Please login to the form below

Not currently logged in

Home-grown colorectal cancer drug approved in China

Major milestone for China's R&D-based companies

Hutchison China MediTech (Chi-Med) has been granted approval in its home market for Elunate, the first drug discovered and developed in China for colorectal cancer (CRC).

The green light from the National Medical Products Administration of China (formerly the China Food and Drug Administration) is for use of the oral VEGF inhibitor in patients with metastatic CRC who have failed at least two prior systemic rounds of therapy.

Elunate (fruquintinib) will be sold in China by Chi-Med’s commercial partner Eli Lilly, although there’s no word yet on whether the two companies are inclined to develop the drug for use in the US or Europe, particularly as the third-line CRC category is more competitive in those markets. China looks set to be a big market for the drug in its own right, however, as CRC is the second-most common form of cancer with an estimated 380,000 new cases every year.

Elunate will have to go up against well-established oral drugs like Bayer’s multikinase inhibitor Stivarga (regorafenib) and Taiho Oncology’s Lonsurf (trifluridine/tipiracil) in the third-line setting.

The approval has sparked a $13.6m milestone payment from Lilly to Chi-Med, and is a major achievement for the Chinese biopharma company, particularly as other companies have struggled to bring oral VEGF inhibitors to market for CRC. 

Simon To

Chi-Med's chairman Simon To

“Today’s approval is a major achievement for Chi-Med,” said Simon To, Chairman of Chi-Med. “Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomised clinical trial in China,” he added, “This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China’s emerging biotech ecosystem.”

Pfizer abandoned a trial of its lung cancer drug Sutent (sunitinib) in first-line CRC a few years ago, while AstraZeneca’s cedirinib failed in this form of cancer as well as other solid tumours. Meanwhile, other orally-active drugs that target VEGF – including Bayer’s Nexavar (sorafenib), Novartis’ Votrient (pazopanib), and Sanofi’s Caprelsa (vandetanib) – have been developed for a range of other solid tumours but not CRC.

Chi-Med says Elunate is a ‘best-in-class’ VEGF inhibitor, which in the phase III FRESCO trial improved overall survival to a median of 9.3 months from 6.6 months with placebo as a third-line therapy for Chinese CRC patients.

One explanation for the good performance of the drug in this trial versus other VEGF drugs tested in Western countries is that Chinese patients are much less likely to have been treated previously with intravenous VEGF drugs, such as Roche’s Avastin (bevacizumab) and Lilly’s Cyramza (ramucirumab).

The Chinese company is now planning to extend fruquintinib’s use into non-small cell lung cancer (NSCLC), as a third-line monotherapy and as part of a first-line regimen alongside AZ’s EGFR inhibitor Iressa (gefitinib), as well as gastric cancer.

Article by
Phil Taylor

5th September 2018



PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs


Add my company
Havas Life Medicom

We’re a specialist-led, unified communications agency delivering connected healthcare communications, informed through fresh insights, smart thinking and inspired ideas. Our...

Latest intelligence

reaching HCPs during pandemic
Reaching patients and HCPs during the pandemic
COVID-19 has caused unprecedented disruption to drug launches, but some pharma companies avoided costly delays by quickly pivoting to digital channels...
#DemandDiversity: Black history in clinical trials: It's more than just Tuskegee [Infographic]
Take a look at this infographic showing some of the most notorious clinical trials and medical research in history....
Looking back at the year when everything changed
COVID-19 has impacted every aspect of our lives, from the way we shop for groceries to the way we conduct work and interact with healthcare providers and our families....