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GSK 06:01

GSK plc

GSK enters Hengrui Pharma collaboration agreements

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GSK PLC has announced a collaboration with Hengrui Pharma to develop up to 12 innovative medicines across respiratory, immunology, inflammation, and oncology. The agreements include a license for a potential best-in-class PDE3/4 inhibitor (HRS-9821) to treat COPD and 11 additional programs that GSK can opt into after phase I completion. GSK will pay $500 million upfront, with potential future milestone payments totaling $12 billion if all programs are successful. This collaboration combines GSKs expertise and global scale with Hengrui Pharmas early discovery capabilities and high-value programs, offering significant growth opportunities for both companies.

Agreement

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GSK 06:01

GSK plc

GSK’s Shingrix Fully Liquid FDA approval

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Here is a summary of the news article

GSK plc has received approval from the US Food and Drug Administration (FDA) for a prefilled syringe presentation of their shingles vaccine, Shingrix. This new presentation simplifies the vaccination process by removing the need for healthcare professionals to reconstitute separate vials before administration. The vaccine is now available in a ready-to-use format, offering a convenient administration option.

Shingles is a painful rash affecting approximately one million people in the US each year, primarily adults over 50. GSKs Shingrix vaccine helps protect against this disease, and the new prefilled syringe presentation is expected to streamline the vaccination process, making it easier for healthcare professionals to provide protection to their patients.

The approval by the FDA is a significant regulatory milestone, and GSK is also seeking approval from the European Medicines Agency (EMA) and exploring submissions to other markets, showcasing their commitment to increasing adult immunization rates globally.

Approvals

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GSK 16:01

GSK plc

US FDA review extended for Blenrep

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The London Stock Exchange plc does not endorse or verify the content on this Website, and users are responsible for ensuring its accuracy. Any news or prospectus addressed to specific individuals or countries should not be relied upon by anyone else or outside the designated countries, and distribution and usage restrictions may apply.

FDA

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GSK 06:01

GSK plc

GSK submits Arexvy for adults 18-49 AIR to FDA

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Here is a summary of the news article

GSK has submitted an application to the US FDA to expand the use of its RSV vaccine, Arexvy, to adults aged 18-49 who are at increased risk due to certain medical conditions. The submission is supported by positive Phase IIIb data showing that the vaccine elicits an immune response and is safe for this age group. The FDAs decision is expected in the first half of 2026.

Currently, GSKs RSV vaccine is approved in the US for adults aged 60 and older and for those aged 50-59 who are at increased risk. RSV is a common and contagious virus that affects the lungs and breathing passages, impacting millions of people globally each year. The virus can lead to severe illness and even death, especially in those with risk factors such as COPD, asthma, and heart disease.

GSK is seeking to expand the indications for its RSV vaccine in other regions, including the European Economic Area and Japan, to help protect more people from this serious respiratory virus.

FDA

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GSK 06:01

GSK plc

2nd Quarter Results

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## GSK Q2 2025 Results Summary

**Strong Performance Driven by Specialty Medicines:**

GSK reported strong Q2 2025 results, driven primarily by its Specialty Medicines division, which saw double-digit sales growth across Respiratory, Immunology & Inflammation, Oncology, and HIV.

**Key Highlights**

* **Total Sales:** £8.0 billion+1% AER+6% CER

* **Specialty Medicines** £3.3 billion, +15%

* **Vaccines:** £2.1 billion+9%

* **General Medicines** £2.6 billion, -6%

* **Core Operating Profit** +12%

* **Core EPS** +15%

* **Cash Generated from Operations** £2.4 billion

**Pipeline Progress**

GSK highlighted significant progress in its pipeline, with

* **5 major new product approvals expected in 2025:** Including meningitis vaccine Penmenvy, antibiotic Blujepa, and Nucala for COPD.

* **14 key opportunities with PYS potential above £2 billion:** Expected to launch between 2025-2031.

* **Targeted business development** Strengthening the Respiratory, Immunology & Inflammation and Oncology pipelines through acquisitions and partnerships.

**Shareholder Returns**

* **Dividend** 16p declared for Q2 2025, 64p expected for full year 2025.

* **Share Buyback** £822 million spent in H1 2025 as part of a £2 billion program.

