Tot Biopharm Co., Ltd., a high-tech bio-pharmaceutical company, and Lee's Pharmaceutical Holdings Limited, a Hong Kong-based public biopharmaceutical company, jointly announced that Lee's Pharma, through its wholly-owned subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited has acquired the exclusive license of TAB014, the monoclonal antibody drug developed and manufactured by Tot Biopharm, within China. TAB014 is a new antibody product that can be used to treat wet age-related macular degeneration (wAMD) and other eye diseases.

According to the agreement, Lee's Pharma will receive the exclusive rights to carry out the clinical and commercial development of TAB014 in China (including mainland China, Hong Kong and Macau), and make the upfront payment, milestone payment and after-launch sales commission to Tot Biopharm. At the same time, Lee's Pharma will pay the costs incurred during the processes of clinical development, regulatory submission and product commercialization in the licensed territory. The early stage of this cooperation will focus on the clinical development of TAB014 in the treatment of wAMD, in which both parties will share the study results and data.

"Through this cooperation, we can put greater emphasis on the oncology field and specialize in the R&D and manufacture of monoclonal antibody/antibody-drug conjugate, oncolytic virus products and specialty anti-cancer drugs," said Gloria Huang, general manager of Tot Biopharm. "Lee's Pharma's achievements in international connection are widely known, and its development in the ophthalmic field has been outstanding in recent years. We are truly pleased to cooperate with Lee's Pharma because it will benefit both parties. We believe that the cooperation will lead to the success of TAB014 and present a new treatment option for patients." Dr. Xiaoyi Li, CEO of Lee's Pharma expressed, "We are honored to work with Tot Biopharm on the development of TAB014. This is the second drug for treating retinopathy after Resolvine ER, which was developed through the cooperation of our company with the US-based Kato Pharmaceuticals. The cooperation with Tot Biopharm has further enriched our ophthalmic product line and again demonstrated our determination to develop ophthalmic drugs."

As there are over two million people in China suffering from wAMD, and existing treatment options are rather limited and pricey, the potential market value of this product will be more than a billion of RMB.

Wet age-related macular degeneration, which is caused by genetic diseases, age-related changes, inflammatory diseases, as well as other retinopathies, may lead to blindness if not treated early. Studies show that the level of the vascular endothelial growth factor (VEGF) was significantly higher in patients with wAMD and other eye diseases, such as diabetic macular edema (DME) and secondary macular edema (ME) of retinal vein occlusion (RVO).

TAB014 is an anti-VEGF monoclonal antibody injection developed independently by Tot Biopharm. The IND application of TAB014 has been submitted to CFDA. The efficacy of anti-VEGF has been confirmed by the results of a series of pharmaceutical quality studies, such as antibody molecular physical and chemical properties, biological activity, in vitro and in vivo efficacy, drug metabolism and toxicology.