On September 5, in a milestone regulatory decision, pharmaceutical firm Hutchison China MediTech, or Chi-Med, won unanimous approval from the Chinese pharmaceutical regulator for a new homegrown cancer drug.
This is the first time the Chinese regulator, the CFDA, has approved a drug discovered and developed solely in China, and is a landmark moment for the country’s emerging biotech sector.
In the past, China has tended to manufacture raw pharmaceutical ingredients and ship them to the US and Europe
The drug, named fruquintinib, has been approved for the treatment of metastatic colorectal cancer in patients who have failed two other treatments. Colorectal cancer is the second most common type of cancer in China, with 380,000 new cases diagnosed every year.
Chi-Med began working on the drug, which will be marketed under the brand name Elunate, in 2007 and began clinical testing in 2011. The Phase III study, published earlier this year in the Journal of American Medical Association, proved that the drug improved median survival rates versus a placebo in 416 colorectal cancer patients who had suffered relapses after two previous chemotherapy treatments.
“Today’s approval is a major achievement for Chi-Med,” said Simon To, the chairman of Chi-Med, in the announcement. “Elunate is the first homegrown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomised clinical trial in China.”
In the past, China has tended to manufacture raw pharmaceutical ingredients and ship them to the US and Europe, as opposed to manufacturing compound drugs on its own soil.
The Chinese regulator is also notorious for its arduous drug approval system and has been extremely slow to approve new drugs in comparison with other countries. For example, between 2001 and 2016, the US Food and Drug Administration approved 433 new drugs. Just 133 were approved by the CFDA in the same time period.
The CFDA has been reluctant to accept the results of initial clinical trials that took place abroad, forcing pharmaceutical firms to repeat initial trials on Chinese soil. This has led to costly approval delays of five to seven years.
However, a number of recent regulatory reforms have made China a more attractive market for pharmaceutical manufacturers. In 2017, the Chinese Government introduced new policies forcing clinical data collected outside China to be accepted in the regulation process. This eliminates the need for pharmaceutical companies to repeat trials, speeding up the CFDA approval process.
What’s more, Hong Kong’s stock exchange recently allowed pre-revenue biotech companies to list on the SEHK index. This sparked the interest of international investors and opened up additional funding streams for Chinese pharmaceutical firms.
These reforms will allow pharmaceutical firms to tap into what could be an extremely lucrative branded drugs market in China. The Chinese pharmaceutical market is the second largest in the world, superseded only by the US market, and is estimated to be worth over $122.6bn.
The CFDA’s approval of fruquintinib is a significant victory for the expanding Chinese biotech sector and will pave the way for other Chinese pharmaceutical firms to follow in Chi-Med’s footsteps. It also represents the end of China’s reliance on other countries for the delivery of drugs and a significant step up for China in the global pharmaceutical sector.
“What that illustrates is that Chinese companies now are conducting science and developing drugs in a way that meets the height of global standards,” said Brad Loncar, Head of Loncar Investments, in an interview with BioPharma Dive. “I think that this is a sign of things to come.”