GSK's Subcutaneous Belimumab Granted New Clinical Trial Approval in China for CTD-ILD
GSK
Pharmaceutical R&D Manufacturer
China's Center for Drug Evaluation (CDE) of the National Medical Products Administration recently announced on its official website that a new clinical trial implied permission has been granted to GlaxoSmithKline PLC. (GSK) for their submission of Belimumab Injection (subcutaneous injection). The purpose of this new permission is to explore the drug’s potential in treating adult connective tissue disease-associated interstitial lung disease (CTD-ILD).
Belimumab, a monoclonal antibody targeting B-lymphocyte stimulator (BLyS) developed by GSK, has previously received approvals for multiple indications in China for its intravenous formulation, marking its widespread application in the treatment of autoimmune diseases.
Screenshot source:CDE Official Website
Belimumab (trade name: Benlysta) is a humanized monoclonal antibody that works by specifically binding to B-lymphocyte stimulator (BLyS), thereby inhibiting the survival and proliferation of B cells. This drug reduces the number of abnormally active B cells in autoimmune responses and prevents their differentiation into immunoglobulin-producing plasma cells.
In July 2019, the intravenous formulation of belimumab was approved for marketing in China. Currently, the drug has been approved in China for the treatment of systemic lupus erythematosus in adults and children, as well as for use in combination with standard therapy for adult patients with active lupus nephritis (LN).
Compared with intravenous injection, the subcutaneous injection formulation of belimumab has the potential to shorten treatment time and improve treatment convenience. According to official information from the China Drug Clinical Trial and Information Disclosure Platform, two clinical studies on the subcutaneous injection of belimumab have been conducted in China. This includes a Phase 1 pharmacokinetic study in Chinese children with systemic lupus erythematosus (SLE) and an international multicenter (including China) Phase 2/3 efficacy and safety study in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). In this Phase 2/3 study, the dosing regimen for the belimumab subcutaneous injection is a single injection once weekly for 52 consecutive weeks.
Connective Tissue Disease-Associated Interstitial Lung Disease (CTD-ILD) is a group of pulmonary lesions associated with connective tissue diseases. These lesions are common fibrosing interstitial lung diseases in the respiratory department. When various connective tissue diseases affect the pulmonary interstitium, they may cause the loss of diffuse alveolar and capillary functional units. CTD-ILD is one of the more severe clinical manifestations of these diseases.
The new clinical trial approval by default for Belimumab Injection (subcutaneous injection) indicates that the drug will soon enter the clinical research phase for CTD-ILD patients. This progress brings a new treatment option for this patient population.
[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 23, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c
[2] Official Website of China Drug Clinical Trial and Information Disclosure Platform. From http://www.chinadrugtrials.org.cn/index.html
