🇺🇸 SECGSK plcQwen · 实盘不做把握 8/10不做原因:无增量信息
北京时间·🕒 发布 18:09:04待核·⟳ 抓取 18:09:30·⚡ 决策 09-10 22:16:57 +4h07m·46.9 天前
GSK 的 Shingrix（重组带状疱疹疫苗）预灌封注射器剂型获日本厚生劳动省批准，属已在美国/欧洲推进中的包装剂型全球推广步骤，无适应症与剂量变化
事件是已获批产品（日本自 2018 年）的包装剂型便利性批准，文件自述无适应症变更、无剂量变更、无任何金额或指引，且 PFS 的全球推广序列（CHMP→欧委会→美国上市→欧洲推广）早已公开，日本只是后续一站，故不构成新增可定价事实；对约 968 亿美元市值的 GSK 而言，即便假设日本接种便利性小幅提升销量，量级也远低于集团收入的千分之一，属典型超大市值软催化。二阶映射（Agenus QS-21 royalty、预灌封包材供应商、A股品类联想）逐一排查后或无经济权益增量、或无法用公告/研报级证据坐实，按纪律不给 probe。因此不做多、也无做空催化（不存在任何公司级净负面新事实），risk_signals 为空。
📄 原文GSK plc↗ 原文
----- a1355u.htm ----- 6-K 1 a1355u.htm JAPAN APPROVAL OF SHINGRIX IN A PREFILLED SYRINGE a1355u UNITED STATES SECURITI…
不做 GSK plc（ADR）（GSK.US）
剂型/包装便利性批准，原文明确无适应症与剂量变化、无金额与指引；PFS 全球推广自 2025-10（CHMP）、2026-01（欧委会）、2026-02（美国上市）已逐站公开，日本一站无增量事实、无预期差。对约 968 亿美元市值而言 materiality 近零（事件日 GSK.US 报 48.32 美元、跌 0.64%、量比 0.82，无任何反应），属超大市值软催化，做多无 edge；文件为正面批准、无公司级净负面新事实，也不满足做空红线，故不做。
不做 Agenus Inc.（AGEN.US）
仅通过子公司 Antigenics LLC 的 QS-21 Stimulon 佐剂许可与 Shingrix 挂钩，royalty 随销量而非剂型变动；日本 PFS 不新增剂量、不扩大适应症人群，无 royalty 增量，且 FactSet 在 2026-01-07 欧委会 PFS 批准时已同样标注 AGEN，市场未将其视为催化，无正期望。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
结论摘要
事实层：GSK 6-K（SEC EDGAR，2026-09-10 发布，伦敦签发）宣布日本 MHLW 批准 Shingrix 预灌封注射器剂型；原文三处限定其性质——仅给药便利性、不改适应症、不改剂量，且 PFS 已于 2026 年 2 月在美国上市、年内登陆欧洲。影响链：剂型切换发生在同一已获批人群内，不新增患者池、不新增定价，理论增量只能来自接种便利性带来的极小幅渗透率提升，作用于日本区（GSK 未单独披露日本 Shingrix 销售）。价格/证据层：内部 KB 显示同一 PFS 推广早在 2025-10-21（CHMP 阳性意见）、2026-01-07（欧委会批准）即已公开，FactSet 当时已把 AGEN.US 与 GSK.GB 一并标注，说明这是既定 rollout 的例行一站而非新信息；GSK.US 盘中 48.32 美元、跌 0.64%、量比 0.82（无放量），近 13 周指数化轨迹 100→93 持续走弱，市场对该消息无任何反应，也印证 materiality 近零。结论：无可交易增量事实、无正 edge、无做空催化，主标的与全部二阶候选均 AVOID。
🔎 新鲜度:最早出现 2026-09-10 · 扩散 low · price-in 风险 high ↗
关键理由
- 本次为剂型/包装便利性批准，原文明确无适应症与剂量变化、无任何金额或指引披露，对 GSK 约 968 亿美元市值无可见收入或利润增量
- PFS 全球推广序列（CHMP 2025-10-21、欧委会 2026-01-07、美国 2026-02 上市）此前已公开，日本批准只是既定路线图的后续一站，缺乏预期差
- 二阶映射均不成立：Agenus 的 QS-21 royalty 随销量而非剂型变动、预灌封包材供应关系无法坐实、中国同业不受日本单一市场剂型事件影响
主要风险
- 若日本后续同步出台公费接种推荐扩大或 PFS 提价（本文件未涉及），量级判断需要重估；但在当前披露下这只影响长期渗透率假设，不构成 1–10 个交易日的可交易催化
- GSK.US 近 13 周持续走弱（指数化 100→93、距 52 周高 -19.1%），说明当前股价由管线/业绩预期主导，剂型类消息既不能扭转趋势也不值得据此建仓
反向证据
- 做多前查反向 · 来源 filing · 日期 2026-09-10 · 影响 invalidates
一手 6-K 原文明确「does not involve a change in indication or dosing」，全文无金额、无销售指引、无日本区收入披露，且 Shingrix 自 2018 年即已在日本获批——LONG 所需的「新增患者池/新增定价/新增收入」三要素全部缺失
检索:Shingrix 预灌封注射器 日本 获批 是否改变适应症/剂量/定价 销售增量 原文 ↗ - 做多前查反向 · 来源 kb_search · 日期 2026-01-07 · 影响 invalidates
KB 命中 CHMP 阳性意见（2025-10-21）与欧委会批准（2026-01-07）两条更早节点，加上 6-K 自述美国 2026 年 2 月已上市，证明该 rollout 序列已被完整披露，日本一站无预期差；事件日 GSK.US 量比 0.82、跌 0.64%，无放量反应
检索:PFS 剂型全球推广是否早已公开、是否已被市场消化 - 做多前查反向 · 来源 supply_chain_lookup · 影响 none
