JUNSHI BIO (01877): Injection JS212 obtained the drug clinical trial application acceptance notification.

JUNSHI BIO (01877) announced that the company has received the "Acceptance Letter" issued by the National Medical Products Administration for the clinical trial application of injection JS212 (project code "JS212"). Due to the long research and development cycle of drugs and the multiple approval processes involved, there is uncertainty as to whether the clinical trial application will be approved. Investors are advised to make cautious decisions and be aware of investment risks. JS212 is a recombinant humanized bispecific antibody-drug conjugate (ADC) targeting the 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, breast cancer, head and neck tumors, etc. The interaction between EGFR and HER3 plays a role in promoting tumor cell proliferation, survival, migration, and angiogenesis, with high HER3 expression being an important mechanism for EGFR drug resistance in tumor tissues. Compared to single-target ADC drugs, JS212 can exert tumor inhibitory effects by binding to either EGFR or HER3, potentially being effective against a wider range of tumors and overcoming drug resistance issues. Preclinical studies have shown that JS212 has high affinity and specific binding to EGFR and HER3, demonstrating significant tumor inhibitory effects in multiple animal models. Additionally, JS212 has shown good and acceptable safety profile.