**Guidance**

GSK revised its 2025 guidance upwards, expecting

* **Turnover growth** Towards the top end of 3% to 5% range.

* **Core operating profit growth** Towards the top end of 6% to 8% range.

* **Core EPS growth** Towards the top end of 6% to 8% range.

**CEO Commentary**

Emma Walmsley, CEO, emphasized GSKs strong momentum, driven by Specialty Medicines and R&D progress. She highlighted 3 major FDA approvals in 2025, 16 assets in late-stage development, and 4 promising medicines entering Phase III by year-end.

**Overall**

GSKs Q2 2025 results demonstrate continued strong performance, driven by Specialty Medicines and pipeline progress. The company is confident in its 2025 guidance and long-term outlook, with a focus on shareholder returns and sustainable growth.

Here is a comparison of GSK's financial performance and debt year-on-year, presented as an HTML table:

Metric	Q2 2025	Q2 2024	Year-on-Year Change
Total Sales (£m)	7,986	7,884	+1% AER; +6% CER
Total Operating Profit (£m)	2,023	1,646	+23% AER; +33% CER
Total EPS (pence)	35.5	28.8	+23% AER; +35% CER
Core Operating Profit (£m)	2,631	2,513	+5% AER; +12% CER
Core EPS (pence)	46.5	43.4	+7% AER; +15% CER
Net Debt (£m)	13,735	13,960	-1.6%

Key Observations:

• Total sales increased by 1% AER and 6% CER, driven by strong performance in Specialty Medicines.
• Total operating profit and Total EPS saw significant growth, primarily due to lower CCL charges and strong operational performance.
• Core operating profit and Core EPS grew at a more moderate rate, reflecting increased investment in R&D and new asset launches.
• Net debt decreased slightly year-on-year, despite significant acquisitions and share buybacks.

This table provides a concise comparison of key financial metrics and debt levels between Q2 2025 and Q2 2024, highlighting the year-on-year changes and growth rates. The observations summarize the main trends and drivers of the financial performance.

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GSK 06:01

GSK plc

2nd Quarter Results

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## GSK Q2 2025 Results Summary

**Strong Performance Driven by Specialty Medicines:**

GSK reported strong Q2 2025 results, driven primarily by its Specialty Medicines division, which saw double-digit sales growth across Respiratory, Immunology & Inflammation, Oncology, and HIV.

**Key Highlights**

* **Total Sales:** £8.0 billion+1% AER+6% CER

* **Specialty Medicines** £3.3 billion, +15%

* **Vaccines:** £2.1 billion+9%

* **General Medicines** £2.6 billion, -6%

* **Core Operating Profit** +12%

* **Core EPS** +15%

* **Cash Generated from Operations** £2.4 billion

**Pipeline Progress**

GSK highlighted significant progress in its pipeline, with

* **5 major new product approvals expected in 2025:** Including meningitis vaccine Penmenvy, antibiotic Blujepa, and Nucala for COPD.

* **14 key opportunities with PYS potential above £2 billion:** Expected to launch between 2025-2031.

* **Targeted business development** Strengthening the Respiratory, Immunology & Inflammation and Oncology pipelines through acquisitions and partnerships.

**Shareholder Returns**

* **Dividend** 16p declared for Q2 2025, 64p expected for full year 2025.

* **Share Buyback** £822 million spent in H1 2025 as part of a £2 billion program.

**Guidance**

GSK revised its 2025 guidance upwards, expecting

* **Turnover growth** Towards the top end of 3% to 5% range.

* **Core operating profit growth** Towards the top end of 6% to 8% range.

* **Core EPS growth** Towards the top end of 6% to 8% range.

**CEO Commentary**

Emma Walmsley, CEO, emphasized GSKs strong momentum, driven by Specialty Medicines and R&D progress. She highlighted 3 major FDA approvals in 2025, 16 assets in late-stage development, and 4 promising medicines entering Phase III by year-end.

**Overall**

GSKs Q2 2025 results demonstrate continued strong performance, driven by Specialty Medicines and pipeline progress. The company is confident in its 2025 guidance and long-term outlook, with a focus on shareholder returns and sustainable growth.

