Research into the reasons why Gefapixant Citrate is not on the market

Gefapixant Citrate (Gefapixant Citrate) is a new P2X3 receptor antagonist, mainly used to treat refractory or unexplained chronic cough (Chronic Cough, RCC/UCC) in adults. As the world's first innovative drug targeting the mechanism of chronic cough, it has been approved for marketing in many overseas countries. However, Gemfapixin has not yet been launched in China. The specific reasons involve many factors such as drug approval, clinical data review and market strategy.

Domestic drug regulatory authorities have very high requirements for clinical data, safety and effectiveness of new drugs. Although overseas clinical trials have shown that Gemfapixin has certain efficacy in patients with refractory chronic cough, the domestic registration application has not been completed or is under review. Drugs need to be verified with complete registration clinical trial data, including efficacy and safety evaluation in Asian populations or Chinese patients, to ensure that the data can be used in the domestic market.

As an original and innovative drug, the price of Gemfapisin is generally high overseas. This faces multiple considerations such as medical insurance coverage, affordability and drug accessibility in the domestic market. Domestic marketed drugs usually need to strike a balance between drug prices, medical insurance negotiations and accessibility. However, Gemfapixin has not yet completed the relevant strategic layout, so the launch time has not yet been determined.

In addition, the market strategies of pharmaceutical companies also affect the pace of listing. Gemfapixin targets a relatively new treatment field of chronic cough, with a limited patient base and awareness. Pharmaceutical companies may want to complete more clinical studies or conduct market education before promoting it domestically to ensure that the drug can gain reasonable market acceptance after it is officially launched.

Generally speaking, the failure of Gemfapixin to be launched in China is not a problem of drug efficacy, but is affected by multiple factors such as approval process, clinical data verification, medical insurance reimbursement and market strategy.

Reference materials:https://synapse.patsnap.com