Zhitong Finance App News, Corning Jerry Pharmaceutical-B (09966) announced that the US Food and Drug Administration (FDA) has approved JSKN021 (a bispecific antibody double load coupling drug (ADC (s)) independently developed by the company and targeting epidermal growth factor receptor (EGFR) /human epidermal growth factor receptor 3 (HER3)) to conduct Phase I clinical research (study number: JSKN021-101), marking the official launch of JSKN021's overseas clinical development application.
JSKN021-101 is an open, multicenter phase I clinical study to include patients with locally advanced or metastatic solid tumors that have recurred or are difficult to treat after standard treatment, or have no approved treatments, to evaluate the safety, tolerability, pharmacokinetic characteristics and initial antitumor activity of JSKN021. The study was previously approved in China, and the first patient administration was completed in June 2026. Currently, clinical research in China is progressing in an orderly manner, and initial curative effects have been observed during the climbing process. The US IND was approved this time, marking another key milestone in the process of internationalizing the company's innovative product pipeline.
JSKN021 is a “2-in-1” dual-antibody dual-load ADC drug targeting EGFR/HER3. It has differentiated product design and unique technical advantages. The drug uses glycos-based fixed-point coupling technology to fixed-point and quantitatively couple two different cytotoxic loads to the sugar chain of the antibody Fc. The process is simple, stable, and efficient, and the obtained antibody conjugation product has high stability and low hydrophobicity. Preclinical studies have shown that the tumor suppression effect of JSKN021 is significantly superior to that of single-load ADCs and is well tolerated. The approval of the US IND is an important part of JSKN021's global development strategy.
In recent years, the company has continued to deepen its global strategy, and various core products have successively obtained overseas regulatory certification and clinical breakthroughs. In the future, the company will steadily advance the clinical development of JSKN021 in China and the US, while relying on an independent technology platform to continuously enrich the innovation pipeline, bringing more hope for treatment to cancer patients around the world.