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Lorlatinib: A Revolution for ALK-positive Lung Cancer

Lorlatinib: A Revolution for ALK-positive Lung Cancer

May 18, 2025

 

Developed by Pfizer, lorlatinib (brand name: Lorbrena®) is a third-generation dual-target tyrosine kinase inhibitor targeting ALK and ROS1. It is specially indicated for patients with locally advanced or metastatic ALK-positive non-small cell lung cancer.

 

Lorlatinib approval for marketing:

  • September 21, 2018:  Approved by Japan's Pharmaceuticals and Medical Devices Agency (PMDA)
  • November 2, 2018:   Granted accelerated approval by the U.S. Food and Drug Administration (FDA)
  • March 2019:  Approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)
  • April 2022: Approved by China's National Medical Products Administration (NMPA)
  • March 2023 :    Included in China's National Medical Insurance Catalogue 

 

Prices of Lorlatinib

  • Original Lorlatinib in China (Reimbursed by Medical Insurance)

After being included in medical insurance in 2023, the reimbursed price ranges from 5,000 to 6,500 RMB per box.

  • Generic Lorlatinib Prices

The price of generic versions is approximately 2,000 to 3,000 RMB per box.

PHOLORLA (Lorlatinib): Pharma 2 Vientiane, Laos

Lorlacare (Lorlatinib): ElementoPharma, Laos

Lorlanib (Lorlatinib): Drug International Limited (DIL), Bangladesh

Lorbrexen (Lorlatinib): Everest Pharmaceuticals, Bangladesh

 

Lorlatinib

 

Target:  ALK × ROS1
Originator: Pfizer Inc. 
Developers:  Pfizer Inc. 
Indications Under Development: ALK-positive Non-Small Cell Lung Cancer
Non-development Indications  Advanced Cancer
Highest R&D Phase:  Approved for Marketing
First Approval Date:  Japan
First Approved Country/Region:  2018-09-21

 

 

Lorlatinib Starting Materials and Intermediates

Intermediates Name CAS NO.
2-Iodo-5-fluoroacetophenone 914225-70-0

 

RELYBO is committed to providing global customers with high-purity, high-quality Lorlatinib  intermediates with stable supply from kilogram to ton cales, accelerating the innovation and commercialization.

 

 

At RELYBO, we create chemistry for a sustainable future.

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