ALPHAMAB-B(09966): The IND application for a Phase I/II clinical trial of JSKN033 has been approved by the CDE.

ALPHAMAB-B (09966) announced that a Phase I/II clinical trial (study number: JSKN033-102) for JSKN033 (a HER2 bispecific antibody-drug conjugate (ADC) combined with a PD-L1 immune checkpoint inhibitor high-concentration subcutaneous injection compound) has received approval from the China National Medical Products Administration Drug Evaluation Center (CDE) for a new drug clinical trial application (IND). JSKN033-102 is an open-label, multicenter, Phase I/II clinical trial designed to assess the safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity of JSKN033 in patients with advanced metastatic malignancies, and to determine the maximum tolerated dose and/or recommended Phase II dose. The initial human Phase I/II clinical study conducted in Australia (JSKN033-101) showed good safety profile of JSKN033 and encouraging anti-tumor activity in patients with disease progression after multiple lines of therapy. Detailed clinical study data were presented at the 2024 Cancer Immunotherapy Symposium and can be referenced in the company's voluntary announcement on November 10, 2024.