supply_chain_lookup 对 GSK.US 返回 not_found（本地 FactSet 关系表未覆盖该标的，Wind 需实体解析未命中）；get_stock_profile「带状疱疹疫苗」概念查询因 MySQL 连接超时报错，未取到成分股——两条候选发现路径均未提供可坐实的亚洲二阶标的，无法以公告/研报级证据建立任何映射腿
检索:GSK 亚洲供应链/二阶受益标的（预灌封包材、佐剂 royalty、日本疫苗同业） - 做空前查反向 · 来源 filing · 日期 2026-09-10 · 影响 none
本文件为正面监管批准，无安全性、召回、竞争流失或业绩下修内容；GSK.US 近期走弱（近 5 日 -4.01%、近 13 周 100→93）由既有管线/业绩预期主导，与本事件无因果关系，不构成做空催化，故不开空、risk_signals 为空
检索:GSK Shingrix 日本 召回 安全事件 竞争替代 业绩下修 利空 原文 ↗
先例如何影响了这次决策
对本次决策的影响:未改变标的与方向选择：先例（KB 里程碑记录）仅强化了「既定 rollout、无增量事实」的判断，直接支持主标的与全部二阶候选 AVOID，而非调整买点或止盈止损
方向:无可交易级先例统计；但内部 KB 已给出同一 PFS 推广序列的两个更早节点（CHMP 阳性意见 2025-10-21、欧委会批准 2026-01-07），FactSet 在欧委会节点同时标注 AGEN.US 与 GSK.GB 却未形成任何后续催化记录，指向「剂型/包装批准」这一机制在 GSK 上历史上不产生可交易价格反应
涨幅量级:无高相似、锚干净的对齐先例可用于校准 tp/sl；本轮不进入交易，故不需要幅度校准
形态:未见见光死或高开低走的证据（事件日 GSK.US 平开后小幅下行、量比 0.82），更符合「无反应」而非「派发」
工具执行结果 · 成功 7 · 降级 0 · 失败 0 · 取消 0
- search_processed_events 成功 stock_tools HTTP · 299 ms
{"result": "search_processed_events:agent query=`gsk shingrix 预灌封注射器 日本批准 | gsk 重组带状疱疹疫苗 rzv 日本 | shingrix prefilled syringe japan mhlw approval | 带状疱疹疫苗 获批 日本厚生劳动省`；结构化索引覆盖完整 72 小时；旧记录兼容扫描近 48.5/72 小时、1576 条本臂决策(完整)，返回 0 条候选。未命中只表示这些 agent query 表达式没有召回候选，不能据此证明消息首发或不是重复；按当前事件继续正常研判。"} - fetch_decision_experience 成功 stock_tools HTTP · 11 ms
{ - kb_search 成功 stock_tools HTTP · 2,255 ms
{ - supply_chain_lookup 成功 stock_tools HTTP · 24 ms
本地 FactSet Supply Chain 未覆盖该标的 - search_case_library 成功 stock_tools HTTP · 26 ms
{"result": "search_case_library「GSK.US」—— 与这些标的相关的自家决策案例(本页 10 条,该标的全历史相关记录共 103 条；ENTER 只按该标的自己的腿统计):\n◆ GSK.US：相关历史决策 103 条 · 其中该标的 ENTER 2 条(1.9%) · 已结算 2 笔 · 胜率 50% · 中位 -0.04% · 均值 -0.04% ⚠️只有 2 笔,样本太薄,只能当线索不能当规律\n↑ 胜率/收益口径:ENTER 当日之后 T+1 开盘入场、次日开盘出场,做空腿已按方向取反(所以正数=这个方向做对了)。统计的只有★那只票自己的腿。\n【对所查 - stock_quote 成功 stock_tools HTTP · 1,128 ms
{ - get_stock_profile 成功 stock_tools HTTP · 5,106 ms
{"result": "查询「带状疱疹疫苗」成分股失败: (2003, \"Can't connect to MySQL server on '192.168.31.176' (timed out)\")"}
原文全文
展开原文 · 7,406 字
----- a1355u.htm -----
6-K
1
a1355u.htm
JAPAN APPROVAL OF SHINGRIX IN A PREFILLED SYRINGE
a1355u
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of September 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 10 September 2026, London UK
GSK’s
Shingrix
(Recombinant Zoster Vaccine) prefilled
syringe presentation approved in Japan
●
Over
one million people develop shingles in Japan each
year
[1]
,
[2]
●
New
presentation offers convenient administration of GSK's shingles
vaccine
GSK plc (LSE/NYSE: GSK) today announced Japan’s Ministry of
Health, Labour and Welfare (MHLW) has approved a prefilled syringe
presentation of
Shingrix
(GSK’s
Recombinant Zoster Vaccine or RZV)
for
the prevention of shingles (herpes zoster).
The vaccine previously came as two vials – a dry
