Jiangsu QYuns Therapeutics Gets NMPA Green Light for CSU Treatment QX013N

Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its monoclonal antibody (mAb), QX013N. The drug is intended to treat chronic spontaneous urticaria (CSU), a common chronic inflammatory skin condition.

CSU is characterized by the spontaneous appearance of wheals and/or vascular edema on the skin that lasts for more than six weeks. The condition is recurrent and often accompanied by persistent itching or a burning sensation, severely impacting the patient’s quality of life and overall well-being.

QX013N is noted as the first candidate biologic in China to target c-kit, a key regulatory factor of mast cells, which play a central role in CSU. By specifically binding to c-kit, QX013N inhibits the differentiation, maturation, survival, proliferation, and degranulation of mast cells, thereby reducing and depleting their numbers. This targeted approach is expected to be effective in treating mast cell-driven diseases such as CSU.- Flcube.com

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