Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that a market filing for its investigational omecamtiv mecarbil has been accepted for review by the Center for Drug Evaluation (CDE). The small molecule is a potential first-in-class cardiac myosin activator being developed as a treatment for heart failure with reduced ejection fraction (HFrEF).
Partnership and Development Rights
In December last year, Ji Xing Pharma struck a USD 400 million deal with US-based Cytokinetics Inc. (NASDAQ: CYTK), securing development and commercialization rights to the drug targeting HFrEF in Greater China. This strategic partnership aims to accelerate the development and availability of omecamtiv mecarbil in the region.
Drug Profile and Clinical Trials
Omecamtiv mecarbil directly targets the heart’s contraction mechanism, increasing the number of cardiac myosin head regions interacting with actin during contraction. The Phase III GALACTIC-HF study demonstrated that, compared to a placebo, omecamtiv mecarbil effectively reduces the risk of cardiovascular death or heart failure events (heart failure hospitalization and other emergency treatments for heart failure) in patients receiving standard treatment, with a good safety profile.
Regulatory Progress
The drug is currently awaiting regulatory decisions in the US, with a market filing made in February this year. The acceptance of the market filing by the CDE marks a significant step forward in making omecamtiv mecarbil available to patients in China, potentially improving treatment options for those with HFrEF.-Fineline Info & Tech
