AstraZeneca, Daiichi Sankyo's Enhertu Gets China's Conditional Approval for New Indication

AstraZeneca (AZN) received FDA approval for Ultomiris in IgA nephropathy, showing 43.4% proteinuria reduction. Launched ZEGFROVY for NSCLC with 46% response rate. Filed for first-line approval in U.S. and China. Shares rose ~2.5%. Partnered with Abu Dhabi Biobank for diabetes and cardiovascular disease detection.

AstraZeneca's Ultomiris (ravulizumab) received FDA accelerated approval for treating IgA nephropathy, showing 43.4% greater reduction in urine protein than placebo in a Phase III trial. The approval is based on proteinuria, a marker for kidney damage, with confirmatory trials ongoing. The drug carries a serious infection warning, requiring vaccination before use.

AstraZeneca will start selling sunvozertinib, a lung cancer drug developed by China's Dizal Pharmaceutical, in the US after delays. The FDA approved the drug in July 2025, but it was unavailable in the US for over a year, prompting some Americans to travel to China for treatment.

The NCCN upgraded durvalumab (Imfinzi; AstraZeneca) recommendations in its Esophageal and Esophagogastric Junction Cancers guidelines, moving certain subgroups from category 2B to 2A. The MATTERHORN trial showed improved survival rates with durvalumab plus FLOT. Zanidatamab-hrii combinations were added for HER2-positive adenocarcinoma. Durvalumab plus FLOT was FDA-approved in 2025.

AstraZeneca PLC (AZN) rose 3.04% on Oct 22, outperforming its sector. The FDA granted accelerated approval for Ultomiris to treat a rare kidney disease, expanding its portfolio. The company also reported positive trial results for Tezspire and Zegfrovy. Analysts have an average price target of $210.32. Risks include clinical trial setbacks and patent expirations.

The FDA granted accelerated approval to AstraZeneca's ravulizumab (Ultomiris) to reduce proteinuria in adults with primary IgA nephropathy (IgAN). The approval is based on proteinuria reduction, with continued approval contingent on confirming clinical benefit in the ongoing I CAN trial. Ravulizumab is the first C5 inhibitor approved for this use, and IgAN is its fifth approved indication. The drug reduced 24-hour UPCR by 46.6% in a trial, compared to 5.6% for placebo.