Novartis Announces NMPA Approval of Brolucizumab for Diabetic Macular Edema in China

Today (May 28), Novartis announcedNew Generation Anti-Vascular Endothelial Growth Factor (anti-VEGF) Monoclonal AntibodyBrolucizumab Injection (brolucizumab) Approved by China's National Medical Products Administration (NMPA) for TreatmentDiabetic Macular Edema (DME)Indications. As a humanized single-chain antibody (scFv) drug used in ophthalmology, brolucizumab leverages its ultra-small molecule (26kDa) and high-concentration innovative advantages to precisely target and inhibit vascular endothelial growth factor-A (VEGF-A).Compared with the previous generation product, it achieves potent control of effusion and extends treatment intervals, among other therapeutic breakthroughs.。

Public information shows,Brolucizumab can be injected once every three months after the loading phase.。Previously, the drugApproved in the United States for the treatment of DME and in the European Union for the treatment of wet age-related macular degeneration (wAMD)., and has been approved for urgent clinical use in medical institutions within China's Guangdong-Hong Kong-Macao Greater Bay Area.

BrolucizumabIt is a humanized single-chain antibody fragment targeting VEGF developed by Novartis. The product achieves clinical treatment breakthroughs with its innovative single-chain antibody structure: the small molecular weight characteristic gives the drug excellent tissue penetration, allowing it to quickly reach the deep lesions at the bottom of the eye. By directly inhibiting the VEGF-A pathway, it effectively blocks pathological vascular leakage, thereby rapidly improving the visual prognosis of patients with DME.According to the introduction in Novartis' press release, DME treatment should quickly reduce edema and maintain long-term vision improvement.The ultra-small single-chain antibody structure of Brolucizumab grants it the ability to rapidly penetrate all layers of the retina, quickly reaching the deep lesions, making it an anti-VEGF agent with a loading interval of 6 weeks.。

According to a Novartis press release, the KESTREL and KITE clinical studies of brolucizumab for treatment-naïve DME patients have both met their primary efficacy endpoints.Vision benefits sustained up to 100 weeks; In two studies, patients in the 6mg brolucizumab group had less IRF (intraretinal fluid) and/or SRF (subretinal fluid),Patients receiving brolucizumab therapy require 7 injections in the first year.The efficacy and safety results of the Phase 3 KINGLET study on DME in the Chinese population are consistent with the global results. The interim analysis of the BEST study, a real-world study from China's Greater Bay Area, shows,DME patients who did not reach the treatment goal experienced a 4.0-letter improvement in BCVA (Best Corrected Visual Acuity) and a -165.4 μm reduction in CST (Central Subfield Thickness) one week after the first injection of Brolucizumab.。

In addition, the marketing authorization applications for brolucizumab in the treatment of neovascular (wet) age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR) were submitted to the NMPA in October 2024 and December 2024, respectively, with the hope of benefiting more patients with fundus diseases in China.

[2]Clear Vision, No Fluid | Novartis' Innovative Ophthalmic Drug Brolucizumab Administered First Injection in the Guangdong-Hong Kong-Macao Greater Bay Area, Bringing New Hope to Patients with Fundus Diseases. Retrieved Mar 28, 2022, from https://mp.weixin.qq.com/s/LbtuRZoAdDyXZTNweVxsxg

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