(lyophilised) antigen and a liquid adjuvant – which had to be
combined manually before use. The new prefilled syringe is
ready-to-use, making administration simpler and more convenient for
healthcare professionals.
Shingrix
(Recombinant
Zoster Vaccine or RZV) is a non-live, recombinant sub-unit
vaccine approved by the Japanese MHLW for the prevention of herpes
zoster (HZ) in adults aged 50 years and older since 2018, and in
adults aged 18 years and older at increased risk of HZ since 2023.
Approximately 1.1 million people in Japan develop shingles each
year,
1
,
2
with
risk increasing with age and among people with weakened immune
systems.
1,2
Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases
Research and Development, said:
“Shingles is a disease that 1 in 3
adults globally will develop in their lifetime. It can have serious
and long-lasting complications. GSK is pleased to support the
healthcare community in Japan by making administration of our
shingles vaccine easier.”
GSK’s prefilled syringe launched in the US in February 2026
and is launching in Europe throughout this year. Approvals are
based on data confirming technical comparability between the
prefilled syringe and the existing vaccine presentation. The new
presentation does not involve a change in indication or
dosing.
About shingles
Shingles is caused by the reactivation of the
varicella-zoster virus (VZV), the same virus that causes
chickenpox.
[3]
Over
90% of adults have the VZV dormant in their nervous system, waiting
to reactivate.
3
,
[4]
,
[5]
,
[6]
In
addition to advancing age, chronic conditions like cardiovascular
disease, chronic kidney disease, chronic obstructive pulmonary
disease, asthma, and diabetes are all linked to higher risk of
shingles.
3
,
[7]
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen or face.
5
Following
the rash, up to 30% of people experience post-herpetic neuralgia
(PHN),
[8]
a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several years.
3
About
Shingrix
(Recombinant Zoster Vaccine or
RZV)
Shingrix
(Recombinant
Zoster Vaccine or RZV) combines an antigen, glycoprotein E,
with an adjuvant system, AS01
B
,
and may help overcome the natural age-related decline in responses
to immunisation that contributes to the challenge of protecting
adults aged 50 and over from shingles.
[9]
,
[10]
RZV
is not indicated to prevent primary varicella infection
(chickenpox). The use of RZV should be in accordance with official
recommendations and local product label.
For product and important safety information, please consult the
country relevant summary of product characteristics.
About 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
www.gsk.com
.
