Respiratory Today—December 5, 2025

This week’s respiratory update highlights major developments across RSV prevention, asthma and COPD innovation, gene-editing advances, and new regulatory milestones shaping future care.

In Today’s Newsletter

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🍼 Sanofi/AstraZeneca’s Beyfortus® (nirsevimab) now available in Malaysia to prevent RSV in infants [1] [Malaysia • 24 Nov 2025]

https://www.prnewswire.com/apac/news-releases/beyfortus-nirsevimab-now-available-in-malaysia-to-protect-all-infants-against-rsv-disease-302624356.html

Context: Malaysia becomes the latest country to approve Beyfortus, a preventive treatment for RSV in infants.
Key point: Beyfortus has shown an 82.7% reduction in RSV hospitalizations.
Implication: This approval may influence RSV vaccination strategies globally, especially in regions with year-round RSV circulation.

🏥 Cipla opens India’s first dedicated Lung Wellness Center [2] [India • 28 Nov 2025]

https://www.cipla.com/press-releases-statements/cipla-launches-indias-first-dedicated-lung-health-diagnostics-center

Context: Cipla introduces a comprehensive lung diagnostics center to improve access to early detection and treatment for respiratory diseases.
Key point: The center will offer over 60 diagnostic tests for various lung conditions, from asthma to interstitial lung diseases.
Implication: This initiative will expand early diagnosis capabilities and improve treatment outcomes for patients across India.

🌬 Mabwell announces Phase IIa results for 9MW1911, showing over 40% reduction in COPD exacerbations [3] [Global • 30 Nov 2025]

https://mabwell.com/en/news_info/id-199.html

Context: 9MW1911 shows significant promise in reducing COPD exacerbations in Phase IIa trials.
Key point: A reduction of over 40% in severe exacerbations was observed, demonstrating the drug’s potential to change COPD treatment paradigms.
Implication: This could be a breakthrough treatment for patients with moderate-to-severe COPD.

🧬 Regeneron and Tessera to jointly develop TSRA-196, a gene-editing therapy for AATD [4] [US • 1 Dec 2025]

https://investor.regeneron.com/news-releases/news-release-details/regeneron-and-tessera-therapeutics-jointly-develop-tsra-196

Context: TSRA-196 aims to correct the genetic mutation behind Alpha-1 Antitrypsin Deficiency (AATD), a genetic disorder affecting the lungs and liver.
Key point: TSRA-196 could be a one-time, durable solution for AATD patients.
Implication: This collaboration could transform the future of gene therapy, offering a new potential treatment for AATD.

💉 Celltrion announces FDA approval of 300mg OMLYCLO® (omalizumab-igec) [5] [US • 3 Dec 2025]

https://www.celltrion.com/en-us/company/media-center/press-release/4297

Context: Celltrion’s OMLYCLO® gains FDA approval for a new 300mg dosing option, expanding treatment flexibility.
Key point: OMLYCLO® is the first interchangeable biosimilar to XOLAIR®, offering a new option for treating moderate-to-severe asthma and allergic conditions.
Implication: This approval could significantly impact asthma treatment regimens, making therapy more convenient for patients.

🔬 Savara and PARI granted European patent for MOLBREEVI® delivered via eFlow® Nebulizer System [6] [EU • 2 Dec 2025]

https://s205.q4cdn.com/999407632/files/doc_news/Savara-and-PARI-Granted-a-European-Patent-Covering-the-Drug-Device-Combination-of-MOLBREEVI-Delivered-Via-the-Proprietary-eFlow-Nebulizer-System

Context: The European patent secures protection for MOLBREEVI, a therapy for autoimmune PAP, when delivered via the eFlow Nebulizer.
Key point: The patent extends market exclusivity until 2043.
Implication: This strengthens Savara’s position in the rare disease market, providing long-term intellectual property protection for MOLBREEVI.

