Mepolizumab

Canada's Drug Agency (CDA-AMC) affirms the value of Nucala for adults with COPD characterized by raised blood eosinophils. This recommendation is a significant step toward securing public funding for eligible patients in Canada, with provincial and territorial governments making the final decision on public coverage. MISSISSAUGA, ON , Aug. 18, 2026 /CNW/ -- GSK is pleased to announce that Nucala (mepolizumab) has received a positive reimbursement recommendation with conditions from Canada's Drug Agency (CDA-AMC). The agency recommends that Nucala be reimbursed as an add-on maintenance treatment in adult patients with COPD characterized by raised blood eosinophils, inadequately controlled by the combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA). This recommendation follows Health Canada's approval of Nucala for this indication in June 2026. "COPD significantly impacts patients' daily lives, and despite existing treatments, many continue to suffer from exacerbations," says Dr. Michelle Horn, Country Medical Director, GSK Canada . "This positive recommendation for Nucala is a crucial step towards providing a much-needed, targeted treatment option for COPD patients with raised eosinophils who are inadequately controlled with triple therapy, helping to reduce flare-ups and improve their quality of life." The CDA-AMC recommendation is based on evidence from the MATINEE, METREX, and METREO Phase III trials. The MATINEE trial demonstrated a statistically significant reduction in the annualized rate of moderate/severe exacerbations with Nucala compared to placebo in a COPD patient population with raised blood eosinophils (rate ratio [RR], of 0.79; 95% confidence interval [CI], 0.66 to 0.94). 1, 2 In a pre-defined secondary endpoint in MATINEE, the annualized rate of COPD exacerbations requiring emergency department visits and/or hospitalization was numerically reduced in the Nucala group compared with placebo but did not meet statistical significance (rate ratio [RR] of 0.65; 95% CI: 0.43, 0.96). 1 "For too long, patients with COPD have faced limited options, especially those who continue to experience debilitating exacerbations despite optimal inhaled therapies," notes Henry Roberts, Managing Director of COPD Canada . "This recommendation offers renewed hope for a more personalized approach to treatment, recognizing the specific needs of COPD patients with raised eosinophils. Access to Nucala can help these individuals better manage their condition and avoid hospitalizations." Full details on the reimbursement recommendation, including clinical criteria and conditions, can be accessed on the CDA-AMC website. About COPD COPD is a progressive and heterogeneous inflammatory lung disease that includes chronic bronchitis and/or emphysema. 3 It affects more than two million Canadians, 26% of them over 85. 4 Patients with COPD experience persistent respiratory symptoms that impact daily life such as breathlessness, cough and sputum along with progressive airflow obstruction due to chronic inflammation. 3,5 Despite inhaled triple therapy, many patients experience persistent symptoms and exacerbations. 6 Exacerbations are acute episodes of worsening COPD symptoms that can result in hospitalization and irreversible lung damage.3 Early intervention is important in preventing exacerbations and cumulative lung damage. 3 About Nucala Nucala is a monoclonal antibody that targets and binds to interleukin-5 (IL-5), one of the messenger proteins (cytokines) involved in eosinophilic inflammation. Nucala is currently approved for use in Canada across four other IL-5 mediated conditions. Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374. About GSK in respiratory GSK continues to build on decades of pioneering work to deliver more ambitious treatment goals, develop the next-generation standard of care and redefine the future of respiratory medicine for hundreds of millions of people with respiratory diseases. With an industry-leading respiratory portfolio and pipeline of vaccines, targeted biologics and inhaled medicines, we are focused on improving outcomes and the lives of people living with all types of asthma and COPD or rarer conditions like systemic sclerosis with interstitial lung disease. GSK is harnessing the latest science and technology with the aim of modifying underlying disease dysfunction and preventing progression. About GSK GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the "Risk Factors" section in GSK's Annual Report on Form 20-F for 2025, and GSK's Q1 Results for 2026. References _______________________ 1 Sciurba F, et al. Mepolizumab to Prevent Exacerbations in COPD with an Eosinophilic pPenotype. N Engl J Med. Apr 2025;392:1710-1720. 2 Pavord ID, et al. Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. N Engl J Med. Oct 2017;377:1613-1629. DOI: 10.1056/NEJMoa1708208 . 3 Global Initiative for Chronic Obstructive Lung Disease (GOLD). 2025 Gold Report. Available at: goldcopd.org. Last accessed May 2025. 4 What is COPD? | Canadian Lung Association 5 2023-CTS-COPD-Pharmacotherapy-Guideline-1.pdf 6 Chen S, Miravitlles M, Rhee CK, et al. Patients with Chronic Obstructive Pulmonary Disease and Evidence of Eosinophilic Inflammation Experience Exacerbations Despite Receiving Maximal Inhaled Maintenance Therapy. Int J Chron Obstruct Pulmon Dis. Sep 9, 2022 ;17:2187–2200. DOI: 10.2147/COPD.S378649. SOURCE GlaxoSmithKline Inc.

