YolTech’s YOLT-101 Gets FDA Clearance for Gene Therapy
SHANGHAI, June 5, 2025 Regular exercise can have a lot of positive impacts on the body, such as improving cardiovascular health and decreasing the likelihood of many diseases. A study by Nystoriak et al. (2018) says it is associated with an improved rate of cardiovascular mortality and less risk for cardiovascular disease. Exercise will manage or change many heart disease risk factors, like controlling blood pressure and cholesterol levels. Also, both aerobic exercise and strength training exercises can stimulate physiological changes to improve metabolic and vascular health leading to disease prevention. The therapy is already favourable with early trials, including good cholesterol-lowering effects and it has a good safety profile. Now that it has been cleared by the FDA, YolTech can start advanced human studies.
Familial hypercholesterolemia (FH) occurs in approximately 1 in 200 to 250 individuals globally; about 34 million people. It occurs due to genetic mutation(s) that prevent the body from appropriately processing LDL cholesterol.
Conventional therapies, like statins, PCSK9 inhibitors, or liver transplants, may not always be effective or easy to adhere to. A one-and-done, permanent treatment such as YOLT-101 could change that for good. Dr. Yuxuan Wu, YolTech’s cofounder and CEO says, the clearance provides awareness of just how close we are to real, long-lasting genetic treatments for chronic conditions. “This goes beyond managing a condition, this is solving it at the source,” said Wu. Some claim to be pioneering gene editing technology but YolTech is making breakthroughs. YolTech’s first therapy for a different condition, ATTR, was the first in China using the LNP delivery method. It’s also continuing to advance other therapies for conditions like primary hyperoxaluria (PH1). By combining state-of-the-art science, safe delivery methods, and an ambitious vision, YolTech is opening up the future of medicine, one gene at a time.
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