China’s first to be approved for listing!

April 10, 2026  Source: drugdu 34

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Today, GlaxoSmithKline (GSK) announced that its innovative biologic, Easily (demozimab) , has been approved by the NMPA for the treatment of adult patients with chronic sinusitis with nasal polyps (CRSwNP), making it the first and currently the only ultra-long-acting biologic in China for the treatment of chronic sinusitis with nasal polyps.
It is worth noting that this comes only about 10 days after the drug was approved for maintenance treatment of severe eosinophilic asthma, marking the achievement of dual indications in the respiratory field in China for this world's first IL-5 ultra-long-acting biologic that is administered once every six months .

Chronic sinusitis with nasal polyps is a chronic upper respiratory tract disease characterized by type 2 inflammation , affecting approximately 30 million patients in China. Patients suffer from long-term symptoms such as nasal congestion, decreased sense of smell, facial swelling and pain, and sleep disturbances. Traditional treatments have significant limitations—long-term use of systemic corticosteroids has significant side effects, and the recurrence rate after nasal polyp removal surgery remains high, requiring some patients to undergo multiple surgeries.

This approval is based on positive results from two pivotal Phase III clinical trials, ANCHOR-1 and ANCHOR-2. The results showed that after 52 weeks of treatment, patients in the demozimab group had a significantly lower total nasal endoscopy score for nasal polyps compared to the placebo group (0.7 points lower in ANCHOR-1 and 0.6 points lower in ANCHOR-2), and their nasal congestion score (VRS) also improved significantly (0.23 and 0.25 points lower, respectively). In both trials, demozimab was generally well-tolerated, with the incidence and severity of adverse events similar to those in the placebo group.

The core competitiveness of demozia malabsorption lies in its ultra-long-acting pharmacological properties . As a new generation of anti-IL-5 monoclonal antibody, this drug achieves a dosing regimen of only once every six months through its molecular design of high binding affinity and extended half-life. This differentiates it from GSK's previous generation product, mepolizumab (once a month), and AstraZeneca's benrelizumab (once every eight weeks).

the internationalization of demozia has accelerated . In December 2025, the drug was approved by the US FDA for severe asthma, and in the same month, it was approved by the UK regulatory agency for asthma and CRSwNP. In January 2026, it received dual approval in Japan; and in February, the EU also approved it for both indications. After approving it for severe asthma at the end of March 2026, China's NMPA quickly added the CRSwNP indication in April, maintaining approval efficiency in sync with major European and American markets.

In the CRSwNP biologics field, demozia faces multiple competitive challenges . Among products targeting the same target, mepolizumab was approved for this indication in China in early 2025; in terms of cross-target competition, Sanofi/Regeneron's dupilumab (anti-IL-4R) has more impressive data on avoiding surgery.

In conclusion , with the approval of demozia in China for dual indications, Chinese patients have officially entered the era of six-month management of biologics, and the treatment paradigm for CRSwNP is undergoing a profound transformation from frequent intervention to long-term control.

https://news.yaozh.com/archive/47722.html

By editor
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