Bora Pharmaceuticals's large molecule CDMO (Contract Development and Manufacturing Organization) business has reported a significant milestone. In collaboration with its Korean client Rophibio, the companies announced yesterday (22nd) that the biosimilar drug Eylea (aflibercept), known as RBS-001, has received Phase III clinical trial approvals from the US FDA, the European EMA, and the Korean MFDS.

Bora Pharmaceuticals stated that obtaining Phase III clinical trial approvals from the US FDA, European EMA, and Korean MFDS marks an important milestone in their long-term collaboration. Leveraging Bora Pharmaceuticals’s expertise in cGMP manufacturing and process development, along with Rophibio’s innovative drug development capabilities, the companies successfully navigated the complex regulatory requirements of multiple countries, making a critical step towards successful market launch.

Stanley Hong, CEO of Rophibio, remarked that this milestone represents the dedication and rigorous research of an outstanding team over the years, emphasizing the significant role of their partnership with Bora Pharmaceuticals. Bobby Sheng, Chairman of Bora Pharmaceuticals, highlighted that this achievement underscores the strength and potential of their collaboration with Rophibio.

Bora Pharmaceuticals explained that Eylea is a widely used biologic on the market, primarily treating various serious retinal diseases, including age-related macular degeneration (AMD). By inhibiting VEGF, Eylea effectively reduces abnormal blood vessel growth and fluid leakage in the eye, thereby protecting and improving vision. The proven efficacy and safety of Eylea make it an important treatment option for millions of patients at risk of severe vision loss.

Resource (mandarin): 保瑞大分子CDMO業務報捷 助韓國客戶獲多國第三期臨床試驗核准