TOT BIOPHARM and LEE'S PHARM Signed an Exclusive Licensing Agreement on Monoclonal Antibody Drug TAB014

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SUZHOU, China and HONG KONG, Jan. 5, 2017 /PRNewswire/ — TOT BIOPHARM Co., Ltd. (“TOT BIOPHARM”) and LEE’S PHARMACEUTICAL HOLDINGS LIMITED (“LEE’S PHARM”, HKEx Code: 950) today jointly announced that LEE’S PHARM, 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 PHARM 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 PHARM 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 PHARM’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 PHARM 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 PHARM 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 U.S.-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.

About wet agerelated macular degeneration (wAMD)

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). Since 2005, some ophthalmologists began to use anti-VEGF drugs to treat eye diseases and have confirmed their efficacy. At present, the anti-VEGF drugs of wAMD approved by the FDA and EU include Ranibizumab (Trade name: Lucentis®) and Aflibercept (Trade name: Eylea®), while the anti-VEGF drugs approved by CFDA include Ranibizumab and Conbercept (Trade name: Lang Mu®).

About TAB014

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.

About TOT BIOPHARM

TOT BIOPHARM Co., Ltd., established in July 2010, is a high-tech bio-pharmaceutical company dedicated to developing, manufacturing and marketing anti-cancer drugs. The company’s products include monoclonal antibodies and antibody⁃drug conjugates (ADC), oncolytic virus products, tumor suppressor genes, immunotherapy therapy and specialty anti-cancer drugs. TOT BIOPHARM established an international competitive oncology drugs manufacturing site in the Suzhou Industrial Park. The first-stage of the construction was completed in 2012; it includes oncology small molecule plants (oral/ injectable) and a 500L-biologic pilot plant. Liposomal Technology is the core technology, to which the company has devoted the development and application of new formulation drugs. Since 2016, a large amount of investment has continued, and Stage 2 construction has commenced; the site will produce monoclonal antibodies and antibody⁃drug conjugates (ADCs), and will be equipped with 5 lines of 2,000L-biologic reactors to accommodate the commercial manufacturing.

TOT BIOPHARM upholds its philosophy, “A Balance between Humanity and Technology”, and strives to break through high-tech barriers and develop economical new medication. The company focuses on providing affordable anti-cancer drugs, and offers patients the optimal treatments. Our ultimate goal as an anti-cancer corporation is to “Help cancer patients achieve physical, mental and spiritual wellness”. If you wish to learn more about TOT BIOPHARM, please visit the official website: http://www.totbiopharm.com

About LEE’S PHARM

LEE’S PHARM is a Hong Kong-based listed company that focuses on the research of bio-drugs and has been running its pharmaceutical manufacturing business for over two decades in China. The Group has fully integrated R&D, manufacturing, sales and marketing and established a solid foundation. While widely cooperating with over 20 international enterprises, the Group currently has 15 products being sold on the market. The businesses of LEE’S PHARM emphasize numerous disease categories, including: ophthalmology, cardiovascular diseases, oncology, gynecology, and dermatology. Through the internal R&D and collaboration with companies in the US, Europe and Japan, Lee’s Pharm has developed 40 products that fight against diseases such as liver cancer and pulmonary hypertension. LEE’S PHARM is striving to become a leading bio-drug manufacturing group in Asia, providing innovative products to fight against diseases and improve patients’ health and life quality. If you wish to learn more about LEE’S PHARM, please visit the official website: http://www.leespharm.com

SOURCE TOT BIOPHARM