On December 24, Gelonghui announced that ALPHAMAB-B (09966.HK) has received a new drug clinical trial application (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for a Phase I/II clinical trial of JSKN033 (a high-concentration subcutaneous combination formulation of HER2 bispecific antibody conjugates ("ADC") and PD-L1 immune checkpoint inhibitors).
JSKN033-102 is an open, multicenter Phase I/II clinical trial aimed at evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of JSKN033 in patients with advanced metastatic malignant tumors, as well as determining the maximum tolerated dose and/or recommended Phase II dose.
The first-in-human Phase I/II clinical study (JSKN033-101) conducted in Australia indicated that JSKN033 has good safety and encouraging antitumor activity in patients with disease progression after multiple lines of treatment. Detailed clinical study data will be presented at the 2024 Congress of Cancer Immunotherapy, and can also be referenced in the company's voluntary announcement on November 10, 2024.
