Summary

GSK plc (LSE/NYSE: GSK) has received approval from China’s National Medical Products Administration for Exdensur (depemokimab) as an add-on therapy for adults with chronic rhinosinusitis with nasal polyps (CRSwNP). The approval makes Exdensur the first and only ultra-long-acting biologic available for CRSwNP in China.

Introduction

GSK plc, one of the UK’s largest FTSE 100 pharmaceutical companies, announced on 8 April 2026 that China’s National Medical Products Administration (NMPA) has approved Exdensur (depemokimab) as an add-on therapy with intranasal corticosteroids for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) for whom systemic corticosteroids and/or surgery do not provide adequate disease control. The approval was confirmed via a Regulatory News Service announcement released at 07:00 BST London time.

The decision is a material milestone for GSK’s respiratory franchise and for the growing class of ultra-long-acting biologics targeting type 2 inflammation. It follows a string of global approvals for depemokimab in severe asthma and CRSwNP across the United States, Japan, the European Union, the United Kingdom, and now China — positioning GSK as a leader in the twice-yearly biologic segment for respiratory and associated inflammatory diseases.

This article explains the clinical data supporting the approval, the commercial context for Exdensur in the Chinese market, what the news means for patients and physicians, and the key takeaways for FTSE 100 investors modelling GSK’s pipeline returns and long-term respiratory growth trajectory.

Detailed Explanation of the Announcement

What the NMPA Has Approved

The NMPA has cleared Exdensur, the brand name for depemokimab, as an add-on therapy used in combination with intranasal corticosteroids to treat adult patients in China with CRSwNP when systemic corticosteroids and/or surgery have failed to adequately control the disease. The approval establishes Exdensur as the first and only ultra-long-acting biologic available in China for this indication, according to GSK.

The authorisation builds on a recent NMPA clearance of Exdensur as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult and paediatric patients aged 12 and older. Together, the two approvals give GSK a significant foothold in the Chinese market for type 2 inflammatory respiratory conditions, supported by a distinctive twice-yearly dosing schedule.

The ANCHOR Phase III Clinical Programme

The CRSwNP approval is underpinned by data from two pivotal phase III trials, ANCHOR-1 and ANCHOR-2. Full results from these studies were presented at the 2025 American Academy of Allergy, Asthma and Immunology and World Allergy Organization Joint Congress, and published in The Lancet. Across the two trials, 528 patients with inadequately controlled CRSwNP were enrolled, all of whom had bilateral nasal polyps with an endoscopic bilateral nasal polyp score (NPS) of at least 5, and had either undergone previous surgery, received previous systemic corticosteroid treatment or were intolerant to systemic corticosteroids.

Patients were randomised to receive depemokimab or placebo at six-monthly intervals (every 26 weeks) in addition to standard of care, which consisted of maintenance intranasal corticosteroids. The trials assessed two primary endpoints: change from baseline in nasal polyp score at 52 weeks (scale 0–8) and nasal obstruction verbal response scale (scale 0–3) over weeks 49–52.

ANCHOR-1 included 143 patients in the depemokimab plus standard-of-care arm and 128 in the placebo plus standard-of-care arm. ANCHOR-2 included 129 patients in the depemokimab arm and 128 in the placebo arm. Results showed a clinically meaningful and statistically significant reduction in nasal polyp score (ANCHOR-1 treatment difference –0.7 with 95% confidence interval –1.1 to –0.3, p<0.001; ANCHOR-2 treatment difference –0.6 with 95% confidence interval –1.0 to –0.2, p=0.004). The nasal obstruction verbal response scale also improved (ANCHOR-1 –0.23, p=0.047; ANCHOR-2 –0.25, p=0.025). Safety data showed depemokimab was well-tolerated, with rates and severity of side effects similar to placebo plus standard of care.

Management Commentary

Kaivan Khavandi, GSK’s Senior Vice President and R&D Head of Respiratory, Immunology & Inflammation, said in the announcement: “Given the continued unmet need amongst patients with CRSwNP, today’s approval of Exdensur could redefine care by protecting from the debilitating symptoms of this disease in just two doses a year. This builds on Exdensur’s recent approval in severe asthma, which means more patients in China could have access to this first and only ultra-long-acting biologic.”

