Ensartinib hydrochloride is under clinical development by Betta Pharmaceuticals and currently in Phase II for Letterer-Siwe Disease (Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis). According to GlobalData, Phase II drugs for Letterer-Siwe Disease (Multifocal and multisystemic (disseminated) Langerhans-cell histiocytosis) have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Ensartinib hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Ensartinib hydrochloride overview

Ensartinib hydrochloride (Bemena) is an anti-neoplastic agent. It is formulated as capsules for oral route of administration. Bemena is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with anaplastic lymphoma kinase (ALK) positive who have progressed after crizotinib treatment or are intolerant to crizotinib. Bemena is indicated for the first-line treatment of anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

Ensartinib (X-396) is under development for the treatment of non-small-cell lung cancer, melanoma, recurrent or refractory pediatric solid tumors including central nervous system tumors, non-Hodgkin lymphomas, Langerhans cell histiocytosis (LCH), juvenile xanthogranuloma (JXG), histiocytic sarcoma, diffuse intrinsic pontine glioma, optic pathway gliomas, pineal tumor, leptomeningeal disease and neuroblastoma. It is administered orally. X-396 is a small molecule inhibitor of ALK tyrosine kinase receptor. It was also under development for breast cancer, head and neck cancer, colorectal cancer and small-cell lung cancer.

Betta Pharmaceuticals overview

Betta Pharmaceuticals, discovers, develops, and supply drugs for the treatment of cancer and diabetes. Its products include icotinib hydrochloride, an orally administered small-molecule, reversible tyrosine kinase inhibitor for treating locally advanced or metastatic non-small cell lung cancer; and ensartinib hydrochloride capsules to treat ALK-mutated advanced non-small cell lung cancer. The company has also developed beantine, a macromolecular biological product for treatment of recurrent non-small lung cancer. Betta Pharmaceuticals is developing its pipeline with small and macromolecules products for multiple cancer treatments. The company operates research and development centers in Hangzhou and Beijing, China and San Diego, the US. Betta Pharmaceuticals is headquartered in Hangzhou, Zhejiang, China.

For a complete picture of Ensartinib hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.