(Yicai Global) Dec. 19 -- A new treatment for kidney-disease anemia is set to hit the Chinese market in the second half of next year, ahead of anywhere else in the world.

China's National Medical Products Administration gave the nod to Roxadustat yesterday. The oral medication, developed by AstraZeneca and FibroGen, is a first-in-class treatment for anemia caused by chronic kidney disease, the NMPA said in its approval document.

No innovative treatments for CKD-anemia have emerged worldwide in almost 30 years, while existing treatments have serious limitations. AstraZeneca showcased its new medication at the first China International Import Expo in Shanghai last month. Researched and developed in China, this innovative medicine will be introduced and sold in the country first, rather than in the US or Japan. 

This has never happened before and presents a new market opportunity, Leon Wang, executive vice president of AstraZeneca International and president of AstraZeneca China, told Yicai Global in an interview during the CIIE.

CKD-induced anemia, or blood iron deficiency, is one of the most common complications of the ailment, and its incidence rises as renal function further declines. Almost all patients with uremia -- excess urea in the blood -- also have anemia.

CKD is estimated to afflict 120 million people in China, one study shows, with some 500,000 patients on dialysis suffering from anemia between September 2009 and September 2010.

Roxadustat was co-developed by UK-based AstraZeneca's China unit and San Francisco-headquartered FibroGen's Chinese subsidiary, based on an agreement the two struck in 2013, public information shows.

FibroGen China conducted the China Phase III clinical trials and submitted the new drug application to Chinese regulators. It is also tasked with production and medical affairs. AstraZeneca will commercialize the medicine in China. 

AstraZeneca holds the commercial rights to Roxadustat in the US, China and other markets, while FibroGen and Tokyo-based Astellas Pharma jointly hold those for Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa, per the agreement.

Editor: Ben Armour