• Easily Reliable® is China's first and currently only ultra-long-acting biological agent for the treatment of chronic sinusitis with nasal polyps.

This approval is based on the results of the ANCHOR clinical trial, which showed that Easily Relief® achieved clinically and statistically significant improvements in reducing nasal polyps and alleviating nasal congestion symptoms.

• Patients with chronic sinusitis and nasal polyps experience persistent symptoms that significantly impact their daily lives, creating an urgent need for novel treatment options.

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the China National Medical Products Administration (NMPA) has approved EasilyLikeli® ( demozimab) in combination with nasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled by systemic corticosteroids and/or surgery. These patients have not achieved adequate disease control despite receiving systemic corticosteroids and/or surgery. The NMPA also recently approved EasilyLikeli® for maintenance therapy in adults and adolescents aged 12 years and older with severe eosinophilic asthma.

The approval of Easily® for CRSwNP is based on data from two Phase III clinical trials, ANCHOR-1 and ANCHOR-2. Data showed that at week 52 of treatment, patients' total endoscopic polyp score (0-8 scale) improved (decreased) from baseline [treatment difference (95% confidence interval) and p-value: ANCHOR-1 -0.7 (-1.1, -0.3), p<0.001; ANCHOR-2 -0.6 (-1.0, -0.2), p=0.004]; from weeks 49 to 52 of treatment, the Nasal Congestion Language Response Scale (0-3 scale) also improved [treatment difference (95% confidence interval) and p-value: ANCHOR-1 -0.23 (-0.46, <0.00), p=0.047; ANCHOR-2 -0.25 (-0.46, -0.03), p=0.025]. In both trials, demozimab was generally well tolerated, with the incidence and severity of adverse reactions being similar to those in the placebo group.

Kaivan Khavandi, Senior Vice President of GlaxoSmithKline, Head of Global Respiratory, Immunological and Inflammatory Research and Development, and Head of Translational and Development Sciences, stated, “Given the unmet need for continued treatment in patients with chronic sinusitis and nasal polyps, the approval of Easily Gel® is expected to redefine their treatment standard—requiring only two injections per year to help patients improve their symptoms. Easily Gel® has also previously been approved in China for the treatment of severe asthma, meaning that more Chinese patients will have access to this world’s first and currently only ultra-long-acting biologic.”

Nearly half of patients with chronic sinusitis and nasal polyps have uncontrolled symptoms, with up to 85% of them having an underlying type 2 inflammation, which is associated with more severe disease phenotypes. An ultra-long-acting treatment regimen that can continuously suppress type 2 inflammation could provide support for these patients who are still troubled by daily symptoms.

GSK Vice President and General Manager of China, Huiming Yu, stated, “The approval of Easily Cure® in China for the treatment of adult patients with chronic sinusitis and nasal polyps is another important new indication following its approval for the treatment of severe asthma. GSK looks forward to providing more patients suffering from type 2 inflammatory diseases with innovative, long-acting treatment options through Easily Cure® . At the same time, we will continue to respond to the national call to continuously improve the accessibility and affordability of innovative medicines, and take concrete actions to fulfill GSK’s corporate social responsibility of caring for patients and protecting public health.”

Easily approved in the United States and China for the treatment of severe asthma, as well as in Japan, the European Union and the United Kingdom for the treatment of severe asthma and chronic sinusitis with nasal polyps.

Regarding chronic sinusitis with nasal polyps (CRSwNP)

Chronic sinusitis with nasal polyps (CRSwNP) is caused by inflammation of the nasal mucosa, which can lead to soft tissue hyperplasia, i.e., nasal polyps.^3,10 Patients with CRSwNP experience symptoms such as nasal congestion, decreased sense of smell, facial pain, sleep disturbances, infections, and rhinorrhea, severely impacting their physical and mental health.^3,10 Similar to asthma, most CRSwNP cases are driven by chronic type 2 inflammation and are closely associated with comorbidities, severe disease, recurrent symptoms, and tissue remodeling.

About Easily Vitaly® ( Demozimab)

Easily Probiotic® is the first ultra-long-acting biologic agent investigated for specific respiratory diseases based on type 2 inflammation. It possesses both high affinity and high binding capacity to interleukin-5 (IL-5), and an extended half-life, allowing for twice-yearly dosing. Interleukin-5 is a key cytokine in type 2 inflammation.

Regarding the ANCHOR Phase III clinical trial

The results of the ANCHOR study have been presented at the 2025 American Association for Allergy, Asthma & Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The Lancet.

In the ANCHOR-1 study, 143 patients were enrolled in the demoxicillin plus standard of care group, and 128 patients were enrolled in the placebo plus standard of care group. In the ANCHOR-2 study, 129 patients were enrolled in the demoxicillin plus standard of care group, and 128 patients were enrolled in the placebo plus standard of care group. All 528 patients had poorly controlled chronic rhinosinusitis with nasal polyps (CRSwNP), including bilateral nasal polyps (endoscopic bilateral nasal polyp score ≥5), and had previously undergone CRSwNP surgery, systemic corticosteroid (SCS) treatment, or were intolerant to SCS. In addition to standard treatment (maintenance intranasal corticosteroids), patients received demoxicillin or placebo every 6 months (26 weeks).

Regarding the dmoxicillin antibody research and development project

Demozimab is currently in Phase III clinical trials, evaluating its use in treating other diseases with type 2 inflammation as a pathological basis, including the OCEAN trial for eosinophilic granulomatous polyangiitis and the DESTINY trial for hypereosinophilic syndrome. GSK has also initiated three Phase III clinical trials, ENDURA-1, ENDURA-2, and VIGILANT, to evaluate the efficacy and safety of demozimab as adjunctive therapy in patients with uncontrolled moderate-to-severe chronic obstructive pulmonary disease (COPD) with type 2 inflammation.

Regarding GSK breathing

Building on decades of pioneering work, GSK continues to help hundreds of millions of patients achieve higher treatment goals, developing next-generation standardized treatments and redefining the future of respiratory disease care. With an industry-leading portfolio of respiratory products and a pipeline of vaccines, targeted biologics, and inhaled medications, GSK focuses on improving treatment outcomes and quality of life for patients with all types of asthma, chronic obstructive pulmonary disease (COPD), poorly understood refractory cough, or rare diseases such as systemic sclerosis with interstitial lung disease. GSK is using cutting-edge technology to alter underlying disease dysfunction and prevent disease progression.

About GSK

GlaxoSmithKline (GSK) is a global biopharmaceutical company whose mission is to "bring together science, technology and people to overcome disease."

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