💉 Jasper Therapeutics reports positive data from ETESIAN study of Briquilimab in asthma [7] [US • 2 Dec 2025]

https://ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-reports-positive-preliminary-data-etesian

Context: Briquilimab, a mast cell-targeting drug, shows potential in asthma treatment.
Key point: A single dose of 180mg led to significant reductions in sputum eosinophils and improvements in lung function.
Implication: Briquilimab could offer a new treatment approach for asthma patients, especially those with mast cell-driven inflammation.

🫁 tiakis Biotech completes data package for Tiprelestat Phase II trial in PAH [8] [Global • 2 Dec 2025]

https://www.globenewswire.com/news-release/2025/12/02/3197638/0/en/tiakis-Biotech-Successfully-Completes-Data-Package-to-Advance-Tiprelestat-into-Phase-II-clinical-trial-in-PAH.html

Context: Tiprelestat advances to Phase II trials for Pulmonary Arterial Hypertension (PAH), a rare and serious lung condition.
Key point: Tiprelestat has shown positive safety results in preclinical studies and is expected to enter Phase II trials in mid-2026.
Implication: This offers hope for PAH patients, with potential for a disease-modifying therapy.

🧪 Qilu Pharmaceutical starts Phase 1 PK similarity study of QL2302 vs Tezspire [9] [China • 25 Nov 2025]

https://finance.sina.cn/2025-11-25/detail-infyqumz4940705.d.html

Context: Qilu begins a Phase 1 study comparing QL2302, a potential biologic, to Tezspire for severe asthma maintenance.
Key point: The study aims to evaluate PK similarity between QL2302 and Tezspire, with a focus on efficacy and safety.
Implication: QL2302 could potentially become a competitor to Tezspire in the biologic asthma treatment market.

Why it matters

RSV Prevention: Beyfortus’ availability in Malaysia could significantly impact global RSV immunization strategies, especially in tropical regions where RSV circulation is prevalent [1].
Lung Health Diagnostics: Cipla’s Lung Wellness Center aims to enhance early lung disease diagnosis in India, improving outcomes for respiratory disease patients [2].
COPD Management: Mabwell’s 9MW1911 shows promise in reducing COPD exacerbations, offering a potential breakthrough treatment for COPD [3].
Gene Therapy: The Regeneron-Tessera partnership for TSRA-196 may transform the future of gene editing in genetic diseases like AATD [4].
Biosimilar Innovation: The approval of OMLYCLO® offers an alternative to XOLAIR® for asthma and allergic diseases, making biologics more accessible and affordable [5].
Rare Disease Treatments: The European patent for MOLBREEVI strengthens its market positioning in autoimmune PAP, a rare and serious lung disease [6].
Asthma Treatment: Briquilimab’s promising data from the ETESIAN study could offer a new way to manage asthma, particularly for patients with mast cell-driven inflammation [7].
PAH Treatment: Tiprelestat’s progression into Phase II trials provides new hope for Pulmonary Arterial Hypertension (PAH) patients [8].
Severe Asthma Competition: Qilu’s study of QL2302 against Tezspire signals growing competition in the biologic asthma market, potentially offering new treatment options [9].

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FAQ

What did Cipla’s Lung Wellness Center offer?

It provides over 60 diagnostic tests, enhancing access to early diagnosis and treatment for various lung diseases across India [2].

How effective was 9MW1911 in reducing COPD exacerbations?

It demonstrated a reduction of over 40% in severe COPD exacerbations in Phase IIa trials, offering a new potential treatment for COPD patients [3].

What is Tiprelestat’s role in PAH treatment?

Tiprelestat is progressing to Phase II trials as a disease-modifying therapy for PAH, a rare and serious condition with limited treatment options [8].

Entities / Keywords

Sanofi; AstraZeneca; Beyfortus; RSV; Cipla; lung diagnostics; Mabwell; COPD; 9MW1911; Regeneron; Tessera; TSRA-196; gene therapy; Celltrion; OMLYCLO; Savara; MOLBREEVI; eFlow Nebulizer; Jasper Therapeutics; Briquilimab; PAH; tiakis Biotech; Tiprelestat; Qilu Pharmaceutical; QL2302; Tezspire; severe asthma.