Breakthrough Drug pUDK HGF: Light for Lower Limb Ischemia Patients

Good news! Humanwell Healthcare and Yaohai Bio-Pharma jointly submitted a BLA for pUDK HGF

On December 4th, according to the CDE website, Humanwell Healthcare and Yaohai Bio-Pharma jointly submitted a biologics license application (BLA) for pUDK hepatocyte growth factor (HGF), a Class 1 new drug recombinant plasmid-hepatocyte growth factor injection. The presumed indication is resting pain in limbs caused by severe lower limb ischemia.

pUDK HGF: A Revolutionary Therapeutic Biological Product

pUDK HGF is a Class 1 new therapeutic biological product with fully independent intellectual property rights and is also the first plasmid DNA drug to enter clinical trials in China. This drug is a biological product with an expression plasmid as the carrier and HGF as the therapeutic gene.

HGF, by binding to the specific membrane receptor c-met, phosphorylates the tyrosine residues of the Met receptor, thereby promoting cell growth and neovascularization.

Phase III Clinical Trial Results and Safety Profile of pUDK-HGF

In October 2024, at the CCVS conference, positive results from a Phase III clinical trial (CTR20181274) of pUDK HGF were announced. The study results showed that, compared to the placebo group, subjects receiving pUDK-HGF began to show efficacy after 60 days of administration; after 180 days of administration, the proportion of subjects with complete pain resolution significantly increased in the pUDK-HGF group. Compared to the placebo group, subjects in the pUDK-HGF group had a significantly shorter average time to complete pain resolution, with a 25.99-day advancement.

In terms of safety, the incidence of adverse reactions to pUDK-HGF was less than 1%, with severity levels ranging from 1 to 2, and there was no significant difference compared to the placebo.

Future Development

Regarding the progress of research and development, pUDK-HGF is continuously expanding into new indications. Among them, peripheral artery occlusive disease, ischemic leg ulcers, and resting pain have all been approved for clinical trials in 2021.

About Humanwell Healthcare

Humanwell Healthcare, founded in 1993, has emerged as a leading integrated healthcare solutions provider serving more than 70 countries. As the Asian market leader in anesthetics/analgesics, fertility drugs, and Uyghur medicine, and a significant player in treating central nervous system (CNS), respiratory, and dermatological diseases in China, Humanwell Healthcare offers top-quality products and solutions at affordable prices. With a core value of integrity, equality, and humanity, the company strives to enhance global healthcare.

About Yaohai Bio-Pharma

Yaohai Bio-Pharma, established in 2010, is a leading CRDMO service provider specializing in microbial expression systems and a national high-tech enterprise. Its business focuses on areas such as recombinant proteins/peptides, recombinant plasmids and novel vaccines, nanobodies, and nucleic acid drugs, aiming to build an open and integrated CRO/CDMO/MAH production and research service platform

We are also actively seeking institutional or individual global partners. We offer the most competitive compensation in the industry. If you have any questions, please feel free to contact us: [email protected]