The $160 million acquisition of a FibroGen subsidiary expands AstraZeneca’s foothold in China while the company works through government investigations into its business practices there.

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat.

More than two years after a high-profile FDA rejection, AstraZeneca has returned rights to the HIF-PH inhibitor in the U.S. and certain other countries but retained an interest in China and South Korea, where the drug is approved under the brand name Evrenzo.

An anemia pill from FibroGen didn’t help patients with a type of bone marrow cancer stop receiving blood transfusions in a Phase 3 trial, the latest setback for a drug that approved internationally but rejected in the U.S.

While anemia med roxadustat’s U.S. fate remains in limbo, FibroGen partner Astellas is trumpeting data that could help clear the air around its disputed safety profile.

In a pooled analysis of four phase 3 studies, roxadustat proved at least as safe as standard of care erythropoietin therapies when it came to patients’ risk of cardiovascular side effects or death, Astellas said Thursday at the 59th Congress of the European Renal Association (ERA).

In the months since the FDA's high-profile rejection for oral anemia drug roxadustat, AstraZeneca and FibroGen have been working to chart a potential path forward for the med in chronic kidney disease (CKD). But the two partners are now split on what that path might look like, leaving dim prospects for a refiling.

After an FDA cold shoulder, FibroGen and partner AstraZeneca still aim to pave a way to market for anemia therapy roxadustat—even if it means conducting another clinical trial. The two companies are now betting the drug’s U.S. future on an upcoming meeting with the FDA.

Amid the delays and mishandling that marked Fibrogen’s attempts to get roxadustat to market in the US, it is easy to forget that a different story lies behind the drug’s progress in Europe. Astellas, which owns rights to the novel anaemia pill in that region and Japan, won broad backing from the EMA last month with no hold-ups.

This is not to say that the EU regulators waved roxadustat through. The EMA requested several additional data analyses and subgroup explorations and asked “many tough questions”, according to Salim Mujais, senior vice-president and head of medical specialties at Astellas. “In my over 20 years in industry this was one of the most rigorous and meticulous processes with regulators,” he told Evaluate Vantage.

FibroGen’s lead drug has cleared another mid-stage study. Or at least the biotech claims it has.

FibroGen, a 28-year-old company whose stock collapsed this past year after it revealed data it had submitted to the FDA was manipulated, said Wednesday that roxadustat, its pill for anemia, successfully treated cancer patients who suffered anemia as a side effect of chemotherapy.

FibroGen Inc said said on Wednesday that the U.S. Food and Drug Administration has declined to approve its treatment for anemia of chronic kidney disease, citing the need for an additional clinical study.

FibroGen (FGEN -6.3%) is trading lower after the FDA posted a report on Roxadustat ahead of a decision by its advisory committee this week.