Lorlatinib

In response to the drug resistance problem in patients with ALK-positive non-small cell lung cancer (NSCLC), the clinical application of the third-generation ALK tyrosine kinase inhibitor lorlatinib has filled the treatment gap after drug resistance to first- and second-generation drugs. This drug can specifically block the activation of downstream signaling pathways mediated by ALK fusion gene mutations, and can efficiently penetrate the blood-brain barrier at the same time, greatly reducing the progression risk of central nervous system metastasis. It is mainly clinically used in patients with ALK-positive locally advanced or metastatic non-small cell lung cancer who have disease progression after previous treatment with one or more ALK inhibitors, or in previously untreated patients, and is currently an important later-line and first-line option in the ALK-targeted treatment pathway.

The global market size of lorlatinib had exceeded 1.8 billion US dollars in 2023, with a compound annual growth rate of more than 32% in the recent three years. The proportion of the Chinese market has been increasing year by year, and the domestic hospital sales exceeded 900 million yuan in 2023. At present, the original research product still dominates the domestic market. With the approaching expiration of patents, more than 20 pharmaceutical companies have laid out the R&D of generic drugs, and the application preparation work related to centralized procurement has been gradually promoted. It is expected that after the launch of generic drugs in the next 2-3 years, the accessibility of the drug will be further improved, and the market size will still maintain an annual growth rate of more than 15%.

The original research enterprise of lorlatinib is Pfizer, with the trade name "Lorbrena". Its Chinese compound patent will expire in 2033, and the crystal form patent will expire in 2035. At present, the originally researched dosage form approved in China is tablet, with specifications of 25mg and 100mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also listed in the FDA Reference Preparations Catalogue. Up to now, there are 6 registration records of lorlatinib active pharmaceutical ingredients (APIs) on the API registration platform of China CDE, among which 3 are in the status of "A" (approved for use in marketed preparations). One domestic generic drug preparation was approved for marketing in 2024. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of lorlatinib impurity reference standards, covering all categories of research reference substances including process impurities, degradation impurities, enantiomers, etc. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet the full-process needs of API R&D, quality research and registration application.