June-July 2024
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- June-July 2024, Qurgen has successfully manufactured two batches of GMP-scale SON-DP anti-tumor transcription factor protein drug. These batches of the manufactured SON-DP drug met the FDA protein drug quality standard and have been used in the US and China Phase I clinical trials.
- The newly built GMP workshop of Qurgen has been officially put into operation and is capable for mass producting the SON-DP anti-tumor drug – a steadily advancment in the Phase I clinical trials’ success in China and the United States. Qurgen, a global innovative enterprise focusing on the R&D of transcription factor protein drugs, recently announced that it has successfully completed two batches of production of the SON-DP anti-tumor transcription factor protein drug under GMP standards in June-July 2024. Manufactured in strict compliance with FDA quality specifications for protein drugs, the drug batches have been officially deployed for Phase I clinical trials in both the United States and China. SON-DP is a self-developed first-in-class anti-tumor protein drug pioneered by Qurgen. Leveraging a unique transcription factor regulation mechanism, it can effectively transform tumor cells into iPS cells, bringing a brand-new breakthrough for the treatment of advanced solid tumors and demonstrating significant clinical application value. The smooth completion of this standardized GMP mass production marks SON-DP’s successful leap from laboratory research and development to large-scale industrial manufacturing. The GMP workshop provides a stable and compliant drug supply for the synchronized clinical trials in China and the US and also lays a solid foundation for the subsequent clinical development and commercialization of this innovative anti-cancer drug. At present, the Phase I clinical trials of SON-DP in China and the United States are progressing steadily to further verify the safety and efficacy of the drug. Qurgen will continue to accelerate its R&D pace, striving to make this innovative drug benefit cancer patients worldwide at an early date.
