What are the specific reasons for the ban on the sale of Fezonatant in China?

Fezolinetant is a non-hormonal selective neurokinin 3 receptor antagonist, mainly used to treat vasomotor symptoms caused by estrogen decline in postmenopausal women, especially hot flashes and night sweats. This type of symptom is one of the most common manifestations in menopausal women and often seriously affects sleep quality, emotional stability and daily life functions. Unlike traditional hormone replacement therapy (HRT), fizolinatant does not contain estrogen or progesterone. It inhibits the excessive stimulation of neurokinin B (NKB) to the hypothalamic temperature regulation center, thereby effectively relieving hot flashes and sweating problems, and provides a new alternative for patients who are unable or unwilling to receive hormone therapy.

Currently, Fezonatant has been approved for marketing in the United States and some European countries under the trade nameVeozah. Overseas clinical data show that it has significant effects in reducing the frequency and intensity of moderate to severe hot flashes and is generally well tolerated. However, despite the gradual advancement in foreign markets, the drug has not yet been approved by the State Food and Drug Administration for marketing in mainland China, which has also caused many patients to pay attention to the reasons for the "ban on sale". In fact, fezonatant is not "banned" in China, but the registration and approval process has not yet been completed. Current public information shows that there is no indication that the drug has been banned from sale in China due to safety or ethical issues.

Another point worth noting is that fezonatant is positioned as a non-hormonal drug. This is a relatively new mechanism in the world. The awareness of domestic clinicians and patients is still low. Before the local market promotion strategy is clear, pharmaceutical companies may be in a wait-and-see state. In addition, relevant departments may also remain cautious about its long-term safety, especially its impact on liver function, during the review period.

Reference materials:https://www.veozah.com/