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Celsion and Zhejiang Hisun Pharma Form Pact

Sign tech transfer, manufacturing and commercial supply agreement for the development of GEN-1 immuno-oncology therapy

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Oncology drug development company Celsion Corporation (www.celsion.com) has signed a long-term technology transfer, manufacturing and commercial supply agreement with Zhejiang Hisun Pharmaceutical (en.huahaipharm.com), a leading pharmaceutical company in China, to pursue an expanded partnership for the technology transfer relating to the clinical and commercial manufacture and supply of GEN-1, Celsion’s proprietary gene mediated, IL-12 immunotherapy, for the greater China territory, with 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 U.S., and for potential future studies of GEN-1 in China. Hisun is one of the largest manufacturers of oncology agents globally, including ThermoDox, Celsion’s heated activated liposomal dosage form of doxorubicin, and is also a leading manufacturer for multinational pharmaceutical companies.

“Hisun has already proven itself to be an exceptional partner through our existing ThermoDox collaboration, and has been the source of high quality, cost-effective manufacturing,” said Michael Tardugno, chairman, president and chief executive officer, Celsion. “We are delighted to have the opportunity to expand our relationship, and to further harness their state-of-the-art manufacturing expertise and facilities through this newly established GEN-1 agreement.

Celsion’s partnership with Hisun serves multiple strategic purposes towards successful GEN-1 approval and eventual product launch both in China and internationally.

“Hisun’s expertise may provide an advantage when seeking China Food and Drug Administration (CFDA) approval, as well as securing a long-term supply for one of the largest markets for ThermoDox in the world,” said Mr. Tardugno.

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