A comprehensive analysis of whether Cemiplimab is an imported drug or a domestic drug

Cemiplimab is a PD-1 immune checkpoint inhibitor jointly developed by Regeneron Pharmaceuticals and Sanofi. It is a typical imported original drug. It was first approved by the FDA in the United States in 2018 for the treatment of advanced solid tumors such as cutaneous squamous cell carcinoma. Subsequent indications have gradually expanded to non-small cell lung cancer and other cancer types. Because this drug has a clear tumor immune mechanism, it has become one of the key innovative drugs in the international cancer treatment field in recent years.

As of2025, cimepilimab has not yet been officially approved for marketing in mainland China. Therefore, the drug cannot be purchased through regular channels in domestic hospitals or pharmacies, and it has not yet been included in the Chinese Medical Insurance List. This means that if domestic patients need to use cimepilimab, they can only obtain it through overseas medical services, purchasing it at their own expense or participating in international clinical trials. Since it cannot be reimbursed by medical insurance, its use threshold is high and it is only suitable for patients with better economic conditions or special conditions.

Currently, cimepilimab is mainly sold in overseas markets in the form of the US version and the European version of the original drug, with a common specification of 350mg/7mL (concentration of 50mg/mL). According to public information and purchase quotations, the price of each box may be between RMB 40,000 and RMB 100,000. Price fluctuations are mainly affected by market supply and demand, international exchange rates and logistics costs. Since no generic version of this drug has been approved for marketing, there is no more affordable alternative at this stage, and the cost of medication for patients is high.

Overall, cimepilimab, as an imported original drug, has not yet entered the Chinese market and medical insurance system, and its domestic accessibility is low and its price is high. If it can be approved for marketing in China and included in medical insurance in the future, it is expected to improve the medication burden and treatment options for domestic patients. Prior to this, patients in need are advised to consult doctors through formal medical channels to avoid the risks of drug use caused by purchasing drugs through informal channels.

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