3SBio Signs Exclusive Patent License Agreement for Tanibirumab, an Anti-VEGFR2/KDR mAb with PharmAbcine

SHENYANG, China and DAEJEON, Korea, Nov. 18, 2014 /PRNewswire/ -- 3SBio Inc., a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive license with PharmAbcine, Inc. for the development, manufacturing and marketing of Tanibirumab, an anti-VEGFR2/KDR antibody for cancer in the territory of Greater China (including Mainland China, Taiwan, Hong Kong and Macau) and several emerging countries, including Thailand, Brazil and Russia. The deal included undisclosed upfront, milestone and royalty payments.

Angiogenesis is correlated with disease progression and poor prognosis in many tumor types, such as colon, lung, breast and gastric cancers. VEGF and KDR (VEGFR2) are over-expressed in most malignant tumors, such as gastric, liver, NSCLC, ovarian, brain, colorectal, and breast cancers and their signaling is key regulator for tumor angiogenesis. Researchers from PharmAbcine have developed Tanibirumab, an anti-VEGFR2/KDR fully human monoclonal antibody to treat solid tumors. Tanibirumab binds KDR and blocks binding of VEGFR ligands, including VEGF-A, VEGF-C and VEGF-D. Consequently, Tanibirumab inhibits ligand-stimulated activation of KDR, therefore inhibits ligand-induced angiogenesis, proliferation, and migration of human endothelial cells.

Tanibirumab had demonstrated anti-angiogenic efficacy against several cancer types and shown cross-species cross reactivity in multiple preclinical animal models including breast cancer, glioblastoma (GBM), lung cancer, colon cancer, and hepatocellular carcinoma (HCC). In November 2011, an open-label, non-randomized, dose-escalating phase I trial began to assess the safety and pharmacokinetics of Tanibirumab, administered intravenously, in 26 patients in Korea with advanced or metastatic cancer. The trial was finished in November 2013, with good safety and efficacy results. A phase II study of Tanibirumab in GBM is being planned.

"We are pleased to collaborate with PharmAbcine and look forward to moving Tanibirumab into clinical trials in China," Dr. Jing Lou, President and CEO of 3SBio commented, "3SBio continues to seek opportunities to expand our biologics pipeline, especially novel mAb candidates for refractory or metastatic cancers and other unmet medical needs, particularly in 3SBio's core therapeutic areas of oncology and nephrology."

"Tanibirumab is a drug candidate with great potential to treat malignant tumors," Dr. Jin-San Yoo, President and CEO of PharmAbcine commented, "3SBio is a well-established industry leader with long-term vision in the innovative biological field in China, which makes them an ideal partner for strategic collaborations. We are looking forward to working with 3SBio to maximize this opportunity and benefit tens of thousands of Chinese patients suffering for cancers and other severe diseases."

Each year, over 1 million patients are diagnosed with various types of cancer in China^[1].

About PharmAbcine, Inc.

PharmAbcine is a clinical stage biotech company that develops fully human therapeutic monoclonal antibodies (mAbs) and next generation bi-specific antibodies using innovative discovery technology and excellent human resources for the treatment of human diseases, such as cancer and inflammatory diseases. Our mission is to develop a first-in-class and best-in-class mAb for those target diseases. PharmAbcine was spun out of the Korea Research Institute of Bioscience and Biotechnology belonging to the Korean government. For more information visit www.pharmabcine.com.

About Tanibirumab

Tanibirumab is an anti-VEGFR2/KDR fully human monoclonal antibody for targeting solid tumors. Angiogenesis is correlated with disease progression and poor prognosis in many tumor types, such as colon, lung, breast and gastric cancers. VEGF and KDR (VEGFR2) are over-expressed in most malignant tumors, and their signaling is key regulator for tumor angiogenesis. Tanibirumab binds KDR and blocks binding of VEGFR ligands, including VEGF-A, VEGF-C and VEGF-D. Consequently, Tanibirumab inhibits ligand-stimulated activation of KDR, therefore inhibits ligand-induced angiogenesis, proliferation, and migration of human endothelial cells.

Tanibirumab had demonstrated anti-angiogenic efficacy against several cancer types and shown cross-species cross reactivity in multiple preclinical animal models, including breast cancer, glioblastoma (GBM), lung cancer, colon cancer, and hepatocelluar carcinoma. In November 2011, an open-label, non-randomized, dose-escalating, phase I trial began to assess the safety and pharmacokinetics of Tanibirumab, administered intravenously, in 26 patients in Korea with advanced or metastatic cancer. The trial was finished in November 2013, with good safety and efficacy profiles. A phase II study of Tanibirumab in GBM is being planned. Tanibirumab phase I and II have been partly supported by Korean Government through KDDF (Korea Drug Development Fund, http://eng.kddf.org/Main/).

About 3SBio Inc.

3SBio is a fully integrated, profitable biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China. Since its founding in 1993, 3SBio's R&D efforts have resulted in four NDAs for biological medicines, including TPIAO, the first rhTPO approved worldwide. Pipeline candidates include Uricase PEG-20, a modified pegylated recombinant uricase from Candida utilis for the treatment of refractory gout and tumor lysis syndrome which has completed US Phase 1 trials; NuPIAO, a long-acting erythropoiesis-stimulating agent (ESA) for anemia associated with renal failure or chemotherapy and peri-operative blood cell mobilization which has received CFDA approval to initiate clinical trials; SSS07, an anti-TNF monoclonal antibody for treating rheumatoid arthritis, psoriasis, and potentially other inflammatory diseases; and Leukotuximab, an anti-CD43/JL-1 monoclonal antibody for treating acute leukemia. A new state-of-the-art mammalian biological manufacturing facility in Shenyang is the first and only rhEPO facility in China that conforms to both Chinese and European pharmacopeia standards. Planning is underway to develop monoclonal antibody manufacturing capabilities. 3SBio is China's leading specialist in nephrology and oncology supportive care with more than 600 sales professionals covering over 3,000 hospitals in key cities supported by a nationwide network of 120 distributors and logistics providers. EPIAO has been the top selling rhEPO product in China since 2002 with a market share over 40%. Please see www.3sbio.com for additional information.

[1] Report of Cancer Incidence and Mortality in China, 2009, China Cancer, 2013, 22(1): 2-12

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