3SBio and Samsung Bioepis enter biosimilar collaboration agreement
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- Published on Monday, 07 January 2019 11:51
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SHENYANG, China I January 6, 2019 I Chinese leading Biopharmaceutical company 3SBio Inc. (01530.HK)("3SBio") announced today that it has entered into a collaboration agreement (the "Agreement") with Samsung Bioepis Co., Ltd. ("Samsung Bioepis") for the clinical development and commercialization of multiple biosimilar candidates developed by Samsung Bioepis, including SB8 Bevacizumab biosimilar candidate ("SB8") in Mainland China (excluding Hong Kong, Macau and Taiwan).
"Samsung Bioepis possesses leading biologic development and manufacturing capabilities in the global market, combined with 3SBio's advantageous integrated platform in China, the two parties can provide patients in China with safe and affordable biological therapies. 3SBio looks forward to accelerating the clinical development of SB8 in China, and to broaden 3Bio's product portfolio in the oncology area," said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio. "3SBio will continue to strengthen its leadership status in biopharmaceutical industry through internal R&D initiatives and strategic collaborations to bring more high quality and urgently needed products to market more quickly, both in China and international market."
"We are very excited to expand our biosimilar business into China, where we hope to see our biosimilars play an important role in widening patient access to high-quality healthcare. We are confident we will achieve this goal through our partnership with 3SBio, which brings together Samsung Bioepis' proven development platform with 3SBio's strong commercialization platform," said Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. "At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world."
Pursuant to the agreement, Samsung Bioepis will be responsible for manufacturing and supply of the products and collaborate with 3SBio across a number of areas including clinical development, regulatory registration and commercialization in China. Samsung Bioepis will receive an upfront payment and product supply income from 3SBio and will be eligible for additional payments associated with pre-specified clinical and regulatory milestones. Further financial terms were not disclosed.
The indications of Bevacizumab biosimilar candidate in China will focus on metastatic colon cancer (mCRC) and Non-Small Cell Lung Cancer ("NSCLC"). According to the Chinese National Cancer Center, in 2015 there were 376,000 new cases of colorectal cancer in China and 191,000 deaths, an incidence rate of 26.6/100,000 and a mortality rate of 13.5/100,000. The rates in urban areas in China are higher than in rural areas and the incidence rate has increased significantly. Most patients are already in the advanced stage when they are diagnosed. In 2015 there were 733,000 new cases of lung cancer in China and 6,102,000 deaths, giving it the highest incidence rate (51.9/100,000) and mortality rate (43.2/100,000) among China's malignant tumors. More than 90% of lung cancer cases in China are caused by NSCLC.
About 3SBio Inc.
3SBio is a fully-integrated biotechnology company in China with market-leading biopharmaceutical franchises in oncology, auto-immune diseases, nephrology, metabolic diseases and dermatology. 3SBio is focusing on building an innovative product pipeline, currently with over 30 product candidates under development. 3SBio's manufacturing capabilities include recombinant proteins, monoclonal antibodies and chemically-synthesized molecules, with production centers in Shenyang, Shanghai, Hangzhou, Shenzhen and Cuomo, Italy. Please visit www.3sbio.com for additional information.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology and hematology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
Bevacizumab is a recombinant humanized monoclonal antibody and in 2004 it became the first clinically used angiogenesis inhibitor. Its development was based on the discovery of human vascular endothelial growth factor (VEGF), a protein that stimulated blood vessel growth. It received its first approval in the United States in 2004, for combination use with standard chemotherapy for metastatic colon cancer (mCRC). It has since been approved for use in certain lung cancers, renal cancers, ovarian cancers, etc. In 1Q10, bevacizumab was approved in China for mCRC. By January 2016, the drug had been approved and launched in China for Non-Small Cell Lung Cancer (NSCLC).