Phase 2 ARTEMIS-003 Trial: HS-20093 for mCRPC

HS-20093  has received Breakthrough Therapy designation from China’s National Medical Products Administration for metastatic castration-resistant prostate cancer. The designation covers patients previously treated with novel endocrine therapy and taxane-based chemotherapy, a setting where later-line treatment options remain limited.

HS-20093 is a B7-H3-targeted antibody-drug conjugate designed to bind tumor cells expressing B7-H3 and deliver a cytotoxic payload more selectively. The drug is being developed across multiple solid tumors, and the new designation adds regulatory momentum to its prostate cancer program.

Earlier in 2026, Phase 2 data for risvutatug rezetecan (ARTEMIS-003 trial), also known as HS-20093 or GSK5764227(we have talked about it here), were presented in patients with metastatic castration-resistant prostate cancer at ASCO GU 2026. Those results were described as showing encouraging antitumor activity with a generally manageable safety profile. The publicly reported ARTEMIS-003 results said that in taxane-pretreated patients, the confirmed objective response rate was 38.9% and the PSA50 response rate was 40.7%. In taxane-naive patients, the confirmed objective response rate was 50.0% and the PSA50 response rate was 64.0%.

Breakthrough Therapy designation is significant because it can help accelerate the development and review of promising treatments for serious diseases. For HS-20093, the decision strengthens its profile as a potentially important oncology asset in China’s competitive market for innovative cancer therapies.

Clinical trial.