Reasons why fezolinetant is banned in China

Fezolinetant is a new type of non-hormonal therapeutic drug, mainly used to relieve moderate to severe vasomotor symptoms in postmenopausal women, namely the common "hot flashes" or "night sweats" in menopause. This drug was developed by Japan's Astellas Pharma. It is a neurokinin 3 receptor antagonist (NK3R antagonist). Its mechanism of action is different from traditional hormone replacement therapy. It can directly act on the central nervous system and regulate the body temperature control center, thereby improving menopausal-related symptoms. However, as of now, Fezonatant has not been approved for marketing in mainland China, nor has it obtained sales permission from the State Food and Drug Administration.

Before being marketed in China, drugs need to go through a strict registration review process, including pharmaceutical research, non-clinical safety verification, and submission of clinical trial data for the Chinese population. Although Fezonatant has been approved in the United States, Japan and Europe, it has not yet completed local verification of clinical data in China. In addition, Chinese regulators often focus on the safety of drugs in terms of liver function. Reversible increases in liver function indicators were observed in some patients in early clinical trials of Fezonatant. This adverse event prompted the FDA to require liver function monitoring before and during use. Therefore, during the approval stage in China, regulatory authorities may require further pharmacokinetic and safety data to ensure the safety of the drug suitable for the Chinese population.

On the other hand, from the perspective of market access, fezonatant is a prescription-grade innovative drug with a long R&D cycle, high cost, and relatively niche market positioning. For manufacturers, whether to initiate registration in China is also related to business strategy. Astellas Pharmaceuticals' current key products in China are still concentrated in the fields of urinary system, oncology and immunotherapy, so the filing progress of fezonatant is relatively lagging behind.

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