JUNSHI BIO (01877): The clinical trial application for JS212 for the treatment of advanced solid tumors has been approved by the FDA.

JUNSHI BIO (01877) announces that the company has received notice from the U.S. Food and Drug Administration (FDA) that the clinical trial application for EGFR/HER3 bispecific antibody-drug conjugate (codenamed: JS212) for the treatment of advanced solid tumors has been approved by the FDA. JS212 is a recombinant humanized antibody-drug conjugate (ADC) targeting both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 3 (HER3), primarily used for the treatment of advanced malignant solid tumors. EGFR and HER3 are highly expressed on the surface of various tumor cells, such as lung cancer, colorectal cancer, head and neck tumors, etc. There is a signaling pathway interaction between EGFR and HER3, jointly involved in promoting tumor cell proliferation, survival, migration, and angiogenesis processes. In addition, HER3 is involved in the resistance mechanisms of various anti-cancer drugs (including EGFR-targeted drugs and chemotherapy). Compared to single-target ADC drugs, JS212 can exert tumor-inhibiting effects by binding to either EGFR or HER3, potentially being effective against a wider range of tumors and overcoming resistance issues. Preclinical studies have shown that JS212 has high affinity and specificity for EGFR and HER3, demonstrating significant anti-tumor effects in multiple animal models. Additionally, JS212 has shown good and acceptable safety profile. In January 2025, the clinical trial application for JS212 was accepted by the National Medical Products Administration (NMPA), and it was approved by the NMPA in March 2025. As of the date of this announcement, a Phase I/II clinical trial of JS212 is underway in mainland China, evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of JS212 in patients with advanced solid tumors. Furthermore, a clinical trial application for a multi-cohort combination therapy with JS212 was approved by the NMPA in November 2025, with plans to initiate related clinical studies in the near future.