The world's first new drug, Soyuan Bioanti-Oncology, has been qualified by the FDA For rapid review channel.

DB102 is a world-first small molecule serine/suine kinase inhibitor, which acts on key tumor targets in tumor fields such as PKC beta, PI3K and AKT, and has a direct effect on inducing tumor cell death and hindering tumor cell growth, as well as an indirect effect of inhibiting tumor-induced blood vessel generation.
DB102 was originally developed for Lilly for first-line treatment of high-risk diffuse large B-cell lymphoma (DLBCL) and GBM.
acquired DB102 from Lilly, Soyuan Bio completed large-scale genomicanalysis analysis of DB102's PHASE IIIPRELUDE clinical trial samples using its reverse whole gene scanning platform technology, and found a new set of biomarkerSDGM1, which had a significant improvement in the survival of DGM1-positive patients after taking DB102.
based on the above findings, Soyuan Bio has initiated and conducted an international multi-center Phase III clinical trial (ENGINE study), which has now completed more than 90% of patients enrolled in the group.
DB102 international multicenter Phase III clinical trial for GBM for the treatment of new diagnoses, has also been approved by the U.S. FDA and the National Drug Administration of China (NMPA) and will be launched this year.
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