China-based Keymed Biosciences Inc. (HKEX: 02162) announced that its Phase II clinical trial of CM512, a recombinant bispecific antibody targeting both thymic stromal lymphopoietin (TSLP) and interleukin-13 (IL-13), met all study endpoints in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The company said it is rapidly initiating a Phase III study and has confirmed 300 mg every 24 weeks as the going-forward dosing regimen. The news also impacts Florida-based biotech Belenos Biosciences, which is developing the molecule outside Greater China. CM512 simultaneously blocks TSLP, an epithelial-derived alarmin that sits upstream of the type 2 inflammatory cascade, and IL-13, a downstream effector cytokine that drives polyp growth and mucosal remodeling. Keymed describes it as the first long-acting IgG-like TSLP × IL-13 dual blocker. The randomized, double-blind, placebo-controlled Phase II study enrolled 120 patients across three active dosing arms — 300 mg every 12 weeks, 300 mg every 24 weeks, and 600 mg every 24 weeks — plus placebo, over a 24-week treatment period followed by a 12-week safety follow-up. The primary endpoint was change from baseline in nasal polyp score at Week 24. Keymed reported that changes from baseline in nasal polyp score at Week 24 were statistically significantly superior to placebo across all CM512 groups, with comparable efficacy across all three dosing regimens. Reductions in nasal polyp size and nasal congestion were observed as early as Week 4, and the company said olfactory function recovery was also facilitated. The incidence of treatment-emergent adverse events was comparable to placebo, no serious adverse events were reported in CM512 groups, and anti-drug antibody rates were described as extremely low. No specific numerical data were disclosed; Keymed said detailed results will be presented at future international journals or conferences. The selection of 300 mg Q24W — a twice-yearly subcutaneous dosing schedule — as the Phase III regimen reflects pharmacokinetic data from the completed Phase I study, which demonstrated a half-life of up to 70 days. That profile, reported in the Journal of Translational Medicine in April 2026, supports extended dosing intervals and would differentiate CM512 from Sanofi/Regeneron's Dupixent (dupilumab) and GSK's Nucala (mepolizumab), both of which require more frequent injections in CRSwNP. Amgen/AstraZeneca's Tezspire (tezepelumab), approved for CRSwNP in October 2025, also targets TSLP as a monotherapy; CM512's dual TSLP/IL-13 blockade represents a mechanistically distinct approach, though cross-trial comparisons of efficacy are not possible without head-to-head data. Keymed received Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA) Center for Drug Evaluation for CM512 in CRSwNP on July 23, 2026, which should support an expedited regulatory pathway in China. The company's existing approved IL-4Rα antibody stapokibart (Kang Yue Da) already holds NMPA approval for CRSwNP, meaning Keymed would be competing against its own marketed product in that indication if CM512 reaches approval. Ex-China rights to CM512 were licensed to Florida-based Belenos Biosciences in July 2024 for an upfront and near-term payment of USD 15 million plus up to USD 170 million in milestones. Belenos is conducting a proof-of-concept study in mild-to-moderate asthma in the US, with a readout expected in 2026. Five additional Phase II studies are ongoing in China across CRSwNP, asthma, COPD, atopic dermatitis, and chronic spontaneous urticaria. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article