Chiesi Advances Its Carbon Minimal Inhaler Journey as European Submissions for Its Single Inhaler Triple Therapy (SITT) and ICS/LABA Combination Next-Generation Propellant pMDIs Are Validated

Key Highlights Regulatory submissions for next-generation propellant pMDIs (pressurized metered-dose inhalers) across Chiesi’s Single Inhaler Triple Therapy (SITT; or ICS/LABA/LAMA) and fixed double ICS/LABA combination (inhaled corticosteroid with a long-acting bronchodilator) range have been validated by Regulatory Agencies in Europe. Transition to HFA‑152a, a next‑generation propellant classified as non‑PFAS* and with low global warming potential (GWP),aimsto reduce the carbon footprint of Chiesi’s pMDIs by up to 90% compared to current ones.1-3 Designed for a seamless transition for patients and HCPs, maintaining established efficacy, safety and usability and supporting continuity of care.4-8 The validation supports Chiesi’s ambition to reach Net Zero† across its full value chain by 20359, following MHRA approval of Chiesi’s beclometasone pMDIs formulated with HFA-152a.

Chiesi Group, an international research-focused biopharmaceutical company and certified B Corp, today announces a further step in its Carbon Minimal Inhaler (CMI) journey with the validation of regulatory submissions in Europe for its SITT and ICS/LABA pMDIs.

The start of regulatory assessment in Europe marks a significant step towards Chiesi’s transition to carbon minimal pMDIs across its respiratory portfolio, combining innovation with responsibility. This supports the Company’s broader ambition to reduce the environmental impact of respiratory care, while enabling a seamless transition for patients and healthcare professionals. In July 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Chiesi’s beclometasone pMDIs formulated with HFA-152a, marking the first UK approval of this next-generation propellant in a pressurised metered-dose inhaler.

Chiesi’s pMDIs are transitioning to HFA-152a, a next-generation propellant classified as non-PFAS* and with low-GWP, designed to reduce the products’ carbon footprint by up to 90% compared with current ones^1-3, while maintaining established efficacy, safety, and usability.^4-8

“Innovation in patient care and environmental responsibility are not a trade-off. Our next-generation carbon minimal pMDIs provide the same level of care, while reducing emissions of up to 90% compared to the ones in use today and at the same level of dry powder inhalers (DPI),” said Andrea Bizzi, Executive Vice President, Region Europe TOP 5 & Interim AIR Franchise. “These submissions are another step on our progression towards a full extrafine CMI portfolio across pMDIs and DPIs.”

“The transition to carbon minimal pMDIs is not only a critical step in reducing the environmental impact of respiratory care,” said Sara Panigone, Senior Director, Global Project Leader AIR Franchise,“but also helps to guarantee the long-term availability of a full range of effective inhaled medicines, protecting patient lives, ensuring access and continuity of care.”

Chiesi’s CMI portfolio transition is focused on reducing the carbon footprint associated with pMDIs, which remains an important option in asthma and COPD care. Transitioning our pMDIs to the next‑generation propellant HFA-152a, supports the decarbonization of respiratory care while helping to safeguard access and continuity of care over the long term.^{1-8, 10-12}

^*PFAS: per- and polyfluoroalkyl substances, non-PFAS means also non-forever chemical

Notes to Editors - Regulatory procedures

• Single Inhaler Triple Therapy (SITT or ICS/LABA/LAMA, beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium bromide) pMDIs have been submitted under the EU centralized procedure to the European Medicines Agency.
• ICS/LABA (beclometasone dipropionate/formoterol fumarate dihydrate) pMDIs are being managed through a coordinated multi-country regulatory procedure with BfArM – the German Federal Institute for Drugs and Medical Devices - acting as Reference Member State.

