1. Scrip
  2. >>Focus On Asia
  3. >>China

East Shines Over West? US Rejection Puts Roxadustat's China Approval In New Spotlight

Japan, EU Offer Other Growth Alternatives?

 
• By Brian Yang

Touted in China after its first approval globally there for chronic kidney disease-associated anemia back in late 2018, FibroGen/AstraZeneca's roxadustat has now been rejected by the US FDA over cardiovascular safety concerns. But ex-US markets may still enable the drug to shine despite safety wording. 

Blood cells
FIBROGEN'S ROXADUSTAT REJECTED IN US BUT CHINA, JAPAN, EU PRESENT OTHER OPPORTUNITIES • Source: Alamy

The US Food and Drug Administration on 11 August declined to approve FibroGen, Inc.’s roxadustat due to cardiovascular safety concerns, after the agency’s expert committee refused to endorse the drug several weeks ago.

An oral hypoxia inducible factor prolyl hydroxylase inhibitor, roxadustat is intended for the treatment of anemia due to chronic kidney disease

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from China

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor Into For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Chinese Vaccine Makers Turn To Emerging Markets

 
• By Dexter Jie Yan

Chinese producers of novel vaccines are increasingly pivoting to developing markets overseas in the face of a collapse in their domestic sales.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By Xu Hu

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.

More from Focus On Asia