Ascletis Pharma Faces US Import Ban for NASH Drugs ASC41 and ASC43F in Trade Secrets Dispute

Ascletis Pharma Faces US Import Ban for NASH Drugs ASC41 and ASC43F in Trade Secrets Dispute

China’s Ascletis Pharma Inc. (HKG: 1672) is navigating legal proceedings involving its oral thyroid hormone receptor-beta (THRβ) agonist ASC41 and a compound preparation ASC43F, both under development for the treatment of non-alcoholic steatohepatitis (NASH). US-based Viking Therapeutics (NASDAQ: VKTX) filed a lawsuit in the United States against Ascletis in December 2022, alleging theft of trade secrets related to its own THRβ agonist V2809 for NASH treatment and breach of contract. Viking sought to prohibit the import of ASC41 and ASC43F into the US for clinical development and commercialization.

On October 4, the U.S. International Trade Commission (ITC) Administrative Law Judge determined that ASC41 and ASC43F violated Section 337 of the Tariff Act of 1930 and recommended a 7-year ban on the importation of these drugs into the United States. However, Ascletis stated that since Viking’s lawsuit does not involve monetary compensation, it does not anticipate a significant adverse impact.

Ascletis has objected to the preliminary ruling and is currently reviewing it alongside its legal advisors to consider possible measures, such as requesting an ITC review and overturning the preliminary ruling. The ITC is expected to make a final ruling on the judge’s recommendations within approximately four months. – Flcube.com

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