GSK enquiries
Media:
Tim
Foley
+44 (0)
20 8047 5502
(London)
Simon
Moore
+44 (0)
20 8047 5502
(London)
Kathleen
Quinn
+1 202
603 5003
(Washington
DC)
Alison
Hunt
+1 540
742 3391
(Washington
DC)
Investor
Relations:
Constantin
Fest
+44 (0)
7831 826525
(London)
Joanna
Tuplin
+44 (0)
7788 351650
(London)
James
Dodwell
+44 (0)
7881 269066
(London)
Mick
Readey
+44 (0)
7990 339653
(London)
Sam
Piper
+44 (0)
7824 525779
(London)
Dan
Smith
+44 (0)
7823 523885
(London)
Jeff
McLaughlin
+1 215
751 7002
(Philadelphia)
Frannie
DeFranco
+1 215
751 3126
(Philadelphia)
Cautionary statement regarding forward-looking
statements
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 in the “Risk
Factors” section in GSK’s Annual Report on Form 20-F
for 2025, and GSK’s Q2 Results for 2026.
Registered in England & Wales:
No. 3888792
Registered Office:
79
New Oxford Street
London
WC1A
1DG
References
1
Adachi-Katayama, M.,
Kanda, N., Sasakura, S., Hatakeyama, S. Epidemiology of herpes
zoster and postherpetic neuralgia in Japan: analysis of a
large-scale claims database. BMC Infect Dis. 2026 Jan 10;26(1):287.
doi: 10.1186/s12879-026-12534-0. [Last accessed: July
2026]
2
Statistics Bureau of Japan.
(2024).
Population
estimates as of October 1, 2023
. [Available
from:
https://www.stat.go.jp/data/jinsui/2023np/index.html
Last
Accessed: July 2026]
[3]
Harpaz, R., et al.
Prevention of herpes zoster: recommendations of the Advisory
Committee on Immunization Practices
(ACIP).
MMWR
Recomm Rep
2008;57(Rr-5):1-30.
[4]
Johnson, R.W., et al.
Herpes zoster epidemiology, management, and disease and economic
burden in Europe: a multidisciplinary
perspective.
Therapeutic advances in
vaccines
.
2015;3(4):109-20.
[5]
Mueller, N.H., et al.
Varicella zoster virus infection: clinical features, molecular
pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[6]
Bricout, H., et al.
Herpes zoster-associated mortality in Europe: a systematic
review.
BMC public
health
.
2015;15:466.
[7]
Steinmann et al. Risk
factors for herpes zoster infections: a systematic review and
meta-analysis unveiling common trends and heterogeneity patterns.
Infection. 2024;52(3):1009-1026. doi: 10.1007/s15010-023-02156-y.
REF-224255.
[8]
Kawai, K., et al.
Systematic review of incidence and complications of herpes zoster:
towards a global perspective. BMJ open.
2014;4(6).
[9]
Cunningham, A.L., et
al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70
Years of Age or Older.
New England Journal of
Medicine
.
2016;375(11):1019-32.
[10]
The GSK proprietary
AS01 adjuvant system contains QS-21 Stimulon® adjuvant
licensed from Antigenics LLC, a wholly owned subsidiary of Agenus
Inc. (NASDAQ: AGEN), MPL and liposomes.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
GSK plc
(Registrant)
Date: September
10, 2026
By:/s/ VICTORIA
WHYTE
--------------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GSK plc
6-K
1
a1355u.htm
JAPAN APPROVAL OF SHINGRIX IN A PREFILLED SYRINGE
a1355u
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of September 2026
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued: 10 September 2026, London UK
GSK’s
Shingrix
(Recombinant Zoster Vaccine) prefilled
syringe presentation approved in Japan
●
Over
one million people develop shingles in Japan each
year
[1]
,
[2]
●
New
presentation offers convenient administration of GSK's shingles
vaccine
GSK plc (LSE/NYSE: GSK) today announced Japan’s Ministry of
Health, Labour and Welfare (MHLW) has approved a prefilled syringe
presentation of
Shingrix
(GSK’s
Recombinant Zoster Vaccine or RZV)
for
the prevention of shingles (herpes zoster).
The vaccine previously came as two vials – a dry
(lyophilised) antigen and a liquid adjuvant – which had to be
combined manually before use. The new prefilled syringe is
ready-to-use, making administration simpler and more convenient for
healthcare professionals.
Shingrix
(Recombinant
Zoster Vaccine or RZV) is a non-live, recombinant sub-unit
vaccine approved by the Japanese MHLW for the prevention of herpes
zoster (HZ) in adults aged 50 years and older since 2018, and in
adults aged 18 years and older at increased risk of HZ since 2023.
Approximately 1.1 million people in Japan develop shingles each
year,
1
,
2
with
risk increasing with age and among people with weakened immune
systems.
