TAB014 / BioDlink, Zhaoke Ophthalmology - LARVOL DELTA

NMPA ACCEPTANCE OF BIOLOGICS LICENSE APPLICATION FOR TAB014 FOR THE TREATMENT OF wAMD (HKEXnews) - "The Board of the Company is pleased to announce that the National Medical Products Administration ('NMPA') of China has recently accepted the Biologics License Application ('BLA') for one of the Company’s core products, TAB014, for the treatment of wet age-related macular degeneration ('wAMD'). It is the first bevacizumab-based antibody filing BLA indicated for wAMD in China. The BLA is based on the successful results of the Company’s Phase III clinical trial in China....The study involved approximately 57 centres and enrolled a total of 488 patients, led by Professor Chen Youxin from Peking Union Medical College Hospital as the Principal Investigator."

China filing • Wet Age-related Macular Degeneration

nAMD: TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=488 | Active, not recruiting | Sponsor: TOT Biopharm Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Mar 2024 ➔ Feb 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Enrollment closed • Trial completion date • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

nAMD: TAB014 Compared to Lucentis® in Patients With Neovascular Age-related Macular Degeneration (clinicaltrials.gov) - P3 | N=488 | Recruiting | Sponsor: TOT Biopharm Co., Ltd.

New P3 trial • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration