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TOT BIOPHARM and Suzhou Kintor Pharmaceuticals Signed Manufacturing Collaboration Agreement

November 28, 2016, Suzhou, China -- TOT BIOPHARM Co., Ltd. and Suzhou Kintor Pharmaceuticals, Inc., both located in the Suzhou Industrial Park, announced the signing of their pharmaceuticals commissioned research and manufacturing contract. Whereby, Suzhou Kintor Pharmaceuticals will commission TOT BIOPHARM to conduct the research, development and manufacturing of a Category 1.1 targeted new drug. This promotes work specialization, and avoids overlapping investments and development, while establishing a long-term trusting relationship between two companies, which will accelerate pharmaceutical innovation and improve medicine quality.

At the end of 2015, the China Food and Drug Administration (CFDA) listed 10 provinces/ provincial cities for Pilot Program of the Drug Marketing Authorization Holder System (MAH). According to regulations, the holder of the drug license may execute or commission the manufacturing of the drug. The separation of marketing and manufacturing licenses greatly accelerates the process and speed for new drugs to come onto the market. In October 2016, Jiangsu Food and Drug Administration introduced the "Jiangsu Province Pilot Program of the Drug Marketing Authorization Holder System (MAH) " to improve the industry’s structural adjustments and optimal resource distribution.

Suzhou Kintor Pharmaceuticals, Inc. is an innovative technological corporation which is primarily dedicated to innovative drug development. TOT BIOPHARM, on the other hand, owns an antineoplastic drug R&D platform for specialty drugs; nano-technology (such as liposomes, etc.) are the key products being developed on this platform. TOT BIOPHARM has accumulated a rich set of skills and experience in R&D and industrialization. "The collaboration between our two companies is an implementation and exploration of the drugs marketing license holder pilot program. The resource advantages on both sides will be leveraged to their full potentials, while leaving the professional issues to the professionals," says TOT BIOPHARM CEO Gloria Huang. "In addition to small molecule chemical drugs, TOT BIOPHARM is also building an antibody drug production base with the scale of 10,000L. It will satisfy our demands for upstream R&D, pilot productions, clinical trials and commercial manufacturing; not only does this fulfill our production needs, it raises the bar and quality of domestic CMO/CDMO service."

About TOT BIOPHARM

TOT BIOPHARM Co., Ltd., established in July 2010, is a high-tech bio-pharmaceutical enterprise 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 cancer medication manufacturing base 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 of a manufacturing site for monoclonal antibodies has begun; 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 affordable anti-cancer drugs, and offers patients the most suitable products at a reasonable price. Our ultimate goal as an anti-cancer corporation is to "Help cancer patients achieve mental and physical wellness".

About Suzhou Kintor Pharmaceuticals

Suzhou Kintor Pharmaceuticals, Inc., established in 2009, is an innovative high-tech pharmaceutical research corporation. The company features high-quality research teams and experimental platforms; its research chain consists of the next generation anti-androgen receptors medication, PI3K/mTOR targeted kinase inhibitors, CETP inhibitors for cardiovascular disease prevention, JAK2 kinase targeted inhibitors for arthritis treatment, and FGFR/EGFR targeted dual kinase inhibitors for the treatment of solid tumors in liver, ovary, lung cancers, etc.

Since its founding, the company has received over 25 "Significant New Drug Creation" awards, the Science and Technology Ministry's small and mid-size enterprise innovation funding, Jiangsu Province Key Technologies R&D Program (social development) and Jiangsu Province Technology Project & Suzhou Innovative Startup Leading Talent funding. In September 2016, the company successfully joined China IPO (name: Kintor Pharmaceuticals; stock number: 839419). Suzhou Kintor Pharmaceuticals has always upheld the concept and mission of "Develop a Truly Local Innovative Medication". The company will continue to research and investigate to offer patients with new and low-cost treatment.