Chinese drug regulator becomes world’s fastest

Bloomberg

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 US — all in less than a year.
The latest announcement that China has approved an anemia treatment from AstraZeneca Plc and FibroGen Inc. ahead of the US 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’s colorectal cancer capsules, fruquintinib, marking the first time a homegrown medication was approved in China ahead of the US 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 partner at EY. “Pharmaceutical companies will pay increasing attention to the Chinese market with respect to research and development.”