Celsion Corp. has signed a long-term commercial supply agreement with Zhejiang Hisun Pharmaceutical Co. Ltd. for the production of ThermoDox, Celsion’s heat-activated liposomal encapsulation of doxorubicin.
The agreement will initially be limited to China, with Hisun retaining an option for global supply after local regulatory approvals in China. Hisun will collaborate with Celsion for the regulatory approval of ThermoDox in China.
“Our partnership with Hisun serves multiple strategic purposes towards successful ThermoDox drug approval and eventual product launch both in China and internationally. Hisun’s expertise will provide an advantage to seeking China SFDA approval, as well as securing a long-term supply for one of the largest markets for ThermoDox in the world,” said Michael H. Tardugno, Celsion’s president and chief executive officer. “In addition, this partnership brings a timely investment for the expansion of our manufacturing and CMC efforts, accelerating our drug development program. As one of the largest suppliers of doxorubicin, Hisun represents an ideal strategic partner.”
Hua Bai, chief executive officer and chairman of Hisun, said, “I can say unequivocally that Hisun is delighted to be a partner of choice for Celsion and to participate in the potential that ThermoDox represents in addressing a significant public health issue in China. Our team is excited to formalize this long-term commercial supply agreement. We are particularly interested in continuing our transition from a traditional generics business to a branded oncology franchise. With the wide prevalence of liver cancer in China, we look forward to supplying ThermoDox for this vast territory.”