ALPHAMAB-B(09966): JSKN021's IND application officially accepted by CDE.

ALPHAMAB-B (09966) announced that the company's self-developed bispecific double-loaded antibody-drug conjugate (ADC(s)) JSKN021 targeting epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor 3 (HER3) has had its new drug clinical trial (IND) application officially accepted by the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE). The company plans to conduct Phase I clinical studies of JSKN021 for the treatment of advanced malignant solid tumors, with the aim of evaluating its safety, tolerability, pharmacokinetics, anti-tumor activity in this patient population, and determining the maximum tolerated dose and/or recommended Phase II dose. Clinical preclinical data presented at the 2025 American Association for Cancer Research annual meeting showed that JSKN021 effectively inhibits the growth of ER3-positive, EGFR-positive, or double-positive tumor cells. In addition, in various CDX models, JSKN021 demonstrated significantly better tumor suppression effects compared to single-loaded ADC drugs.