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Recently, Salubris announced that JK07, independently developed by its subsidiary Salubris Biotherapeutics, Inc., was approved by NMPA to carry out Phase II clinical trial in adults with chronic heart failure (RENEU-HF).

JK07 (Recombinant human neuregulin 1 (NRG-1) -anti-HER3 antibody fusion protein injection, original domestic project code: SAL007), independently developed by Salubris, is an NRG-1 fusion antibody drug with global intellectual property rights. It is the first selective ErbB4 agonist to enter the clinical development stage in the field of heart failure. The proposed indication is for the treatment of chronic heart failure in adults. 

As the first Sino-American innovative biologics of Salubris, this product is planned to carry out an international multi-center clinical trial in the United States, China and Canada. The results of preclinical study showed that the product has the characteristics of long half-life, good safety profile and great development potential.

The successful launch of JK07 will provide patients with more medical options to meet unmet clinical needs.

Source:

1. Clinicaltrials.gov in April 2024

Related information

About NRG-1

NRG-1 is a group of proteins containing the epidermoid growth factor domain, which regulates cell growth and differentiation by activating tyrosine kinase protein receptors (HER3, HER4), and plays an important role in the normal development and function of the nervous system and heart. The unique design of JK07 solves the limitations of recombinant NRG-1 protein therapy, blocks the function of HER3 receptor without affecting the activation of HER4, and greatly improves the druggability and safety of the product.

About heart failure

Heart failure is a serious manifestation or late stage of various heart diseases, which has become an important public health problem affecting the health of residents. Based on a patient's left ventricular ejection fraction (LVEF) level at first evaluation, heart failure can be divided into three basic types: "heart failure with reduced ejection fraction (HFrEF)," "heart failure with mildly reduced ejection fraction (HFmrEF)," and "heart failure with conserved ejection fraction (HFpEF)."