Johnson & Johnson's blockbuster product has applied for a new indication domestically.

On August 22, the official website of CDE showed that the new indication application for Johnson & Johnson's abiraterone acetate tablet has been accepted. Based on public information and clinical progress, it is speculated that the indication for this application is hormone-dependent prostate cancer. Public information shows that abiraterone acetate is a complex formulation launched by Johnson & Johnson, which was approved for marketing in the European Union and the United States in 2023 for the first-line treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) with BRCA1/2 mutations using it in combination with prednisone or prednisolone. In October 2024, the drug was approved for marketing in China for the first time, becoming the first and only approved dual-acting complex formulation in the country. In terms of safety, the incidence of grade 3/4 adverse events (AE) in the trial group was 75.2%, compared to 58.9% in the control group, with the most common being anemia and hypertension. The rate of discontinuation due to AE was relatively low (11.0% vs 6.9%).