Here is a comparison of GSK's financial performance and debt year-on-year, presented as an HTML table:

Metric	Q2 2025	Q2 2024	Year-on-Year Change
Total Sales (£m)	7,986	7,884	+1% AER; +6% CER
Total Operating Profit (£m)	2,023	1,646	+23% AER; +33% CER
Total EPS (pence)	35.5	28.8	+23% AER; +35% CER
Core Operating Profit (£m)	2,631	2,513	+5% AER; +12% CER
Core EPS (pence)	46.5	43.4	+7% AER; +15% CER
Net Debt (£m)	13,735	13,960	-1.6%

Key Observations:

• Total sales increased by 1% AER and 6% CER, driven by strong performance in Specialty Medicines.
• Total operating profit and Total EPS saw significant growth, primarily due to lower CCL charges and strong operational performance.
• Core operating profit and Core EPS grew at a more moderate rate, reflecting increased investment in R&D and new asset launches.
• Net debt decreased slightly year-on-year, despite significant acquisitions and share buybacks.

This table provides a concise comparison of key financial metrics and debt levels between Q2 2025 and Q2 2024, highlighting the year-on-year changes and growth rates. The observations summarize the main trends and drivers of the financial performance.

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GSK 06:01

GSK plc

GSK enters Hengrui Pharma collaboration agreements

AI Expand: Explanation + Tables

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Return to today’s catalyst cards, chart beacons and AI charts.

GSK PLC has announced a collaboration with Hengrui Pharma to develop up to 12 innovative medicines across respiratory, immunology, inflammation, and oncology. The agreements include a license for a potential best-in-class PDE3/4 inhibitor (HRS-9821) to treat COPD and 11 additional programs that GSK can opt into after phase I completion. GSK will pay $500 million upfront, with potential future milestone payments totaling $12 billion if all programs are successful. This collaboration combines GSKs expertise and global scale with Hengrui Pharmas early discovery capabilities and high-value programs, offering significant growth opportunities for both companies.

Agreement

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GSK 16:01

GSK plc

US FDA review extended for Blenrep

AI Expand: Explanation + Tables

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The London Stock Exchange plc does not endorse or verify the content on this Website, and users are responsible for ensuring its accuracy. Any news or prospectus addressed to specific individuals or countries should not be relied upon by anyone else or outside the designated countries, and distribution and usage restrictions may apply.

FDA

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GSK 06:01

GSK plc

GSK’s Shingrix Fully Liquid FDA approval

AI Expand: Explanation + Tables

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Here is a summary of the news article

GSK plc has received approval from the US Food and Drug Administration (FDA) for a prefilled syringe presentation of their shingles vaccine, Shingrix. This new presentation simplifies the vaccination process by removing the need for healthcare professionals to reconstitute separate vials before administration. The vaccine is now available in a ready-to-use format, offering a convenient administration option.

Shingles is a painful rash affecting approximately one million people in the US each year, primarily adults over 50. GSKs Shingrix vaccine helps protect against this disease, and the new prefilled syringe presentation is expected to streamline the vaccination process, making it easier for healthcare professionals to provide protection to their patients.

The approval by the FDA is a significant regulatory milestone, and GSK is also seeking approval from the European Medicines Agency (EMA) and exploring submissions to other markets, showcasing their commitment to increasing adult immunization rates globally.

Approvals

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GSK 06:01

GSK plc

GSK submits Arexvy for adults 18-49 AIR to FDA

AI Expand: Explanation + Tables

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Here is a summary of the news article

GSK has submitted an application to the US FDA to expand the use of its RSV vaccine, Arexvy, to adults aged 18-49 who are at increased risk due to certain medical conditions. The submission is supported by positive Phase IIIb data showing that the vaccine elicits an immune response and is safe for this age group. The FDAs decision is expected in the first half of 2026.

Currently, GSKs RSV vaccine is approved in the US for adults aged 60 and older and for those aged 50-59 who are at increased risk. RSV is a common and contagious virus that affects the lungs and breathing passages, impacting millions of people globally each year. The virus can lead to severe illness and even death, especially in those with risk factors such as COPD, asthma, and heart disease.

GSK is seeking to expand the indications for its RSV vaccine in other regions, including the European Economic Area and Japan, to help protect more people from this serious respiratory virus.

FDA

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