Novartis Submits Brolucizumab for Marketing Approval in China Targeting Diabetic Macular Edema

On August 2, the CDE website showed that Novartis's brolucizumab was submitted for marketing authorization in China. Based on the clinical trial progress, the indication for this submission is speculated to be diabetic macular edema.

Brolucizumab is a single-chain antibody targeting vascular endothelial growth factor A (VEGF-A). It was first approved for marketing in the United States in October 2019 under the trade name Beovu for the treatment of wet age-related macular degeneration (wAMD). In March 2022, brolucizumab expanded its indications to include diabetic macular edema (DME).

The advantage of Brolucizumab lies in its injection frequency of once every 3 months, with a longer dosing interval compared to Ranibizumab (once a month) and Aflibercept (once every 2 months). In the Phase III HAWK and HARRIER studies targeting wAMD, Brolucizumab demonstrated non-inferiority to Aflibercept in improving Best Corrected Visual Acuity (BCVA) scores; in the Phase III KESTREL and KITE studies for DME, Brolucizumab also showed non-inferior efficacy in improving patients' vision compared to Aflibercept.

Public information shows that Novartis has conducted Phase III clinical trials in China for brolucizumab in the treatment of wAMD (CRTH258A2307 study) and DME (KINGLET study). Among them, the CRTH258A2307 study is still ongoing, while the KINGLET study was completed in February this year.

The financial report shows that the sales of Brolucizumab in 2022 were 203 million US dollars, and the sales in the first half of 2023 were 104 million US dollars.

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