Alphamab-B (09966) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Investigational New Drug (IND) application for JSKN021, a dual-payload antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), independently developed by the company, to proceed with a Phase I clinical study (Study Number: JSKN021-101), marking the official launch of overseas clinical development for JSKN021.
JSKN021-101 is an open-label, multicenter Phase I clinical study designed to enroll patients with locally advanced or metastatic solid tumors who have relapsed or are refractory after standard treatment, or for whom no approved therapies exist, in order to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor activity of JSKN021.
The study was previously approved in China, with the first patient dosed in June 2026. Currently, the clinical study in China is progressing in an orderly manner, and preliminary efficacy has been observed during the dose escalation process. The approval of the U.S. IND represents another key milestone in the company's internationalization of its innovative product pipeline.
JSKN021 is a "2-in-1" bispecific dual-payload ADC targeting EGFR/HER3, featuring a differentiated product design and unique technological advantages. The drug employs site-specific glycan conjugation technology to conjugate two different cytotoxic payloads site-specifically and quantitatively onto the glycan chains of the antibody Fc region. The process is simple, stable, and efficient, yielding antibody-drug conjugates with high stability and low hydrophobicity. Preclinical studies have shown that JSKN021 has significantly superior tumor suppression effects compared to single-payload ADCs and demonstrates good tolerability.
The U.S. IND approval is an important component of JSKN021's global development strategy. In recent years, the company has continued to deepen its globalization strategy, with multiple core products successively obtaining overseas regulatory designations and clinical breakthroughs. Going forward, the company will steadily advance the clinical development of JSKN021 in both China and the United States, while continuously enriching its innovative pipeline through its proprietary technology platforms, bringing more treatment hope to cancer patients worldwide.