Huadong Medicine's subsidiary gets approval for eye drug

Huadong Medicine (SZSE:000963) announced that its wholly-owned subsidiary, Hangzhou Sino-American Huadong Pharmaceutical Co., Ltd., has received a Notice of Acceptance from the National Medical Products Administration (NMPA) for its Ranibizumab Injection, a biosimilar of Lucentis®. The application is for domestic production and registration for marketing of a Class 3.3 therapeutic biological product. The drug is indicated for treating conditions like wet age-related macular degeneration (AMD) and diabetic macular edema (DME) among other conditions. According to Novartis' 2024 financial report, Lucentis® recorded sales of USD 10.44 billion. Huadong Medicine has invested approximately CNY 21,992 in the Ranibizumab Injection project and the company owns the global rights. The company completed phase III clinical trials in November 2024 and found that its Ranibizumab Injection has equivalent efficacy to Lucentis®.