ALPHAMAB-B's IND Filing for JSKN021 Accepted by Regulatory Center

Stock News03-13

ALPHAMAB-B (09966) announced that the Investigational New Drug (IND) application for JSKN021, its self-developed bispecific antibody-drug conjugate (ADC) targeting EGFR/HER3, has been formally accepted by the Center for Drug Evaluation (CDE). The company plans to initiate a Phase I clinical study of JSKN021 for the treatment of advanced malignant solid tumors. The study aims to evaluate the drug's safety, tolerability, pharmacokinetics, and anti-tumor activity in this patient population, and to determine the maximum tolerated dose and/or the recommended Phase II dose. Preclinical data presented at the 2025 American Association for Cancer Research annual meeting showed that JSKN021 effectively inhibits the growth of HER3-positive, EGFR-positive, or dual-positive tumor cells. Furthermore, in multiple CDX models, the tumor suppression effect of JSKN021 was significantly superior to that of single-payload ADC drugs.

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