China’s Hengrui Medicine Co., Ltd. (SHA: 600276) announced that its Category 1 drug SHR3680 has received conditional approval from the National Medical Products Administration (NMPA) via priority review procedures. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden.
Mechanism and Advantages
SHR3680 is a second-generation androgen receptor (AR) inhibitor designed to overcome the limitations of first-generation AR inhibitors. It demonstrates stronger AR inhibitory effects without agonistic activity, representing a significant advancement in the treatment of mHSPC.
Market Context
The global market for AR inhibitors includes several nonsteroidal options such as bicalutamide, enzalutamide, apalutamide, and darolutamide. In 2021, second-generation AR inhibitors enzalutamide, apalutamide, and darolutamide collectively generated USD 6.297 billion in global sales, highlighting the substantial market potential for SHR3680.-Fineline Info & Tech
