Novaral TQJ230 injections are declared clinically in China

January 8, the official website of CDE showed that Novartic's domestic clinical application for TQJ230 injection has been accepted by CDE, a specific targeted lipoprotein (a) elevated antisypolytic drug pioneering therapy has started the Chinese market launch process.Specific targeted lipoprotein (a) elevated antonymAntonymic drug is a new drug design method developed in recent years, usually refers to antonym oligonucleotides, that is, based on the principle of complementary base pairing and nucleic acid hybridization principle synthetic DNA or RNA single-strand fragments, by specific binding of the target gene DNA or messenger RNA to inhibit gene expression. Compared with the way traditional drugs directly act on disease-treating proteins, antiseptic drugs act on genes that produce disease-treating proteins, and the potential application of diseases is broad, and has the characteristics of high selectivity and low toxicity.In the body, lipoprotein (a) is a blood lipoprotein, and high levels of lipoprotein (a) greatly increase the risk of coronary heart disease, atherosclerosis, blood clots and stroke. At present, millions of people worldwide suffer from elevated lipoprotein (a), clinically there is no specific treatment to reduce hyperlipidin (a), the need for treatment is urgent.TQJ230, formerly known as AKCEA-APO(a)-LRx, uses Ionis' advanced ligand binding anisotym (LICA) technology to specificly target lipoprotein (a) elevation and inhibit its production process for targeted treatment of cardiovascular disease.

phase II clinical results were positiveIn September 2018, Ionis and its subsidiary Akcea Pharmaceuticals published the results of akCEA-APO(a)-LRx Phase II clinical studies, a randomized, double-blind, placebo-controlled clinical trial designed to evaluate drug-to-drug Increased lipoprotein levels and safety and efficacy in patients with cardiovascular disease ranged from 20 mg to 60 mg, patients were drugged for at least 6 months, and the main endpoint of efficacy was the percentage of baseline change in Lp(a) over 6 months compared to placebo. The results showed that Lp(a) had significant dose dependence reduction compared to placebo at all dose levels, and that the patient's safety and tolerance were good.In November of the same year, AKCEA-APO(a)-LRx Phase II clinical findings were presented at the annual meeting of the American Heart Association (AHA), raising concerns about the reduced effect of lipoprotein (a) in patients with cardiovascular disease.

introduced commercial cooperation with NovarIn February 2019, Novarma acquired the right to develop and commercialize TQJ230 under the authority of Akcea Pharmaceuticals. Under the partnership agreement, Akcea Pharmaceuticals will receive a $150 million milestone payment, 50 percent of which will go to parent company Ionis, while Novarlor will be responsible for further development of TQJ230, including planned Global Phase III cardiovascular outcome research and global commercialization activities following regulatory approval.Phase III Clinical has been initiatedNovarma plans to conduct a Phase III cardiovascular clinical study of TQJ230 to address the unseatable medical needs of the Lp(a) patient population for effective therapeutic drugs.At present, the TQJ230 injection randomized, double-blind, multi-center Phase III clinical trial has been published in Therinical Trials. Public information indicates that the trial will be used in patients with cardiovascular disease (CVD) and elevated Lp(a) levels, with 7,680 subjects to be recruited and a dose of 80 mg in the TQJ230 injection group, with the entire trial expected to end in early April 2024.Multi-party collaboration to promote the commercialization of antiseptic drug pipelinesIn May 2019, Volanesorsen, an antisemical drug developed by Iomis and its subsidiary Akcea Pharmaceuticals, was approved by EMA for complementary treatment outside of diet control for adult patients with familial celiac particulateemia syndrome (FCS).As a global leader in antisal drug development, Ionis has accumulated a number of First-in-class or Best-in-class drugs in its product pipeline, and the company has actively promoted the commercialization of its products under development through enhanced cooperation with major pharmaceutical giants. Working with Novartic to promote the late development of TQJ230 is part of its product development strategy, Ionis has reached a cooperation agreement with Pfizer, Roche and other giants, the future will be expected to witness a number of the company's research and development of antisythetic drugs on the market. (cphipharma.co.).