Hutchison China Meditech looks to first drug approval this year

AIM-listed cancer drug developer Hutchison China MediTech Limited (LON:HCM) expects this year will see fruquintinib become China’s first approved Tyrosine-Kinase inhibitor (TKI).

TKIs inhibit cancer cells’ ability to adapt and fruquintinib successfully passed a phase III study in colorectal cancer last year.

A new drug application was submitted to China’s Center for Drug Evaluation of the CFDA in June 2017 and is undergoing technical reviews and manufacturing inspections.

Trials using fruquintinib, where Eli Lily is the Chi-Med’s partner, are also underway for gastric cancer and various stages of non-small cell lung cancer.

A second TKI, Savolitinib, is also going through clinical trials as a combination with AstraZeneca’s lung cancer treatments Tagrisso and Iressa.

These drugs are for patients suffering mutations on a gene called EGFR.

All told Chi-Med has six phase III trials either ongoing or enrolling at present and eight in total.

Simon To, chairman, said: “In our Innovation Platform, we have progressed our deep portfolio of eight clinical drug candidates, now in active or completing clinical trials in 36 TPPs around the world. 

“Two major milestones were the formal NDA submission for fruquintinib in CRC in China; and the initiation of our first global Phase III registration study of savolitinib in c-MET-driven metastatic PRCC. 

“We also presented positive Phase Ib/II data at major scientific conferences on savolitinib in PRCC, NSCLC and gastric cancer; fruquintinib in NSCLC and gastric cancer; sulfatinib in NET and thyroid cancer; and theliatinib in esophageal cancer, all positioning us well for 2018.”

Revenues in 2017 rose by 12% to $241.2mln (2016: US$216.1mln), with a net loss of US$26.7mln (US$11.7mln) afterUS $88mln spent on R&D.

Cash at the year-end was US$480mln after the company raised US$293mln when it joined Nasdaq late last year. 

Story by ProactiveInvestors