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Home > News > Policy & Regulation > Jimin's innovative polycystic kidney disease innovative drug was approved by the FDA for clinical trials

Jimin's innovative polycystic kidney disease innovative drug was approved by the FDA for clinical trials

yaozh.com 2023-01-11

Jimin Trust Group recently announced that its subsidiary Shanghai Jiyu Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Shanghai Jiyu") has been approved by the US FDA for the innovative drug JMKX003142 oral tablet new drug application (IND), agreeing to carry out clinical trials of the drug in patients with polycystic kidney disease indications.

 

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Autosomal dominant polycystic kidney (ADPKD) is often found in middle adolescence, with an incidence of about 1/400 – 1/1000, and is expected to have 12.5 million patients worldwide and 1.5 million patients in China. [1] Due to the lack of targeted therapeutic drugs, about 40-50% of these patients will develop end-stage renal disease and have to undergo dialysis or kidney transplantation, which puts a greater burden on the patient's family and society.

 

JMKX003142, independently developed by Shanghai Jiyu Small Molecule Innovation Institute, is the first innovative drug research and development project for polycystic kidney disease in China, with the world's best (BIC) potential. Preclinical animal efficacy studies and safety evaluation showed that JMKX003142 can inhibit the proliferation of LLC-PK1 cells in a dose-dependent manner and inhibit the volume of human ADPKD renal vesicle cells, avoiding the side effects caused by the Hook effect of other drugs (high concentration promotes proliferation), and has differentiated global competitiveness.

 

It is understood that JMKX003142 will carry out clinical trials in many places in the near future. It is hoped that in the near future, the drug will become a boon for the majority of ADPKD patients and change the situation in which no drug is available.

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