China's First Bevacizumab Ophthalmic Formulation Files for Market Approval with Yidu Tech's Full Support in Phase III Clinical Research

Recently, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) accepted the New Drug Application (NDA) for TAB014, a bevacizumab intravitreal injection jointly submitted by Zhaoke Ophthalmology and TOT Biopharm. TAB014 is intended for the treatment of wet age-related macular degeneration (wAMD) and is the first bevacizumab-based ophthalmic formulation submitted for approval in China, as well as the first bevacizumab product targeting wAMD to enter the registration stage.

As a core service partner in the Phase III clinical trial of this innovative drug, Yidu Tech provided comprehensive clinical research services, including trial operations, medical monitoring, data management, statistical analysis, and patient recruitment for select trial sites. These efforts ensured the smooth and efficient completion of the study.

wAMD is a leading cause of vision loss and irreversible blindness in individuals aged 50 and above, both in China and globally. Its primary pathological feature is choroidal neovascularization in the macula, where vascular endothelial growth factor (VEGF) plays a key role in angiogenesis.

TAB014 is a recombinant humanized anti-VEGF monoclonal antibody, developed specifically as an ophthalmic formulation for wAMD. It binds specifically to VEGF, blocking its interaction with receptors and thereby inhibiting abnormal blood vessel growth. The drug is administered via intravitreal injection for wAMD treatment.

In January 2025, Zhaoke Ophthalmology announced that TAB014 met both the primary and key secondary endpoints in its Phase III clinical trial for wAMD.

This randomized, double-blind, non-inferiority study (CTR20211015) aimed to compare the change in best-corrected visual acuity (BCVA) from baseline at Week 52 between the TAB014 treatment group and the Lucentis (ranibizumab) control group. The trial involved 57 clinical centers and 488 patients, with Professor Youxin Chen from Peking Union Medical College Hospital serving as the lead principal investigator.

As a close collaborator of Zhaoke Ophthalmology, Yidu Tech played a pivotal role in the execution of the TAB014 Phase III trial, demonstrating its expertise in end-to-end clinical research services. Since establishing a strategic partnership in late 2021, the two companies have worked closely on critical projects. The NDA submission of TAB014 marks a significant milestone in their collaboration and exemplifies Yidu Tech's commitment to empowering innovative drug development and addressing unmet medical needs in ophthalmology.

Yidu Tech has long focused on ophthalmic diseases, forging strategic partnerships with internationally renowned ophthalmologists, hospitals, academic institutions, and pharmaceutical companies to advance medical research, clinical translation, and industry collaboration, thereby contributing to the development of eye health in China.

Xu Jiming, Co-founder and CEO of Yidu Tech, stated: "TAB014, as the first domestically developed bevacizumab ophthalmic formulation to reach the NDA stage, represents a major breakthrough in the treatment of blinding eye diseases in China. We are honored to have contributed as a clinical research partner in this milestone achievement, which also validates Yidu Tech's forward-looking strategy and integrated capabilities in ophthalmology. Moving forward, we will continue to deepen our expertise in ophthalmic diseases, collaborating with industry partners to tackle critical clinical challenges through technological innovation and professional excellence, ultimately improving eye health standards in China and beyond."