Shionogi's Lusutrombopag and Two Other Class 5.1 Imported New Drugs File for Clinical Trials in China

Authors: Mi Hu, Heng Yan

According to Xianda Data, in the past week (July 15–21, 2019), the Center for Drug Evaluation (CDE) accepted nine new drug applications for clinical trials; one new drug application for marketing approval was accepted by the CDE; and consistency evaluation applications were submitted for 23 varieties.

Highlight 1

Shionogi’s Class 5.1 imported chemical drug, lusutrombopag tablets, has been accepted by the Center for Drug Evaluation (CDE). The acceptance number is JXHL1900166.

This product is a TPO-RA (Thrombopoietin Receptor Agonist). Thrombopoietin receptor agonists are standard treatments for thrombocytopenia in Europe and the United States. The product was launched in Japan in 2015 and in the United States in 2019, with the indication of thrombocytopenia.

Highlight 2

Eli Lilly’s Class 5.1 imported chemical drug, Abemaciclib, has been accepted by the CDE. The acceptance numbers for this product are JXHL1900161, JXHL1900162, and JXHL1900163.

This product is a selective CDK4/6 inhibitor; CDK4/6 can promote tumor cell growth. In September 2017, the FDA approved Eli Lilly and Company’s Verzenio (brand name; generic name: abemaciclib) for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer that has progressed after endocrine therapy. The same indication is being applied for in this submission to the Center for Drug Evaluation (CDE).

Highlight 3

Jiangxi Qingfeng’s Class 1 new chemical drug application for QF-036 tablets has been accepted by the Center for Drug Evaluation (CDE). The acceptance numbers are CXHL1900225, CXHL1900226, and CXHL1900227.

As the product is in the early stages of research and development, limited information has been disclosed; the editor has not yet identified relevant data on its mechanism of action or indications.

Highlight 4

The Class 1 new chemical drug CX1440 capsules, jointly submitted by Hangzhou Sanyintai Pharmaceutical and Hangzhou Aojin Biotechnology, have been accepted by the CDE. The acceptance numbers for this product are CXHL1900222, CXHL1900223, and CXHL1900224.

As this product is in the early stages of research and development, limited information has been disclosed; the editor has not yet identified relevant data on its mechanism of action or indications.

Highlight 5

Hanmi Pharmaceutical’s Class 1 new drug application for Poziotinib film-coated tablets has been accepted by the Center for Drug Evaluation (CDE). The acceptance numbers are JXHL1900164 and JXHL1900165.

Poziotinib is an innovative, oral, pan-HER inhibitor. It irreversibly blocks signal transduction mediated by all HER family receptor tyrosine kinases. Preclinical studies have demonstrated that poziotinib inhibits HER receptors harboring exon 20 insertion mutations with potency tens of times greater than that of existing tyrosine kinase inhibitors. Currently, poziotinib is undergoing multiple clinical trials for indications including breast cancer, lung cancer, gastric cancer, and head and neck cancer. The indication for which clinical trial approval is being sought from the Center for Drug Evaluation (CDE) in this submission is non-small cell lung cancer.

Highlight 6

A total of 23 drug products submitted for consistency evaluation in the past week are listed below:

Original Title: Shionogi’s Lusutrombopag and Two Other Class 5.1 Imported New Drugs Submitted for Clinical Trial Approval (Review Weekly Report Issue 229)