On the 4th, Biotech announced that its BAT800 (recombinant humanized anti-Trop2 monoclonal antibody-maytansine conjugate for injection) and BAT1306 (recombinant humanized anti-PD-1 monoclonal antibody) Antibody injection) is in the clinical research stage
But recently, the company has carefully considered the subsequent development risks of the drug and decided to terminate the clinical trial of the project
Reason for project termination
BAT8003 is an innovative drug independently developed by the company.
It is an ADC drug targeting Trop2.
It is formed by covalently linking a glycosylated recombinant humanized anti-Trop2 monoclonal antibody to Batansine through site-directed coupling technology
The clinical indication of BAT8003 is Trop2-positive advanced epithelial carcinoma
BAT8003 was launched in March 2019 in a phase I clinical trial for patients with Trop2-positive advanced epithelial cancer.
In the preclinical evaluation, BAT8003 has proven good tolerability, PK characteristics and good efficacy in preclinical studies
Taking into account the changes in the market structure in the field of Trop 2 ADC today, and considering that BAT8003 and BAT8001 have similar technical features (although 8003 is fixed-point coupled, batansine technology is also used), there is a high clinical development and market risk
BAT1306 is a monoclonal antibody against immune suppression checkpoint PD-1 developed by the company.
The single-agent indication is EBV-related gastric cancer.
Currently, BAT1306 combined with XELOX has been launched in the first-line treatment of EBV-related gastric cancer clinical trials and BAT8001 combined with BAT1306 in the second-line treatment of HER2-positive advanced Clinical trials of solid tumors
The company has terminated the advancement of the BAT8001 project, and the clinical trial of BAT8001 combined with BAT1306 for the second-line treatment of HER2-positive advanced solid tumors has also been terminated due to the termination of the above-mentioned project
At the same time, judging from the clinical data of various PD-1 monoclonal antibodies, it is estimated that in the next 2-3 years, there will be more than 20 PD-1 products on the market globally, and the market competition will become increasingly fierce
China is the region with the most intense PD-1 competition.
There are 154 PD-1s in the world, 85 of which are developed or jointly developed by Chinese companies, accounting for 55%
PD-1 The global and domestic PD-1 monoclonal antibody research and development track has become crowded, and a large number of research and development competing products have also intensified the competition with CRO companies, which further intensified the development cost
Combining the above reasons, given that BAT8003 and BAT1306 are currently in clinical phase I and phase II respectively, both are relatively early stages, subsequent clinical trials will require a lot of human and financial resources for the company
In order to rationally allocate the company's R&D resources and focus on advantageous projects in the R&D pipeline, after careful consideration by the company, the company decided to terminate the clinical trials of the above-mentioned projects
Regarding the company’s losses from terminating the above-mentioned projects, Biotech frankly, in addition to the BAT8003 project’s cumulative R&D investment of 61.
65 million yuan (as of December 2020), and the BAT1306 project’s cumulative R&D investment of 51.
974 million yuan (as of December 2020), it may also cause The company lost its competitive position in the aforementioned markets
Biotech announced on February 8 that it had terminated the clinical development of the HER2 ADC project BAT8001 for breast cancer.
The previous research and development investment totaled 226 million yuan
In addition to the two projects terminated this time, the cumulative R&D investment loss is 340 million yuan