On April 19, Xinlitai announced that the clinical trial application of the drug recombinant human neuregulin 1-anti-HER3 antibody fusion protein injection (domestic project code: SAL007) has been accepted
.
The application submitted by the company this time is a Phase I clinical trial application of SAL007 for the indication of HFpEF (heart failure with preserved ejection fraction) in chronic heart failure
.
SAL007 (US project code: JK07, hereinafter referred to as "07") is an NRG-1 (neuregulin-1) fusion antibody drug independently developed by Salubris Bio in the United States and has global intellectual property rights.
The intended indication is chronic heart failure
.
This product is the company's first innovative biological drug that is reported in both China and the United States.
It was approved for clinical trials by the US FDA in February 2020, and was approved for clinical trials by China's CDE in September 2020
.
At present, SalubrisBio in the United States is enrolling the second dose group of the HFrEF (heart failure with reduced ejection fraction) phase I clinical trial, and it is expected to complete the enrollment in the near future; at the same time, it is preparing for the initiation of the HFpEF clinical trial
.
A phase I clinical trial of HFrEF is underway in China
.
