3SBio Announces Acceptance of IND application for bevacizumab biosimilar in China
(Shenyang, China, September 14, 2020)Chinese leading biopharmaceutical company 3SBio Inc.（01530.HK), today announced that the National Medical Products Administration has accepted its IND application for SB8(the Company's development code: 615), a biosimilar product of bevacizumab. According to the collaboration agreement between 3SBio Inc. and Samsung Bioepis as announced on January 7, 2019,Sunshine Guojian will conduct clinical development and be responsible for commercialization of SB8 in mainland China (excluding Hong Kong, Macao and Taiwan). Marketing authorization for SB8 was granted by the European Commission on Aug 19, 2020， for multiple oncology indications, including metastatic colorectal cancer, metastatic breast cancer, non–small cell lung cancer, advanced/metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer.
SB8’s Phase III clinical study results had been presented at the 2019 European Society of Medical Oncology (ESMO) congress. The study was a randomized, double-blind, multi-center study, and compared the efficacy, safety, pharmacokinetics, and immunogenicity of SB8 and Avastin in 763 patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC). The data showed that SB8 has no clinically meaningful differences from Avastin in terms of efficacy, safety, pharmacokinetics and immunogenicity.
The indications of Bevacizumab biosimilar candidate in China will focus on metastatic colon cancer and Non-Small Cell Lung Cancer. 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 733,300 new cases of lung cancer in China and 610,200 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 85% of lung cancer cases are NSCLC. According to Frost & Sullivan report, the sales revenue of bevacizumab biosimilars in Chinese market is expected to grow at a compound annual growth rate of 343.5% from 2019. The market size in 2023 will be about RMB 6.4 billion, while by 2030, the market size of bevacizumab biosimilars in Chinese market will reach RMB 9.9 billion.
“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 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.”
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.Amongst more than 30 product candidates within the Company’s active pipeline, 22 were being developed as National New Drugs. 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.
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 1Q2010, 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).