Celsion Corporation, an oncology drug-development company based in Lawrenceville, New Jersey, has signed a long-term technology transfer, manufacturing, and commercial supply agreement for the greater China territory with Zhejiang Hisun Pharmaceutical Co., based in Taizhou, Zhejiang, China for the technology transfer relating to the clinical and commercial manufacture and supply of Celsion's anti-cancer drug candidate, GEN-1, a gene-mediated, interleukin-12 (IL-12) immunotherapy. The agreement includes the option to expand into other countries in the rest of the world after all necessary regulatory approvals are in effect. GEN-1 is currently being evaluated by Celsion in first-line ovarian cancer patients.

The agreement will help to support supply for both ongoing and planned clinical studies in the US and for potential future studies of GEN-1 in China. Celsion will provide Hisun a certain percentage of China’s commercial unit demand, and, separately, a certain percentage of global commercial unit demand, subject to regulatory approval. The two companies will begin technology-transfer activities relating to the manufacture of GEN-1, including all studies required by the China Food and Drug Administration (CFDA) for site approval. Hisun will also collaborate with Celsion around the regulatory approval activities for GEN-1 with the CFDA.

This expanded partnership deal follows a long-term commercial supply agreement formed by the two companies in June 2012 for the production of ThermoDox, Celsion’s heat-activated liposomal encapsulation of doxorubicin, an anti-cancer therapy. In July 2013, the ThermoDox collaboration was expanded to focus on liposomal formulation development. During 2015, Hisun completed the manufacture of three registration batches for ThermoDox and has obtained regulatory approvals to supply ThermoDox to participating clinical trial sites in Southeast Asia, Europe, and North America as well as to the European Union countries.

Source: Celsion