China is blowing through regulatory milestones as it completes an astonishing transformation from a market where basic Western drugs were once scarce to one where life-saving treatments are available ahead of the U.S. — all in less than a year.
Tuesday’s announcement that China has approved an anemia treatment from AstraZeneca Plc and FibroGen Inc. ahead of the U.S. and other markets is the latest high-water mark from a regulator that started the year with a backlog of foreign drugs that were available elsewhere globally.
In April, it approved in nine days Merck & Co.’s HPV vaccine, Gardasil 9, which has been in use worldwide since 2014. A few months later, it gave the green light to Hutchison China MediTech Ltd.’s colorectal cancer capsules, fruquintinib, marking the first time a homegrown medication was approved in China ahead of the U.S. and Europe.
With AstraZeneca and FibroGen’s roxadustat, an anemia treatment for patients with chronic kidney disease who are dependent on dialysis, China has now green-lighted a potential blockbuster — a drug with the potential to hit $1 billion in sales — before the rest of the world.
“This is a milestone, and a sign that the China government is following through with its focus on innovation,” said John J. Lin, Shanghai-based life sciences and health-care partner at EY. “Pharmaceutical companies will pay increasing attention to the Chinese market with respect to research and development.”
The regulator’s rapid reinvention has come in the face of pressure from its growing middle class to gain access to the best drugs and health care available. Where once patients had to travel outside of China to get life-saving medication, Beijing is now determined that its citizens, who have some of the highest rates of cancer, diabetes and liver disease in the world, can get direct access to top drugs first.
China is on track to approve some 50 drugs this year, according to research from consultancy McKinsey & Co., a bigger number than what it approved in total over the last decade.
— With assistance by Rachel Chang
(Source: Bloomberg: https://www.bloomberg.com/news/articles/2018-12-19/china-drug-regulator-transforms-to-world-s-fastest-within-months )