Hangzhou Dingle Xinwei Biotech has selected CDMO Hongene Biotech Corporation to advance DNV001.
Through this agreement, Hongene will be responsible for raw material supply of the novel GalNAc-conjugated siRNA, as well as chemoenzymatic synthesis process development, drug substance and drug product manufacturing and regulatory documentation.
The therapeutic, which is designed to treat dyslipidaemia, recently received investigational new drug (IND) clearance from China's drug evaluation body.
Hongene has also been instrumental in DNV001's progression from preclinical to clinical phase, with the company providing both development and manufacturing services to Hangzhou.
DNV001 is designed to reduce low-density lipoprotein cholesterol (LDL-C) by silencing the expression of PCSK9 in liver cells.
By utilising Hongene's proprietary chemoenzymatic synthesis platform, the project achieved high-purity, clinical-grade batches with enhanced scalability and reduced downstream complexity.
"What differentiates Hongene is our vertically integrated platform, strategic investments in advanced technologies such as chemoenzymatic ligation, and our scalable manufacturing — all of which enable the accelerated, high-purity, and cost-efficient production of RNA-based therapeutics,” said Dr. David Butler, Chief Technology Officer at Hongene.
“The scalability and efficiency of our chemoenzymatic technology translates directly into lower production costs and simplified development,” said Dr. Butler. “This is critical for delivering large volumes of next-generation RNA therapeutics that meet global access and pricing expectations.”
Preclinical studies indicate that DNV001 offers durable lipid-lowering efficacy with just two injections per year.
The candidate demonstrated pharmacological activity comparable to a competitor’s in vitro and in vivo, including dose-dependent reductions in PCSK9 and LDL-C in animal models.
“Our work on DNV001 exemplifies Hongene’s commitment to scientific rigor and manufacturing innovation,” said Dr. Butler. “We look forward to collaborating with other partners to bring their transformative medicines to market.”
Hongene’s vertically integrated CDMO services cover a range of oligonucleotide formats, including siRNAs, sgRNAs, antisense oligonucleotides (ASOs), aptamers, phosphorodiamidate morpholino oligomers (PMOs), and conjugates, supporting programs from early research through to commercial launch.
