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tot biopharm self-developed biological drug tab008 (pusintin®) meets primary endpoint in phase iii clinical trial

date time:2020-04-21

(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.

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