Ascletis-B receives ITC's preliminary ruling on legal proceedings involving ASC41 and ASC43F
Ascletis-B received a preliminary ruling from the United States International Trade Commission (ITC) on its candidate drugs ASC41 and ASC43F, stating that their importation into the United States violates Section 337 of the 1930 Tariff Act. The ITC recommended a 7-year import ban on these two drugs. The company stated that the lawsuit will not have a significant impact on its operations, expressed objections to the preliminary ruling, and is evaluating follow-up measures. The ITC is expected to make a final decision within four months
According to the news from Zhitong Finance and Economics APP, Ascletis-B (01672) announced that it is involved in a legal dispute with Viking Therapeutics, Inc. (Viking), a pharmaceutical company based in the United States. On December 29, 2022, Viking filed a complaint with the United States International Trade Commission (ITC) in Washington, D.C., requesting the ITC to prohibit the importation of the company's candidate drugs ASC41 and ASC43F produced outside the United States (such as in China) for clinical development and commercialization in the United States.
On October 4, 2024, the company received a preliminary ruling (initial ruling) from the ITC regarding the complaint. The Administrative Law Judge of the ITC ruled that the importation of the company's candidate drugs ASC41 and ASC43F into the United States violates Section 337 of the Tariff Act of 1930 (as amended). The judge who issued the initial ruling also recommended that the ITC issue an injunction against the importation of ASC41 and ASC43F produced outside the United States (such as in China) into the United States for a period of 7 years (until 2031), and Viking should report on the development progress of its candidate drug VK2809 as required. This means that if Viking stops the development of VK2809, the import ban on ASC41 and ASC43F will be lifted ahead of schedule.
Since the complaint filed by Viking with the ITC does not involve any monetary compensation, the company believes that the complaint will not have any significant adverse impact on the group. The company's current business operations are proceeding as usual.
The company has objections to the initial ruling of the judge and is reviewing the ruling and discussing with its legal advisors to assess the measures that can be taken, including but not limited to requesting a review by the ITC and overturning the initial ruling.
As of the date of this announcement, the ITC is reviewing the above recommendations made by the judge and is expected to make a final ruling in approximately four months.
ASC41 is an orally administered tablet developed independently by the company using its own technology, targeting the thyroid hormone receptor β (THRβ) for the treatment of non-alcoholic steatohepatitis (NASH). ASC43F is a dual-target fixed-dose combination (FDC) oral tablet developed independently by the company using its own technology, targeting THRβ and farnesoid X receptor (FXR) for the treatment of NASH. Previously, ASC41 and ASC43F produced in China were imported into the United States for clinical trials and did not pose any threat or harm to Viking, as Viking's VK2809 is still a candidate drug in the clinical stage, and the commercialization of VK2809 still faces many clinical and regulatory obstacles, as well as competition from other NASH drugs (such as GLP-1 drugs)
