Estimated launch time of lorlatinib/lorlatinib in China

As of April 2024, the original drug lorlatinib/lorlatinib (Lorlatinib) produced by Pfizer has been approved by the National Medical Products Administration in China. It is sold on the market as Lorlatinib tablets (LORBRENA), and has also entered the scope of Class B medical insurance reimbursement through the relevant policies of the National Medical Insurance Administration. Patients who meet the indications can use medical insurance for reimbursement. This drug may be sold in domestic hospitals or pharmacies and other places.

Lorlatinib is a third-generationALK tyrosine kinase inhibitor (TKI) used to treat patients with ALK-positive metastatic non-small cell lung cancer. It was first approved overseas by the U.S. Food and Drug Administration (FDA) in November 2018. Subsequently, the European Medicines Agency (EMA) approved it in 2019 for the treatment of patients with previously treated advanced ALK-positive non-small cell lung cancer. It was considered that its benefits outweighed its risks. In 2022, it expanded the approval of loratinib as a first-line treatment option for advanced ALK-positive non-small cell lung cancer.

Due to the fact that the domestically produced lorlatinib original drug has been on the market for a short time and is relatively expensive, the common specifications are 25mg*90 tablets and 100mg*30 tablets. The price per box may be around 10,000 to 20,000 RMB. For the Hong Kong original version, the price per box may be 30,000 to 50,000 RMB (the price may fluctuate due to the exchange rate). There are relatively cheap generic drugs sold overseas, and their drug ingredients are basically the same as the original drugs. Taking the ones produced by relevant pharmaceutical factories in Laos as an example, the price of each box of 100mg*30 tablets may be around 3,000 yuan (the price may fluctuate due to the exchange rate).