China-based Jiangsu Hengrui Pharmaceutials (SHA: 600276) has announced that a market filing for its Category 1 biologic product, SHR-1209, has been accepted for review by the National Medical Products Administration (NMPA). The product is intended to treat hypercholesterolemia, a condition characterized by high levels of cholesterol in the blood.
Phase III Studies and Filing Basis
The filing is supported by three multi-center, randomized, double-blind, placebo-controlled Phase III studies, all of which have successfully met pre-set superiority criteria and demonstrated clinically meaningful improvement. This robust clinical trial foundation underscores the potential efficacy and safety of SHR-1209 in managing hypercholesterolemia.
SHR-1209: A Monoclonal Antibody Targeting PCSK9
SHR-1209 is a monoclonal antibody (mAb) that targets PCSK9, a protein that plays a role in regulating cholesterol levels. By inhibiting PCSK9, SHR-1209 has the potential to lower low-density lipoprotein cholesterol (LDL-C) levels, a key factor in the treatment of hypercholesterolemia.
Market Competition and Domestic Developments
Amgen’s Repatha (evolocumab) and Sanofi’s Praluent (alirocumab), both PCSK9 inhibitors, are already marketed in China. Domestic biotechs are also actively developing similar products, including Innovent Bio’s IBI306, Hengrui Medicine’s SHR-1209, Junshi Bio’s JS-002, and Akeso Bio’s AK102. The acceptance of SHR-1209 for review by the NMPA signifies the continued growth and innovation in the domestic biologics sector, offering more treatment options for patients with hypercholesterolemia.-Fineline Info & Tech
