New drug for multiple myeloma! Tj202 / mor202, the first case of clinical trial in mainland China, was administered!

January 6, 2020 / Biovalley BIOON / - Tianjing Biotechnology (Shanghai) Co., Ltd (hereinafter referred to as "Tianjing biology") recently announced that tj202 / mor202, the innovative human CD38 antibody for multiple myeloma (mm), was administered to the first patient who completed the phase II clinical trial registered in China's large land area multi center in Institute of Hematology, Chinese Academy of Medical Sciences Tianjing biology has launched two clinical trials of tj202 / mor202 in relapsed or refractory MM in Taiwan in 2019 At the end of 2019, it was approved by the State Drug Administration of China to expand these trials to the mainland of China The first phase II trial (nct03860038) was designed to evaluate the efficacy and safety of tj202 / mor202 as a three-line treatment in patients with recurrent or refractory MM The second phase III clinical trial (nct03952091) was designed to evaluate the safety and efficacy of tj202 / mor202 in combination with lenalidomide (len) and dexamethasone (DEX) in patients with relapsed or refractory MM after at least first-line treatment At present, the first patient in mainland China has been successfully administered Tj202 / mor202 is a key research project of the company according to the strategy of "fast listing" of Tianjing biology It is expected to submit new drug application in Greater China after the successful completion of the test Dr Zang Jingwu, founder and honorary chairman of Tianjing biology, said: "we are very happy that the first patient's medication has been successfully implemented as planned Tj202 / mor202 is a key tumor drug for multiple myeloma patients in our product pipeline, and Tianjing biology will fully and efficiently promote the project process in Greater China The completion of the first patient administration in mainland China is a full verification of our clinical development and resource integration capabilities in mainland China and Taiwan We will work closely with the pharmaceutical regulatory department to accelerate the development of innovative biological drugs and benefit multiple myeloma patients " Tj202 / mor202 is developed by morphasys, and Tianjing biology has exclusive development and commercialization rights and interests including Mainland China, Hong Kong, Macao and Taiwan The antibody is a highly differentiated CD38 monoclonal antibody, which has good potential in preclinical animal studies and early clinical trials Tianjing biology is committed to the development of tj202 / mor202 in multiple myeloma and autoimmune diseases including lupus erythematosus Tj202 / mor202 is a human monoclonal antibody developed exclusively by morphasys using HuCAL technology The CD38 antigen on the surface of multiple myeloma targeted by this antibody belongs to the most strongly expressed and uniform tumor antigen on the surface of malignant plasma cells The mechanism of action of the antibody is to kill CD38 positive tumor cells through antibody dependent cytotoxicity and antibody dependent cell phagocytosis However, complement dependent cytotoxicity (CDC) was not involved Studies have shown that CD38 antibody has potential in the treatment of other cancers and autoimmune diseases According to the license agreement signed by and between Tianjing biology and MorphoSys in November 2017, Tianjing biology has the exclusive right to develop and commercialize tj202 / mor202 in mainland China, Taiwan, Hong Kong and Macao I-mab biopharma announcements doing of first patient in a pivotal phase 2 study of tj202 / mor202 in multiple myeloma in mainland China