Is Lazertinib currently officially available in China?

As of June 2025, Lazertinib has not been officially launched in China. The drug is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, mainly used to treat patients with EGFR Patients with mutated non-small cell lung cancer (NSCLC), especially those who are resistant to previous generation EGFR-TKI such as osimertinib. Lazertinib has been approved in South Korea and was approved by the U.S. FDA in August 2024 for the first-line treatment of advanced non-small cell lung cancer with EGFR mutations in combination with evantumumab.

In China, lazertinib has not yet been approved by the National Medical Products Administration (NMPA). However, on January 26, 2024, Johnson & Johnson submitted a marketing application for lazertinib, and on the same day It was accepted by the Center for Drug Evaluation of the China State Medical Products Administration (CDE) on January 1 on January 27. The indication for this application is the combination treatment with evantumumab in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations.

Currently, lazertinib has not yet entered the clinical trial stage in China. However, on January 26, 2024, Johnson & Johnson submitted a marketing application for lazertinib, and on the same day It was accepted by the Center for Drug Evaluation of the China State Medical Products Administration (CDE) on January 1 on January 27. The indication for this application is the combination treatment with evantumumab in patients with locally advanced or metastatic non-small cell lung cancer with EGFR mutations.

In short, lazetinib has not yet been officially launched in China. If patients need to use this drug, they should pay attention to the latest approval developments from the National Medical Products Administration and choose an appropriate treatment plan under the guidance of a doctor. At the same time, patients should pay attention to drug side effects and interactions to ensure the safety and effectiveness of treatment.

Reference materials:https://www.drugs.com/donanemab.html