SHENYANG, China—Chinese biopharmaceutical company 3SBio Inc. announced yesterday a collaboration agreement with Samsung Bioepis Co., Ltd. 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).
Pursuant to the agreement, Samsung Bioepis will be responsible for manufacturing and supply of the products and collaboration 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.
“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.”
Bevacizumab is a recombinant humanized monoclonal antibody. 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. Bevacizumab 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).
The indications of Bevacizumab biosimilar candidate SB8 in China will focus on mCRC and 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 an 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.
“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,” added Christopher Hansung Ko, President and Chief Executive Officer, Samsung Bioepis. “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. 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.”