- China's national drugs regulator has approved a new anemia medicine from AstraZeneca and partner Fibrogen, clearing the treatment for use well ahead of any other health authority, including the U.S. Food and Drug Administration.
- Approval of the drug, called roxadustat, in China flips the script on the historic pattern of medicines initially arriving first in doctors' offices and pharmacies in Western countries before eventually reaching markets like China.
- Recently, however, China's pharmaceutical market has heated up. Regulatory and financial reforms have buoyed the county's domestic biotech sector, which in September saw the first OK for a drug discovered and developed in China. Quickening sales, meanwhile, have reignited the interest of major drugmakers like AstraZeneca.
AstraZeneca has bet heavily on the emergence of China's pharmaceutical sector, which is now the British pharma's second largest market by sales.
Approval of roxadustat, which AstraZeneca will sell in China, could help that push and help establish the company's renal disease business there.
The OK also underscores the increasing speed by which China's National Medical Products Administration is accepting and reviewing new drug applications. AstraZeneca has twice been the beneficiary of the NMPA's faster process, receiving a green light for its cancer medicines Lynparza (olaparib) and Tagrisso (osimertinib) in less than a year from when priority review was granted.
Fibrogen, which led Phase 3 development of roxadustat, submitted the drug for Chinese approval in October 2017.
So far, AstraZeneca's success in China has mostly been due to its respiratory medicines like Pulmicort (budesonide), but it hopes to drive sales in oncology and, now, renal disease as well.
The NMPA OK'd the drug for chronic kidney disease (CKD) patients with anemia who are on dialysis — a population AstraZeneca estimates to total about 500,000 in China.
Much larger is the broader group of CKD patients with anemia, for which AstraZeneca and Fibrogen also aim to develop roxadustat.
AstraZeneca plans to launch the drug in the second half of 2019. In the U.S., the British drugmaker expects its roxadustat application to be accepted sometime in the first half of 2019, with an approval likely to follow between six and 10 months later.
The pharma's not alone in targeting China. Other multinational drugmakers, including Novartis and Sanofi, have stepped up their activities in the country, both through marketing drugs in China developed elsewhere and through partnerships and R&D within China.
Eli Lilly, for example, teamed up with the Hutchinson China MediTech, more commonly known as Chi-Med, on a cancer drug recently approved by China. Elunate (fruquintinib), as the drug is called, was the first product both discovered and developed in China to receive an unconditional OK by the NMPA.
Industry watchers marked the approval as a milestone in the emergence of the county's biotech sector, which has been boosted by rule changes that permit pre-revenue biotech companies to list on the Hong Kong stock exchange. In response, money has flowed into the sector with a number of major initial public offerings over the past year.