drugset / Press release

TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin®) Meets Primary Endpoint in Phase III Clinical Trial

2020-04-21 · BioDlink Biopharm Co., Ltd. · original biodlink.com ↗

(Hong Kong, 21April 2020) 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.

The release as fetched from its publisher. biodlink.com ↗