Novartis Submits Clinical Application in China for TQJ230, a Novel RNA-Targeted Therapy for Elevated Lipoprotein(a)

On January 8, the Center for Drug Evaluation (CDE) accepted Novartis’s clinical trial application for TQJ230 injection. Currently, this drug is in global Phase III clinical trials. If approved, it will become the first-in-class therapy specifically targeting elevated lipoprotein(a).

TQJ230, formerly known as AKCEA-APO(a)-LRx, is an investigational drug from Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, targeted for cardiovascular therapy. TQJ230 was discovered by Ionis Pharmaceuticals and has been jointly developed with Akcea Therapeutics to date. Novartis is now responsible for the global development and commercialization of this drug.

Lipoprotein(a) is a type of lipoprotein in the blood. High levels of lipoprotein(a) accumulate in the arteries, causing them to gradually narrow and restrict blood supply to the heart, brain, kidneys, and legs, thereby increasing the risk of coronary heart disease, atherosclerosis, thrombosis, and stroke.

Millions of people worldwide have elevated lipoprotein(a) levels, an independent risk factor for hereditary cardiovascular disease. It is estimated that 20–30% of patients with cardiovascular disease also have elevated lipoprotein(a) [Lp(a)] levels. Currently, there are no specific treatments to lower high lipoprotein(a) levels, and dietary or other lifestyle modifications do not effectively reduce lipoprotein(a) concentrations.

A Phase II study presented at the 2018 AHA Scientific Sessions demonstrated that TQJ230 significantly reduced lipoprotein(a) levels in patients with elevated lipoprotein(a) and established cardiovascular disease.