The Chinese patent authority has granted approval for Medivir’s patent application for fostroxacitabine bralpamide (Fostrox).
The patent covers substance claims for Fostrox as well as its use to treat liver cancer.
It will remain valid until 2035 and is expected to be extended up to five years after that in important markets.
The company already holds patents for Fostrox in the EU, Japan, the US and a number of other countries, mainly in Asia.
The drug has been designed for the selective treatment of liver cancers and for minimising the treatment’s side effects.
It is being developed as an orally administrated drug to treat patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.
The US Food and Drug Administration has already granted orphan drug designation to Fostrox for HCC treatment, and the European Medicines Agency has issued a positive opinion on orphan medicinal drug designation.
The company has already completed a Phase Ib monotherapy trial of the drug.
A combination trial of Fostrox in HCC patients is currently underway.
Medivir CEO Jens Lindberg stated: “This important patent approval in the largest HCC market, combined with our exciting clinical data from the ongoing Phase Ib/IIa study with Fostrox, are key components to enable in-depth discussions with potential partners in China and other countries in Asia.”
Approximately 42,000 patients in the US are diagnosed with primary liver cancer each year.
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