1,2
Sanjay Gurunathan, GSK Head of Vaccines and Infectious Diseases
Research and Development, said:
“Shingles is a disease that 1 in 3
adults globally will develop in their lifetime. It can have serious
and long-lasting complications. GSK is pleased to support the
healthcare community in Japan by making administration of our
shingles vaccine easier.”
GSK’s prefilled syringe launched in the US in February 2026
and is launching in Europe throughout this year. Approvals are
based on data confirming technical comparability between the
prefilled syringe and the existing vaccine presentation. The new
presentation does not involve a change in indication or
dosing.
About shingles
Shingles is caused by the reactivation of the
varicella-zoster virus (VZV), the same virus that causes
chickenpox.
[3]
Over
90% of adults have the VZV dormant in their nervous system, waiting
to reactivate.
3
,
[4]
,
[5]
,
[6]
In
addition to advancing age, chronic conditions like cardiovascular
disease, chronic kidney disease, chronic obstructive pulmonary
disease, asthma, and diabetes are all linked to higher risk of
shingles.
3
,
[7]
Shingles typically presents as a rash, with painful blisters across
the chest, abdomen or face.
5
Following
the rash, up to 30% of people experience post-herpetic neuralgia
(PHN),
[8]
a
long-lasting nerve pain that can last weeks or months and can
occasionally persist for several years.
3
About
Shingrix
(Recombinant Zoster Vaccine or
RZV)
Shingrix
(Recombinant
Zoster Vaccine or RZV) combines an antigen, glycoprotein E,
with an adjuvant system, AS01
B
,
and may help overcome the natural age-related decline in responses
to immunisation that contributes to the challenge of protecting
adults aged 50 and over from shingles.
[9]
,
[10]
RZV
is not indicated to prevent primary varicella infection
(chickenpox). The use of RZV should be in accordance with official
recommendations and local product label.
For product and important safety information, please consult the
country relevant summary of product characteristics.
About 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
www.gsk.com
.
GSK enquiries
Media:
Tim
Foley
+44 (0)
20 8047 5502
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Cautionary statement regarding forward-looking
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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 in the “Risk
Factors” section in GSK’s Annual Report on Form 20-F
for 2025, and GSK’s Q2 Results for 2026.
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References
1
Adachi-Katayama, M.,
Kanda, N., Sasakura, S., Hatakeyama, S. Epidemiology of herpes
zoster and postherpetic neuralgia in Japan: analysis of a
large-scale claims database. BMC Infect Dis. 2026 Jan 10;26(1):287.
doi: 10.1186/s12879-026-12534-0. [Last accessed: July
2026]
2
Statistics Bureau of Japan.
(2024).
Population
estimates as of October 1, 2023
. [Available
from:
https://www.stat.go.jp/data/jinsui/2023np/index.html
Last
Accessed: July 2026]
[3]
Harpaz, R., et al.
Prevention of herpes zoster: recommendations of the Advisory
Committee on Immunization Practices
(ACIP).
MMWR
Recomm Rep
2008;57(Rr-5):1-30.
[4]
Johnson, R.W., et al.
Herpes zoster epidemiology, management, and disease and economic
burden in Europe: a multidisciplinary
perspective.
Therapeutic advances in
vaccines
.
2015;3(4):109-20.
[5]
Mueller, N.H., et al.
Varicella zoster virus infection: clinical features, molecular
pathogenesis of disease, and latency. Neurologic clinics.
2008;26(3):675-97.
[6]
Bricout, H., et al.
Herpes zoster-associated mortality in Europe: a systematic
review.
BMC public
health
.
2015;15:466.
[7]
Steinmann et al. Risk
factors for herpes zoster infections: a systematic review and
meta-analysis unveiling common trends and heterogeneity patterns.
Infection. 2024;52(3):1009-1026. doi: 10.1007/s15010-023-02156-y.
REF-224255.
[8]
Kawai, K., et al.
Systematic review of incidence and complications of herpes zoster:
towards a global perspective. BMJ open.
2014;4(6).
[9]
Cunningham, A.L., et
al. Efficacy of the Herpes Zoster Subunit Vaccine in Adults 70
Years of Age or Older.
New England Journal of
Medicine
.
2016;375(11):1019-32.
[10]
The GSK proprietary
AS01 adjuvant system contains QS-21 Stimulon® adjuvant
licensed from Antigenics LLC, a wholly owned subsidiary of Agenus
Inc. (NASDAQ: AGEN), MPL and liposomes.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
GSK plc
(Registrant)
Date: September
10, 2026
By:/s/ VICTORIA
WHYTE
--------------------------
Victoria Whyte
Authorised
Signatory for and on
behalf
of GSK plc
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