August 9, 2025
Source: drugdu
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On August 7, Bio-Thera(688177) issued an announcement that the company recently received the "Notice of Approval for Drug Clinical Trial" approved and issued by the National Medical Products Administration, approving the clinical trial application for BAT1308 injection combined with BAT4706 injection and BAT8008 injection for the treatment of advanced solid tumors.
According to the announcement, BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by the company, BAT4706 injection is an optimized IgG1 fully human monoclonal antibody targeting CTLA-4, and BAT8008 is an antibody-drug conjugate (ADC) targeting Trop2.
The announcement stated that BAT1308 Injection, BAT4706 Injection, and BAT8008 Injection all met the relevant drug registration requirements and were approved for clinical trials. According to relevant data, Phase I/II clinical trials for anti-cancer drugs typically last approximately two years. The rate of progression from Phase I completion to Phase II is approximately 48.8%, while the rate of progression from Phase II completion to Phase III is approximately 24.6%. The announcement reminds investors that drug development and clinical trials are subject to numerous uncertainties and require careful decision-making and awareness of investment risks.
In the first quarter of 2025, Bio-thera achieved revenue of 207 million yuan and a net profit attributable to shareholders of the parent company of -93.33 million yuan.
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