China's Zhejiang Hisun picks up new U.S. deal despite FDA troubles

China

China’s Zhejiang Hisun Pharmaceutical has gotten in progressively hotter water with the FDA but its troubles have not kept it from striking deals globally with other drugmakers, including one this week with New Jersey-based Celsion.

Celsion announced on Tuesday that it has struck a long-term deal for Hisun to handle clinical, and potentially commercial, production of an immuno-oncology product it has under development. Under the deal, Hisun gets commercial rights to the drug in China.

Celsion said 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. It pointed out that Celsion and Hisun already have a deal in which Hisun produces its ThermoDox, a heated activated liposomal dosage form of Johnson & Johnson’s cancer drug Doxil. It said Hisun “is also a leading manufacturer for multinational pharmaceutical companies.”

True. It is a joint venture partner with Pfizer ($PFE). But Hisun also had a plant put on the FDA import alert list in September 2015 and then was issued a warning letter in January. At the time, it excluded tuberculosis treatment capreomycin and 13 others over concerns that shortages might arise. Then in February it updated the order to also exclude daunorubicin HCl, the active pharmaceutical ingredient (API) used in the injected med DaunoXome, because of a "critical drug shortage concern."

That ban was followed by the warning letter in December which faulted the facility for "systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs."

It said its concerns were "heightened by the significant number of customer complaints for subpotency and out-of-specification (OOS) impurity levels the company received from 2012-2014." More than 60 complaints for impurity problems were filed in the two-year period.

Still, Hisun keeps bagging new deals. In June, Tokyo-based Fujifilm licensed the API for the flu drug Avigan (favipiravir) to Zhejiang Hisun. Fuji said the patent license agreement for the API will allow Zhejiang Hisun Pharmaceuticals to develop, produce and market an anti-influenza drug in China in return for an unspecified lump-sum payment and potential royalties if a drug is launched in China.

- here’s the Celsion release

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