Key Financial and Operational Details

Filing Fundamentals at a Glance

  • Issuer: GSK plc
  • Listings: London Stock Exchange and New York Stock Exchange (LSE/NYSE: GSK)
  • FTSE Index: FTSE 100 constituent
  • Announcement type: RNS Miscellaneous
  • RNS number: 5394Z
  • Release time: 07:00:09 BST on 8 April 2026
  • Regulator: China’s National Medical Products Administration (NMPA)
  • Product: Exdensur (depemokimab)
  • Indication: CRSwNP add-on therapy with intranasal corticosteroids for adult patients not adequately controlled by systemic corticosteroids and/or surgery
  • Positioning: First and only ultra-long-acting biologic in China for CRSwNP

Dosing and Mechanism

  • Twice-yearly dosing (every 26 weeks) enabled by an extended half-life
  • High interleukin-5 (IL-5) binding affinity
  • Targets type 2 inflammation, a driver in severe asthma and CRSwNP

Existing Global Approvals for Exdensur

  • United States: severe asthma
  • China: severe asthma and (as of 8 April 2026) CRSwNP
  • Japan: severe asthma and CRSwNP
  • European Union: severe asthma with type 2 inflammation and CRSwNP
  • United Kingdom: severe asthma with type 2 inflammation and CRSwNP

Why This Announcement Matters

CRSwNP is a debilitating chronic disease characterised by inflammation of the nasal lining that can lead to soft tissue growths known as nasal polyps. Patients experience nasal obstruction, loss of smell, facial pain, sleep disturbance, recurrent infections and nasal discharge. These symptoms have a meaningful impact on physical functioning, emotional well-being and productivity. Up to 85% of CRSwNP cases are driven by chronic type 2 inflammation, the same immunological pathway that drives many cases of severe asthma, and almost half of all CRSwNP patients remain uncontrolled even with standard care.

An ultra-long-acting biologic that can be administered only twice a year represents a potential shift in the standard of care. It reduces the treatment burden associated with monthly or more frequent injections of other biologics, may improve adherence, and addresses an unmet need for patients for whom steroids and surgery have failed. For a market as large as China, where the patient population with type 2 inflammatory respiratory disease is significant, this approval opens access to a medicine with distinctive properties.

From a commercial perspective, Exdensur is central to GSK’s strategy of building a leading respiratory franchise anchored by vaccines, targeted biologics and inhaled medicines. The additional CRSwNP label in China broadens the commercial opportunity beyond severe asthma and creates a platform for cross-indication promotion and physician familiarity.

Business and Market Context

The Chinese Pharmaceutical Market

China is one of the most consequential markets for new biologic launches. NMPA approvals open access to a large and growing patient population, and recent reforms have accelerated review timelines for drugs already approved in other major jurisdictions. A biologic with strong phase III evidence and a differentiated dosing profile has a clear pathway to uptake, subject to reimbursement, pricing negotiations, and hospital formulary decisions.

Multinational pharmaceutical companies compete in China against both other large international players and a rapidly growing domestic biotech sector. Differentiation matters. Exdensur’s ultra-long-acting profile is a tangible point of difference that can influence physician preference, particularly in CRSwNP where existing biologics typically require more frequent dosing.

Competitive Landscape in CRSwNP

The CRSwNP biologic class already includes other monoclonal antibodies targeting type 2 inflammation. Exdensur’s clinical value proposition rests on its combination of clinical efficacy, safety profile comparable to placebo plus standard of care, and twice-yearly dosing. The twice-yearly dosing schedule is a meaningful differentiator for patients who otherwise face monthly or bi-monthly injections.

Beyond CRSwNP, GSK is progressing depemokimab in additional type 2 inflammatory indications. Phase III trials are under way in eosinophilic granulomatosis with polyangiitis (OCEAN), hypereosinophilic syndrome (DESTINY) and chronic obstructive pulmonary disease with type 2 inflammation (ENDURA-1, ENDURA-2 and VIGILANT). A successful label expansion across these areas could significantly broaden depemokimab’s commercial footprint.

Implications for Investors

Revenue and Peak Sales Considerations

For equity investors, the China CRSwNP approval is an incremental positive that expands depemokimab’s addressable patient pool. China is a market where pricing and reimbursement dynamics can temper per-patient revenue, but the scale of demand has the potential to compensate. Analysts updating peak sales models for depemokimab will want to stress-test assumptions about penetration, duration of therapy, pricing, and competitive response.

Franchise Strategy

GSK has positioned respiratory as a core long-term growth engine. A platform of biologics, inhaled medicines and vaccines targeting asthma, COPD and related inflammatory diseases offers both cross-selling opportunities and scientific synergies. The China CRSwNP approval builds on depemokimab’s recent severe asthma clearance in the same market, reinforcing the franchise narrative and giving commercial teams a reason to engage physicians more comprehensively on type 2 inflammation.

Catalyst Watchlist

Investors should track upcoming readouts from the OCEAN, DESTINY, ENDURA-1, ENDURA-2 and VIGILANT phase III programmes. Positive data in any of these indications could materially expand depemokimab’s commercial potential and support further approvals globally. Equally, real-world prescribing data and uptake trends in markets where the drug has already launched will shed light on execution by GSK’s commercial organisation.

Risks, Caveats, and Uncertainty Factors

Market access in China depends on successful reimbursement negotiations and formulary placement. Even with NMPA approval, national or regional reimbursement bodies may seek price concessions that compress the per-patient revenue opportunity. Investors should watch for updates on any inclusion in the National Reimbursement Drug List or related programmes.

