Hansoh Pharmaceutical (03692.HK): HS-20093 Meets Primary Endpoint in Phase III Osteosarcoma Trial, to Advance NDA Filing

NewTimeSpace News: Hansoh Pharmaceutical Group Company Limited (stock code: 3692) announced that its self-developed B7-H3-targeted antibody-drug conjugate (ADC) HS-20093 has met the primary endpoint in the pivotal Phase III clinical trial (ARTEMIS-011) in patients with osteosarcoma who have progressed or relapsed after receiving at least two prior lines of systemic therapy.

According to the announcement, compared with chemotherapy, HS-20093 demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as assessed by the Independent Review Committee (IRC). Consistent benefits were also observed in secondary clinical endpoints including overall survival (OS) and investigator-assessed PFS. The safety profile was consistent with previous study results, and no new safety signals were identified.

Based on these positive results, the group will initiate communication with relevant regulatory authorities in the near term to advance the preparation for a new drug application in China. Detailed data from the ARTEMIS-011 study are expected to be presented at an international oncology academic conference in the future.

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