On September 18, 2020, Salubris received the Notice of Approval of Clinical Trials from National Medical
Products Administration, which grants Salubris to carry out clinical trials
with "Recombinant fusion protein consisting of a fully human
immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the
human growth factor NRG-1". The therapeutic indication of SAL007 is to
treat chronic heart failure with reduced ejection fraction (NYHA II-III).
Recombinant fusion protein consisting of a fully
human immunoglobulin G1 monoclonal antibody and an active polypeptide fragment
of the human growth factor NRG-1 (project code: SAL007, JK07) is an NRG-1
(Neuregulin-1) fusion antibody drug which is independently developed by Salubris
Biotherapeutics, Inc. and has global intellectual property rights. The
indication to be developed is chronic heart failure. SAL007 IND is the first innovative biologics filed by
Salubris in China and the United States. It was also granted by FDA for a clinical
trial in February 2020, and is currently undergoing human clinical trial in the
United States.
NRG-1 is a protein containing epidermoid growth factor domain, which regulates cell growth and differentiation by activating tyrosine kinase protein receptors (HER3, HER4), including an important role in the normal development and function of nervous system and heart. SAL007 has a unique molecular design, which blocks the function of HER3 receptor without affecting the activation of HER4， solves the limitations of recombinant NRG-1 protein therapy, and provides a safe new choice for clinical practice.
Nowadays, there are no approved drugs with the same therapeutic target in China or abroad, thus SAL007 has great market potential. Salubris will carry out clinical trials according to the relevant regulations and requirements, and submit a new drug application after successful clinical trials. SAL007 is expected to provide a new choice for the treatment of chronic heart failure, and bring hope to patients with chronic heart failure.