†Net Zero Commitment

Chiesi plans to be the first pharmaceutical company to achieve Net Zero greenhouse gas emissions across its entire value chain by 2035, 15 years ahead of the European Climate Neutrality target. This commitment covers all emission scopes. Chiesi’s targets were validated by the Science Based Targets initiative (SBTi) in April 2024. The Group has consolidated its greenhouse gas inventory in line with ISO 14064 and the GHG Protocol standards, with annual audits carried out by independent third parties.

The transition to the next-generation propellant HFA-152a is one of the most impactful actions in Chiesi’s Net Zero roadmap, as inhaler propellants represent the single largest source of the Group’s greenhouse gas emissions.

About Chiesi Group

Chiesi is a research-oriented international biopharmaceutical group that develops and markets innovative therapeutic solutions in respiratory health, rare diseases, and specialty care. The company’s mission is to improve people’s quality of life and act responsibly towards both the community and the environment.

By adopting the legal form of Benefit Corporation in Italy, the US, France, and Colombia, Chiesi’s commitment to creating shared value for society as a whole is legally binding and central to company-wide decision-making. As a certified B Corp since 2019, Chiesi is part of a global community of businesses that meet high standards of social and environmental impact. The company aims to reach Net Zero greenhouse gases (GHG) emissions by 2035.

With 90 years of experience, Chiesi is headquartered in Parma (Italy), with 31 affiliates worldwide, and counts more than 7,500 employees. The Group’s research and development center in Parma works alongside 6 other important R&D hubs in France, the US, Canada, China, the UK, and Sweden.

For further information please visit www.chiesi.com

References:

1. Panigone S et al 2020, BMJ Open Respiratory Research: Environmental impact of inhalers for respiratory diseases: decreasing the carbon footprint while preserving patient-tailored treatment (https://doi.org/10.1136/bmjresp-2020-000571)
2. EU ECHA Webinar: Restriction of per- and polyfluoroalkyl substances (PFAS) under REACH
3. OECD Reconciling Terminology of the Universe of Per- and Polyfluoroalkyl Substances 2021
4. Rony F et al 2024, Pulmonary Pharmacology & Therapeutics: Evaluating the pharmacokinetics of beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide delivered via pressurized metered-dose inhaler using a low global warming potential propellant. (https://doi.org/10.1016/j.pupt.2024.102299)
5. Almeida M et al. Relative lung availability and total systemic exposure after inhalation of medium or high strength doses of beclometasone dipropionate/formoterol fumarate, formulated as pMDI with a next generation propellant. Thorax 2025 BTS Winter meeting
6. Salvadori M et al 2025, Pulmonary Pharmacology & Therapeutics: The low global warming potential propellant HFA-152a does not induce bronchoconstriction or impair mucociliary clearance (https://doi.org/10.1016/j.pupt.2025.102358)
7. Singh D et al 2026, Respiratory Medicine: Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS study (https://doi.org/10.1016/j.rmed.2026.108814)
8. Matturro A et al 2025, An Official Journal of the American Association of Pharmaceutical Scientists: Innovative drug development approach to address the transition to low global warming potential propellant using hydrofluoroalkane‑152a, for triple combination pressurized metered‑dose inhaler products targeting small airways (https://doi.org/10.1208/s12249-025-03057-z)
9. Chiesi’s Sustainability Report 2025 https://www.chiesi.com/en/sustainability/sustainability-report
10. Pernigotti D et al 2021, BMJ Open Respiratory Research: Reducing carbon footprint of inhalers: analysis of climate and clinical implications of different scenarios in five European countries (https://doi.org/10.1136/bmjresp-2021-001071)
11. Attar-Zadeh D et al 2021, Journal of Health Economics and Outcomes Research: Health-care Resource Requirements and Potential Financial Consequences of an Environmentally Driven Switch in Respiratory Inhaler Use in England (https://doi.org/10.36469/001c.26113)
12. Usmani O et al 2022, Journal of Allergy Clinical Immunology Practice. Real-World Impact of Nonclinical Inhaler Regimen Switches on Asthma or COPD: A Systematic Review. (https://doi.org/10.1016/j.jaip.2022.05.039)

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