Abiraterone acetate is a highly selective, irreversible CYP17 enzyme inhibitor, and CYP17 is a key enzyme essential for androgen biosynthesis. By inhibiting the key enzyme involved in androgen synthesis, abiraterone acetate reduces androgen levels.
1. Originator Drug: Global First Launch and Market Access in China
Global Market Developed by Johnson & Johnson, abiraterone acetate was approved by the US FDA in April 2011 for the treatment of metastatic castration-resistant prostate cancer (mCRPC), establishing itself as a benchmark for global prostate cancer therapy.
Chinese Market It was approved in China in May 2015 and officially launched in early 2016. At the initial launch stage, the monthly treatment cost exceeded RMB 16,000, with an annual cost as high as RMB 200,000, affordable only for a small number of patients.
2. Domestic Generics: Batch Approvals and Intensified Market Competition
As of September 2023, a total of 11 domestic pharmaceutical enterprises have obtained registration approvals for abiraterone acetate tablets, and another 3 enterprises are in the clinical research stage.These generics are approved under Class.
4 New Drugs (Consistency Evaluation) , with quality and therapeutic efficacy equivalent to the originator product.
3. R&D Pipeline Updates: Parallel Progress in Dosage Form Innovation and Strength Supplement
Dosage Form Exploration Among the 3 enterprises under development, 2 are developing capsule formulations, aiming to improve patient medication convenience and reduce production costs.
Modified New Drugs Hengrui Medicine's nanocrystal formulation has been launched. Subsequent enterprises may focus on the R&D of sustained-release formulations and compound preparations (combined with other antitumor drugs) to prolong drug half-life and optimize therapeutic efficacy.
Strength Supplement Multiple enterprises are conducting clinical studies on the 250mg low strength to adapt to patients with different body weights and reduce medication costs.
