The board of directors of the Alphamab Alphamab Oncology announced that a phase I/II clinical trial ("JSKN033-101") of JSKN033 independently developed by Group for the treatment of human epidermal growth factor receptor 2 ("HER2")-expressing advanced or metastatic solid tumors, has been approved by the Bellberry Human Research Ethics Committee in Australia. JSKN033-101 is an open-label, multicenter, phase I/II clinical trial which consists of two phases: (i) the phase I (the dose escalation phase) designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JKSN033 in patients with HER2-expressing advanced or metastatic solid tumors and to determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (the "RP2D"); and (ii) the phase II (the dose expansion phase) designed to evaluate the efficacy and safety of JSKN033 in HER2-expressing gastrointestinal tumors at the RP2D. JSKN033 is a global first subcutaneous formulation with JSKN003, the HER2 bispecific antibody- conjugated drug and Envafolimab, the programmed death ligand 1 (" PD-L1 ") monoclonal antibody, developed by Group.

JSKN003 is a biparatopic HER2-targeting antibody-drug conjugate, of which a topoisomerase I inhibitor is linked to the N glycosylation site of the antibody KN026 (a recombinant humanized anti-HER2 bispecific antibody) via the glycosite-specific conjugation. Envafolimab is a Fc fusion protein consisting of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment, which has been approved by the National Medical Products Administration of China as the global-first subcutaneous injection PD-L1 inhibitor in November 2021.