Taizhou-based Zhejiang Hisun Pharmaceuticals will handle greater China development to commercialization on ovarian immuno-oncology prospect GEN-1 from Celsion in an expanded partnership aimed at lower costs and quicker approvals.
The effort includes a technology transfer agreement to Zhejiang Hisun, which has a joint venture with Pfizer ($PFE) in China, Hisun-Pfizer Pharmaceuticals. The company is currently facing heat from U.S. FDA for manufacturing violations.
In a release, Celsion said the mediated, IL-12 immunotherapy pact would start with greater China--which includes Hong Kong and Macau--and possibly expand if regulatory approvals are obtained.
Financial terms were not detailed, but Celsion said the expanded agreement is aimed at lower costs for clinical supplies of GEN-1 compared to current providers. In return, Zhejiang Hisun would receive an unspecified percentage of China’s commercial unit demand, as well as global commercial unit demand, if the candidate reaches approval.
"The agreement will help to support supply for both ongoing and planned clinical studies in the United States, and for potential future studies of GEN-1 in China," the release said.
In March, Celsion announced an Optima study in China related to its ThermoDox candidate via work with Hisun, which it said in the release was possibly key for regulatory approval. The same focus applies to GEN-1.
"Hisun’s expertise may provide an advantage when seeking China Food and Drug Administration approval," Michael H. Tardugno, chairman, CEO and president, said in a statement.
- here's the release