3SBio Signs Exclusive Patent License Agreement for ALT-P7, an Antibody-drug Conjugate Targeting HER2 with Alteogen

SHENYANG, China, and DAEJEON, Korea, Oct. 11, 2015 /PRNewswire/ -- 3SBio Inc. ("3SBio") (01530.HK), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced it has entered into an exclusive licensing deal with Alteogen Inc. ("Alteogen") (196170.KS) for the development, manufacturing and marketing of ALT-P7, a novel antibody-drug conjugate ("ADC") targeting HER2 pathway for cancer in the territory of Mainland China, Hong Kong and Macau. The deal included undisclosed upfront, milestone and royalty payments.

Approximately 20% of breast cancers and 15% of gastric cancers are characterized by amplification of the human epidermal growth factor receptor 2 (HER2) gene and over-expression of HER2ALT-P7, developed based on Alteogen's proprietary NexMab™ ADC technology, is expected to be more efficacious and stable compared with first generation ADC products. Preclinical proof-of-concept, including in vitro binding assays and in vivo efficacy in animal models, has demonstrated superiority of ALT-P7 over current drugs in murine models of HER2-positive breast cancer.

"This is our first collaboration with Alteogen," Dr. Jing Lou, Chairman and CEO of 3SBio commented, "We are impressed by Alteogen's NexMab™ ADC technology and look forward to working with them as we seek regulatory approvals to move ALT-P7 into clinical trials in China. Novel mAb candidates, including ADCs and bispecific antibodies, shed light on the treatment for refractory or metastatic cancers, such as breast and gastric cancers, which is consistent with 3SBio's core therapeutic areas of oncology and nephrology."

"We are very pleased to start our partnership with 3SBio," Dr. Soon Jae Park, CEO of Alteogen 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 in the long term. ALT-P7 is a novel ADC with great potential to treat refractory tumors. We are looking forward to working with them to develop this drug in China, so that tens of thousands of patients suffering for cancers can benefit from this drug candidate."

About 3SBio Inc.

3SBio is a leading biotechnology company in the People's Republic of China founded in 1993.  As a pioneer in the PRC biotechnology industry, 3SBio has extensive expertise in developing, manufacturing and marketing biopharmaceuticals. Two core products, TPIAO and EPIAO, are market leaders in the PRC. TPIAO is the only commercialized recombinant human thrombopoietin (rhTPO) product in the world. EPIAO, a recombinant human erythropoietin (rhEPO) product, together with the other rhEPO product acquired recently, SEPO, is the dominant market leader in the rhEPO market, with a market share more than the combined market shares of the next five largest competitors. In addition, 3SBio has eight other products in nephrology, oncology and other therapeutic areas.

Pipeline candidates include:

• Uricase PEG-20 for the treatment of refractory gout and tumor lysis syndrome which has completed US Phase I 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 entered into Phase I clinical trial in China;
• SSS07, an anti-TNF mAb for treating rheumatoid arthritis, psoriasis, and potentially other inflammatory diseases which has entered into Phase I clinical trial in China;
• Leukotuximab (SSS19), an anti-CD43/JL-1 mAb for treating acute leukemia;
• Tanibirumab (SSS23), an anti-VEGFR2 mAb for treating solid tumors;
• DIG-KT (SSS25), a bispecific mAb with dual inhibition of VEGFR-2 and TIE 2 for treating refractory tumors.  

3SBio maintains operation facilities in Shenyang, Benxi, Hangzhou and Shenzhen, as well as in Como, Italy, with a total of over 1,400 employees. A 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. In July 2015, 3SBio acquired Zhejiang Wansheng Pharmaceutical, which specializes in R&D, production and sales of chemically synthesized pharmaceuticals. Planning is underway to develop mAb manufacturing capabilities.

3SBio's pharmaceutical products are marketed and sold in 32 provinces, autonomous regions and special municipalities in the PRC, as well as a number of foreign countries and regions. 3SBio's nationwide sales and distribution network covers over 3,400 hospitals and medical institutions in the PRC. 3SBio is also actively pursuing international expansion through acquisition, licensing and partnerships.

Please visit www.3sbio.com for additional information.

About Alteogen Inc.

Alteogen (196170.KS) is a biopharmaceutical company devoted to develop the next generation long-acting biobetters (NexP™ long acting carrier) which have properties of the increased in-vivo half life. It is also developing monoclonal antibody biobetter with its proprietary antibody-drug conjugate (ADC) technology and monoclonal antibody biosimilars with blockbuster market potential. For more information visit www.alteogen.com.

About ALT-P7

ALT-P7 is a novel antibody-drug conjugate (ADC) that binds and neutralizes HER2 resulting in sustained inhibition of tumor growth. ALT-P7, developed based on Alteogen's proprietary NexMab™ ADC technology, is expected to be more efficacious and stable compared with first generation ADC products. Preclinical proof-of-concept, including in vitro binding assays and in vivo efficacy in animal models, has demonstrated superiority of ALT-P7 over current drugs in murine models of HER2-positive breast cancer.

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