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TOT BIOPHARM signed an exclusive licensing agreement for monoclonal antibody TAB014 with li's pharmaceutical company

发布时间:2017-01-05

TOT BIOPHARM And li dachang holding co., LTD. (stock code :950) jointly announced today that li dachang pharmaceutical co., LTD., through its wholly-owned subsidiary zhaoko (guangzhou) ophthalmic pharmaceuticals co., LTD., has obtained the exclusive license for the monoantibody TAB014 developed and produced by TOT BIOPHARM in China. TAB014 is a novel monoclonal antibody for the treatment of wet macular retinopathy (wAMD) and other eye diseases.

Under the terms of the agreement, lee pharma will be granted exclusive rights to conduct clinical and commercial development of TAB014 in China (including mainland China, Hong Kong and Macao), and pay down payment, milestone payment and sales commission to TOT BIOPHARM after the future listing. At the same time, li's pharmaceutical company will pay for the clinical research and development, registration approval and product commercialization of TAB014 in the authorized territory. The initial work of this cooperation project will focus on the clinical research and development of TAB014 for the treatment of wet macular retinopathy, and the two parties will share the results and data of the study.

 

"Through this collaboration, we can focus more on the field of anti-tumor, specializing in monoclonal antibody/antibody conjugated drugs, oncolytic virus products, and the development and production of anti-cancer drugs with specific dosage forms." Wong chun-ying, general manager of TOT BIOPHARM said, "the achievements of li's pharmaceutical company in the international chain are obvious to all. We are very excited to be working with big pharma, which is a win-win, and we believe we will soon be working together to bring success to TAB014 and new treatment options for patients." "It is a great honor to cooperate with TOT BIOPHARM in the development of TAB014 for the treatment of wet age-related degenerative macular disease," said Dr. Li xiaoyi, chief executive officer of li's pharmaceutical company. This is another fundus disease treatment following the development of Resolvine ER for diabetic retinopathy in collaboration with Kato. This collaboration further enriches our product line of ophthalmic drugs and demonstrates once again our commitment to research and development of ophthalmic drugs."

As more than 2 million patients in China suffer from wet macular retinopathy, currently available treatment options are limited and the price is high, the market potential of this product in the future could reach more than 1 billion yuan.

About wet macular retinopathy

Wet sex macular retinopathy is transmissibility pathological change, senile sex changes, inflammation venereal change place is caused, also can get the retinopathy that other fundus pathological change involves, if do not treat, will ahead of schedule blindness. The latest research shows that senile macular degeneration is more common in patients over 45 years old, and its incidence increases with age. It is one of the major eye diseases that cause vision loss and blindness in the elderly. With the accelerated pace of aging in China and the popularization of digital products, the incidence of blinding eye diseases caused by wet macular retinopathy is on the rise year by year, and the age group is declining. More than 2 million patients in China have suffered from wet macular retinopathy. Studies have shown that VEGF levels are significantly increased in wet age-related macular degeneration (wet-amd) and other eye diseases, such as diabetic macular edema (DME) and macular edema (ME) secondary to retinal vein occlusion (RVO). Since 2005, some ophthalmologists have used anti-vegf in the treatment of eye diseases and proved its efficacy. Currently, anti-vegf drugs approved by the FDA and the European Union for wet macular retinopathy include renizumab (trade name: Lucentis®) and apecipe (trade name: Eylea®). Anti-vegf drugs approved by the state food and drug administration include leizumab and compaq ® (trade name: langmu ®).

About TAB014

TAB014 is a biological drug for anti-vascular endothelial growth factor (anti-vegf) monoclonal injection independently developed by TOT BIOPHARM, which can inhibit pathological angiogenesis. By blocking vegf-mediated signal transmission and inhibiting the growth of diseased neovascularization, it has the potential to treat a variety of fundus neovascularization diseases, including wet macular retinopathy (wAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), pathological myopia (PM), etc. TAB014 has completed the clinical application of the state food and drug administration. The results of dozens of pharmaceutical quality studies on the molecular physical and chemical characteristics, biological activity, in vivo and in vitro efficacy, drug substitution and toxicological data of the antibody have been confirmed to have the efficacy of anti-vascular endothelial growth factor.