Salubris's cholesterol drug application accepted for review

Shenzhen Salubris Pharmaceuticals announced that the marketing application for its Class 1 biological drug, Tai Kesi Xidan Monoclonal Antibody Injection (project code: SAL003), has been accepted by the National Medical Products Administration. The drug is intended for the treatment of high cholesterol and mixed dyslipidemia.

SAL003 is a recombinant fully human anti-PCSK9 monoclonal antibody developed independently by Salubris. If approved, this drug offers a potential improvement in patient convenience and adherence, as it is administered once every four weeks via a single subcutaneous injection. Some existing PCSK9 monoclonal antibodies require multiple injections or sterile compounding for the same frequency.

The company noted that the drug development process is lengthy and carries inherent risks, with no guarantee of market approval. Salubris will provide updates on future progress as required, urging investors to exercise caution.