TOT BIOPHARM Self-Developed Biological Drug TAB008 (Pusintin®) Meets Primary Endpoint in Phase III Clinical Trial
(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.
About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)
TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumor drugs and therapies, striving to build a leading brand of oncology treatments worthy of the trust of patients and their families, and medical professionals.
The Company has in place three major integrated technology platforms. They are:
Therapeutic Monoclonal Antibody and ADC Technology Platform: it integrates research and development (R&D) and production capacities for antibody-based drugs and ADC, with the designed production capacity of the commercialization base of biological drugs reaching 16,000L to accommodate high-quality commercialization of drug candidates;
Gene Engineering Based Therapeutics Technology Platform: it integrates anti-tumor immunotherapy, gene therapy and viral therapy and pursues R&D and production of tumor-targeted oncolytic virus products;
Innovative Drug Delivery Technology Platform: a comprehensive platform for the process development and commercial production of high intensity and frequency of drug injections. It adopts a production design with aseptic lyophilization and aseptic filling to satisfy the GMP production requirement of OEB 4/5 active level lyophilized powder and water needle
Using these platforms, the Company has studied and developed various anti-tumour drug series and genres, and has formed a high quality and comprehensive drug product chain. Currently, the Company has 12 drugs under research and development. On top of developing innovative proprietary drugs, the Company also draws on its own industry value chain to build a complete industry chain platform that supports operations from R&D and clinical development to production and marketing. By adopting an open platform business model, it is able to cooperate with biomedical enterprises and third parties at different stages along its industry value chain.