GSK plc (LSE/NYSE: GSK) – The Exdensur (depemokimab) China approval marks a historic milestone in the management of respiratory diseases. GSK recently announced that China’s National Medical Products Administration (NMPA) has granted marketing authorization for Exdensur (depemokimab) as an add-on maintenance treatment for adults with severe asthma with an eosinophilic phenotype.
This approval is particularly significant as Exdensur is the first ultra-long-acting biologic to be approved in China, requiring only two doses per year. For millions of patients struggling with the burden of daily treatments or monthly injections, this represents a major leap in treatment convenience and adherence.
The Significance of Exdensur Depemokimab China approval
Severe asthma affects a substantial portion of the population in China, often leading to frequent hospitalizations and a high reliance on oral corticosteroids (OCS). The Exdensur depemokimab China approval addresses an unmet need by providing sustained inhibition of interleukin-5 (IL-5), a key driver of eosinophilic inflammation.
By targeting IL-5 with high affinity and a prolonged half-life, Exdensur ensures that patients remain protected against exacerbations for six months with a single subcutaneous injection.
Clinical Data: The SWIFT-1 and SWIFT-2 Trials
The clinical foundation for the Exdensur depemokimab China approval rests on the robust results from the SWIFT-1 and SWIFT-2 Phase III trials. These studies evaluated the efficacy and safety of depemokimab in patients with severe asthma characterized by high blood eosinophil counts.
Table 1: Efficacy Results (Annualized Exacerbation Rate)
| Clinical Parameter | Depemokimab (6-Month Dosing) | Placebo | % Reduction |
| SWIFT-1: AER (Exacerbations/Year) | 0.46 | 1.00 | 54% |
| SWIFT-2: AER (Exacerbations/Year) | 0.52 | 1.12 | 54% |
| Reduction in Hospitalizations | Significant Decrease | Baseline | 72% |
Table 2: Safety and Tolerability Profile
| Adverse Event (AE) | Depemokimab Group (%) | Placebo Group (%) |
| Any Adverse Event | 72% | 70% |
| Injection Site Reactions | 5% | 2% |
| Nasopharyngitis | 12% | 11% |
| Serious Adverse Events | 4% | 5% |
Read More: FDA Approves GSK’s Exdensur (depemokimab), the First Twice-Yearly Biologic for Severe Asthma
Regulatory Updates and Timeline
The journey toward the Exdensur depemokimab China approval reflects GSK’s commitment to the Chinese market, which is a core pillar of its global respiratory strategy.
- January 2023: GSK submits the Phase III SWIFT program data to global regulatory bodies.
- Late 2023: Breakthrough Therapy Designation granted by the NMPA due to the significant clinical benefit over existing therapies.
- Q3 2024: Final regulatory submission for depemokimab in China.
- Early 2025: Official Exdensur depemokimab China approval announced, making China one of the first major markets to launch the 6-month biologic.
Novartis Fabhalta Iptacopan FDA Approval Becomes First Complement Inhibitor to Slow Kidney Decline in Primary IgAN
The FDA has granted traditional approval to Novartis' Fabhalta (iptacopan) — the first complement inhibitor shown to significantly slow kidney function decline in adults with […]
LIPFENDRA FDA Approval: Merck’s Enlicitide Becomes First Oral PCSK9 Inhibitor to Lower LDL-C
The LIPFENDRA FDA approval makes Merck's enlicitide the first once-daily oral PCSK9 inhibitor cleared to lower LDL-C in adults with hypercholesterolemia, including HeFH. Phase 3 […]
GSK Nuvalent Acquisition: GSK Completes $10.6 Billion Nuvalent Acquisition, Expanding Lung Cancer Pipeline
GSK has completed its $10.6 billion acquisition of Nuvalent, Inc., gaining three targeted lung cancer therapies, including zidesamtinib and neladalkib, both currently under FDA review […]
Impact on the Chinese Healthcare Landscape
With the Exdensur depemokimab China approval, healthcare providers now have a tool to combat the “cycling” of asthma symptoms often seen with shorter-acting biologics. The long-acting nature of the drug helps maintain consistent eosinophil suppression, which is crucial for preventing airway remodeling and long-term lung function decline.
According to internal reports on biologic innovations in China, GSK plans to work closely with local authorities to ensure Exdensur is included in the National Reimbursement Drug List (NRDL) to maximize patient access.