Competitive pressure is significant. Existing and emerging biologics targeting type 2 inflammation could erode differentiation over time. Additionally, biosimilar competition for older biologics may reset overall price expectations in the class, affecting how premium-priced newer therapies are valued by payers.

Clinical programmes in adjacent indications such as EGPA, hypereosinophilic syndrome and COPD carry standard phase III risk. Trial failures or delays would limit depemokimab’s long-term addressable market.

GSK also reminds investors that forward-looking statements are subject to the risk factors described in its Annual Report on Form 20-F for 2025. Readers should consult that filing for a comprehensive discussion of risks to GSK’s business.

Short-Term and Long-Term Outlook

Short-Term Outlook

In the short term, investor focus will be on NMPA reimbursement pathways for Exdensur in CRSwNP and severe asthma, as well as on the commercial ramp in China following the twin approvals. Physician education will be important as GSK positions depemokimab’s twice-yearly dosing as a differentiator against incumbent biologic therapies requiring more frequent administration. Equity analysts are likely to update consensus forecasts to reflect the broader label in China.

Long-Term Outlook

Over the long term, Exdensur has the potential to become a multi-indication franchise across type 2 inflammatory respiratory and allergic diseases. Success in the ongoing OCEAN, DESTINY, ENDURA-1, ENDURA-2 and VIGILANT trials could extend depemokimab into areas such as EGPA, hypereosinophilic syndrome and COPD with type 2 inflammation. Combined with GSK’s broader respiratory portfolio, this positions the company to remain a central player in the respiratory biologics market for years to come.

For GSK shareholders, the key long-term thesis is the compounding value of a respiratory portfolio that combines vaccines, inhaled medicines and targeted biologics. The China CRSwNP approval adds another building block to that thesis and enhances the strategic credibility of the company’s R&D engine in inflammation science.

Further Context and Analysis

Disease Burden and Unmet Need in CRSwNP

CRSwNP is a chronic and often debilitating inflammatory condition. Symptoms such as nasal obstruction, loss of smell, facial pain and sleep disturbance can significantly affect quality of life, productivity and mental health. Standard treatment pathways typically include intranasal corticosteroids, systemic corticosteroids and, in more severe cases, sinus surgery. Even with these interventions, many patients experience recurring polyps and incomplete symptom control, creating a clear medical need for targeted biologic therapies.

Depemokimab addresses this gap by suppressing interleukin-5-driven type 2 inflammation, one of the key biological drivers of polyp growth and persistence. Its twice-yearly dosing profile is designed to make chronic biologic therapy less burdensome for patients and more straightforward for health systems to administer, potentially improving real-world adherence and outcomes.

Commercial Execution and Access Considerations

For Exdensur to realise its potential in China, GSK will need to execute on multiple commercial fronts: securing favourable reimbursement under the country’s tiered medical insurance schemes, building physician awareness across ear, nose and throat (ENT), allergy and respiratory specialities, and ensuring reliable distribution to hospitals and specialist clinics. The recent severe asthma approval in China provides a commercial runway that may help speed adoption in CRSwNP.

GSK’s decades of experience in respiratory disease, including inhaled therapies, biologics and vaccines, gives it an established platform from which to launch depemokimab in both indications. The ability to cross-train sales forces, repurpose medical affairs content and coordinate with local healthcare systems could be important advantages in a competitive market.

Conclusion

The NMPA approval of Exdensur (depemokimab) for CRSwNP in China is a meaningful milestone for GSK, reinforcing the commercial trajectory of the first and only ultra-long-acting biologic in this indication. Backed by robust phase III data from the ANCHOR-1 and ANCHOR-2 trials, the approval offers Chinese patients a new option for a debilitating disease with persistent unmet need.

For FTSE 100 investors, the news strengthens GSK’s respiratory franchise narrative, adds incremental value to depemokimab’s peak sales profile and underscores the company’s continued execution in inflammatory disease. Combined with the pipeline of pivotal trials across adjacent indications, this approval highlights why GSK remains one of the most closely watched pharmaceutical names on the London Stock Exchange.

Key Takeaways for Investors

  • China’s NMPA has approved GSK’s Exdensur (depemokimab) as an add-on therapy for adults with CRSwNP.
  • Exdensur is positioned as the first and only ultra-long-acting biologic in China for CRSwNP.
  • Approval is based on the ANCHOR-1 and ANCHOR-2 phase III trials involving 528 patients.
  • Depemokimab targets interleukin-5 and is dosed twice yearly (every 26 weeks).
  • Exdensur is now approved for CRSwNP in Japan, the EU, the UK and China, and for severe asthma in the US, China, Japan, the EU and the UK.
  • Phase III programmes are ongoing in EGPA, hypereosinophilic syndrome and COPD with type 2 inflammation.
  • The announcement supports GSK’s strategy of building a leading respiratory biologics franchise.

Disclaimer

This content is for informational purposes only and does not constitute financial advice, investment advice, or a recommendation to buy or sell any security.