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GNI Group surges on approval filing acceptance for liver fibrosis treatment F351 in China

Wed May 13, 2026 11:10 am JST Catalyst

GNI Group <2160> surged after announcing that Chinese regulators officially accepted a new drug application (NDA) for F351, a liver fibrosis treatment developed by its Nasdaq-listed subsidiary, Gyre Therapeutics . The acceptance notification for the drug, also known as Hydronidone, was issued by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA).

The treatment, which targets liver fibrosis associated with chronic hepatitis B, has already been designated for priority review by the CDE, a status expected to accelerate the approval process compared to standard timelines. GNI Group stated that the impact on its earnings remains under review, as it depends on regulatory progress and the eventual timing of the market launch.

Source: MINKABU PRESS

*Translated by generative AI. Click here for the original article.

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