Huadong Medicine Files for NMPA Approval of Ranibizumab Biosimilar

Huadong Medicine Files for NMPA Approval of Ranibizumab Biosimilar

China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its market approval filing for a biosimilar version of Novartis’ Lucentis (ranibizumab) has been accepted for review by China’s National Medical Products Administration (NMPA).

Ranibizumab and Its Clinical Applications
Ranibizumab is a vascular endothelial growth factor A (VEGF-A) antagonist that provides clinical benefits by inhibiting angiogenesis. Novartis first introduced Lucentis to China in December 2011. The drug has received multiple indication approvals, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization, and retinopathy of prematurity (ROP).

Huadong Medicine’s Biosimilar Development
In November 2024, Huadong Medicine demonstrated the equivalent efficacy of its biosimilar to the originator in an AMD study. This filing marks a significant step in bringing a more accessible treatment option to patients in China.-Fineline Info & Tech