Description of the launch time and approval progress of Ritlecitinib in China

Ritlecitinib is an oral JAK3/TEC dual kinase inhibitor developed by Pfizer. It is mainly used to treat autoimmune diseases such as Alopecia Areata. It reduces hair follicle damage and promotes hair growth by selectively inhibiting the over-activated JAK signaling pathway in the immune system. The drug was approved by the US FDA for marketing in 2023, becoming the first oral small molecule targeted drug specifically used to treat moderate to severe alopecia areata, with the trade name Litfulo. Due to its unique mechanism of action and good clinical tolerance, Ritlecitinib has quickly attracted widespread attention around the world and has become an important breakthrough in the fields of dermatology and immunomodulation in recent years.

In China, Pfizer China is responsible for submitting the registration application for ritexitinib. The National Medical Products Administration (NMPA) has officially approved its domestic marketing in early 2025. It is mainly suitable for patients aged 12 and above with moderate to severe alopecia areata. This approval marks China’s official entry into the era of targeted alopecia areata treatment. The drug is currently sold online in some domestic tertiary hospitals and large pharmacy channels, but it has not yet been included in the medical insurance catalog. Clinicians usually determine whether Ritlecitinib is suitable for use based on the patient's degree of hair loss, previous treatment response, and individual constitution. At the same time, domestic medical institutions are also actively promoting real-world efficacy research on Asian populations to further evaluate its long-term safety and stability of treatment response.

According to current market information, ritexitinib has been launched in China, but has not yet been included in the scope of medical insurance reimbursement. Patients can purchase it at some tertiary hospital pharmacies or Pfizer-authorized online pharmacies with a doctor's prescription. The domestic price is about more than 3,000 yuan. The specific price will vary slightly depending on the region, channel and packaging specifications. In foreign markets, the price of the original European version of rituxitinib is about more than 10,000 yuan, which is relatively high. In overseas channels, the Lao version of generic drugs is more affordable due to its low production cost, about more than 1,000 yuan per box, and the drug ingredients are basically the same as the original drugs. However, if patients purchase through overseas channels, they should choose regular cross-border pharmacies or international patient assistance channels to ensure the quality and legality of the drugs and avoid purchasing unsupervised counterfeit products.
The launch of ritexitinib brings new hope for the treatment of alopecia areata and provides a scientific solution for patients who have long been troubled by traditional treatments that are ineffective. Clinical studies have shown that after 24 weeks of treatment, more than 40% of patients experienced significant hair regrowth, and some patients regained significant appearance improvement within 1 year. Although the drug is well tolerated, some patients may still experience reactions such as mild headache, fatigue, elevated liver enzymes, or mild infection. Therefore, it is recommended to regularly monitor liver function and immune status under the guidance of a doctor. Looking to the future, with the accumulation of real-world research and the advancement of medical insurance access negotiations, ritexitinib is expected to be further popularized in China and may become a standard first-line option for the treatment of alopecia areata. By then, drug prices are expected to drop further with the process of localization or adjustments to medical insurance policies, thereby benefiting more hair loss patients.
Reference: https://www.drugs.com/