China pulls through for AstraZeneca again, roxadustat in focus

China once again aided AstraZeneca ($AZN), with full-year sales up 15%, the same pace as Latin America, and up 10% on the fourth quarter.

Much of the boost in China came through respiratory. But in the pipeline space, the company is closely watching the regulatory chain for anemia medicine roxadustat. The details of that regulatory process for that candidate provoked quite a discussion among executives and analysts on the Feb. 4 call, as it jibes with a $100 million investment announced in December last year for biologics manufacture and development with WuXi AppTec.

Seamus Fernandez, an analyst with Leerink Partners, wanted to know whether this year, or next, would see news on roxadustat in China. He was joined by Matthew Weston, an analyst with Credit Suisse.

First off, Luke Miels, executive vice president for the Global Portfolio and Product Strategy, Global Medical Affairs & Corporate Affairs, took a crack.

"In terms of tracking approval time frames in China, I've seen so many reports on this and have tracked it myself," Miels said. "It's almost impossible to do the analysis because the key thing for roxadustat is it's actually treated as a local product."

"So it's produced, the material is in China, it's actually a different formulation than the global supply. So we said the correct terminology for the Chinese submission for roxa (roxadustat) is rolling submission."

That brought in Sean Bohen, executive vice president for Global Medicines Development and Chief Medical Officer.

"It's rolling submission. To that end, what we said is the submission would initiate this year. We did not say there would be clinical data available this year."

Then CEO Pascal Soriot added this bit. 

AstraZeneca CEO Pascal Soriot

"The … product is still part of the … a new process called the green pass and clearly the authorities have put it in this process because it is a local product as Luke was explaining. And it's really addressing an enormous need in China."

He then went on to add that "clearly they have a lot of reasons to fast-track this project, but it's not very codified. And so it's hard to predict how long it will take."

Finally though, Bohen found some detail buried in the product approval timeline guide and managed to pin down the timeframe--sort of.

"Let me go back to the roxadustat," Bohen said. "It's 2017, but again, the submission is rolling, it's ongoing. As Luke said, we're not 100% sure what the review time is. It is not codified … 2017 there will be data from trials outside of China as well."

Soriot and other executives also spent a bit of time on Japan and prospects for Tagrisso (osimertinib)‎ as early as the first half of 2016.

Miels added a bit on what the game plan is for Tagrisso in Japan.

"We actually expect that Tagrisso will benefit from our existing presence and infrastructure in lung, and naturally it represents quite an opportunity because of the prevalence of EGFR mutations in Japanese patients," he said.

- here's the release