们能够进一步推进。

altSonflex1-2-3

altSonflex1-2-3

through late-stage development, and if successful, through regulatory pathways, and large-scale manufacturing. The use of GMMA technology represents a potential breakthrough in vaccine design that aligns with our mission to make science-driven, accessible vaccines. Together with GSK, we aim to contribute to the fight against Shigella, prevent suffering, and help combat the rise of antimicrobial resistance, which continues to threaten millions of lives worldwide.”.

通过后期开发，并且如果成功，通过监管途径和大规模生产。使用GMMA技术代表了疫苗设计中的潜在突破，这与我们致力于研发基于科学、易于获取的疫苗的使命相契合。与GSK一起，我们旨在为抗击志贺菌、预防痛苦以及帮助对抗不断威胁全球数百万人生命的抗菌素耐药性做出贡献。"

Today’s announcement underscores GSK and BBIL’s shared ambition to get ahead of disease together and deliver health impact at scale through cutting-edge science and partnership.

今天的公告强调了GSK和BBIL共同预防疾病的雄心，并通过尖端科学和合作大规模地提供健康影响。

About the vaccine candidate

关于候选疫苗

GSK’s vaccine candidate, called altSonflex1-2-3, combines

GSK的候选疫苗，称为altSonflex1-2-3，结合了

S. sonnei

S. sonnei

with

with

S. flexneri

弗莱克斯纳氏菌属

1b, 2a and 3a O Antigens, has been designed by scientists in GSK’s Global Health team with the ambition to develop an affordable vaccine with broad protection against the most prevalent

1b、2a 和 3a O抗原，由GSK全球健康团队的科学家设计，旨在开发一种价格实惠且对最普遍的菌株具有广泛保护作用的疫苗。

Shigella

志贺菌属

serotypes. The vaccine uses GMMA technology (Generalized Modules for Membrane Antigens), a novel platform based on bacterial outer membranes for delivery of the O Antigen to the immune system

血清型。该疫苗采用GMMA技术（通用膜抗原模块），这是一种基于细菌外膜的新平台，用于将O抗原递送至免疫系统。

. GSK’s goal is to advance vaccine innovation against infectious diseases such as

GSK 的目标是推进针对传染病的疫苗创新，例如

Shigella

志贺菌属

, contributing to the fight against antimicrobial resistance, which still causes millions of deaths worldwide.

，为抗击仍然导致全球数百万人死亡的抗菌素耐药性做出贡献。

About Shigella

关于志贺菌

Shigellosis is an acute human infection of the large intestine, characterised by watery diarrhea, fever, abdominal cramps and pain, bloody and mucus stools, caused by Gram-negative

志贺菌病是一种人类大肠的急性感染，特征为水样腹泻、发热、腹痛和痉挛、血便和粘液便，由革兰氏阴性菌引起。

Shigella

志贺菌属

. Humans are the only natural host for Shigella

人类是志贺菌的唯一自然宿主

Shigella

志贺菌属

is a facultatively anaerobic, non-motile Gram-negative rod, from the family

是一种兼性厌氧、非运动性的革兰氏阴性杆菌，属于

Enterobacteriacae

肠杆菌科

. There are four different

。共有四种不同的

Shigella

志贺菌属

, divided into more than 50 different serotypes by the outer polysaccharide (O Antigen) of the lipopolysaccharide expressed on the bacteria surface

，根据细菌表面表达的脂多糖的外多糖（O抗原）分为50多种不同的血清型

. The prevalence of these serotypes varies by country economic status, between geographical regions and changes over time even within one region, which has long presented a major challenge for vaccine development.

这些血清型的流行率因国家经济状况、地理区域而异，甚至在同一区域内也会随着时间的推移而变化，这长期以来一直是疫苗开发面临的主要挑战。

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。

About Bharat Biotech International Limited

关于巴拉特生物国际有限公司

BBIL is a biotechnology company headquartered in Genome Valley Hyderabad, India, focused on providing affordable vaccines and bio-therapeutics for combating infectious diseases. BBIL has more than 145 global patents, a product portfolio of more than 19 vaccines and four biotherapeutics, registrations in more than 125 countries, and the World Health Organization (WHO) Pre-qualifications.

BBIL是一家总部位于印度海得拉巴基因组谷的生物技术公司，专注于提供可负担的疫苗和生物治疗药物以对抗传染病。BBIL拥有超过145项全球专利，超过19种疫苗和四种生物治疗药物的产品组合，在超过125个国家注册，并获得世界卫生组织（WHO）预认证。

BBIL has delivered more than 9 billion doses of vaccines worldwide, and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, Cholera, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid..

BBIL已在全球范围内提供了超过90亿剂疫苗，并研发了针对甲型H1N1流感、轮状病毒、乙型脑炎、狂犬病、基孔肯雅热、寨卡病毒、霍乱的疫苗，以及全球首款结合破伤风类毒素的伤寒疫苗。