|Denovo CSO Wen Luo|
Denovo Biopharma will conduct clinical trials in China for its exclusively licensed pomaglumetad methionil, a late-stage neuroscience drug licensed from Eli Lilly ($LLY), Wen Luo, chief scientific officer of the company told FiercePharmaAsia.
"Yes, that's exactly we are planning to do," Wen said in an email asking if trials would be held in China. "Run a trial in China and get CFDA approval. We have three late stage drugs now."
Wen said the plan is to develop the drug for use in Asia.
"Actually we are a Chinese company, and Denovo Pharma is our U.S. subsidiary. We will bring this drug to re-develop in Asia."
Western firms have watched China's drug approval process warily in the past year as the China FDA moved to review the use of multi-region clinical trials (MRCTs) and lags on in-country approvals.
That in turn has prompted companies to look at other ways to enter the market in China for drugs that require extensive regulatory scrutiny.
In the case of the Denovo license, the company gains all rights to develop, manufacture and commercialize pomaglumetad globally, including transfer of all intellectual property and other rights, data, and information.
"Lilly has an option to re-acquire pomaglumetad upon a successful clinical trial, for predetermined undisclosed financial terms," Denovo said in a release.
Wen managed the genomic group and provided bioinformatic support to a broad range of research projects across a number of therapeutic areas including oncology, hematology, inflammation and metabolic diseases at Ligand Pharmaceuticals before joining Denovo.
He was also responsible for developing clinical biomarkers for drugs in various stages of clinical trials. Before joining Ligand, he was senior bioinformatician at Incyte Genomic, where he managed one of the largest proteomic databases at the time, LifePro.
Pomaglumetad was primarily developed and tested in schizophrenia, including in Phase II and Phase III clinical trials.
Denovo said it will use its proprietary platform to identify genetic biomarkers as a companion diagnostic to screen for appropriate patient subsets in future clinical trials and eventual commercialization.
- here's the release