Alphamab Oncology announces IND application for TROP2/HER3 bispecific ADC JSKN016SC officially accepted by CDE

CAR-T Digest - August 2020

30 April 2026: Alphamab Oncology announces IND application for TROP2/HER3 bispecific ADC JSKN016SC officially accepted by CDE

Alphamab Oncology announced that the IND application for its TROP2/HER3 bispecific antibody–drug conjugate JSKN016SC (subcutaneous formulation) has been officially accepted by the Center for Drug Evaluation of China’s NMPA, with review proceeding under the 30-day fast-track channel for innovative therapies
JSKN016SC represents a key pipeline asset and is the first subcutaneous formulation of a bispecific ADC targeting TROP2 and HER3, designed to improve treatment convenience by reducing administration time from hours to seconds while potentially enhancing patient compliance and optimizing healthcare resource use
The candidate builds on encouraging clinical data from JSKN016, which has demonstrated strong efficacy and a favorable safety profile across multiple solid tumors in early-phase studies, with additional results in HER2-negative metastatic breast cancer expected to be presented at the ASCO Annual Meeting
The IND supports initiation of the Phase 1b JSKN016SC-102 trial, an open-label, multicenter study designed to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity, while determining the maximum tolerated dose and recommended Phase 2 dose
With ongoing Phase 3 development of JSKN016 in triple-negative breast cancer and prior validation of subcutaneous ADC delivery approaches, Alphamab is advancing a differentiated strategy aimed at improving both efficacy and patient experience in ADC-based cancer therapy