- Hongene Biotech supported the clinical advancement of DNV001, a GalNAc-conjugated siRNA targeting dyslipidemia, developed by Hangzhou Dingle Xinwei Biotechnology.
- The company provided end-to-end CDMO services, including chemoenzymatic process development, manufacturing, and regulatory support.
Hongene Biotech Corporation, a contract development and manufacturing organisation (CDMO) focused on nucleic acid therapeutics, has played a central role in progressing DNV001, a novel GalNAc-conjugated siRNA therapy developed by Hangzhou Dingle Xinwei Biotechnology. The investigational new drug (IND) application for DNV001 has received clearance from China’s Center for Drug Evaluation.
The therapy targets dyslipidaemia by silencing PCSK9 expression in liver cells, thereby aiming to reduce low-density lipoprotein cholesterol (LDL-C). According to preclinical studies, DNV001 has demonstrated durable lipid-lowering effects, requiring only two injections annually. The compound exhibited dose-dependent pharmacological activity in animal models, comparable to existing therapies.
Hongene supported the project from preclinical stages through to IND clearance by delivering a fully integrated CDMO package. Services included raw material supply, chemoenzymatic synthesis process development, drug substance and drug product manufacturing, and the preparation of regulatory documentation.
“What differentiates Hongene is our vertically integrated platform, strategic investments in advanced technologies such as chemoenzymatic ligation, and our scalable manufacturing infrastructure,” said Dr David Butler, Chief Technology Officer at Hongene.
The company’s CDMO portfolio spans various oligonucleotide formats, including siRNAs, sgRNAs, antisense oligonucleotides, aptamers, and conjugates. Hongene emphasises that its scalable, in-house technologies reduce production costs while supporting the efficient delivery of high-purity clinical-grade RNA therapeutics.
