Ensartinib Capsules 25 mg, 100 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 25 mg, 100 mg

Reference Brands: Ensacove (Xcovery); Betta Pharmaceuticals (China)

Category: Oncology Cancer Care

Ensartinib (Ensacove) is an oral ALK inhibitor for ALK-positive non-small cell lung cancer. It was developed by Xcovery with Betta Pharmaceuticals, approved in China in 2020 and by the US FDA in December 2024. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers, API makers and licensees preparing for patent expiry.

Product Description:

Ensartinib is a second-generation ALK tyrosine kinase inhibitor. It blocks the ALK fusion protein that drives about 3 to 5 percent of non-small cell lung cancers and reaches the brain, a common site of spread. It is taken once a day; the US dose is 225 mg, given as capsules of 25 mg and 100 mg.

Betta Pharmaceuticals launched ensartinib in China in 2020 for patients previously treated with crizotinib, followed by first-line approval in 2022. The US FDA approved it as Ensacove in December 2024 for adults with ALK-positive locally advanced or metastatic non-small cell lung cancer who have not had an ALK inhibitor before.

Sourcing and licensing notes. Ensartinib is patented, and there is no generic. Crizotinib, alectinib, brigatinib and lorlatinib, the other main ALK options, are also listed on PharmaTradz. We handle authorised-supply enquiries for ensartinib and connect developers and licensees interested in the molecule ahead of patent expiry.