On June 30, 2022, the National Medical Products Administration (NMPA) approved the market launch of Revelumide Tablets (brand name: Airuien), a Class 1 new drug independently developed by Hengrui Medicine.
Revelumide is the first novel androgen receptor (AR) inhibitor independently developed in China. It was granted conditional approval for the indication of high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC).
The marketing application was included in the priority review and approval procedure by the NMPA as a breakthrough therapy in October 2021. This formal approval will provide a new treatment option for Chinese patients with prostate cancer.
About Revelumide
Revelumide is a novel AR inhibitor with independent intellectual property rights developed by Hengrui Medicine. It was supported by the National Major Science and Technology Project for the Creation and Development of Major New Drugs under the 13th Five-Year Plan in 2018.
As a novel AR inhibitor, revelumide features major innovations in its molecular structure. It achieves high AR inhibitory activity, while its blood-brain barrier permeability is significantly reduced compared with similar marketed products, thus lowering central nervous system toxicity. It also presents more optimized pharmacokinetic properties.
Basis for the Approval of Revelumide
The approval of revelumide is mainly based on CHART, a multicenter, randomized, controlled Phase III clinical trial.
This study aimed to evaluate the efficacy and safety of revelumide plus androgen deprivation therapy (ADT) versus standard therapy plus ADT in patients with high tumor burden mHSPC. A total of 654 patients were enrolled, of whom 90.4% were Chinese patients, making the trial more consistent with the clinical practice of Chinese patients.
The study results were presented as an oral report at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022, demonstrating the important progress of China’s innovative urologic oncology drugs on the international stage.
Based on these results, revelumide has been included as a Grade I recommendation (Level 1A evidence) in the Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Prostate Cancer (2022 Edition), and is expected to provide a new therapeutic option for Chinese patients with prostate cancer.
