TOT BIOPHARM International Company Limited (“TOT BIOPHARM” or the “Company”; stock code: 1875.HK) is pleased to announce that the randomized Phase III clinical trial of TAB008 (Pusintin) has recently reached the predefined primary endpoint. The Company will continue to push forward the new drug application (NDA) of TAB008 (Pusintin) as scheduled.
Ms. Yeh Huang, Chun Ying, General Manager of TOT BIOPHARM, said, “We are very excited about the Phase III Clinical Trial of TAB008 (Pusintin) reaching the predefined primary endpoint. There are many combination therapies and other opportunities for expansion of indications which can be explored by TAB008 (Pusintin) in the future, which could fulfill the needs of an enormous number of patients. After the commercialization of TAB008 (Pusintin), it is expected to create more profits for us. In the future, we will continue to develop new anti-tumor drug products with high technological barriers and economic value, providing an appropriate and affordable product portfolio.”
About TAB008 (Pusintin)
TAB008 is an anti-vascular endothelial growth factor monoclonal antibody (anti-VEGF mAb), a biosimilar drug candidate for bevacizumab. Bevacizumab was approved for launch by the U.S. Food and Drug Administration as early as 2004, under the product name of Avastin. It has obtained recognition for treatment of seven indications, including metastatic colorectal cancer, NSCLC, malignant glioma, renal cell carcinoma, ovarian carcinoma, breast cancer and cervical cancer. According to a report by Frost & Sullivan, China’s market size for bevacizumab biosimilars will reach approximately RMB14.2 billion in 2024 through enormous market demand.